Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation
Status:
Unknown status
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
Despite the demonstrated effectiveness of agonist treatment for opioid dependence and
alarming recent increases in overdose deaths, waiting lists for treatment persist. In a
Behavioral & Integrative Treatment Development pilot study, the investigators demonstrated
the initial efficacy a novel Interim Buprenorphine Treatment (IBT) to mitigate the risks
(e.g., illicit opioid use, IV drug use) associated with treatment delays. However, consistent
with that R34 mechanism, our initial pilot study involved a limited sample size and was
conducted at a single academic, well-controlled research clinic with an extensive history of
research. It is important to replicate these very positive pilot results and begin to
evaluate whether they generalize to less-controlled rural environments that are being so
adversely impacted by the current opioid abuse epidemic. In this Stage II randomized parallel
two-group trial, the investigators will evaluate the efficacy of IBT using a larger sample of
100 waitlisted opioid-dependent adults (50 IBT, 50 WLC). UVM will serve as the coordinating
center and we will aim to partner with health centers and other convenience sites in rural
Vermont counties to conduct study visits while overcoming barriers commonly encountered in
rural areas (e.g., transportation issues, socioeconomic barriers). The proposed research
builds directly on the promising Stage I results and has the potential to substantially
reduce the vast individual and societal costs associated with opioid treatment delays.
Phase:
Phase 2
Details
Lead Sponsor:
University of Vermont
Treatments:
Buprenorphine Buprenorphine, Naloxone Drug Combination Naloxone