NCT04240093: CoMBAT_OUD

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

Completed NA Results posted Last updated 26 May 2023

What this trial tests

NA trial testing Behavioral Activation (BA) Therapy in Opioid-use Disorder in 44 participants. Completed in 31 March 2022.

Timeline

15 November 2019

Primary endpoint
18 February 2022

31 March 2022

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	15 November 2019
Primary completion	18 February 2022
Estimated completion	31 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Behavioral Activation (BA) Therapy
• Substance Abuse and Health Navigation Counseling
• Medications for Opioid Use Disorder

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →
• Medication Adherence — all drugs for Medication Adherence →
• Health Care Utilization — all drugs for Health Care Utilization →

Sponsor

Brown University

Who can join

18 and older, any sex, with Opioid-use Disorder or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Missed Medication Doses - Past 30 Days Primary · Baseline, 3 month follow-up, and 6 month follow-up

Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.

Baseline

Group	Value	95% CI
CoMBAT (Experimental)	3.13	± 3.48
Standard of Care (SOC; Control)	2.81	± 3.00

3 Month Follow-Up

Group	Value	95% CI
CoMBAT (Experimental)	3.71	± 4.41
Standard of Care (SOC; Control)	2.25	± 3.00

6 Month Follow-Up

Group	Value	95% CI
CoMBAT (Experimental)	1.19	± 2.43
Standard of Care (SOC; Control)	1.69	± 4.29

Number of Missed Medication-related Visits - Past 30 Days Primary · Baseline, 3 month follow-up, and 6 month follow-up

Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.

Baseline

Group	Value	95% CI
CoMBAT (Experimental)	1.13	± 1.20
Standard of Care (SOC; Control)	0.94	± 0.85

3 Month Follow-Up

Group	Value	95% CI
CoMBAT (Experimental)	0.14	± 0.36
Standard of Care (SOC; Control)	0.25	± 0.45

6 Month Follow-Up

Group	Value	95% CI
CoMBAT (Experimental)	0.06	± 0.03
Standard of Care (SOC; Control)	0.06	± 0.35

Fentanyl and Opiate-positive Urine Toxicology Screen Secondary · Baseline, 3 month follow-up, and 6 month follow-up

Fentanyl or opiate-positive urine screen (opiates refer to natural opioids such as heroin, morphine so buprenorphine, methadone, and other synthetic opioids are not included)

Baseline

Group	Value	95% CI
CoMBAT (Experimental)	6
Standard of Care (SOC; Control)	3

3 Month Follow-Up

Group	Value	95% CI
CoMBAT (Experimental)	3
Standard of Care (SOC; Control)	4

6 Month Follow-Up

Group	Value	95% CI
CoMBAT (Experimental)	2
Standard of Care (SOC; Control)	3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An initial randomized controlled trial of a Combined Medication and Behavioral Activation Treatment (CoMBAT) for people with opioid use disorder.
   Hughto JMW, Hughes LD, Nelson KM, Perry NS, et al · · 2025 · cited 1× · PMID 39672333 · DOI 10.1016/j.josat.2024.209602