CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Behavioral Activation (BA) Therapy +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04240093
NCT04240093N/ACompleted

CoMBAT Opioid Use Disorder: A Pilot Randomized Controlled Trial of a Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder

Brown University·interventional·Posted Jan 27, 2020·Updated May 26, 2023

In Brief

A clinical study evaluating Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling, and 1 other intervention for Opioid-use Disorder and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance abuse and health navigation counseling for individuals who are receiving medications for opioid use disorder (i.e., methadone; suboxone) to help them improve engagement in care and opioid use treatment outcomes. Participants will be randomized 1:1 to two arms: (1) the CoMBAT intervention (2 sessions of substance abuse and health navigation counseling + 8 sessions of BA counseling); or the (3) the standard of care (SOC) comparison condition, including two equivalent substance abuse and health navigation counseling. Participants will be followed for 6 months post-randomization, with assessments at months 3 and 6.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 27, 2020
Enrollment StartNov 15, 2019
Primary CompletionFeb 18, 2022
Study CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.4 years ago

Interventions

Behavioral Activation (BA) Therapybehavioral

8 sessions of behavioral activation therapy

Substance Abuse and Health Navigation Counselingbehavioral

2 standard substance abuse and health navigation counseling

Medications for Opioid Use Disorderother

Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).