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The objective of this study was to estimate the associations of jail-initiated medication for opioid use disorder (MOUD) and patient navigation (PN) with opioid use disorder (OUD) at 6 months post-release. Three randomized trials (combined N = 330) were combined to assess whether MOUD (extended-release naltrexone or interim methadone) initiated prior to release from jail with or without PN would reduce the likelihood of a DSM-5 diagnosis of OUD 6 months post-release relative to enhanced treatment-as-usual (ETAU). Across the three studies, assignment to MOUD compared to ETAU was not associated with an OUD diagnosis at 6 months post-release (69% vs. 75%, respectively, OR = 0.67, 95% CI: 0.42 to 1.20). Similarly, PN compared to MOUD without PN was not associated with an OUD diagnosis (63% vs 77%, respectively, OR = 0.61, 95% CI: 0.27 to 1.53). Results underscore the need to further optimize the effectiveness of MOUD for patients initiating treatment in jail, beginning with an emphasis on post-release treatment adherence. [ABSTRACT FROM AUTHOR]

Background Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. Methods This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30 days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. Results We describe the background and rationale for the study, its aims, hypotheses, and study design. Conclusions Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. ClinicalTrials.gov : NCT02334215 . [ABSTRACT FROM AUTHOR]

Background: Obtaining data on attitudes toward buprenorphine and methadone of opioid-dependent individuals in the United States may help fashion approaches to increase treatment entry and improve patient outcomes. Objectives: This secondary analysis study compared attitudes toward methadone and buprenorphine of opioid-dependent adults entering short-term buprenorphine treatment (BT) with opioid-dependent adults who are either entering methadone maintenance treatment or not entering treatment. Methods: The 417 participants included 132 individuals entering short-term BT, 191 individuals entering methadone maintenance, and 94 individuals not seeking treatment. Participants were administered an Attitudes toward Methadone scale and its companion Attitudes toward Buprenorphine scale. Demographic characteristics for the three groups were compared using χ2 tests of independence and one-way analysis of variance. A repeated-measures multivariate analysis of variance with planned contrasts was used to compare mean attitude scores among the groups. Results: Participants entering BT had significantly more positive attitudes toward buprenorphine than toward methadone ( p < .001) and more positive attitudes toward BT than methadone-treatment (MT) participants and out-of-treatment (OT) participants ( p < .001). In addition, BT participants had less positive attitudes toward methadone than participants entering MT ( p < .001). Conclusions: Participants had a clear preference for a particular medication. Offering a choice of medications to OT individuals might enhance their likelihood of entering treatment. Treatment programs should offer a choice of medications when possible to new patients, and future comparative effectiveness research should incorporate patient preferences into clinical trials. Scientific Significance: These data contribute to our understanding of why people seek or do not seek effective pharmacotherapy for opioid addiction. [ABSTRACT FROM AUTHOR]

Abstract: Background: Longer tenure in methadone treatment has been associated with positive outcomes such as reductions in drug use and crime, HIV seroconversion, and overdose death. Methods: Retention in treatment was examined for 351 opioid-dependent individuals who had been newly admitted to one of six methadone programs in Baltimore, Maryland. Cox proportional hazards regression was used to predict number of days retained in treatment to 90 days from baseline ASI Composite scores and Treatment Motivation scales. A second analysis predicted days in treatment to 365 days using the same baseline variables plus 3-month Motivation scales, Patient Satisfaction scales, and methadone dose in the 248 individuals who had remained in treatment at least 3 months. Analyses held constant gender, race, age, whether participants had a history of regularly smoking cocaine, whether participants were on parole/probation, and program site. Results: Retention at 90 days was predicted by female gender, and greater baseline Treatment Readiness (p =.005) but lower Desire for Help (p =.010). Retention at 365 days was predicted by higher baseline ASI Medical Composite scores (p =.037) and lower Legal Composite scores (p =.039), higher 3-month Treatment Satisfaction scores (p =.008), and higher dose (p =.046). Conclusions: Greater satisfaction with treatment at 3 months was a significant predictor of retention at 12 months, indicating the importance of understanding the role satisfaction plays in determining retention. Greater severity of legal problems was associated with shorter retention, suggesting that program efforts to increase services to criminal justice patients (e.g., legal counseling) may constitute a useful addition to treatment. [Copyright &y& Elsevier]

