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The Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) was developed to identify prescription opioid misuse and abuse among patients with chronic pain. A clinical scoring algorithm was developed and refined to align with the patient experience. This study utilized data from the POMAQ validation study (3033-4, NCT02660606) conducted on a sample of patients with chronic pain living in the United States. The study was carried out in two phases. Two purposefully enriched patient samples, one for each phase, were created based on patient responses to select POMAQ items and the availability of urine and hair samples. Two clinical experts (SHS, SFB) reviewed patient data to classify prescription opioid use behavior. Classification differences were adjudicated by a third clinical expert (JTF). Comparisons were made between the final clinical classification determined by the experts and the proposed classification based on the POMAQ algorithm. Sixty patients were included in Phase I (only POMAQ data) and 52 in Phase II (including POMAQ and ancillary sources [e.g. electronic medical records, urine toxicity screen]). Refinements were made to the POMAQ scoring algorithm following discussions with clinical experts to ensure it was clinically relevant. For both phases, classifications were reviewed and discussed to achieve maximal concordance of classifications across experts. The proposed scoring algorithm was then modified to maximize agreement with the expert interpretation of clinically relevant patient experiences. The clinical scoring algorithm for the POMAQ was developed and refined to reflect clinically relevant patient behaviors identified by expert review. Future testing is needed to determine the sensitivity and specificity of this measure.

To identify patient risk factors associated with prescription opioid misuse and abuse as well as groupings of misuse and abuse behaviors as measured by the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). Adults with chronic pain requiring long-term treatment with opioids completed the POMAQ and other study questionnaires. Latent class analysis (LCA) was used to examine underlying subgroups exhibiting particular risk profiles. Patient demographic and clinical characteristics were examined as covariates and the concordance between the identified latent classes at-risk classifications and the POMAQ clinical scoring algorithm was assessed. Analysis of data from 809 patients revealed four classes: “chronic pain, low risk” (n = 473, low to no prevalence of POMAQ behaviors), “chronic pain, comorbid condition” (n = 152, high prevalence of anti-anxiety, sleeping pill, and antihistamine use), “at risk” (n = 154, taking more opioids than prescribed and drinking alcohol with opioids more frequently than other groups), and “high risk” (n = 30, highest prevalence of each behavior). The “high risk” group was associated with being younger, less educated, and unemployed compared to other groups. When examining the LCA classes by groups defined by the original POMAQ clinical scoring algorithm, the “high risk” class had the highest proportion of participants identified with abuse behaviors (46.7%), compared to just 4.7% in the “chronic pain, low risk” group. Findings suggest there are four distinct subgroups of patients defined by chronic opioid misuse and abuse behaviors and support the use of the POMAQ to identify risk factors associated with prescription opioid misuse and abuse.

A chronic pain patient sample living in the United States who participated in a cross-sectional study to evaluate the validity and reproducibility of the Prescription Opioid Misuse and Abuse Questionnaire is characterized.Patients with chronic pain identified through electronic medical records as refilling at least one opioid prescription within the prior 3 months were recruited from five United States Department of Defense Military Health System clinics. Patients completed the Prescription Opioid Misuse and Abuse Questionnaire, Brief Pain Inventory-Short Form, Medical Outcomes Study: 36-item Short Form, and sociodemographic questions online. Clinical characteristics and electronic medical records for 1 year prior to consent were collected.809 (86.2%) participants completed the Prescription Opioid Misuse and Abuse Questionnaire. Mean (± standard deviation) age was 55.4 ± 12.7 years; the majority female (55.5%) and white (74.8%). Mean duration of chronic pain was 14.7 ± 10.5 years; the most common pain conditions were lower back pain (76.6%), neck or shoulder pain (60.3%), and osteoarthritis (38.7%). The most commonly prescribed opioids were oxycodone (35.7%), tramadol (34.5%), and hydrocodone (26.9%); 54.8% took one opioid, 44.9% took 2 or more opioids.Participants' health status was poor; pain severity and interference were moderate. Electronic medical record data revealed high healthcare resource utilization. This chronic pain population was severely impacted by their pain condition(s).

The Prescription Opioid Misuse and Abuse Questionnaire was developed to identify prescription opioid abuse and misuse among patients with chronic pain, however evidence of construct validity and reproducibility is needed. Chronic pain patients were recruited from five Department of Defense Military Health System clinics across the United States. Construct validity was examined using subjective clinician-reported and patient-reported measures as well as objective information (e.g., hair/urine drug screens and electronic medical records). Test-retest reliability was assessed across 2-time points among a subgroup of patients with stable chronic pain. Of 3,263 screened patients, 938 (28.7%) met eligibility and were enrolled; 809 (86.2%) completed the Prescription Opioid Misuse and Abuse Questionnaire. Construct validity was supported by comparison to other validated questionnaires and hair and urine screens which yielded high agreements with patient reports on the Prescription Opioid Misuse and Abuse Questionnaire. Electronic medical record data supported patients’ Prescription Opioid Misuse and Abuse Questionnaire responses regarding physician and emergency room visits and opioid refills. The Prescription Opioid Misuse and Abuse Questionnaire had excellent test-retest reliability; the percentage agreement between the two Prescription Opioid Misuse and Abuse Questionnaire administrations was high (>90%) for most questions. Results suggest that the Prescription Opioid Misuse and Abuse Questionnaire is a valid and reproducible tool that can be used to assess the presence of prescription opioid misuse and abuse among patients with chronic pain.

Content validation is essential in the development of patient-reported instruments to ensure relevancy and understandability. The aim was to evaluate patient understanding of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) using cognitive interviewing among adults with chronic moderate to severe pain.This qualitative study involved a one-time in-clinic visit to conduct one-on-one cognitive interviews among participants with chronic moderate to severe pain from four groups: (1) Known Opioid Abuse; (2) Known Abuse of Other Substances (e.g. alcohol, benzodiazepines); (3) Opioid Non-abuse; and (4) No Chronic Opioid Use. Patients were recruited from 6 US clinical centers. Concept elicitation questions regarding misuse and abuse were asked at interview start; the POMAQ was completed56 patients were enrolled. Mean age was 48.7 ± 12.3 years; 57% female; 80% Caucasian; mean duration of chronic pain was 11.2 ± 8.2 years with lower back pain predominating at 75%. Overall, the POMAQ was well-understood and received positive feedback. A few (The POMAQ demonstrated content validity among patients with moderate to severe chronic pain and is undergoing psychometric evaluation among a larger cohort of patients.

Introduction Drug safety studies regarding comparative risk of different opioid compounds are important as providers and regulatory agencies in the United States continue to balance pain management with an ongoing opioid epidemic. Objective The aim of this study was to evaluate nonmedical use (NMU) and diversion of tramadol and comparator opioids using real-world data from the Addiction Severity Index—Multimedia Version (ASI-MV®). Methods A cross-sectional study design was used to evaluate past 30-day tramadol and comparator opioid NMU among adults assessed for substance abuse treatment using the ASI-MV from 2010 to 2018. Population and drug utilization-adjusted rates were studied, as well as patient characteristics, route of administration, and diversion. Results Past 30-day NMU of one or more prescription opioid was reported in 125,048 (22.6%) of ASI-MV assessments (2010–2018); 46.5% reported oxycodone, 43.2% hydrocodone, 8.1% morphine, and 7.2% tramadol. Male respondents ranged from 43.2% in the tramadol group to 51.8% in the oxycodone group. Majority (~ 76%) were Caucasian in all groups, with 86.9% Caucasian in the morphine group. Prevalence of past 30-day tramadol NMU was significantly lower than that of morphine, oxycodone, and hydrocodone for both population and utilization-adjusted rates. Rate of snorting of tramadol was 4–7 times lower than comparator opioids and injection was 14–34 times lower than morphine and oxycodone. Tramadol was most likely to be obtained via the patient’s own prescription while the comparator opioids were more often obtained via dealers or family/friends. Conclusion Tramadol had a significantly lower rate of NMU than comparator opioids and was less likely to be diverted or used via higher-risk non-oral routes. These findings support previous evaluations by WHO and the United States Drug Enforcement Agency that concluded that tramadol has a low potential for abuse.

