Availability and Opportunities for Expansion of Buprenorphine for the Treatment of Opioid Use Disorder.

There is an urgent need to expand access to treatment for persons with opioid use disorder (OUD). As neurologists may frequently encounter patients with chronic pain who have developed OUD, they are in a position to serve as advocates for treatment. Buprenorphine is the most scalable medication for OUD in the United States, yet expansion has plateaued in recent years despite growing treatment needs. Reluctance of providers to establish treatment with new patients, challenges with rural expansion, stigma related to buprenorphine-based care, and pharmacy pressures that incentivize low dispensing and inventories may have stalled expansion. This review introduces these challenges before outlining actionable and evidenced-based strategies that warrant investigation, including methods to improve patient access to care (remotely delivered care, mobile delivery programs, Bridge programs) and provider retention and confidence in prescribing (expert consults, Extension for Community Healthcare Outcomes, a telementoring model, hub-and-spoke services), as well as novel innovations (virtual reality, artificial intelligence, wearable technologies). Overall, fortifying existing delivery systems while developing new transformative models may be necessary to achieve more optimal levels of buprenorphine treatment expansion.

Correlates of illness uncertainty in cancer survivors and family caregivers: a systematic review and meta-analysis.

PURPOSE: Illness uncertainty is widely recognized as a psychosocial stressor for cancer survivors and their family caregivers. This systematic review and meta-analysis aimed to identify the sociodemographic, physical, and psychosocial correlates that are associated with illness uncertainty in adult cancer survivors and their family caregivers. METHODS: Six scholarly databases were searched. Data synthesis was based on Mishel's Uncertainty in Illness Theory. Person's r was used as the effect size metric in the meta-analysis. Risk of bias was assessed using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. RESULTS: Of 1116 articles, 21 articles met the inclusion criteria. Of 21 reviewed studies, 18 focused on cancer survivors, one focused on family caregivers, and 2 included survivors and family caregivers. Findings identified distinct correlates for illness uncertainty in cancer survivors, including sociodemographic factors (e.g., age, gender, race), stimuli frame (e.g., symptom, family history of cancer), structure providers (e.g., education), coping, and adaptation. Notable effect sizes were observed in the correlations between illness uncertainty and social support, quality of life, depression, and anxiety. Caregivers' illness uncertainty was associated with their race, general health, perception of influence, social support, quality of life, and survivors' prostate-specific antigen levels. Insufficient data precluded examining effect size of correlates of illness uncertainty among family caregivers. CONCLUSION: This is the first systematic review and meta-analysis to summarize the literature on illness uncertainty among adult cancer survivors and family caregivers. Findings contribute to the growing literature on managing illness uncertainty among cancer survivors and family caregivers.

Validation of the TAPS-1: A Four-Item Screening Tool to Identify Unhealthy Substance Use in Primary Care.

BACKGROUND: The Tobacco, Alcohol, Prescription Medication, and Other Substance use (TAPS) tool is a combined two-part screening and brief assessment developed for adult primary care patients. The tool's first-stage screening component (TAPS-1) consists of four items asking about past 12-month use for four substance categories, with response options of never, less than monthly, monthly, weekly, and daily or almost daily. OBJECTIVE: To validate the TAPS-1 in primary care patients. DESIGN: Participants completed the TAPS tool in self- and interviewer-administered formats, in random order. In this secondary analysis, the TAPS-1 was evaluated against DSM-5 substance use disorder (SUD) criteria to determine optimal cut-points for identifying unhealthy substance use at three severity levels (problem use, mild SUD, and moderate-to-severe SUD). PARTICIPANTS: Two thousand adult patients at five primary care sites. MAIN MEASURES: DSM-5 SUD criteria were determined via the modified Composite International Diagnostic Interview. Oral fluid was used as a biomarker of recent drug use. KEY RESULTS: Optimal frequency-of-use cut-points on the self-administered TAPS-1 for identifying SUDs were ≥ monthly use for tobacco and alcohol (sensitivity = 0.92 and 0.71, specificity = 0.80 and 0.85, AUC = 0.86 and 0.78, respectively) and any reported use for illicit drugs and prescription medication misuse (sensitivity = 0.93 and 0.89, specificity = 0.85 and 0.91, AUC = 0.89 and 0.90, respectively). The performance of the interviewer-administered format was similar. When administered first, the self-administered format yielded higher disclosure rates for past 12-month alcohol use, illicit drug use, and prescription medication misuse. Frequency of use alone did not provide sufficient information to discriminate between gradations of substance use problem severity. Among those who denied drug use on the TAPS-1, less than 4% had a drug-positive biomarker. CONCLUSIONS: The TAPS-1 can identify unhealthy substance use in primary care patients with a high level of accuracy, and may have utility in primary care for rapid triage.

