N/A
N=32
CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
Opioid-use Disorder · Medication Adherence · Health Care Utilization
Bottom Line
View on ClinicalTrials.gov: NCT04240093 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Number of Missed Medication Doses - Past 30 Days — 3.13; 2.81; 3.71; 2.25 Number of missed doses — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation (BA) Therapy (Behavioral); Substance Abuse and Health Navigation Counseling (Behavioral); Medications for Opioid Use Disorder (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Missed Medication Doses - Past 30 Days |
3.13; 2.81; 3.71; 2.25; 1.19; 1.69 | 0.17 |
| PRIMARY Number of Missed Medication-related Visits - Past 30 Days |
1.13; 0.94; 0.14; 0.25; 0.06; 0.06 | 0.90 |
| SECONDARY Fentanyl and Opiate-positive Urine Toxicology Screen |
6; 3; 3; 4; 2; 3 | 0.02 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Initiated medications for opioid use >= 30 day prior to screening
- Current depressive symptoms
- Plans to stay in Rhode Island or Massachusetts for at least 6-months
- Able to read, speak, and understand English
- Willing and able to provide informed consent
Exclusion Criteria
- Does not plan to continue taking medications for opioid use disorder
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Discovery of active suicidal ideation at the time of interview
- In the second or third trimester of pregnancy
Data sourced from ClinicalTrials.gov (NCT04240093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.