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 perod. 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 th patients and settings that stand to benefit most from it. We 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.

Public Health Relevance

Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence, an alarming number of clinics, both nationally and internationally, have extensive waitlists for treatment slots. We propose to leverage efficacious pharmacotherapy, state-of-the-art technology and rigorous methodology to develop a novel Interim Buprenorphine Treatment that can bridge these delays in treatment access. 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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Planning Grant (R34)
Project #
5R34DA037385-02
Application #
8825482
Study Section
Special Emphasis Panel (ZRG1-RPIA-N (09))
Program Officer
Aklin, Will
Project Start
2014-04-01
Project End
2016-03-31
Budget Start
2015-04-01
Budget End
2016-03-31
Support Year
2
Fiscal Year
2015
Total Cost
$325,969
Indirect Cost
$112,219
Name
University of Vermont & St Agric College
Department
Psychiatry
Type
Schools of Medicine
DUNS #
066811191
City
Burlington
State
VT
Country
United States
Zip Code
05405
Parker, Maria A; Ochalek, Taylor A; Rose, Gail L et al. (2018) Feasibility of an interactive voice response system for daily monitoring of illicit opioid use during buprenorphine treatment. Psychol Addict Behav 32:956-960
Streck, Joanna M; Ochalek, Taylor A; Badger, Gary J et al. (2018) Interim buprenorphine treatment during delays to comprehensive treatment: Changes in psychiatric symptoms. Exp Clin Psychopharmacol 26:403-409
Ochalek, Taylor A; Heil, Sarah H; Higgins, Stephen T et al. (2018) A novel mHealth application for improving HIV and Hepatitis C knowledge in individuals with opioid use disorder: A pilot study. Drug Alcohol Depend 190:224-228
Brooklyn, John R; Sigmon, Stacey C (2017) Vermont Hub-and-Spoke Model of Care for Opioid Use Disorder: Development, Implementation, and Impact. J Addict Med 11:286-292
Dunn, Kelly E; Barrett, Frederick S; Yepez-Laubach, Claudia et al. (2016) Opioid Overdose Experience, Risk Behaviors, and Knowledge in Drug Users from a Rural versus an Urban Setting. J Subst Abuse Treat 71:1-7
Dunn, Kelly E; Barrett, Frederick S; Herrmann, Evan S et al. (2016) Behavioral risk assessment for infectious diseases (BRAID): Self-report instrument to assess injection and noninjection risk behaviors in substance users. Drug Alcohol Depend 168:69-75
Sigmon, Stacey C; Ochalek, Taylor A; Meyer, Andrew C et al. (2016) Interim Buprenorphine vs. Waiting List for Opioid Dependence. N Engl J Med 375:2504-2505
Sigmon, Stacey C (2016) Additive burdens of malnutrition, poverty, and substance abuse. Lancet 388:1879-1880
Dunn, Kelly E; Saulsgiver, Kathryn A; Miller, Mollie E et al. (2015) Characterizing opioid withdrawal during double-blind buprenorphine detoxification. Drug Alcohol Depend 151:47-55
Sigmon, Stacey C; C Meyer, Andrew; Hruska, Bryce et al. (2015) Bridging waitlist delays with interim buprenorphine treatment: initial feasibility. Addict Behav 51:136-42

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