Update on Barriers to Pharmacotherapy for Opioid Use Disorders.

PURPOSE OF REVIEW: The recent heroin and prescription opioid misuse epidemic has led to a sharp increase in the number of opioid overdose deaths in the USA. Notwithstanding the availability of three FDA-approved medications (methadone, buprenorphine, and naltrexone) to treat opioid use disorder, these medications are underutilized. This paper provides an update from the recent peer-reviewed literature on barriers to the use of these medications. FINDINGS: These barriers are interrelated and can be categorized as financial, regulatory, geographic, attitudinal, and logistic. While financial barriers are common to all three medications, other barriers are medication-specific. The adverse impact of the current opioid epidemic on public health can be reduced by increasing access to effective pharmacotherapy for opioid use disorder.

Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients.

BACKGROUND: Substance use, a leading cause of illness and death, is underidentified in medical practice. OBJECTIVE: The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool was developed to address the need for a brief screening and assessment instrument that includes all commonly used substances and fits into clinical workflows. The goal of this study was to assess the performance of the TAPS tool in primary care patients. DESIGN: Multisite study, conducted within the National Drug Abuse Treatment Clinical Trials Network, comparing the TAPS tool with a reference standard measure. (ClinicalTrials.gov: NCT02110693). SETTING: 5 adult primary care clinics. PARTICIPANTS: 2000 adult patients consecutively recruited from clinic waiting areas. MEASUREMENTS: Interviewer- and self-administered versions of the TAPS tool were compared with a reference standard, the modified World Mental Health Composite International Diagnostic Interview (CIDI), which measures problem use and substance use disorder (SUD). RESULTS: Interviewer- and self-administered versions of the TAPS tool had similar diagnostic characteristics. For identifying problem use (at a cutoff of 1+), the TAPS tool had a sensitivity of 0.93 (95% CI, 0.90 to 0.95) and specificity of 0.87 (CI, 0.85 to 0.89) for tobacco and a sensitivity of 0.74 (CI, 0.70 to 0.78) and specificity of 0.79 (CI, 0.76 to 0.81) for alcohol. For problem use of illicit and prescription drugs, sensitivity ranged from 0.82 (CI, 0.76 to 0.87) for marijuana to 0.63 (CI, 0.47 to 0.78) for sedatives; specificity was 0.93 or higher. For identifying any SUD (at a cutoff of 2+), sensitivity was lower. LIMITATIONS: The low prevalence of some drug classes led to poor precision in some estimates. Research assistants were not blinded to participants' TAPS tool responses when they administered the CIDI. CONCLUSION: In a diverse population of adult primary care patients, the TAPS tool detected clinically relevant problem substance use. Although it also may detect tobacco, alcohol, and marijuana use disorders, further refinement is needed before it can be recommended broadly for SUD screening. PRIMARY FUNDING SOURCE: National Institute on Drug Abuse.

Assessing the impact of jail-initiated medication for opioid use disorder: A multisite analysis of the SOMATICS collaborative.

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.

Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine (OUTLAST-B): Rationale, Design, and Evolution of a Randomized Controlled Trial.