Abstract: Interim methadone (IM; with emergency counseling only) is an effective but highly restricted alternative to methadone treatment program (MTP) waiting lists. However, it is not known whether IM disadvantages patients as compared with standard methadone treatment (SM). In this clinical trial, conducted in two MTPs, 230 newly admitted patients were randomly assigned to IM, SM, and “restored” methadone treatment (SM with a counselor with a reduced caseload). Data were analyzed using generalized estimating equations and generalized linear modeling. There were no significant differences among conditions in days in treatment or of heroin or cocaine use and heroin- or cocaine-positive urine drug tests. The IM as compared to the SM group had significantly fewer self-reported days of criminal activity and lower amounts of money spent on drugs and illegal income. These findings suggest that when SM is unavailable, IM should be more widely used and less restricted. [Copyright &y& Elsevier]

Objective: Gender differences were explored among 355 in- and out-of-treatment opioid-addicted adults in Baltimore. Methods: Addiction Severity Index and other variables were compared among: 1) in-treatment women vs. out-of-treatment women; 2) out-of-treatment: women vs. men; and, 3) in-treatment: women vs. men. Results: Analysis indicated that in-treatment and out-of-treatment women worked less and used more cocaine than their male counterparts (ps < .01). Moreover, out-of-treatment women used heroin and cocaine more often, spent more money on drugs, earned more illegal income, and had fewer treatments than in-treatment women (ps ≤ .01). Conclusions: Findings indicate greater severity of drug and employment problems of opioid-addicted women and underline the need for gender-specific drug-treatment services. [ABSTRACT FROM AUTHOR]

Attitudes and beliefs about drug abuse treatment have long been known to shape response to that treatment. Two major pharmacological alternatives are available for opioid dependence: methadone, which has been available for the past 40 years, and buprenorphine, a recently introduced medication. This mixed-methods study examined the attitudes of opioid-dependent individuals toward methadone and buprenorphine. A total of 195 participants (n = 140 who were enrolling in one of six Baltimore area methadone programs and n = 55 who were out-of-treatment) were administered the Attitudes toward Methadone and toward Buprenorphine Scales, and a subset (n = 46) received an ethnographic interview. The in-treatment group had significantly more positive attitudes toward methadone than did the out-of-treatment group (p < .001), while they did not differ in their attitudes toward buprenorphine. Both groups had significantly more positive attitudes toward buprenorphine than methadone. Addressing these attitudes may increase treatment entry and retention. [ABSTRACT FROM AUTHOR]

Locating and recruiting out-of-treatment drug-dependent individuals for inclusion in research studies are important and challenging tasks. Targeted sampling, a technique to reach such populations, has been described in the substance abuse literature. However, this literature has generally lacked a recent detailed account of the procedures for planning and implementing targeted sampling. This article provides a review of the literature of targeted sampling in drug abuse studies and a detailed description of methodology employed in our ongoing study of entry and engagement among opioid-dependent individuals in Baltimore, Maryland. Findings indicate that the out-of-treatment samples recruited from the streets are quite similar to those recruited from new admissions to opioid treatment programs, except for their prior treatment experience. This article indicates that targeted sampling can be useful in an urban setting with pervasive drug use. [ABSTRACT FROM AUTHOR]