Chronic widespread pain (CWP) is common and associated with loss of functioning and health. Subjects with chronic nonwidespread pain (CnWP) are at increased risk of developing CWP, but few studies have described the nature of the development over time. We followed a random sample of 3105 participants from the population-based HUNT 3 study with 5 annual measurements of pain over 4 years. Although 29% reported CWP on at least 1 occasion, only 7% reported it consistently on 4 or 5 occasions. The average annual cumulative incidence was 5%, and the recovery rate was 38%. In mutual adjusted analysis, the risk of developing CWP from 1 year to the next was higher in subjects with chronic pain (relative risk [RR] = 2.4; 95% confidence interval [CI]: 1.8-3.4), 2 or more pain regions (RR = 3.3; 95% CI: 2.5-4.4), moderate pain or more (RR = 1.8; 95% CI: 1.5-2.6), and with comorbid chronic disease (RR = 1.6; 95% CI: 1.3-1.9). Developing CWP was associated with a modest concurrent change in self-reported mental and physical health. The risk of developing CWP between the fourth and fifth occasions was 80% lower for subjects without a history of CWP, compared to those with a history of CWP. For subjects without previous CWP, the development was associated with previously reported CnWP, but not with the number of occasions with CnWP, in analyses adjusted for sex, age, and pain severity. A substantial proportion of the new cases of CWP originates from subjects floating below and above the definition for CWP over time and, thus, does not seem to involve major transitions in health.

Jody L Green, Rebekkah S Robbins, Taryn Dailey-Govoni, Stephen F Butler Inflexxion, A Division of Integrated Behavioral Health, Irvine, CA, USACorrespondence: Jody L GreenInflexxion, A Division of Integrated Behavioral Health, 2 Park Plaza, Suite 1200, Irvine, CA, 82614, USATel +1 303 618 9044Email jgreen@inflexxion.comPurpose: The purpose of this study was to evaluate real-world data related to past 30-day nonmedical use (NMU) and routes of administration of Xtampza® ER and comparator oxycodone medications in the US as captured within the Addiction Severity Index-Multimedia Version® (ASI-MV®).Methods: Data were collected from July 2016 through December 2019 from 647 centers located in 44 states using the ASI-MV, a clinical instrument used to evaluate substance use and treatment planning. Demographic characteristics were assessed using Pearson’s chi-square test for categorical data and quarterly NMU rates were calculated. Distribution of route of administration was studied using a proportional reporting ratio (PRR) analysis.Results: Of 192,810 assessments, 42,279 (21.9%) indicated past 30-day NMU of at least one prescription opioid, including Xtampza ER (N=73, 0.2%), other oxycodone ER (n=3802, 9.0%) and oxycodone IR (n=14,579, 34.5%). All quarterly Xtampza ER NMU rates per 100 ASI-MV assessments were significantly lower than those for other oxycodone ER and oxycodone IR. Overall, quarterly Xtampza ER NMU drug utilization adjusted rates were significantly lower than quarterly rates observed for other oxycodone ER NMU but not consistently significantly lower than oxycodone IR NMU. Although not all statistically significant, all ratios from the PRR analysis were less than 1.0, indicating that rates of use of any alternate route, any non-oral route, snorting, and injecting were higher for other oxycodone ER and oxycodone IR than for Xtampza ER.Conclusion: Xtampza ER had significantly lower rates of NMU than other oxycodone ER products and oxycodone IR products, as well as significantly lower rates of non-oral NMU than oxycodone IR products, in a population of individuals seeking substance abuse treatment. Understanding risks associated with different opioid medications is important for prescribers as they manage risks of opioid misuse and abuse with effective pain therapy.Keywords: pain management, analgesic, opioid, drug abuse, substance abuse treatment, real-world data

Introduction: Non-medical use (NMU) of prescription stimulant medications is a continuing public health concern. Stimulant medications prescribed for attention-deficit/hyperactivity disorder (ADHD) are widely available on college campuses, and, as a consequence, college students may have multiple opportunities to engage in prescription stimulant NMU. This online self-report survey examined prescription stimulant NMU among college students, including: (1) patterns of non-oral route of administration (ROA); (2) motivations for non-oral ROAs; and (3) retrospectively recalled pathways of initiation.Method: The survey sample was created from a pool of 3,379 respondents, who were matched to a sampling frame constructed from the 18–26-year-old, college student sample of the 2016 American Community Survey (ACS). About 14% (n = 486) from the overall pool were identified as college students with self-reported prescription stimulant NMU, all of whom completed the survey. The survey covered user characteristics, prescription and illicit substance use, age of first NMU, motivations for NMU, sources of procurement, and ROAs used.Results: Among 486 students reporting prescription stimulant NMU, 43% had a lifetime diagnosis of ADHD. More than 90% reported polysubstance use, with 55% using illicit substances other than marijuana. Slightly more than 2 in 5 (43.3%) reported using illicit substances prior to prescription stimulant NMU, 24.6% used both at the same age, and 32.0% engaged in NMU of prescription stimulants prior to using illicit substances. Prescription stimulant NMU preceded prescription opioid NMU 45% of the time. More than a quarter of those engaged in prescription stimulant NMU (27.9%) initiated prescription stimulants alone or at the same age as other drugs. Most prescription stimulant NMU was oral, however 23.0% reported any non-oral use: snorting (20.4%), smoking (6.0%)and/or injection (3.5%). Non-oral use was associated with being male, obtaining medication from a dealer, use to get high, and/or a substance use disorder diagnosis.Conclusions: Prescription stimulant NMU often occurs in the larger context of other substance use among college students. Injection, an under-researched route for prescription stimulants, was associated with male gender, history of substance use and higher likelihood of illicit substance use. Nearly a quarter of college student survey respondents reported use with non-oral routes, which is associated with other high-risk behaviors. Efforts to reduce non-oral prescription stimulant NMU in college students are warranted.

Objective: The purpose of the present study was to characterize prescription stimulant non-medical use (NMU) in adolescents between the ages of 13 and 18 years seeking treatment for substance use disorder (SUD) with the Comprehensive Health Assessment Tool for Teens (CHAT™). Method: Adolescents being evaluated for SUD treatment between Q1 2010 and Q3 2017 ( n = 20,189) completed the CHAT™. Results: About 4.3% of the sample ( N = 867) of adolescents in SUD treatment reported past 30-day prescription stimulant NMU. Compared to those without past 30-day prescription stimulant NMU, more reported a lifetime diagnosis of learning disorder or ADHD, more took medication for emotional, behavioral, or learning disorders, received past-month inpatient treatment, or were currently not enrolled in school. Prescription stimulants were most often taken orally for NMU, however, approximately half reported using alternate routes of administration, the most prominent of which was intranasal use. Conclusion: About 4.3% of adolescents in SUD treatment evaluation reported past 30-day prescription stimulant NMU. Greater percentages of lifetime learning disorder, medication use, past-month inpatient treatment, school unenrollment, and overall substance misuse were associated with prescription stimulant NMU, as were alternate routes of administration. These data reveal an ongoing, persistent level of past-30-day NMU of prescription stimulants among adolescents being evaluated for SUD treatment.

The objectives were to examine the abuse prevalence and route-of-administration (ROA) profiles of sublingual buprenorphine/naloxone combination (BNX) film in comparison with the BNX tablet and to identify clinically-relevant subgroups of patients or geographic patterns.Between Q1 2015 through Q3 2015, data were collected from two major surveillance systems: (1) assessment of individuals in substance use disorder (SUD) treatment collected from the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO®) ASI-MV® system and (2) intentional abuse/misuse exposures in the RADARS® System Poison Center Program. Poisson regression models were tailored to each system's data characteristics by population (all SUD treatment patients, US census) and adjusted for prescription volume. Effects of gender, race, age and US region as well as ROA profile were examined.For the ASI-MV study, 45,695 assessments of unique adults evaluated for substance use problems were collected. The abuse rate unadjusted for prescription volume of BNX tablet formulation was 2.64 cases/100 ASI-MV respondents versus 7.01 cases for the film formulation (RR=0.390, p0.001). Prescription-adjusted abuse, however, was greater for the tablet version (0.47 abuse cases/100 ASI-MV respondents/100,000 dosage units compared with 0.38 for the film) (RR=1.25, p0.001). Results among the US population from the RADARS System Poison Center Program data revealed a similar pattern; population rates for film abuse (0.0364) were greater than for tablet (0.0161), while prescription-adjusted rates were greater for tablet (0.2114) than for film (0.1703) per 100,000 prescriptions. ASI-MV ROA analyses indicated less abuse of the film by any alternate route, insufflation or injection than the tablet. Poison center data found more injection of tablets than film, although insufflation was not significantly different.On a prescription-adjusted basis, overall abuse of the BNX tablet is greater than that of the sublingual film formulation. For those who continue to abuse BNX, use by alternate ROAs was, in general, lower for the film.