Background: Despite the effectiveness and growing availability of treatment for opioid use disorder (OUD) with buprenorphine, many people with OUD do not access treatment services. This article describes the rationale, methodological design, evolution, and progress of an ongoing clinical trial of treatment linkage strategies for people with untreated OUD. Methods: The study, titled Opioid Use Disorder Treatment Linkage at Strategic Touchpoints using Buprenorphine (OUTLAST-B), uses "strategic touchpoints", initially sexual health clinics and subsequently broadened to other service venues and participant social networks, for recruitment and screening. Adults with untreated OUD (target N = 360) are randomized to one of the three arms: Usual Care (UC, enhanced with overdose education and naloxone distribution), Patient Navigation (PN), or Patient Navigation with an immediate short-term bridge prescription for buprenorphine (PN + BUP). In the PN and PN + BUP arms, the Patient Navigator works with participants for 2 months to facilitate treatment entry and early retention, resolve barriers (e.g., ID cards, transportation), and provide motivational support. Results: The primary outcome is OUD treatment entry within 30 days of enrollment. Participants are assessed at baseline and followed at 3- and 6-months post-enrollment on measures of healthcare utilization, substance use, and general functioning. Challenges and recruitment adaptations pursuant to the COVID-19 pandemic are discussed. Conclusions: This study could provide insights on how to reach people with untreated OUD and link them to care through non-traditional routes. Trial Registration: The study is registered at ClinicalTrials.gov (NCT04991974).

Culturally sensitive prevention programs for substance use among adolescents of color: A systematic review and meta-analysis of randomized controlled trials.

This systematic review and meta-analysis aims to synthesize the efficacy of culturally sensitive prevention programs for substance use outcomes among U.S. adolescents of color (aged 11 to 18 years old) and explore whether the intervention effects vary by participant and intervention characteristics. Eight electronic databases and grey literature were searched for eligible randomized controlled trials through September 2022. Robust variance estimation in meta-regression was used to synthesize treatment effect size estimates and to conduct moderator analysis. After screening, 30 unique studies were included. The average treatment effect size across all substance use outcomes (including 221 effect sizes) was Hedges's g = -0.20, 95% CI = [-0.24, -0.16]. The synthesized effect sizes were statistically significant across types of substances (alcohol, cigarette, marijuana, illicit and other drugs, and unspecified substance use), racial/ethnic groups (Hispanic, Black, and Native American), and different follow-ups (0-12 months, >12 months). Very few studies reported substance use consequences as outcomes and the synthesized effect size was non-significant. Meta-regression findings suggest that the intervention effects may vary based on the type of substance. This meta-analysis found supportive evidence of culturally sensitive prevention programs' efficacy in preventing or reducing substance use among Black, Hispanic, and Native American adolescents. More substance use prevention efforts and evidence is needed for Asian American, Pacific Islander, and multiracial adolescents.

Sexually Transmitted Infection Testing After Brief Intervention for Risk Behaviors in School-Based Health Centers.

PURPOSE: The initiation and escalation of substance use and sex behaviors is prevalent during adolescence. School-based health centers (SBHCs) are well-equipped to provide interventions for risky behaviors and offer sexually transmitted infection (STI) testing services. This study examined receipt of STI testing following brief intervention (BI) among sexually active adolescents. METHODS: This is a secondary analysis of data from a randomized trial comparing computer versus nurse practitioner-delivered BI approaches among adolescents (ages 14-18) with risky alcohol and/or cannabis use at two SBHCs within two urban high schools. Associations were examined among receipt of STI testing and participant characteristics, BI format, site, and frequency of substance use/sexual behaviors. RESULTS: Among sexually active participants (N = 254), 64.2% received STI testing at their SBHC within 6 months of receiving a BI. Participants receiving nurse practitioner-delivered BI had higher odds of getting STI testing than participants receiving computer-delivered BI (adjusted odds ratio 2.51, 95% confidence interval 1.41-4.47, p = .002). Other variables associated with STI testing in multivariable logistic regression included female sex (p = .001), being in a serious relationship (p = .018), and SBHC site (p < .001). Frequency of substance use and sexual risk behaviors were not independently associated with receipt of STI testing services. CONCLUSION: Sexually active adolescents who received in-person BI from a nurse practitioner were more likely to get STI testing than adolescents who received BI via computer. Nurse practitioners working in SBHCs can successfully engage adolescents in additional sexual health services subsequent to BI for risky behaviors.