This study compared the characteristics of opioid-addicted adults seeking (n = 169) and not seeking (n = 74) methadone treatment in Baltimore, Maryland. Participants entering treatment were recruited from six methadone treatment programs, while out-of-treatment participants were recruited from the streets using targeted sampling methods. Measures included the Addiction Severity Index, a Supplemental Questionnaire, and urine drug test. Data were analyzed using ANOVA, χ2, and regression, holding key background variables constant. Despite the lack of differences between the samples in demographic characteristics, the out-of-treatment sample reported significantly more days of heroin, cocaine, and alcohol use and spent significantly more money on drugs and earned more illegal income at baseline. [ABSTRACT FROM AUTHOR]

Background: We report on the 24-month post-release outcomes of arrestees with opioid use disorder (OUD) enrolled in a randomized trial comparing three treatment approaches initiated in jail.Methods: Adults (N = 225) receiving medically supervised withdrawal from opioids in the Baltimore Detention Center within a few days of arrest were randomly assigned to: (1) interim methadone treatment plus patient navigation (IM + PN) started in the Detention Center; (2) IM; or (3) Enhanced Treatment-as-Usual (ETAU) consisting of detoxification with methadone and referral to treatment in the community. Participants in both methadone conditions could transfer to standard methadone treatment following release. Participants were interviewed at baseline, and 1, 3, 6, 12, and 24 months post-release. Urine was drug tested at follow-up and official arrest records were obtained.Results: On an intention-to-treat basis, there were no significant differences among the three conditions over the 24-month post-release period in terms of opioid- or cocaine-positive urine test results or self-reported opioid or cocaine use, meeting opioid or cocaine use disorder criteria, self-reported criminal behavior, or the number of official arrests. There were 9 fatal overdoses, none occurring during methadone treatment, and 109 hospitalizations unrelated to the study.Conclusions: Given the high morbidity and mortality found in this population of arrestees and costs to society associated with their health care utilization and continued crime and arrests, research aimed at finding more effective interventions should be continued.Clinical Trial Registration: ClinicalTrials.gov: NCT02334215. [ABSTRACT FROM AUTHOR]

Background: There are limited data from randomized trials about the impact of starting methadone treatment in jail on subsequent arrest after release for adults with opioid use disorder (OUD).Methods: Official arrest records were obtained for 212 participants with OUD who were enrolled in a three-group randomized controlled trial of initiating methadone treatment in jail either with or without patient navigation vs. enhanced treatment-as-usual in Baltimore, Maryland. Participants treated for opioid withdrawal in jail were assigned to: 1) interim methadone (IM) with patient navigation (PN; IM + PN); 2) IM without PN (IM); or 3) enhanced treatment-as-usual (ETAU). Participants in both IM groups were able to continue treatment at a community-based methadone treatment program with counseling upon release, while ETAU participants received overdose information and a city-wide treatment assessment/referral number. Likelihood of arrest, time to first subsequent arrest, and severity of arrest charges in the 12 months following release were examined for: 1) combined IM + PN and IM groups compared to ETAU; and 2) IM + PN compared to IM.Results: Within 12 months of release from the index incarceration, 50.5% of the sample had been arrested. The majority of arrest charges (71%) were for low-level, nonviolent crimes. On an intention-to-treat basis, there were no significant differences between the combined IM + PN and IM groups vs. ETAU or IM + PN vs. IM in the likelihood of arrest, time to first subsequent arrest, or severity of arrest charges.Conclusion: Initiating IM with or without PN during pretrial detention did not have a significant effect on subsequent arrest during a 12-month post-release follow-up compared to not starting methadone maintenance during detention, despite the high rate of methadone treatment entry in the community following release. This finding may be attributable to the considerable attrition from treatment in the community or other systematic factors. Additional interventions may be needed to reduce the likelihood of subsequent arrest. [ABSTRACT FROM AUTHOR]

