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BackgroundInformation about the effectiveness of oral antivirals in preventing short- and long-term COVID-19-related outcomes in the setting of Omicron variant transmission and COVID-19 vaccination is limited.ObjectiveTo measure the effectiveness of nirmatrelvir-ritonavir and molnupiravir for outpatient treatment of COVID-19.DesignThree retrospective target trial emulation studies comparing matched cohorts of nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir-ritonavir versus molnupiravir.SettingVeterans Health Administration (VHA).ParticipantsNonhospitalized veterans in VHA care who were at risk for severe COVID-19 and tested positive for SARS-CoV-2 during January through July 2022.InterventionNirmatrelvir-ritonavir or molnupiravir pharmacotherapy.MeasurementsIncidence of any hospitalization or all-cause mortality at 30 days and from 31 to 180 days.ResultsEighty-seven percent of participants were male; the median age was 66 years, and 18% were unvaccinated. Compared with matched untreated control participants, those treated with nirmatrelvir-ritonavir (n = 9607) had lower 30-day risk for hospitalization (22.07 vs. 30.32 per 1000 participants; risk difference [RD], -8.25 [95% CI, -12.27 to -4.23] per 1000 participants) and death (1.25 vs. 5.47 per 1000 participants; RD, -4.22 [CI, -5.45 to -3.00] per 1000 participants). Among persons alive at day 31, reductions were seen in 31- to 180-day incidence of death (hazard ratio, 0.66 [CI, 0.49 to 0.89]) but not hospitalization (subhazard ratio, 0.90 [CI, 0.79 to 1.02]). Molnupiravir-treated participants (n = 3504) had lower 30-day and 31- to 180-day risks for death (3.14 vs. 13.56 per 1000 participants at 30 days; RD, -10.42 [CI, -13.49 to -7.35] per 1000 participants; hazard ratio at 31 to 180 days, 0.67 [CI, 0.48 to 0.95]) but not hospitalization. A difference in 30-day or 31- to 180-day risk for hospitalization or death was not observed between matched nirmatrelvir- or molnupiravir-treated participants.LimitationThe date of COVID-19 symptom onset for most veterans was unknown.ConclusionNirmatrelvir-ritonavir was effective in reducing 30-day hospitalization and death. Molnupiravir was associated with a benefit for 30-day mortality but not hospitalization. Further reductions in mortality from 31 to 180 days were observed with both antivirals.Primary funding sourceU.S. Department of Veterans Affairs.

PurposeAlcohol use among adolescents and emerging adults is an important public health issue requiring prevention approaches. Herein, we describe outcomes from a randomized controlled trial testing the efficacy of group-based social media interventions targeting risky drinking among youth.ProceduresUsing social media advertisements to screen potential participants, we recruited 955 youth (ages 16-24) reporting recent risky drinking. After completing a baseline assessment, participants were randomized to 8-week secret Facebook group conditions: Social Media Intervention + Incentives for engagement, Social Media Intervention only, and attention-placebo control. Electronic coaches trained in motivational interviewing facilitated interaction in intervention groups. Primary outcomes include past 3-month alcohol use and consequences over 3-, 6-, and 12-month follow-ups. Secondary outcomes include other drug use, consequences, and impaired driving. We also measured intervention engagement and acceptability.ResultsThe interventions were well-received, with significantly greater acceptability ratings and engagement in the SMI+I condition relative to other groups. In adjusted analyses, there were no significant differences between interventions and control on alcohol-related outcomes, with all groups showing reductions. Regarding secondary outcomes (70.4% used other drugs), compared to control, the incentivized group reduced other drug use, consequences, and cannabis-impaired driving; the non-incentivized group did not significantly differ from the control condition.ConclusionsAmong this predominantly poly-substance using sample, findings were mixed, with significant effects of the incentivized social media intervention on drug (but not alcohol) outcomes. Future studies are needed to further refine social media-delivered interventions to reduce alcohol and other drug use.Trial registrationClinicalTrials.gov NCT02809586; University of Michigan HUM#00102242.