Invariance of the Household Food Insecurity Access Scale Across Different Groups of Adolescents and Young Adults.

BACKGROUND: Cross-group comparisons of household food insecurity and its associations using multiple-item scales assume that scale scores can be interpreted as identical across groups. However, scores should not be interpreted as identical across groups without evidence of measurement invariance. Noninvariant measures indicate that the underlying construct may be different across groups. OBJECTIVE: To determine whether the Household Food Insecurity Access Scale (HFIAS) is invariant across different groups of Ghanaian and South African youth aged 15 to 24. METHODS: We analyzed cross-sectional quantitative data from 1437 and 4165 young South Africans and Ghanaians, respectively. Multi-group confirmatory factor analysis was used to examine whether the HFIAS was invariant across different groups of youth, including sex (male or female), age group (middle adolescence, late adolescence, or emerging adulthood), and receipt of child support grant (yes or no). We assessed 3 levels of invariance: configural, metric, and scalar. The model fit between nested models was compared using χ2 difference testing. RESULTS: Invariance tests indicated that the HFIAS had configural, metric, and scalar invariance across different groups of Ghanaian and South African youth. Model fit statistics across all invariance levels indicated good fit of our hypothesized model with the observed data. χ2 difference testing results were not statistically significant across all nested models. CONCLUSIONS: Food insecurity, as measured by the HFIAS, meant the same thing for different groups of Ghanaian and South African youth. Evidence of invariance means that the HFIAS scores could be interpreted as identical across youth groups in our study.

Randomized trial of methadone treatment of arrestees: 24-month post-release outcomes.

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.

Exploring nonprescribed use of buprenorphine in the criminal justice system through qualitative interviews among individuals recently released from incarceration.

BACKGROUND: Buprenorphine treatment remains unavailable in many jails and prisons, but use of nonprescribed (i.e., diverted) buprenorphine has been reported in these settings. The purpose of this analysis is to explore the experiences and motivations behind the use of diverted buprenorphine among recently incarcerated individuals. METHODS: Adults with opioid misuse who were recently released from jail or prison (n= 26; 58% male) completed semi-structured qualitative interviews as part of a study focused on buprenorphine diversion in the criminal justice system. Qualitative interviews explored participants' incarceration experiences and opioid use background, knowledge of buprenorphine and other substance use in jails/prisons, personal use of buprenorphine while incarcerated, reasons for using buprenorphine while incarcerated, and knowledge of how buprenorphine is brought into and acquired in jails/prisons. The study recorded and transcribed interviews, and analyzed the narratives for content related to these predetermined thematic areas. RESULTS: Key themes emerging from the interviews surrounding buprenorphine diversion during incarceration included: 1) the perceived high prevalence of diverted buprenorphine in jail/prison settings, 2) how the perception of prevalence is related to buprenorphine sublingual film formulation, 3) adaptive routes of administration related to the high cost of diverted buprenorphine, and 4) reasons individuals who are incarcerated use diverted buprenorphine (to achieve euphoric effects and cope with confinement, in contrast to using for self-treatment/withdrawal management as is done in the community). CONCLUSION: Participants reported widespread availability of diverted buprenorphine in criminal justice facilities, and characterized reasons for its use specific to these contexts. More research is needed to determine the impact of expanding buprenorphine treatment in jails and prisons on inmates' use of diverted buprenorphine, and future research should explore these intersections as treatment initiation opportunities.

Use of non-prescribed buprenorphine in the criminal justice system: Perspectives of individuals recently released from incarceration.

