CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder

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.

Conditions

• Opioid-use Disorder
• Medication Adherence
• Health Care Utilization

Interventions

BEHAVIORAL

Behavioral Activation (BA) Therapy

8 sessions of behavioral activation therapy

BEHAVIORAL

Substance Abuse and Health Navigation Counseling

2 standard substance abuse and health navigation counseling

OTHER

Medications for Opioid Use Disorder

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

Sponsors & Collaborators

• Boston University

  collaborator OTHER

• University of Massachusetts, Boston

  collaborator OTHER

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• Rhode Island Hospital

  collaborator OTHER

• Brown University

  lead OTHER

Principal Investigators

• Jaclyn W Hughto, PhD, MPH · Brown University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-15

Primary Completion

2022-02-18

Completion

2022-03-31

Countries

• United States

Study Locations