Objective Some crush-resistant tablet formulations (CRTs) reduce prescription opioid abuse by nonoral routes of administration (ROAs), especially insufflation and injection, while oral abuse increases. Oral abuse involving product manipulation vs swallowing whole for CRTs and comparators was examined. Methods Abuse by oral modes of administration (e.g., swallowing whole, chewing, dissolving in the mouth), was examined using the ASI-MV, a computerized, clinical interview for adults in substance abuse treatment from January 2009 to March 2015. CRTs (reformulated oxycodone extended-release [ER], reformulated oxymorphone ER, and tapentadol ER) were compared with non-CRT versions, morphine ER, and oxycodone immediate-release single entity. Analyses employed descriptive statistics and logistic regression. Results Among 364,329 unique assessments, 18,135 patients reported oral abuse of the CRTs and comparators examined. CRTs had a higher prevalence of oral abuse involving product manipulation than comparators (P

The purpose of this study was to develop and validate a computer adaptive testing (CAT) version of the Addiction Severity Index-Multimedia Version (ASI-MV), the Addiction Severity CAT. This goal was accomplished in 4 steps. First, new candidate items for Addiction Severity CAT domains were evaluated after brainstorming sessions with experts in substance abuse treatment. Next, this new item bank was psychometrically evaluated on a large nonclinical (n = 4,419) and substance abuse treatment (n = 845) sample. Based on these results, final items were selected and calibrated for the creation of the Addiction Severity CAT algorithms. Once the algorithms were developed for the entire assessment, a fully functioning prototype of an Addiction Severity CAT was created. CAT simulations were conducted, and optimal termination criteria were selected for the Addiction Severity CAT algorithms. Finally, construct validity of the CAT algorithms was evaluated by examining convergent and discriminant validity and sensitivity to change. The Addiction Severity CAT was determined to be valid, sensitive to change, and reliable. Further, the Addiction Severity CAT's time of completion was found to be significantly less than the average time of completion for the ASI-MV composite scores. This study represents the initial validation of an Addiction Severity CAT based on item response theory, and further exploration of the Addiction Severity CAT is needed. (PsycINFO Database Record

BACKGROUND The prevalence of abuse, diversion, and web-based endorsement of tapentadol (extended-release [ER], immediate-release [IR]) has been characterized as low compared with other prescription opioids. Little is known about individual experience with tapentadol nonmedical use (NMU). OBJECTIVE This study aims to pilot web-based survey technologies to investigate the motivation for tapentadol NMU, sources of procurement, routes of administration, tampering methods, doses used, and impressions of tapentadol products (Nucynta and Nucynta ER). METHODS Recruitment flyers and banner advertisements were placed on the Bluelight website [DragonByte Technologies Ltd] with a link to a web-based survey (Qualtrics) designed to query about individuals’ lifetime tapentadol NMU. This web-based survey was followed by an interactive web-based chat (Cryptocat) with respondents who were willing to be contacted. Respondents were queried about sources for obtaining tapentadol, motives for use, routes of administration, tampering methods, drugs used in combination, tablet strengths and dosages, and reasons for continued or discontinued use. Desirability and attractiveness for NMU was rated. RESULTS Web-based recruitment successfully attracted difficult-to-find study participants. A total of 78 participants reported that tapentadol was obtained from friends and family (ER 11/30, 37%; IR 18/67, 27%), the internet (ER 11/30, 37%; IR 12/67, 18%) or participants’ own prescriptions from a doctor (ER 9/30, 30%; IR 17/67, 25%). It was used nonmedically for pain relief (ER 18/30, 60%; IR 33/67, 49%) and multiple psychotropic effects, including relaxation (ER 13/30, 43%; IR 29/67, 43%), reduction in depression or anxiety (ER 7/30, 23%; IR 30/67, 45%), or getting high (ER 12/30, 40%; IR 33/67, 49%). Tapentadol was primarily swallowed (ER 22/30, 73%; IR 55/67, 82%), although snorting (ER 2/30, 7%; IR 8/67, 12%) and injection (ER 2/30, 7%; IR 5/67, 8%) were also reported. The preferred dose for NMU was 100 mg (both ER and IR). The participants reported tapentadol use with benzodiazepines (ER 12/21, 57%; IR 28/47, 60%). Most participants had discontinued tapentadol NMU at the time of survey completion (ER 22/30, 73%; IR 55/67, 82%). Reasons for discontinued ER NMU included side effects (10/22, 46%) and lack of effective treatment (10/22, 46%). Reasons for discontinued IR NMU included lack of access (26/55, 47%) and better NMU options (IR 21/55, 38%). Few individuals were willing to divulge identifying information about themselves for the interactive chat (8/78, 10%), demonstrating the strength of anonymous, web-based surveys. Interactive chat supported the survey findings. A subgroup of participants (4/78, 5%) reported hallucinogenic side effects with high doses. CONCLUSIONS Web-based surveys can successfully recruit individuals who report drug NMU and those who are difficult to find. Tapentadol NMU appears to occur primarily for pain relief and for its psychotropic effects. Although it was liked by some, tapentadol did not receive a robust pattern of endorsement for NMU.

Background The prevalence of abuse, diversion, and web-based endorsement of tapentadol (extended-release [ER], immediate-release [IR]) has been characterized as low compared with other prescription opioids. Little is known about individual experience with tapentadol nonmedical use (NMU). Objective This study aims to pilot web-based survey technologies to investigate the motivation for tapentadol NMU, sources of procurement, routes of administration, tampering methods, doses used, and impressions of tapentadol products (Nucynta and Nucynta ER). Methods Recruitment flyers and banner advertisements were placed on the Bluelight website [DragonByte Technologies Ltd] with a link to a web-based survey (Qualtrics) designed to query about individuals’ lifetime tapentadol NMU. This web-based survey was followed by an interactive web-based chat (Cryptocat) with respondents who were willing to be contacted. Respondents were queried about sources for obtaining tapentadol, motives for use, routes of administration, tampering methods, drugs used in combination, tablet strengths and dosages, and reasons for continued or discontinued use. Desirability and attractiveness for NMU was rated. Results Web-based recruitment successfully attracted difficult-to-find study participants. A total of 78 participants reported that tapentadol was obtained from friends and family (ER 11/30, 37%; IR 18/67, 27%), the internet (ER 11/30, 37%; IR 12/67, 18%) or participants’ own prescriptions from a doctor (ER 9/30, 30%; IR 17/67, 25%). It was used nonmedically for pain relief (ER 18/30, 60%; IR 33/67, 49%) and multiple psychotropic effects, including relaxation (ER 13/30, 43%; IR 29/67, 43%), reduction in depression or anxiety (ER 7/30, 23%; IR 30/67, 45%), or getting high (ER 12/30, 40%; IR 33/67, 49%). Tapentadol was primarily swallowed (ER 22/30, 73%; IR 55/67, 82%), although snorting (ER 2/30, 7%; IR 8/67, 12%) and injection (ER 2/30, 7%; IR 5/67, 8%) were also reported. The preferred dose for NMU was 100 mg (both ER and IR). The participants reported tapentadol use with benzodiazepines (ER 12/21, 57%; IR 28/47, 60%). Most participants had discontinued tapentadol NMU at the time of survey completion (ER 22/30, 73%; IR 55/67, 82%). Reasons for discontinued ER NMU included side effects (10/22, 46%) and lack of effective treatment (10/22, 46%). Reasons for discontinued IR NMU included lack of access (26/55, 47%) and better NMU options (IR 21/55, 38%). Few individuals were willing to divulge identifying information about themselves for the interactive chat (8/78, 10%), demonstrating the strength of anonymous, web-based surveys. Interactive chat supported the survey findings. A subgroup of participants (4/78, 5%) reported hallucinogenic side effects with high doses. Conclusions Web-based surveys can successfully recruit individuals who report drug NMU and those who are difficult to find. Tapentadol NMU appears to occur primarily for pain relief and for its psychotropic effects. Although it was liked by some, tapentadol did not receive a robust pattern of endorsement for NMU.