Buprenorphine, an effective treatment for opioid use disorder (OUD), remains underutilized in many U.S. jails and prisons. However, use of non-prescribed (i.e., diverted) buprenorphine has been reported in these settings. The current study examined non-prescribed buprenorphine use experiences in correctional and community contexts. The study conducted face-to-face interviews with 300 adults with OUD/opioid misuse and recent incarceration, recruited in Baltimore, MD, and New York, NY (n = 150 each). Illicit/non-prescribed opioid use during incarceration was reported by 63% of participants; 39% reported non-prescribed buprenorphine. Non-prescribed buprenorphine was considered the most widely available opioid in jails/prisons in both states (81% reported "very" or "somewhat" easy to get). The average price of non-prescribed buprenorphine in jail/prison was ~10× higher than in the community (p < 0.001). Participants were more likely to endorse getting high/mood alteration as reasons for using non-prescribed buprenorphine during incarceration, but tended to ascribe therapeutic motives to use in the community (e.g., self-treatment; p < 0.001). Multivariable logistic regression analyses showed that different individual-level characteristics were associated with history of non-prescribed buprenorphine use during incarceration and in the community. Use of non-prescribed buprenorphine during incarceration was associated with younger age (p = 0.006) and longer incarceration history (p < 0.001), while use of non-prescribed buprenorphine in the community was associated with MD recruitment site (p = 0.001), not being married (p < 0.001), prior buprenorphine treatment experience (p < 0.001), and housing situation (p = 0.01). These findings suggest that different dynamics and demand characteristics underlie the use of non-prescribed buprenorphine in community and incarceration contexts, with implications for efforts to expand OUD treatment in correctional settings.

Impact of methadone treatment initiated in jail on subsequent arrest.

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.

The relationship between substance misuse and complicated grief: A systematic review.

Complicated grief is a prolonged, bereavement-specific disorder with significant psychological and physical consequences. Although complicated grief represents a risk to individuals with substance misuse, this relationship is poorly understood. Consequently, this systematic literature review examined empirical findings regarding the relationship between substance misuse and complicated grief. We searched 11 databases to identify pertinent quantitative studies published in English. Our search yielded 12 peer-reviewed journal articles (N = 1749) published between 1997 and 2017. Included studies evaluated the prevalence, assessment, etiology, correlates, risk factors, and treatment of complicated grief and substance misuse among individuals with one or both conditions. Our review found evidence of a positive relationship between complicated grief and substance misuse. Individuals with substance misuse were at increased risk for subsequent development of complicated grief, particularly when increases in substance consumption preceded bereavement. Conversely, complicated grief predicted increases in smoking and alcohol dependence. Multiple risk factors for individuals with complicated grief and substance misuse were identified and discussed. An existing complicated grief assessment performed well among individuals with substance misuse, and grief interventions were effective in reducing symptoms of complicated grief and substance misuse simultaneously. Given the severity of consequences associated with both conditions, more research is needed to understand this relationship, identify effective assessment tools, and evaluate intervention strategies to improve outcomes.

Pharmacotherapy for opioid dependence in jails and prisons: research review update and future directions.

PURPOSE: The World Health Organization recommends the initiation of opioid agonists prior to release from incarceration to prevent relapse or overdose. Many countries in the world employ these strategies. This paper considers the evidence to support these recommendations and the factors that have slowed their adoption in the US. METHODS: We reviewed randomized controlled trials (RCTs) and longitudinal/observational studies that examine participant outcomes associated with the initiation or continuation of opioid agonists (methadone, buprenorphine) or antagonists (naltrexone) during incarceration. Papers were identified through a literature search of PubMed with an examination of their references and were included if they reported outcomes for methadone, buprenorphine, or naltrexone continued during incarceration or initiated prior to release in a correctional institution. RESULTS: Fourteen studies were identified, including eight RCTs and six observational studies. One RCT found that patients treated with methadone who were continued on versus tapered off methadone during brief incarceration were more likely to return to treatment upon release. A second RCT found that the group starting methadone treatment in prison versus a waiting list was less likely to report using heroin and sharing syringes during incarceration. A third RCT found no differences in postrelease heroin use or reincarceration between individuals initiating treatment with methadone versus those initiating treatment with buprenorphine during relatively brief incarcerations. Findings from four additional RCTs indicate that starting opioid agonist treatment during incarceration versus after release was associated with higher rates of entry into community treatment and reduced heroin use. Finally, one pilot RCT showed that providing extended-release naltrexone prior to discharge resulted in significantly lower rates of opioid relapse compared to no medication. CONCLUSION: Reasons why uptake of these pharmacotherapies is limited in the US and relatively widespread in Europe are discussed. Recommendations for future research are outlined.

Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial.

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 30days 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.