BackgroundEfforts to reduce opioid overdose fatalities have resulted in tapering (i.e., reducing or discontinuing) opioid prescriptions despite a limited understanding of patients' experiences.ObjectiveTo explore patients' perspectives on opioid taper experiences to ultimately improve taper processes and outcomes.DesignQualitative study.ParticipantsPatients on long-term opioid therapy for chronic pain who had undergone a reduction of opioid daily prescribed dosage of ≥50% in the past 2 years in two distinct medical systems and regions.ApproachFrom 2019 to 2020, we conducted semi-structured interviews that were audio-recorded, transcribed, systematically coded, and analyzed to summarize the content and identify key themes regarding taper experiences overall and with particular attention to patient-provider relationships and provider communication during tapers.Key resultsParticipants (n=41) had lived with chronic pain for an average of 17.4 years (range, 3-36 years) and described generally adverse experiences with opioid tapers, the initiation of which was not always adequately justified or explained to them. Consequences of tapers ranged from minor to substantial and included withdrawal, mobility issues, emotional distress, exacerbated mental health symptoms, and feelings of social stigmatization for which adequate supports were typically unavailable. Narratives highlighted the consequential role of patient-provider relationships throughout taper experiences, with most participants describing significant interpersonal challenges including poor provider communication and limited patient engagement in decision making. A few participants identified qualities of providers, relationships, and communication that fostered more positive taper experiences and outcomes.ConclusionsFrom patients' perspectives, opioid tapers can produce significant physical, emotional, and social consequences, sometimes reducing trust and engagement in healthcare. Patient-provider relationships and communication influence patients' perceptions of the quality and outcomes of opioid tapers. To improve patients' experiences of opioid tapers, tapering plans should be based on individualized risk-benefit assessments and involve patient-centered approaches and improved provider communication.

AbstractChronic pain is associated with mental and physical health difficulties and is prevalent among veterans. Cannabis has been put forth as a treatment for chronic pain, and changes in laws, attitudes, and use patterns have occurred over the past 2 decades. Differences in prevalence of nonmedical cannabis use and cannabis use disorder (CUD) were examined across 2 groups: veterans or nonveterans and those reporting or not reporting recent pain. Data from the National Epidemiologic Survey on Alcohol and Related Conditions-III (2012-2013; n = 36,309) were analyzed using logistic regression. Prevalence differences (PDs) for 3 cannabis outcomes (1) past-year nonmedical cannabis use, (2) frequent (≥3 times a week) nonmedical use, and (3) DSM-5 CUD were estimated for those reporting recent moderate to severe pain (veterans or nonveterans) and veterans reporting or not reporting recent pain. Difference in differences was calculated to investigate PDs on outcomes associated with residence in a state with medical cannabis laws (MCLs). Associations between physical and mental health and cannabis variables were tested. The results indicated that the prevalence of recent pain was greater among veterans (PD = 7.25%, 95% confidence interval (CI) [4.90-9.60]). Among veterans, the prevalence of frequent cannabis use was greater among those with pain (PD = 1.92%, 98% CI [0.21-3.63]), and among veterans residing in a state with MCLs, the prevalence of CUD was greater among those reporting recent pain (PD = 3.88%, 98% CI [0.36-7.39]). Findings failed to support the hypothesis that cannabis use improves mental or physical health for veterans with pain. Providers treating veterans with pain in MCL states should monitor such patients closely for CUD.

Background: High-intensity drinking (HID; 8+ U.S. standard drinks for women, 10+ men) is initiated during adolescence/emerging adulthood, increasing risk for negative outcomes, including blackouts. We examined baseline data from a study of risky drinking youth to identify factors associated with HID. Methods: Risky drinkers (ages 16-24) were recruited online (positive 3-month AUDIT-C score) as part of a larger study to examine social media interventions for risky drinking. We used baseline survey data to examine HID in relation to demographics, substance use-related variables, and individual and social factors. Results: Among 931 risky drinkers, 29.8% reported past-month HID, and those with HID reported greater substance use and consequences. In multivariable analysis, HID was associated with male sex; greater social motives, impulsivity, and motivation; lower self-efficacy; and greater likelihood of not living with parents, drinking with important peers, and parental disapproval of posting drinking pictures. When examining age group interactions (16-20; 21-24), underage drinkers with high sensation-seeking scores and lower parental disapproval of posting drinking pictures on social media reported greater HID. Conclusions: Among risky drinking youth, male sex, social motives, impulsivity, higher motivation to and lower-self-efficacy to reduce drinking, living away from parents, more frequent drinking with important peers, and lower parental disapproval of posting drinking pictures on social media were positively associated with HID. Further, HID was associated with greater health consequences, underscoring the need for HID interventions. Such interventions may benefit from enhancing motivation and self-efficacy, particularly in social contexts, as well as increasing positive peer and leisure activities to reduce HID.

BackgroundAlcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available treatments. Insomnia is a robust predictor of relapse and pilot studies have shown that CBT for insomnia improves insomnia and daytime functioning in adults with AUD and insomnia. The impact of CBT for insomnia on relapse, however, is unclear. This trial will compare telemedicine-delivered CBT for insomnia (CBT-TM) with sleep hygiene education (SHE-TM) on improving insomnia/sleep, daytime symptom, and drinking outcomes in treatment-seeking AUD adults with insomnia. The study will also determine the effects of treatment on sleep mechanisms and their association with clinical outcomes.MethodsThis is a single-site randomized controlled trial with planned enrollment of 150 adults meeting criteria for both AUD and chronic insomnia. Eligible participants will be randomized 1:1 to 6 sessions of telemedicine-delivered Cognitive Behavioral Therapy for Insomnia (CBT-TM) or Sleep Hygiene Education (SHE-TM) with clinical assessments conducted at pre-treatment, post- treatment, and at 3, 6, and 12 months post-treatment. Overnight polysomnography will be conducted before and after treatment. Primary clinical outcomes will include post-treatment scores on the Insomnia Severity Index and the General Fatigue subscale of the Multidisciplinary Fatigue Inventory, and the percent of days abstinent (PDA) on the interview-administered Time Line Follow Back. EEG delta activity, derived from overnight polysomnography, will be the primary endpoint to assess the sleep homeostasis mechanism.DiscussionThis adequately powered randomized controlled trial will provide clinically relevant information about whether targeting insomnia is effective for improving treatment outcomes among treatment-seeking adults with AUD. Additionally, the study will offer new scientific insights on the impact of an evidence-based non-medication treatment for insomnia on a candidate mechanism of sleep dysfunction in this population - sleep homeostasis.Trial registrationCClinicalTrials.gov NCT # 04457674 . Registered on 07 July 2020.

Preventing opioid misuse and opioid use disorder is critical among at-risk adolescents and young adults (AYAs). An Emergency Department (ED) visit provides an opportunity for delivering interventions during a rapidly changing opioid landscape. This paper describes pilot data and the protocol for a 2 × 2 factorial randomized controlled trial testing efficacy of early interventions to reduce escalation of opioid (prescription or illicit) misuse among at-risk AYAs. Interventions are delivered using technology by health coaches. AYAs ages 16-30 in the ED screening positive for prescription opioid use (+ ≥ 1 risk factor) or opioid misuse will be stratified by risk severity, sex, and age group. Participants will be randomly assigned to a condition at intake, either a live video health coach-delivered single session or a control condition of an enhanced usual care (EUC) community resource brochure. They are also randomly assigned to one of two post-intake conditions: health coach-delivered portal-like messaging via web portal over 30 days or EUC delivered at 30 days post-intake. Thus, the trial has four groups: health coach-delivered session+portal, health coach-delivered session+EUC, EUC + portal, and EUC + EUC. Outcomes will be measured at 3-, 6-, and 12-months. The primary outcome is opioid misuse based on a modified Alcohol Smoking and Substance Involvement Screening Test. Secondary outcomes include other opioid outcomes (e.g., days of opioid misuse, overdose risk behaviors), other substance misuse and consequences, and impaired driving. This study is innovative by testing the efficacy of feasible and scalable technology-enabled interventions to reduce and prevent opioid misuse and opioid use disorder. Trial Registration:ClinicalTrials.gov University of Michigan HUM00177625 NCT Registration: NCT04550715.