An extended-release opioid analgesic (OxyContin, OC) was reformulated with abuse-deterrent properties to deter abuse. This report examines changes in abuse through oral and nonoral routes, doctor-shopping, and fatalities in 10 studies 3.5 years after reformulation. Changes in OC abuse from 1 year before to 3 years after OC reformulation were calculated, adjusted for prescription changes. Abuse of OC decreased 48% in national poison center surveillance systems, decreased 32% in a national drug treatment system, and decreased 27% among individuals prescribed OC in claims databases. Doctor-shopping for OC decreased 50%. Overdose fatalities reported to the manufacturer decreased 65%. Abuse of other opioids without abuse-deterrent properties decreased 2 years later than OC and with less magnitude, suggesting OC decreases were not due to broader opioid interventions. Consistent with the formulation, decreases were larger for nonoral than oral abuse. Abuse-deterrent opioids may mitigate abuse and overdose risks among chronic pain patients.

Objective. A comprehensive electronic self-report assessment, called PainCAS® (Clinical Assessment System), was developed and implemented in three clinics. PainCAS captures demographic information, pain assessment, quality-of-life variables, and contains validated, electronic versions of screeners for risk of aberrant opioid-related behaviors (the SOAPP and COMM). This investigation sought to determine the impact of PainCAS on documentation of pain and opioid risk evaluations. Exploratory hypotheses examined changes in the content of the patient- provider interaction and any impact on outcome. Methods. In study 1, chart reviews were conducted between pain patients who completed the electronic program (N = 89) and controls who represented standard of care (N = 120). In study 2, two groups of chronic pain patients (treatment-as-usual Control condition = 75, PainCAS Experimental condition = 72) were interviewed after completing their index clinic visit and completed mailed questionnaires 3 months later. Results. Results revealed significantly more key, pain-relevant chart elements documented in charts of patients who completed the PainCAS than those using a traditional paper questionnaire (Study 1

The aim was to examine prevalence of past 30-day prescription stimulant nonmedical use (NMU) by adults assessed for substance use problems and to better understand patterns of route of administration (ROA) and drug problem severity. Data were collected from a computer administered assessment of substance use problems completed by adults (age ≥ 18) using the Addiction Severity Index-Multimedia Version (ASI-MV

This study evaluated the biopsychosocial characteristics of adults undergoing substance abuse evaluation with potential schizophrenia/psychotic disorder, or possible schizophrenia/psychosis-like symptoms, compared with those with no schizophrenia/psychosis-like symptoms. A cross-sectional, observational study examined 170,201 adults, aged 18 to 30, who completed the Addiction Severity Index-Multimedia Version (ASI-MV). Approximately 10% were classified as having possible schizophrenia/psychosis-like symptoms or potential schizophrenia/psychotic disorder. These patients were more likely to exhibit moderate to extreme severity on employment, medical, legal, substance use, social, and psychiatric status than nonsymptomatic patients. The potential schizophrenia or psychotic disorder cohort was also more likely to have ever experienced physical abuse (odds ratio [OR] = 4.30, 95% confidence interval [CI] = 4.12-4.48) and/or sexual abuse (OR = 4.32, 95% CI = 4.15-4.51) versus the no schizophrenia/psychosis-like symptoms cohort. Findings support a recommendation for routine screening for mental health issues, particularly schizophrenia/psychosis-like symptoms, for adults entering substance use disorder treatment settings. This may increase the likelihood of appropriate and earlier intervention.

Objectives This study aimed to: (a) determine the percentage of ED patients receiving prescriptions for opioid pain medications that meet the criteria for “high-risk for abuse potential” on the Screener and Opioid Assessment for Patients with Pain (SOAPP®-R), (b) determine the percentage of patients with high-risk behavior on the state prescription drug monitoring program (PDMP) database, (c) compare the SOAPP-R with data from the PDMP, and (d) determine psychometric properties of SOAPP-R for ED patients Methods Convenience sample of ED patients who were being considered for discharge with a prescription for an opioid pain medication. Subjects completed SOAPP-R on an electronic tablet and PDMP data was obtained. Scores on SOAPP-R ≥18 were defined as “at-risk”, and PDMP data showing both ≥4 opioid prescriptions and ≥4 providers in 12 months was considered the criterion standard for high-risk behavior. Results 82 patients (88.2%) provided consent. 32.9% (n = 27) were determined to be “at-risk” (score ≥18) by SOAPP-R. 15.9% (n = 13) subjects met PDMP criteria and 53.9% (n = 7) of those had SOAPP-R scores ≥18 (sensitivity 54%, specificity 71%, positive predictive value 26%, negative predictive value 89%). The association of an at-risk SOAPP-R score and PDMP high-risk criteria was an adjusted odds ratio of 1.39 (95% confidence interval 0.73–3.68). Conclusions In our population, about one-third of patients being considered for discharge with an opioid prescription scored “at-risk” on SOAPP-R and 15.9% met the PDMP high-risk criteria. The high negative predictive value of SOAPP-R indicates it may be a useful screening tool for the ED patient population.

Background: The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item self-report instrument that was developed to aid providers in predicting aberrant medication-related behaviors among chronic pain patients. Although the SOAPP-R has garnered widespread use, certain patients may be dissuaded from taking it because of its length. Administrative barriers associated with lengthy questionnaires further limit its utility.Objective: To investigate the extent to which two techniques for computer-based administration (curtailment and stochastic curtailment) reduce the average test length of the SOAPP-R without unduly affecting sensitivity and specificity.Design: Retrospective study.Setting: Pain management centers.Subjects: Four hundred and twenty-eight chronic non-cancer pain patients.Methods: Subjects had taken the full-length SOAPP-R and been classified by the Aberrant Drug Behavior Index (ADBI) as having engaged or not engaged in aberrant medication-related behavior. Curtailment and stochastic curtailment were applied to the data in post-hoc simulation. Sensitivity and specificity with respect to the ADBI, as well as average test length, were computed for the full-length test, curtailment, and stochastic curtailment.Results: The full-length SOAPP-R exhibited a sensitivity of 0.745 and a specificity of 0.671 for predicting the ADBI. Curtailment reduced the average test length by 26% while exhibiting the same sensitivity and specificity as the full-length test. Stochastic curtailment reduced the average test length by as much as 65% while always exhibiting sensitivity and specificity for the ADBI within 0.035 of those of the full-length test.Conclusions: Curtailment and stochastic curtailment have potential to improve the SOAPP-R's efficiency in computer-based administrations.

Objective: To examine abuse prevalence for OxyContin and comparator opioids over a 6-year period prior to and following market entry of reformulated OxyContin and assess consistency in abuse across treatment settings and geographic regions. Design: An observational study examining longitudinal changes using cross-sectional data from treatment centers for substance use disorder. Setting: A total of 874 facilities in 39 states in the United States within the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO ® ) surveillance system. Participants: Adults (72,060) assessed for drug problems using the Addiction Severity Index-Multimedia Version (ASI-MV ®) from January 2009 through December 2015 who abused prescription opioids. Main outcome measure(s): Percent change in past 30-day abuse. Results: OxyContin had significantly lower abuse 5 years after reformulation compared to levels for original OxyContin. Consistency of magnitude in OxyContin abuse reductions across geographic regions, ranging from 41 to 52 percent with differences in abuse reductions in treatment setting categories occurred. Changes in geographic region and treatment settings across study years did not bias the estimate of lower OxyContin abuse through confounding. Conclusion: In the postmarket setting, limitations and methodologic challenges in abuse measurement exist and it is difficult to isolate singular impacts of any one intervention given the complexity of prescription opioid abuse. Expectations for a reasonable threshold of abuse for any one ADF product or ADF opioids as a class are still uncertain and undefined. A significant decline in abuse prevalence of reformulated OxyContin was observed 5 years after its reformulation among this treatment sample of individuals assessed for substance use disorder that was lower historically for the original formulation of this product.

