Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence,
current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an
alarming number of clinics have extensive waitlists for treatment slots. Patients can remain
on these waitlists for years, placing them at elevated risk for illicit drug use, criminal
activity, infectious disease, overdose and mortality during this period. These delays in
treatment access represent a significant barrier to the widespread delivery of effective
opioid treatment, and there is a critical need to develop creative new approaches for
mitigating these delays. Our overarching goal in this application is to develop a novel
Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our
integrative treatment package includes five key components, each strategically chosen to
maximize patient access to pharmacotherapy for opioid dependence while minimizing
nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth
clinical support delivered via Interactive Voice Response, Automated random call-backs for
urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The
Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is
to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in
which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to
receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants
who have not entered treatment by Week 12 will be offered the opportunity to cross over to
IBT at that time, contributing additional within-subject data with which to evaluate the
efficacy of the IBT intervention. The proposed research is innovative in several important
ways: By facilitating the eradication of waitlists for opioid treatment, it 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. The IBT components are highly
novel, both individually and as an integrative interim treatment package for opioid
dependence. This study will be the first to investigate the utility of IBT in the patients
and settings that stand to benefit most from it. The investigators also propose a
multi-pronged dissemination approach that will ensure that our work is readily transported to
clinical practice and will have a direct impact on real-world treatment of opioid dependence.
Taken together, the proposed project will produce a highly innovative technology-assisted
pharmacotherapy protocol that can be widely disseminated to increase access to life-saving
opioid treatment. The overarching and specific aims of this proposal are directly relevant to
NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse
treatment.