Interim Buprenorphine Treatment to bridge waitlist delays: Stage II evaluation

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PROJECT SUMMARY Despite the efficacy of opioid maintenance and alarming increases in overdose (OD) deaths, waiting lists for treatment persist. During these treatment delays opioid abusers are at risk for illicit drug use, criminal activity, infectious disease, OD and premature death. With a Behavioral & Integrative Treatment Development R34, we have developed an Interim Buprenorphine Treatment (IBT) for waitlisted opioid abusers that includes four key components: Buprenorphine dispensed via secure computerized device; nightly calls from an Interactive Voice Response (IVR) phone system assessing drug use, withdrawal and craving; IVR-generated random call-backs; HIV+Hepatitis Education delivered via iPad. Our Stage I data strongly support the initial efficacy of IBT, with 87%, 87% and 75% of IBT participants abstinent at Weeks 4, 8 and 12 vs. 0%, 0% and 0% of Waitlist Control (WLC) participants (p<.0001). IBT participants are also reporting greater reductions in IV drug use frequency (p<.001) and completing 95% of daily IVR calls and random call-backs. Consistent with the R34 mechanism, our pilot study involved a limited sample size (n=48) and a single academic research clinic. It is important to evaluate whether these extremely promising results are replicated when implemented on a larger scale. Primary Aim: In this Stage II randomized trial, we evaluate IBT efficacy in 200 waitlisted opioid-dependent adults. UVM will serve as the coordinating center and primary recruitment site where we will enroll 100 participants. We will partner with federally qualified health centers in two rural Vermont counties to enroll 50 participants per site. IBT participants will receive the intervention above; WLC participants will remain on waitlists but complete the same 4-, 8- and 12-week assessments. We hypothesize that IBT participants will achieve significantly greater illicit opioid abstinence relative to WLC participants. Secondary Aims: (1) While our pilot study suggests some IBT-related benefits beyond abstinence per se, it was insufficiently powered to examine IBT effects other than abstinence. This trial will permit us to thoroughly examine IBT's broader impacts in important areas of psychosocial functioning. (2) Data from our R34 indicate that education around opioid OD prevention is an area of critical need for these patients. We will develop and evaluate an OD prevention education. (3) While favorable cost-benefit outcomes have been demonstrated for conventional methadone and buprenorphine treatment, no study has investigated the cost effectiveness of IBT. We will conduct economic analyses that will inform providers' decisions around IBT adoption. This project builds directly on the promising results from our Stage I research and is poised to reduce the vast economic and societal costs associated with opioid treatment delays. By facilitating the eradication of waitlists, this project represents a significant departure from the status quo and stands to produce a fundamental shift in how treatment of opioid dependence is conceptualized and delivered.