Objective Formulating prescription opioids to limit abuse remains a priority. OROS extended-release (ER) hydromorphone HCl (EXALGO) may have lower abuse potential than many other opioid products. Three postmarketing studies of the relative abuse liability of OROS hydromorphone ER were conducted. Methods Estimates of abuse, unadjusted, and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data. Comparators were selected for compound, market penetration, and route of administration (ROA) profile. ROA comparisons were made among the substance abuse treatment population. Internet discussion was examined to determine abusers' interest in and desire for the OROS formulation. Results Examination of abuse prevalence among adults within substance abuse treatment, intentional poison exposures, and Internet discussion levels generally support the hypothesis that OROS hydromorphone ER may have lower abuse potential than many other opioid products. OROS hydromorphone ER also seems to be abused less often by alternate ROAs (eg, snorting and injection). Lower levels of online discussion were observed along with relatively low endorsement for abuse. Discussion Abuse of OROS hydromorphone ER was observed in high-risk substance abuse and general population samples but at a very low relative prevalence compared to comparators. Evidence suggests it may be less often abused by alternate ROAs than some comparators. Online data did not find evidence of high levels of desire for OROS hydromorphone ER by recreational abusers. Continued monitoring of this product's abuse liability is warranted.

Objective Research on substance abusers in treatment suggests that tapentadol, a prescription analgesic, may have relatively low abuse potential. Messages posted by recreational drug abusers on online forums were examined for amount of discussion and endorsement for abuse of tapentadol and comparator drugs. Methods Internet messages posted between January 1, 2011 and September 30, 2012 on seven drug-abuse web forums were evaluated. Proportions of posts and unique authors discussing tapentadol were compared with eight comparator compounds. Postcontent was coded to compare endorsement for abuse of tapentadol with two comparators, one drug with high desirability for abuse and one with low desirability for abuse. Results A total of 1,940,121 messages posted during the study period were copied from selected web forums. The proportion of all posts discussing tapentadol (proportion = 0.0003) was significantly lower than any of the comparator compounds (range of odds ratios from 16.6 to 104.3; P

Introduction: Tablet computer-based screening may have the potential for detecting patients at risk for opioid abuse in the emergency department (ED). Study objectives were a) to determine if the revised Screener and Opioid Assessment for Patients with Pain (SOAPP®-R), a 24-question previously paper-based screening tool for opioid abuse potential, could be administered on a tablet computer to an ED patient population; b) to demonstrate that >90% of patients can complete the electronic screener without assistance in 35 years. One hundred percent of subjects completed the screener. Median time to completion was 148 (interquartile range 117.5-184.3) seconds, and 95% (n=78) completed in

Objective The Current Opioid Misuse Measure (COMM) is a commonly used self-report instrument to identify and monitor aberrant opioid-related behavior in chronic pain patients on opioid therapy. However, the length of the COMM may limit its clinical utility. Additionally, this paper-and-pencil screener requires hand scoring, which increases paperwork and staff burden. Therefore, the current study presents development of the "COMM-9," a brief electronically administered form of the COMM. Methods Patients (N = 517) with chronic noncancer pain on opioid therapy completed the COMM. Patients were classified as either being positive or negative for aberrant drug-related behavior based on self-report data from a structured interview, physician-report data, and urine toxicology screen (the Aberrant Drug Behavior Index [ADBI]). COMM items with the strongest classification accuracy were identified using the LASSO method as the selection criterion in conjunction with the leave-one-out cross-validation method as the stop criterion. A sub-set of patients (n=55) completed a second administration of the COMM one week later to evaluate test-retest reliability. Results Nine items were identified before the selection criterion stopped, and logistic regression was utilized to predict probabilities of positive ADBI from the 9 COMM items using all data and the cross-validation procedure. Receiver operating characteristic curves revealed high levels of classification accuracy that were essentially equivalent to the full COMM. Cut-points were identified to classify patients as having no/low risk, moderate risk, and high risk for aberrant opioid-related behavior. Test-retest reliability of the COMM-9 was comparable to the full 17-item COMM. Conclusions This study presents the successful development of a brief electronic screener to identify current aberrant opioid-related behavior in chronic pain patients on long-term opioid therapy.

The PainCAS is a web-based clinical tool for assessing and tracking pain and opioid risk in chronic pain patients. Despite evidence for its utility within the clinical setting, the PainCAS scales have never been subject to psychometric evaluation. The current study is the first to evaluate the psychometric properties of the PainCAS Interference with Daily Activities, Psychological/Emotional Distress, and Pain scales. Patients (N = 4797) from treatment centers and hospitals in 16 different states completed the PainCAS as part of routine clinical assessment. A subsample (n = 73) from two hospital-based treatment centers also completed comparator measures. Rasch Rating Scale Models were employed to evaluate the Interference with Daily Activities and Psychological/Emotional Distress scales, and empirical evaluation included assessment of dimensionality, discrimination, item fit, reliability, information, and person-to-item targeting. Additionally, convergent and discriminant validity were evaluated through classical test theory approaches. Convergent validity of the Pain scales was evaluated through correlations with corresponding comparator items. One Interference with Daily Activities item was removed due to poor functioning and discrimination. The retained items from the Interference with Daily Activities and Psychological/Emotional Distress scales conformed to unidimensional Rasch measurement models, yielding satisfactory item fit, reliability, precision, and coverage. Further, results provided support for the convergent and discriminant validity of these two scales. Convergent validity between the PainCAS Pain and BPI Pain items was also strong. Taken together, results provide strong psychometric support for these PainCAS Pain scales. Strengths and limitations of the current study are discussed.

Objective Although the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) has become a widely used screener for aberrant opioid-related behavior in adults, the length of the instrument may limit its utility. The purpose of the current study was to develop a short form of the SOAPP-R by retaining as few items as possible while maximizing predictive accuracy. Methods Participants (N = 555), recruited from pain clinics, completed the 24-item SOAPP-R and participated in a five-month follow-up visit to evaluate aberrant drug-related behaviors. Opioid aberrant-related behavior was determined through self-report, physician report, and urine toxicology screen. The optimal subset of SOAPP-R items to predict aberrant opioid-related behavior was identified empirically by employing the LASSO selection method and the leave-one-out cross-validation (LOOCV) method offered in the GLMSELECT procedure in SAS 9.4 in conjunction with content expertise. Results Eight items were identified before the selection method stopped. The receiver operating characteristic curve generated from the predicted probabilities from the model produced an area under the curve (AUC) value greater than the AUC value produced by the 24-item SOAPP-R total score and yielded a sensitivity of 0.74 and a specificity of 0.66. Conclusions These results provide strong preliminary support for the SOAPP-8 as a brief screening tool of aberrant opioid-related behavior in chronic pain patients.