This secondary analysis compared outcomes in African American adults newly admitted to buprenorphine treatment and who were on parole and probation with outcomes in patients who were not under criminal justice (CJ) supervision. Buprenorphine patients (N = 300) were randomly assigned to receive either intensive outpatient (IOP) treatment or standard outpatient (OP) treatment and were assessed at baseline, and 3 and 6 months. There were no differences between groups in treatment retention. Among probationers/parolees, IOP treatment was associated with lower 3-month treatment retention compared with OP treatment, but among participants not on probation/parole, the relationship was reversed (p = .004). Both conditions showed significant declines in heroin and cocaine use, illegal activity, and in meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) criteria for opioid and cocaine dependence. Probationers/parolees reported a lower frequency of illegal activities at 3 months compared with nonprobationers/nonparolees (p = .007). Buprenorphine treatment should be made more widely available to individuals on parole/probation as they respond as well to treatment as patients not supervised by the CJ system. [ABSTRACT FROM PUBLISHER]

Methadone maintenance treatment has proven effectiveness in the treatment of opioid use disorder, but significant barriers remain to treatment retention. In a randomized clinical trial, 300 newly-admitted methadone patients were randomly assigned to patient-centered methadone (PCM) v. treatment-as-usual (TAU). In PCM, participants were treated under revised program rules which permitted voluntary attendance at counseling and other changes focused on reducing involuntary discharge, and different staff roles which shifted disciplinary responsibility from the participant's counselor to the supervisor. The study found no significant differences in treatment retention, measures of opioid use, or other patient outcomes. This paper employs an activity-based costing approach to estimate the cost and cost-effectiveness of the two study conditions. We found that service use and costs were similar between PCM and TAU. Specifically, the average cost for PCM patients was $2396 compared to $2292 for standard methadone, while the average length of stay was 2 weeks longer for PCM patients. Incremental cost-effectiveness ratios (ICER) for self-reported heroin use, opioid positive urine screens, and meeting DSM-IV criteria for opioid dependence were mixed, with TAU achieving non-significantly better outcomes at lower treatment episode costs (i.e., economically dominating) for opioid positive urine screens. PCM patients reported slightly more days abstinent from heroin and fewer meet the opioid dependence criteria. While these differences are small and not statistically significant, we can still examine the cost-effectiveness implications. For days, abstinent from heroin, the ICER was $242 for one additional day of abstinence, however, there was notable uncertainty around this estimate. For opioid dependence criteria, the ICER was $1160 for a one-percentage point increase in the probability that a participant no longer met criteria for opioid dependence at follow-up. This economic study finds that patient choice concepts can be introduced into methadone treatment without significant impacts on costs or patient outcomes. [ABSTRACT FROM AUTHOR]

Background Among the nearly 750,000 inmates in U.S. jails, 12% report using opioids regularly, 8% report use in the month prior to their offense, and 4% report use at the time of their offense. Although ample evidence exists that medications effectively treat Opiate Use Disorder (OUD) in the community, strong evidence is lacking in jail settings. The general lack of medications for OUD in jail settings may place persons suffering from OUD at high risk for relapse to drug use and overdose following release from jail. Methods The three study sites in this collaborative are pooling data for secondary analyses from three open-label randomized effectiveness trials comparing: (1) the initiation of extended-release naltrexone [XR-NTX] in Sites 1 and 2 and interim methadone in Site 3 with enhanced treatment-as usual (ETAU); (2) the additional benefit of patient navigation plus medications at Sites 2 and 3 vs. medication alone vs. ETAU. Participants are adults with OUD incarcerated in jail and transitioning to the community. Results We describe the rationale, specific aims, and designs of three separate studies harmonized to enhance their scientific yield to investigate how to best prevent jail inmates from relapsing to opioid use and associated problems as they transition back to the community. Conclusions Conducting drug abuse research during incarceration is challenging and study designs with data harmonization across different sites can increase the potential value of research to develop effective treatments for individuals in jail with OUD. [ABSTRACT FROM AUTHOR]

Background: Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.Methods: We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.Results: The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.Conclusions: IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective. [ABSTRACT FROM AUTHOR]