Recruiting
Phase 2

Buprenorphine

Sponsor:

University of Vermont

Code:

NCT03420313

Conditions

Opioid-use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Buprenorphine/naloxone sublingual tablets

Study Details

Brief 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.

Conditions

Opioid-use Disorder

Study ID

NCT03420313

Start date

Mar 1, 2018

Status verified date

May, 2019

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • For inclusion, participants must be >=18 years old, in good health, meet DSM-V criteria for opioid use disorder, provide an opioid-positive urine and be currently waitlisted with a community opioid treatment clinic or provider.

Exclusion Criteria:

  • 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. 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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interim Buprenorphine Treatment

Interim Buprenorphine Treatment includes (a) Maintenance treatment with Buprenorphine/ naloxone sublingual tablets with bi-monthly clinic visits for observed dosing and the remaining doses dispensed at home via a secure computerized portable device (Med-O-Wheel, Addoz, Finland).

(b) nightly calls from an automated Interactive Voice Response (IVR) phone system to assess any drug use, withdrawal and craving, (c) IVR-generated random call-backs for urinalysis and pill counts, and (d) HIV+Hepatitis education delivered via iPad. (e) monthly follow-up assessments

no intervention: Waitlist Control

Waitlist Control participants will remain on the waitlist for their treatment of choice but complete the same monthly assessments.

Interventions

Buprenorphine/naloxone sublingual tablets

24-week maintenance with buprenorphine/naloxone sublingual tablets (plus other technology-assisted components described previously)

Primary outcome measure

  • Illicit opioid abstinence [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Stacey C Sigmon, PhD

802-656-9987ssigmon@uvm.edu

Locations

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Contacts

More Information

Sponsor

University of Vermont

Last update posted

May 3, 2019

Last verified

May, 2019

Keywords

  • buprenorphine
  • waitlist
  • interim treatment
  • opioid use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2019-05-03.