Background Opioid use disorder (OUD) poses medical and societal concerns. Although most individuals with OUD in the United States are not in drug abuse treatment, buprenorphine is considered a safe and effective OUD treatment, which reduces illicit opioid use, mortality, and other drug-related harms. However, as buprenorphine prescriptions increase, so does evidence of misused, abused, or diverted buprenorphine. Users’ motivations for extratreatment use of buprenorphine (ie, misuse or abuse of one’s own prescription or use of diverted medication) may be different from the motivations involved in analgesic opioid products. Previous research is based on small sample sizes and use surveys, and none directly compare the motivations for using buprenorphine products (ie, tablet or film) with other opioid products having known abuse potential. Objective The aim of the study was to describe and compare the motivation-to-use buprenorphine products, including buprenorphine/naloxone (BNX) sublingual film and oxycodone extended-release (ER), as discussed in online forums. Methods Web-based posts from 2012 to 2016 were collected from online forums using the Web Informed Services internet monitoring archive. A random sample of posts was coded for motivation to use. These posts were coded into the following motivation categories: (1) use to avoid withdrawal, (2) pain relief, (3) tapering from other drugs, (4) opioid addiction treatment, (5) recreational use (ie, to get high), and (6) other use. Oxycodone ER, an opioid analgesic with known abuse potential, was selected as a comparator. Results Among all posts, 0.81% (30,576/3,788,922) discussed motivation to use one of the target products. The examination of query-selected posts revealed significantly greater discussion of buprenorphine products than oxycodone ER (P Conclusions An analysis of spontaneous, Web-based discussion among recreational substance users who post on online drug forums supports the contention that motivation-to-use patterns associated with buprenorphine products are different from those reported for oxycodone ER. Although the findings presented here are not expected to reflect the actual use of the target products, they may represent the interests and motivations of those posting on the online forums. Buprenorphine-related posts were more likely to discuss treatment for OUD, tapering, and withdrawal management than oxycodone ER. Although the findings are consistent with a purported link between the limited availability of medication-assisted therapies for substance use disorders and use of diverted buprenorphine products for self-treatment, recreational use was a motivation expressed in more than one-third of buprenorphine posts.

Abstract. The Screener and Opioid Assessment for Patients with Pain – Revised (SOAPP-R) is a 24-item self-report questionnaire that assesses risk of aberrant medication-related behavior among chronic pain patients. Recently, an 8-item version of the SOAPP-R that weights items differentially was proposed. However, no previous study had compared the 8-item form with other short versions of the SOAPP-R, including a static 12-item short form and computer-based versions customizing the test length to the individual respondent. Moreover, no prior research had investigated combining the 8-item short form with customized computer-based stopping rules to further enhance efficiency. The objectives of this study were to compare the 8-item version with previously recommended short forms of the SOAPP-R, and to develop and evaluate a new version of the SOAPP-R combining the 8-item version with computer-based stopping rules. Versions were compared via sensitivity, specificity, and mean test length using real-data simulation of three datasets. Although results varied across datasets, the 8-item SOAPP-R compared favorably to previously recommended forms. Combining the 8-item form with computer-based stopping rules reduced the mean test length without affecting sensitivity or specificity; thus, the combined approach is recommended. The methodology used to shorten questionnaires via computer-based testing can also be applied to other instruments.

Objectives A preliminary electronic pain assessment program known as Pain Assessment Interview Network, Clinical Advisory System (painCAS), was implemented in 2 pain centers over the course of 10 months to understand the tool's impact on opioid risk assessment documentation and clinical workflow. The program contains validated electronic versions of screeners for opioid misuse risk (SOAPP-R and Current Opioid Misuse Measure). Methods Charts of patients with an initial and 2 follow-up visits were randomly selected for review of presence of opioid risk assessments before and after implementation of the electronic assessment program. Clinical and administrative staff members were interviewed to gain their perceptions of the impact of the program. Results Significant increases were observed in the documentation of opioid risk assessments between the baseline patient chart reviews before implementation of the program (n = 66) and the postintervention patient chart reviews after the implementation of the program (n = 39), for both initial and follow-up clinic visits (P

Introduction. Given the increase in misuse and abuse of prescription opioids, clinicians clearly benefit from a standardized tool to screen patients being considered for chronic opioid therapy. The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a widely used opioid risk assessment tool in clinical practice. As one third of the US population experiences chronic noncancer pain at any given time, and the Hispanic population now accounts for about 16% of the nation's population, the availability of a Spanish-language SOAPP-R fills an important clinical need. Objective. To derive a linguistically validated Spanish-language version of the SOAPP®-R. Method. Each step of Spanish translation and linguistic validation of the SOAPP-R was based on the US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research translation process. Result. A linguistically validated Spanish-language version of the SOAPP-R. Conclusion. The Spanish SOAPP-R may be useful as a risk assessment tool, considered along with other clinical information, by clinicians who prescribe opioid therapy for patients whose preferred language is Spanish.

Oxycodone hydrochloride controlled-release, also known as extended-release oxycodone (ER oxycodone), was reformulated with physicochemical barriers to crushing and dissolving intended to reduce abuse through nonoral routes of administration (ROAs) that require tampering (eg, injecting and snorting). Manufacturer shipments of original ER oxycodone (OC) stopped on August 5, 2010, and reformulated ER oxycodone (ORF) shipments started August 9, 2010. A sentinel surveillance sample of 140,496 individuals assessed for substance abuse treatment at 357 U.S. centers between June 1, 2009, and March 31, 2012, was examined for prevalence and prescription-adjusted prevalence rates of past-30-day abuse via any route, as well as abuse through oral, nonoral, and specific ROAs for ER oxycodone and comparators (ER morphine and ER oxymorphone) before and after ORF introduction. Significant reductions occurred for 8 outcome measures of ORF versus OC historically. Abuse of ORF was 41% lower (95% CI: −44 to −37) than historical abuse for OC, with oral abuse 17% lower (95% CI: −23 to −10) and nonoral abuse 66% lower (95% CI: −69 to −63). Significant reductions were not observed for comparators. Observations were consistent with the goals of a tamper resistant formulation for an opioid. Further research is needed to determine the persistence and generalizability of these findings. Perspective This article presents preliminary findings indicating that 8 outcome measures of abuse of a reformulated ER oxycodone were lower than that for original ER oxycodone historically, particularly through nonoral ROAs that require tampering (ie, injection, snorting, smoking), in a sentinel sample of individuals assessed for substance use problems for treatment planning.

BackgroundThe Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item assessment designed to assist in the prediction of aberrant drug-related behavior (ADB) among patients with chronic pain. Recent work has created shorter versions of the SOAPP-R, including a static 12-item short form and two computer-based methods (curtailment and stochastic curtailment) that monitor assessments in progress. The purpose of this study was to cross-validate these shorter versions in two new populations.MethodsThis retrospective study used data from patients recruited from a hospital-based pain center (n = 84) and pain patients followed and treated at primary care centers (n = 110). Subjects had been administered the SOAPP-R and assessed for ADB. In real-data simulation, the sensitivity, specificity, and area under the curve (AUC) of each form were calculated, as was the mean test length using curtailment and stochastic curtailment.ResultsCurtailment reduced the number of items administered by 30% to 34% while maintaining sensitivity and specificity identical to those of the full-length SOAPP-R. Stochastic curtailment reduced the number of items administered by 45% to 63% while maintaining sensitivity and specificity within 0.03 of those of the full-length SOAPP-R. The AUC of the 12-item form was equal to that of the 24-item form in both populations.ConclusionsCurtailment, stochastic curtailment, and the 12-item short form have potential to enhance the efficiency of the SOAPP-R

Objective: To determine what, if any, public health and societal impacts are associated specifically with injection of prescription opioids. Design: Cross-sectional observational study. Setting: Five hundred forty treatment facilities in 35 states across the United States performing Addiction Severity Index-Multimedia Version (ASI-MV) assessments. Participants: Adult patients (29,459) who reported past 30-day abuse of any prescription opioid on the ASI-MV assessment between January 2007 and January 2011. Main outcome measures: The public health indicators selected for this study were liver disease, HIV/AIDS status, recent visit to an emergency room, treatment for pain, treatment for overdosing, homelessness, residence with alcohol/substance abuser, and unemployment. Results: Prescription opioid injection was significantly associated with health problems, psychosocial problems, and utilization of medical services. Conclusions: This study demonstrates an approach to measure the potential impact of injecting prescription opioids on public health indicators. Findings indicate a positive association between injection of prescription opioids and public health indicators suggesting a need for prescription opioid formulations that may inhibit injection of these medications. Keywords: prescription drug injection, public health, correlates DOI:10.5055/jom.2013.0142

