Faculty Bibliography

This study aims to describe which substance use service (SUS) organizations and who within these organizations support the maintenance of policies targeted at improving substance use treatment services. An online survey assessing respondent, organizational and program demographics, and knowledge and support regarding policy changes was distributed to all certified SUS and harm reduction programs in NYS. Bivariate and latent class analyses were used to identify patterns and associations to policy choices. Across the 227 respondents, there was a support for maintaining expansion of insurance coverage, virtual behavioral health/counseling and medication initiation/maintenance visits, reductions in prior authorizations, and access to prevention/harm reduction services. Three classes of support for policies were derived: (1) high-supporters (n = 49; 21%), (2) low-supporters (n = 66; 29%), and (3) selective-supporters. Having knowledge of policy changes was associated with membership in the high-supporters class. Implications regarding the role of knowledge in behavioral health policies dissemination structures, decision-making, and long-term expansion of SUS are discussed.

BACKGROUND:Medications for the treatment of opioid use disorder, such as buprenorphine, are effective and essential for addressing the opioid epidemic. However, high dropout rates from medication remain a challenge. Behavioral treatment with contingency management and cognitive behavioral counseling has shown promise for improving the outcomes of buprenorphine treatment but is complicated to deliver. The delivery of behavioral treatment through technology-based platforms has the potential to make it more feasible for widespread dissemination. OBJECTIVE:reSET-O is a prescription digital therapeutic and a commercial adaptation of the Therapeutic Education System, an internet-based program with a Community Reinforcement Approach to cognitive behavioral therapy. It delivers cognitive behavioral therapy modules and contingency management rewards upon completion of modules and negative urine drug screens. This pilot study aims to assess the feasibility and acceptability of reSET-O in a community-based opioid treatment program with a Hub and Spoke model of care as part of a larger strategy to maintain individuals in treatment. Objective and qualitative results, as well as acceptability and likeability of reSET-O, were obtained from 15 individuals. METHODS:English-speaking individuals aged ≥18 years with a diagnosis of current opioid use disorder were recruited after being on buprenorphine for at least 1 week of treatment. Two 12-week prescriptions for reSET-O were written for the 24-week study. Patient reports of drug use and likeability scales of reSET-O were conducted at weeks 4, 8, 12, and 24 of the study. Qualitative interviews were also conducted. A total of 4 providers were recruited and provided feedback on the acceptability and feasibility of reSET-O. RESULTS:Of the 15 participants who participated in this pilot study, 7 (47%) completed 24 weeks, and 8 (53%) were unable to complete because of dropout after enrollment, attrition in treatment, or incarceration. An average of US $96 in contingency management rewards were earned by participants for the completion of modules for the duration of the pilot study. Participants' subjective feedback revealed that reSET-O was easy to use, enjoyable, and helped provide a safe space to admit recurring substance use. CONCLUSIONS:reSET-O was well accepted based on patient and provider feedback in this pilot study; however, adherence and retention in treatment remain areas for improvement. Randomized control trials are needed to assess whether retention of community-based buprenorphine treatment is enhanced through the use of technology-based behavioral interventions such as reSET-O.

BACKGROUND:Extended-release injectable naltrexone (XR-naltrexone) is effective for treatment of patients with opioid use disorder (OUD), but initiation remains a barrier due to the challenge of tolerating opioid withdrawal prior to administration. Understanding factors associated with successful initiation of XR-naltrexone could facilitate its implementation through patient-treatment matching. METHODS:We combined data from five consecutive studies that sought to initiate patients with active opioid use onto XR-naltrexone using a rapid procedure consisting of minimal buprenorphine, non-opioid medications for treating opioid withdrawal, and ascending low doses of oral naltrexone. Associations between patient characteristics and initiating naltrexone were estimated with logistic regression models. To evaluate whether associations differed between inpatient and outpatient settings, patient characteristic-by-setting interactions were also estimated. RESULTS:409 patients were included in the analyses and 228 (56%) received the first injection. A significantly greater percent of inpatients (62%) vs outpatients (48%) initiated XR-naltrexone. Initiation success was significantly more likely on an inpatient basis for heroin (60.9% inpatient vs 36.2% outpatient), intravenous (56.3% inpatient vs 22.5% outpatient), and speedball users (68.1% inpatient vs 32.3% outpatient). Prescription opioid users showed similar, higher initiation rates across settings (68.9% inpatient; 73.7% outpatient). CONCLUSIONS:An inpatient setting may be the preferred strategy for rapid initiation of XR-naltrexone for opioid users with greater severity, including heroin or speedball injection users or those who use opioids intravenously. Initiation on an outpatient basis may be more likely to succeed for prescription opioid users.

