Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access

NCT02360007 | Completed Phase 1

• 1 other identifier: CHRMS 14-063
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-related Disorders

Keywords

opioids; buprenorphine; interim treatment; opioid dependence

Outcome Measures

Primary Outcomes (1)

• Illicit opioid abstinence

  IBT and WLC experimental groups will be compared on percentage of subjects abstinent for illicit opioids across Week 4, 8, and 12 assessments

  12 weeks

Secondary Outcomes (1)

• ASI subscale scores

  12 weeks

Study Arms (2)

Interim Buprenorphine Treatment

EXPERIMENTAL

IBT participants will visit the clinic every 2 weeks while receiving the IBT package. Our integrative IBT treatment package includes five key components, each strategically chosen to maximize patient access to pharmacotherapy for opioid dependence while minimizing nonadherence, abuse and diversion: (1) Buprenorphine (BUP), (2) Computerized adherence monitoring (CAM), (3) Mobile health clinical support, (4) Urinalysis and adherence monitoring, and (5) HIV+Hepatitis Education.

Drug: Interim Buprenorphine Treatment (IBT)

Waitlist Control

NO INTERVENTION

WLC participants will remain on the waitlist for their treatment of choice but complete the same scheduled follow-up assessments as IBT participants.

Interventions

Interim Buprenorphine Treatment (IBT) DRUG

The Interim Buprenorphine Treatment (IBT) includes: 1. Buprenorphine (BUP) 2. Computerized adherence monitoring (CAM): BUP will be dispensed via a portable device that makes each day's dose available only at a predetermined time. 3. Mobile health clinical support: An Interactive Voice Response (IVR) system to deliver clinical support 4. Urinalysis and adherence monitoring with participants contacted via IVR for random call-backs 5. HIV+Hepatitis Education delivered via iPad

Interim Buprenorphine Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To minimize disruption due to treatment becoming available during the study, we will limit enrollment to those who joined a waitlist in the prior 12 months.

You may not qualify if:

• Those with a significant psychiatric or medical illness that may interfere with consent or participation will be excluded, as will those who are pregnant or nursing.
• Females will be tested for pregnancy and, should a participant become pregnant during the trial, her participation will be terminated and she will be assisted with accessing treatment at the high-risk pregnancy clinic.
• Those dependent on sedative-hypnotics will be excluded, due to the medical risks and notably low success rates with sedative-dependent opioid abusers (Stitzer \& Chutuape, 1999).

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

Substance Abuse Treatment Center, University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Streck JM, Ochalek TA, Badger GJ, Sigmon SC. Interim buprenorphine treatment during delays to comprehensive treatment: Changes in psychiatric symptoms. Exp Clin Psychopharmacol. 2018 Aug;26(4):403-409. doi: 10.1037/pha0000199. Epub 2018 Jun 25.

  PMID: 29939049 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fletcher Allen Health Care

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 10, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2018-04

Locations

US (1)