BackgroundEfforts to address opioid-involved overdose fatalities have led to widespread implementation of various initiatives to taper (i.e., reduce or discontinue) opioid prescriptions despite a limited understanding of patients' experience.MethodsFrom 2019-2020, we recruited patients with chronic, non-cancer pain who had undergone a reduction in opioid daily dosage of ≥50 % in the past two years at Boston Medical Center or Michigan Medicine. Participants completed semi-structured interviews exploring health history, opioid use, and taper experiences. Inductive analysis, guided by theoretical conceptualizations of structural stigma, identified emergent themes.ResultsAmong 41 participants, three elements of structural stigma were identified across participants' lives. First, participants identified themselves as overlooked subjects of the U.S. opioid crisis, who experienced overprescribing, subsequent stigmatization and surveillance of opioid use (e.g., toxicology screening, "pill counts"), and various tapering initiatives. Second, during the course of pain treatment, participants felt stigmatized and invalidated by cultural norms linking chronic pain to stereotypes of acting disingenuously (e.g., "drug-seeking"). Finally, during and after tapers, institutional policies and programs further increased participants' feelings of marginalization, producing multiple unintended consequences, including reduced access to medical care and feeling "orphaned by the system."ConclusionsOpioid tapers may exacerbate the social production and burden of stigma among patients with chronic pain, especially when processes are perceived to invalidate pain, endorse stereotypes, and label previously effective, acceptable treatment as inappropriate. Findings highlight how various tapering initiatives reinforce the devalued status of people living with chronic pain while also reducing patients' wellbeing and confidence in medical systems.

Child obesity is a major public health issue with a high disease burden. Although numerous contributing factors have been identified, the family home environment is a central context of influence that requires deeper understanding. The level of organization in the family home environment may influence obesity and obesogenic behaviors, but the literature has suffered from the lack of a strong overarching construct and model to guide this area of research. Family entropy is a conceptual framework that fills this gap by representing the level of organization across the home environment. The current study empirically assesses family entropy using factor analysis in a longitudinal sample of 968 children measured yearly from Grades 3 to 6 as part of the NICHD Study of Early Child Care and Youth Development. Mixed modeling using MPLUS examined the influence of family entropy on child weight both directly and indirectly through weight-related health behaviors (i.e., sleep and physical activity), and considered the moderating role of socioeconomic status (SES). Results suggest that family entropy is comprised of distinct elements of household organization and disorganization, which are moderately related. Household disorganization may be particularly detrimental to child sleeping behavior both concurrently and over time in families of both high and low SES. The study concludes with recommendations for advancing understanding of the home environment by using nuanced measurement strategies, and incorporating support for household organization within child obesity prevention and intervention efforts.

Child obesity is a major public health issue with a high disease burden. Although numerous contributing factors have been identified, the family home environment is a central context of influence that requires deeper understanding. The level of organization in the family home environment may influence obesity and obesogenic behaviors, but the literature has suffered from the lack of a strong overarching construct and model to guide this area of research. Family entropy is a conceptual framework that fills this gap by representing the level of organization across the home environment. The current study empirically assesses family entropy using factor analysis in a longitudinal sample of 968 children measured yearly from Grades 3 to 6 as part of the NICHD Study of Early Child Care and Youth Development. Mixed modeling using MPLUS examined the influence of family entropy on child weight both directly and indirectly through weight-related health behaviors (i.e., sleep and physical activity), and considered the moderating role of socioeconomic status (SES). Results suggest that family entropy is comprised of distinct elements of household organization and disorganization, which are moderately related. Household disorganization may be particularly detrimental to child sleeping behavior both concurrently and over time in families of both high and low SES. The study concludes with recommendations for advancing understanding of the home environment by using nuanced measurement strategies, and incorporating support for household organization within child obesity prevention and intervention efforts.

Child obesity is a major public health issue with a high disease burden. Although numerous contributing factors have been identified, the family home environment is a central context of influence that requires deeper understanding. The level of organization in the family home environment may influence obesity and obesogenic behaviors, but the literature has suffered from the lack of a strong overarching construct and model to guide this area of research. Family entropy is a conceptual framework that fills this gap by representing the level of organization across the home environment. The current study empirically assesses family entropy using factor analysis in a longitudinal sample of 968 children measured yearly from Grades 3 to 6 as part of the NICHD Study of Early Child Care and Youth Development. Mixed modeling using MPLUS examined the influence of family entropy on child weight both directly and indirectly through weight-related health behaviors (i.e., sleep and physical activity), and considered the moderating role of socioeconomic status (SES). Results suggest that family entropy is comprised of distinct elements of household organization and disorganization, which are moderately related. Household disorganization may be particularly detrimental to child sleeping behavior both concurrently and over time in families of both high and low SES. The study concludes with recommendations for advancing understanding of the home environment by using nuanced measurement strategies, and incorporating support for household organization within child obesity prevention and intervention efforts.