Matthew D Finkelman,1 Ronald J Kulich,2,3 Stephen F Butler,4 William C Jackson,3 Franklin D Friedman,5 Niels Smits,6 Scott G Weiner7 1Department of Public Health and Community Service, Tufts University School of Dental Medicine, Boston, MA, USA; 2Craniofacial Pain and Headache Center, Tufts University School of Dental Medicine, Boston, MA, USA; 3Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, 4Inflexxion Inc, Newton, MA, USA; 5Department of Emergency Medicine, Tufts Medical Center, Boston, MA, USA; 6Department of Methods and Statistics, Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, the Netherlands; 7Department of Emergency Medicine, Brigham and Women’s Hospital, Boston, MA, USA Background: Respondents’ scores to the Screener and Opioid Assessment for Patients with Pain – revised (SOAPP-R) have been shown to be predictive of aberrant drug-related behavior (ADB). However, research is lacking on whether an individual’s completion time (the amount of time that he/she takes to finish the screener) has utility in predicting ADB, despite the fact that response speed has been useful in predicting behavior in other fields. The purpose of this study was to evaluate the degree to which SOAPP-R completion time is predictive of ADB.Materials and methods: This retrospective study analyzed completion-time data from 82 adult emergency department patients who completed the SOAPP-R on a tablet computer. The utility of SOAPP-R completion times in predicting ADB was assessed via logistic regression and the area under the curve (AUC) statistic. An external measure of ADB using Prescription Drug Monitoring Program data defined ADB to have occurred in individuals with at least four opioid prescriptions and at least four prescribers in 12 months.Results: Although there was a slight trend for individuals with greater completion times to have greater odds of ADB (odds ratio 1.004 in simple logistic regression), the association between SOAPP-R completion time and ADB was not statistically significant in either simple logistic regression (P=0.307) or multiple logistic regression adjusting for SOAPP-R score (P=0.419). AUC values for the prediction of ADB using completion time alone, SOAPP-R score alone, and both completion time and SOAPP-R score were 0.63, 0.64, and 0.65, respectively.Conclusion: There was no significant evidence that SOAPP-R completion times were predictive of ADB among emergency department patients. However, the AUC value for completion times was only slightly less than that for SOAPP-R total scores. Keywords: chronic pain, substance abuse, risk stratification, aberrant drug-related behavior, response times, response latency

PURPOSE: The ability to track prescription opioid abusers' endorsement of compounds may be valuable in forecasting abuser's preferences. We developed a metric, referred to as the Endorsement Ratio (ERo), to explore the feasibility of quantifying the sentiment expressed by opioid abusers who post online about prescription opioid products. METHODS: Internet posts written between April 1, 2010 and March 31, 2011 and related to six prescription opioid compounds (oxycodone ER, hydrocodone, hydromorphone, oxymorphone, morphine ER, and tramadol) were identified and qualitatively coded. A mixed effects multinomial logistic regression was employed to model the probability of observing endorsing, discouraging, mixed, or unclear messages per compound. Endorsement-to-discouragement ratio (ERo) and ratio of endorsement-to-discouragement ratios (RERo) were estimated for each compound. RESULTS: In the study sample of 12 838 Internet posts, a ranking of endorsement could be established, with oxymorphone as most endorsed (ERo = 7.39), followed by hydromorphone (ERo = 5.02), hydrocodone (ERo = 3.53), oxycodone ER (ERo = 3.23), morphine ER (ERo = 2.71), and tramadol (ERo = 1.76). Relative rankings of products required that route of administration be considered. CONCLUSIONS: This study expands existing Internet monitoring approaches by developing a metric to estimate the endorsement of specific prescription opioid compounds as viewed through the lens of Internet communities. Route of administration must be taken into account when examining preferences of drug abusers for various products. This study did not assess whether the novel metric is valid with respect to classification of abuse rates of different drugs. Further studies examining external validation studies are warranted. Copyright © 2012 John Wiley & Sons, Ltd. Language: en

Although Rasch models have been shown to be a sound methodological approach to develop and validate measures of psychological constructs for more than 50 years, they remain underutilized in psychology and other social sciences. Until recently, one reason for this underutilization was the lack of syntactically simple procedures to fit Rasch and item response theory (IRT) models in general statistical software packages. In this article, the authors demonstrate how to fit the standard dichotomous Rasch model and a dichotomous one-parameter logistic IRT model with nested random effects via the easy-to-use GLIMMIX procedure in SAS 9.3. For comparison purposes, the standard dichotomous Rasch model was also fit using the Rasch specialized software, WINSTEPS 3.68.2. The SAS code used to simulate the data on which the Rasch model was fit is provided to allow replication of estimates. Findings suggest that the GLIMMIX procedure may be a viable option for fitting the standard dichotomous Rasch and dichotomous IRT models.

The Current Opioid Misuse Measure (COMM), a self-report assessment of past-month aberrant medication-related behaviors, has been validated in specialty pain management patients. The performance characteristics of the COMM were evaluated in primary care (PC) patients with chronic pain. It was hypothesized that the COMM could identify patients with prescription drug use disorder (PDD). English-speaking adults awaiting PC visits at an urban, safety-net hospital, who had chronic pain and had received any opioid analgesic prescription in the past year, were administered the COMM. The Composite International Diagnostic Interview served as the "gold standard," using DSM-IV criteria for PDD and other substance use disorders (SUDs). A receiver operating characteristic (ROC) curve demonstrated the COMM's diagnostic test characteristics. Of the 238 participants, 27 (11%) met DSM-IV PDD criteria, whereas 17 (7%) had other SUDs, and 194 (82%) had no disorder. The mean COMM score was higher in those with PDD than among all others (ie, those with other SUDs or no disorder, mean 20.4 [SD 10.8] vs 8.4 [SD 7.5], P.0001). A COMM score of⩾13 had a sensitivity of 77% and a specificity of 77% for identifying patients with PDD. The area under the ROC curve was 0.84. For chronic pain patients prescribed opioids, the development of PDD is an undesirable complication. Among PC patients with chronic pain-prescribed prescription opioids, the COMM is a promising tool for identifying those with PDD. Among primary care patients with chronic pain-prescribed opioids, the validated Current Opioid Misuse Measure (COMM) is a promising tool for identifying patients with prescription opioid use disorder.

Objectives—The Current Opioid Misuse Measure (COMM) is a self-report measure of risk for aberrant medication related behavior among persons with chronic pain who are prescribed opioids for pain. It was developed to complement predictive screeners of opioid misuse potential and improve a clinician's ability to periodically assess a patient's risk for opioid misuse. The aim of this study was to cross validate the COMM with a new sample of chronic noncancer pain patients. Methods—Two hundred and twenty six (N=226) participants prescribed opioids for pain were recruited from five pain management centers in the US. Subjects completed the 17-item COMM and a series of self-report measures. Patients were rated by their treating physician, had a urine toxicology screen, and were classified on the Aberrant Drug Behavior index. Results—The reliability and predictive validity in this cross validation as measured by the area under the curve (AUC) were found to be highly significant (AUC =.79) and not significantly different from the AUC obtained in the original validation study (AUC =.81). Reliability (coefficient α) was . 83, which is comparable to the .86 obtained in the original sample. Discussion—Results of the cross validation suggest that the psychometric parameters of the COMM are not based solely on unique characteristics of the initial validation sample. The COMM appears to be a reliable and valid screening tool to help detect current aberrant drug-related behavior among chronic pain patients.

