Faculty Bibliography

Background/UNASSIGNED:Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder. Objective/UNASSIGNED:To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone. Design/UNASSIGNED:Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs. Data Sources/UNASSIGNED:Study instruments. Target Population/UNASSIGNED:Adults with opioid use disorder. Time Horizon/UNASSIGNED:24-week intervention with an additional 12 weeks of observation. Perspective/UNASSIGNED:Health care sector and societal. Interventions/UNASSIGNED:Buprenorphine-naloxone and extended-release naltrexone. Outcome Measures/UNASSIGNED:Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids. Results of Base-Case Analysis/UNASSIGNED:Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective. Results of Sensitivity Analysis/UNASSIGNED:The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation. Limitation/UNASSIGNED:Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs. Conclusion/UNASSIGNED:Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone. Primary Funding Source/UNASSIGNED:National Institute on Drug Abuse, National Institutes of Health.

BACKGROUND:Criminal justice involved (CJS) populations with opioid use disorder (OUD) have high rates of relapse, future arrests, and death upon release. While medication for OUD (MOUD) reduces opioid relapse, concerns regarding diversion and stigma limit treatment in CJS populations. Extended release naltrexone (XR-NTX), as an opioid antagonist, may be more acceptable to CJS administrators. However, the impact of XR-NTX on criminal recidivism remains unknown. METHODS:Arrest data from a published randomized trial comparing XR-NTX to treatment as usual (TAU) was captured by self-report and official state arrest records. Comparisons of future arrests, time to first arrest and total number of arrests were performed using chi square tests and multivariable generalized regression models. Secondary outcomes explored differences in arrests by type and severity of crime, use of opioid and other drugs, and study phase. RESULTS:Of 308 participants randomized, 300 had arrest data. The incidence of arrests did not differ between XR-NTX (47.6%) and TAU (42.5%) participants. (ChiSq p = 0.37). Additionally, there was no significant difference in time to first arrest (adjusted HR 1.35, CI 0.96-1.89) and number of arrests per participant (adjusted IR 1.33, CI 0.78-2.27). Controlling for gender, age, previous criminal activity, and use of non-opioid drugs, logistic regression demonstrated no significant difference in incidence of arrests between groups (adjusted OR 1.38, 95% CI 0.85-2.22). CONCLUSIONS:We detected no significant difference in arrests between CJS participants with OUD randomized to XR-NTX or TAU. Despite its efficacy in reducing opioid use, XR-NTX alone may be insufficient to reduce criminal recidivism.

Background/UNASSIGNED:Smoking remains a major public health burden among persons with opioid and/or alcohol use disorder. Methods/UNASSIGNED:A 49-item semi-structured survey was conducted among urban, inpatient detoxification program patients eliciting demographic and clinical characteristics, smoking profile, technology use patterns, and preferences for adopting technology-based smoking cessation interventions. Multivariate logistic regression models further evaluated the association between participant demographic and clinical characteristics and technology preferences. Results/UNASSIGNED:Participants were mostly male (91%), and admitted for detoxification for alcohol (47%), heroin (31%), or both alcohol and heroin (22%). Past 30-day smoking was reported by 78% of the sample. Mobile phone ownership was common (89%); with an average past-year turnover of 3 mobile phones and 3 phone numbers. Computer ownership was low (28%) and one third reported daily internet use (34%). Telephone (41%) and text message-based interventions (40%) were the most popular platforms to facilitate smoking cessation. Conclusions/UNASSIGNED:Despite concurrent AUD-OUD, most respondents had attempted to quit smoking in the last year and preferred telephone- and text message-based interventions to facilitate smoking cessation. High turnover of mobile phones, phone numbers, and limited access to computers pose barriers to dissemination of technology-based smoking cessation interventions in this vulnerable population.

OBJECTIVES:To estimate the costs of providing extended-release injectable naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX) following inpatient detoxification using data derived from a multisite randomized controlled trial at 8 US community-based treatment programs. STUDY DESIGN:Cost data were collected for 3 intervention phases: program start-up, inpatient detoxification, and up to 24 weeks of medication induction and management visits (post detoxification). Cost analyses were from the healthcare sector perspective (2015 US$); patient costs are also reported. METHODS:We conducted site visits, administered a cost survey to treatment programs, and analyzed study data on medication and services utilization. Nationally representative sources were used to estimate unit costs. Uncertainty was evaluated in sensitivity analyses. RESULTS:Mean start-up costs were $1071 per program for XR-NTX and $828 per program for BUP-NX. Mean costs per participant were $5416 for XR-NTX (57% detoxification, 37% medication, 3% provider, 3% patient) and $4148 for BUP-NX (64% detoxification, 12% medication, 10% provider, 14% patient). Total cost per participant ranged by site from $2979 to $8963 for XR-NTX and from $2521 to $6486 for BUP-NX. CONCLUSIONS:For treatment providers, offering XR-NTX and/or BUP-NX as part of existing detoxification treatment modalities generates modest costs in addition to the costs of detoxification, which vary substantially among the 8 sites. From the patient's perspective, the costs associated with medication management visits may be a barrier for some individuals considering these treatments.

The risk of severe precipitated opioid withdrawal (POW) is amplified when precipitated by a long-acting opioid antagonist. IM extended release naltrexone (XRNTX;Vivitrol®) is an FDA approved therapy to prevent relapse of opioid and alcohol abuse. Two cases of precipitated opioid withdrawal from XRNTX are presented that illustrate different patient reactions to POW. A 56-year-old woman developed a hypertensive emergency and required continuous intravenous vasodilator, clonidine, and intensive care monitoring after re-initiation of XRNTX following opioid relapse. A 25-year-old man developed agitation and altered mental status after receipt of XRNTX at the conclusion of a twelve-day detoxification program during which he continued surreptitious use of heroin. The patient received benzodiazepines and haloperidol without adequate affect, and required intubation with propofol, lorazepam, and dexmedetomidine infusions. Management of POW from XRNTX is a challenge to emergency providers and protocols to guide management do not exist. Recommended therapies include intravenous fluids, anti-emetics, clonidine, or benzodiazepines as well as therapy tailored to the organ system affected. To minimize risk of POW it is important for providers instituting XRNTX to adhere to the manufacturers warnings and clinic protocols including a naloxone challenge and ensure an adequate opioid free period prior to administration of XRNTX.

Individuals must feel free to exert personal control over decisions regarding research participation. We present an examination of participants' perceived personal control over, as well as reported pressures and threats from others, influencing their decision to join a study assessing the effectiveness of extended-release naltrexone in preventing opioid dependence relapse. Most participants endorsed a strong sense of control over the decision; few reported pressures or threats. Although few in number, participants' brief narrative descriptions of the pressures and threats are illuminating and provide context for their perceptions of personal control. Based on this work, we propose a useful set of tools to help ascertain participants' sense of personal control in joining research.