BACKGROUND:To address the US opioid epidemic, there is an urgent clinical need to provide persons with opioid use disorder (OUD) with effective medication treatments for OUD (MOUD). Formulations of sublingual buprenorphine/naloxone (SL-BUP/NLX) are considered the standard of care for OUD including within the Veterans Healthcare Administration (VHA). However, poor retention on MOUD undermines its effectiveness. Long-acting injectable monthly buprenorphine (INJ-BUP) (e.g., Sublocade®) has the potential to improve retention and therefore reduce opioid use and overdose. Designing and conducting studies for OUD pose unique challenges. The strategies and solutions to some of these considerations in designing Cooperative Studies Program (CSP) 2014, Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE), a randomized, 20-site, clinical effectiveness trial comparing INJ-BUP to SL-BUP/NLX conducted within the VHA may provide valuable guidance for others confronted with similar investigation challenges. METHODS:This 52-week, parallel group, open-label, randomized controlled trial (RCT) evaluates the comparative effectiveness of two current FDA-approved formulations of buprenorphine: (1) daily SL-BUP/NLX vs. (2) monthly (28-day) INJ-BUP for Veterans with moderate to severe OUD (n = 952). The primary outcomes are (1) retention in MOUD and (2) opioid abstinence. Secondary outcomes include measures of other drug use, psychiatric symptoms, medical outcomes including prevalence rates of HIV, hepatitis B and C as well as social outcomes (housing instability, criminal justice involvement), service utilization and cost-effectiveness. Special considerations in conducting a comparative effectiveness trial with this population and during COVID-19 pandemic were also included. DISCUSSION:The evaluation of the extended-release formulation of buprenorphine compared to the standard sublingual formulation in real-world VHA settings is of paramount importance in addressing the opioid epidemic. The extent to which this new treatment facilitates retention, decreases opioid use, and prevents severe sequelae of OUD has not been studied in any long-term trial to date. Positive findings in this trial could lead to widespread adoption of MOUD, and, if proven superior INJ-BUP, by clinicians throughout the VHA and beyond. This treatment has the potential to reduce opioid use among Veterans, improve medical, psychological, and social outcomes, and save lives at justifiable cost. Trial registration Registered at Clinicaltrials.gov NCT04375033.

BACKGROUND:Methamphetamine use is increasing among persons with opioid use disorder (OUD). The study aims were to describe methamphetamine/amphetamine (MA/A) use among patients treated for OUD with buprenorphine/naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and to explore associations between treatment arm and MA/A use. METHODS:Secondary analysis of data from a multi-site, open-label, randomized controlled trial of XR-NTX versus BUP-NX for 24 weeks. The outcome variable was MA/A use defined by either positive urine drug toxicology or self-report. The main predictor was treatment assignment (BUP-NX v. XR-NTX). Longitudinal mixed-effects logistic regression models were fit to model the odds of MA/A use during the study. Additional predictors included study visit and baseline MA/A use. RESULTS:Among the sample of 570 participants with OUD, baseline use of MA/A was observed in 105 (18.4%). There was no significant treatment effect over the study period, though BUP-NX subjects, on average, had about half the odds of MA/A use compared to XR-NTX subjects (OR=0.50; p = 0.051). In the same model, baseline MA/A use and study visit were both significantly associated with MA/A use over time. CONCLUSION:In this sample of treated OUD patients, nearly a fifth of participants had MA/A use at baseline and the frequency of use did not decline over time: in fact, the odds of use slightly increased for each later visit. These secondary analyses found no significant difference in MA/A use between BUP-NX and XR-NTX treatment arms, however, the observation of less MA/A in the buprenorphine arm merits further investigation. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov (NCT02032433).

In this paper, we present a method for conducting global sensitivity analysis of randomized trials in which binary outcomes are scheduled to be collected on participants at prespecified points in time after randomization and these outcomes may be missing in a nonmonotone fashion. We introduce a class of missing data assumptions, indexed by sensitivity parameters, which are anchored around the missing not at random assumption introduced by Robins (Statistics in Medicine, 1997). For each assumption in the class, we establish that the joint distribution of the outcomes is identifiable from the distribution of the observed data. Our estimation procedure uses the plug-in principle, where the distribution of the observed data is estimated using random forests. We establish

INTRODUCTION:Due to the COVID-19 pandemic, regulations for substance use services changed to accommodate stay-at-home orders and physical distancing guidelines. METHODS:Using in-depth interviews (N = 14) and framework analysis, we describe how policymakers developed, adopted, and implemented regulations governing services for substance use disorders during COVID-19, and how policymakers' perceived the impacts of these regulations in New York State. RESULTS:During the COVID-19 pandemic, policymakers shifted to more inclusive approaches of knowledge generation and co-production of recommendations. Barriers to adoption and implementation of new regulations included medication/services supply, lack of integration, stigma, and overcriminalization. CONCLUSION:Findings from this study highlight the potential feasibility and benefits of co-produced policies for substance use services and the need for consistent service supply, better integration with health care services, reduced stigma, improved funding structures, best practice guidelines, criminal justice reform, and harm reduction support. These considerations should inform future policy maintenance and modifications to substance use services related to COVID-19.