There has been a growing use of opioids for the treatment of chronic pain, primarily from providers who prescribe them for chronic noncancer pain.18 It is also estimated that between 3% and 16% of the general population has a substance use disorder,14,19,27,29 and increasing notice has been given to the abuse of and dependence on prescription opioid medication.15,17,18,28 Some pain centers where opioids are prescribed for pain are overwhelmed with patients who are known or suspected to be abusing their prescribed opioids,25 and many physicians prescribing pain medication have little training in addiction and/or aberrant drug-related behavior.45 These physicians prescribe opioids for patients with chronic pain without an indication of the level of risk for medication abuse.3 While opioids may be an effective treatment for chronic pain, some providers are reluctant to prescribe opioids because of concerns over tolerance, dependence, and addiction. Optimal use of opioids must include an evaluation of risk associated with potential abuse of opioid medication.3,46 Opioid misuse and aberrant drug-related behaviors may indicate a treatment adherence issue, or may signal a more serious addiction problem, if accompanied by a lack of control over use despite negative consequences. There have been an increasing number of investigations on gender differences among chronic pain patients. Studies show that women have a higher incidence of pain 40 and report higher pain intensity compared with men.2,13,16 Women are also prescribed opioids more often than men,20,24,34,36 while men demonstrate more substance abuse behavior than women.21,35,47,48 Women report more depression and sexual abuse than men, and these qualities have been shown to be risk factors for substance misuse.48 Psychological distress especially has been associated with misuse of prescription medications both in the general population4 and in chronic pain patients.23 Overall statistics regarding opioid misuse among men and women, however, are conflicting.5,8,31,39 Little has been written about gender differences and assessment of misuse of prescription opioid medication. Given that some risk characteristics for opioid misuse (e.g., depression) are differentially prevalent as a function of sex, and that many features of substance abuse behavior are different in men and women,42 it may be important to document whether the risk factors that predict opioid misuse are to some degree sex-specific. There are hints in the general substance abuse literature that some of the factors affecting relapse differ between the sexes, with relapse among women more closely tied to psychological distress and interpersonal processes compared to men.42 The purpose of this study was to examine, among persons prescribed opioids for pain, gender differences in: 1) the rates and characteristics of problematic opioid use, 2) the profile of risk factors for potential opioid misuse, and 3) longitudinal predictive associations between risk factors and subsequent misuse behaviors. It was hypothesized that indices of substance misuse (e.g., physician documentation, aberrant urine screens, etc.) would be higher among men relative to women, and that the predictors of that misuse would differ across the sexes, with opioid misuse among women more closely related to affective distress.

Objective. The present study builds on research to model abusers' perceptions of particular analgesics' attractiveness for abuse and extends these methods to derive an estimate of attractiveness for abuse of a not-yet-marketed abuse-deterrent formulation (ADF) of a prescription opioid (Remoxy®, Pain Therapeutics, Inc., San Mateo, CA, and King Pharmaceuticals, Inc., Bristol, TN). In a previous study, the Opioid Attractiveness Technology Scaling (OATS) method identified, from a drug abuser's point of view, the particular features of a prescription opioid relevant to its attractiveness for recreational use. A second online sample rated the extent to which these features applied to particular products they had actually used/abused. These data were used to model the abusers' overall preference for prescription opioids they had used/abused. Design. In the present study, this method was applied to a not-yet-marketed ADF using substance abuse counselors as proxies for prescription opioid abusers. Thirty-eight counselors were given materials describing the new ADF along with four known products. Results. Thirty-two counselors demonstrated sufficient agreement with abusers' ratings of the overall attractiveness of these drugs. The overall model yielded a significant pseudo R2 of 0.15 ( P < 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R2 = 0.06; P < 0.001) and best for those who preferred to inject (pseudo R2 = 0.40; P < 0.001). Data from a cross-validation group of 16 counselors/proxies were used to calculate the OATS scores for the five rated drugs and revealed significant differences between the ADF and OxyContin® (Purdue Pharma LP, Stamford, CT), Percocet® (Endo Pharmaceuticals, Chadds Ford, PA), and Vicodin® (Abbott Laboratories, Abbott Park, IL), but not Talwin® NX (Sanofi-aventis, Bridgewater, NJ), which was identified in the prior study as a highly unattractive drug for recreational purposes. Conclusions. The OATS method shows promise for providing pre-marketing estimates of attractiveness for abuse of not-yet-marketed ADFs.

Objective. Prescription opioids are the second most misused/abused drug in the United States behind only marijuana. Recreational prescription opioid users appear to prefer some products over others; however, the extent to which attributes of any particular formulation account for such preferences has yet to be determined. The Opioid Attractiveness Technology Scaling was developed to identify the particular features of a prescription opioid that are relevant to its attractiveness for recreational use, and to use these features to model attractiveness for recreational use of particular prescription opioid formulations. Design. Four hundred and ninety-one self-reported recreational prescription opioid users identified 43 product features as being relevant to determining whether a product is “attractive” or “unattractive” for recreational use. Average ratings were used to determine appropriate weights to be applied to the features. A factor analysis yielded 10, highly differentiated factors. Five hundred and sixty-four prescription opioid abusers were then asked to rate the extent to which the 43 features identified in Study 1 were relevant to specific prescription opioid products they had used. Results. Respondents provided an overall preference rating of these products and a model was created. A random intercept model yielded a significant pseudo R2 of 0.14 (chi-square = 310.02, degrees of freedom [df] = 10, P < 0.001). The model fit least well, albeit significantly, for abusers who preferred to swallow the drug (pseudo R2 = 0.06; chi-square = 55.52, df = 10, P < 0.001) and best for those who preferred to inject (pseudo R2 = 0.37; chi-square = 199.34, df = 10, P < 0.001). Conclusions. The relevance of the model is discussed along with possible modifications that might allow prediction of “attractiveness” of “abuse deterrent” formulations that have not yet been marketed.

There has been a growing use of opioids for the treatment of chronic pain, especially for chronic, noncancer pain, and due, in part, to this growth, increasing notice has been given to the abuse of prescription opioid medication 1, 2. Opioids can be an effective treatment for chronic pain, yet providers are reluctant to prescribe opioids because of concerns over tolerance, dependence, and addiction. Some pain centers where opioids are prescribed have been overwhelmed with patients seeking pain medication for purposes other than to control their pain or to control their pain in ways not medically prescribed, and many physicians prescribing pain medication have little training to deal with addiction or in dealing with aberrant medication-related behavior 3. In a survey of primary care physicians, one-third of respondents indicated that they would not, under any circumstance, prescribe opioids to patients with chronic, noncancer pain 4, 5. However, seventy percent of these same physicians indicated that this type of pain is usually inadequately treated 4, 5. Clinicians continuously identify the need for additional opioid risk management tools and training to objectively assess and monitor chronic pain patients being considered for opioid therapy. The Screener and Opioid Assessment for Patients with Pain - Revised (SOAPP-R)6 was developed to complement current risk assessment practices and to improve a clinician’s ability to assess a patient’s risk for opioid abuse. The SOAPP-R addresses some of the limitations of the original SOAPP V.1. The SOAPP-R was empirically, rather than conceptually, derived; it was validated in a more systematic fashion and it contains more subtle items and items that do not require admission of socially unacceptable behaviors. The SOAPP-R was found to have good psychometric properties in a test with 284 chronic pain patients on long-term opioid therapy. Classical test development methods require that the primary reliability and validity be confirmed in a cross-validation study 7. Any validity coefficient computed on a given sample can be spuriously high since such values capitalize on random sampling errors within the particular sample. It is expected that the validity and reliability parameters will “shrink” when tested on a new sample, however, the scale should still remain valid and reliable. Cross-validation reflects a high, but necessary standard for any assessment where the results may impact important clinical decisions. The purpose of this study was to cross-validate the SOAPP-R with a new sample of chronic, noncancer pain patients.

This pilot case-control study retrospectively assessed between-groups differences in subjective opioid effects in patients treated for the first time with opioids for chronic pain. Cases were individuals in an inpatient substance abuse treatment center for primary prescription opioid addiction whose initial exposure to prescription opioids was reported for chronic pain. Controls had not developed prescription opioid addiction as measured in part by close monitoring on long-term opioid therapy at a pain management center. Twenty subjects in each group completed a battery of measures to capture data related to the individual's first exposure to prescription opioids. The Morphine Benzedrine Group subscale of an adapted 49-item Addiction Center Research Inventory (ARCI), designed to measure euphoria and other drug effects, showed an average score of 8.70 (+/-4.18) in cases versus 2.55 (+/-3.36) in controls (p

Objectives: This study describes the development of a systematic approach to the analysis of Internet chatter as a means of monitoring potentially abusable opioid analgesics. Methods: Message boards dedicated to drug abuse were selected using specific inclusion criteria. Threaded discussions containing 48,293 posts were captured. A coding system was created to compare content of posts related to 3 opioid analgesics: Kadian, Vicodin, and OxyContin. Results: The number of posts containing mentions of the target drugs were significantly different [OxyContin (1813) > Vicodin (940)>Kadian (27), P