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

Not Applicable

Completed

Conditions: Health Care Utilization
Medication Adherence
Opioid-use Disorder

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

Registration Number: NCT04240093

Lead Sponsor: Brown University

Brief 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.

Detailed Description: Opioid use disorder (OUD) is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medications for opioid use disorder (i.e., methadone; buprenorphine) have been shown to reduce opioid use in diverse populations; however, long-term use of these medications and engagement in care are often suboptimal. Depression has been shown to contribute to medication discontinuation and care disengagement. Behavioral activation (BA) therapy is an evidence-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression and build the capacity to navigate life challenges, pairing BA with medications for OUD could help to ensure continued engagement in care and improve OUD treatment outcomes.

This study, therefore, seeks to determine the feasibility of study procedures, enhance participant acceptability, and demonstrate preliminary efficacy of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. The investigators will enroll individuals currently being treated with methadone or buprenorphine for OUD in a pilot randomized controlled trial (RCT) of the CoMBAT intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 8-session CoMBAT intervention; or 2) standard of care. The primary outcome is engagement in care. Secondary outcomes include self-reported days of opioid use and opioid-positive urinalysis. Intervention feasibility and acceptability will also be assessed. Participants will complete major assessment visits (survey and toxicology testing) at baseline and 3- and 6-months post-randomization.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Behavioral Activation (BA) Therapy	Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Experimental	Substance Abuse and Health Navigation Counseling	Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Experimental	Medications for Opioid Use Disorder	Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Standard of Care	Medications for Opioid Use Disorder	Substance Abuse and Health Navigation Counseling (2 sessions) + Meds
Standard of Care	Substance Abuse and Health Navigation Counseling	Substance Abuse and Health Navigation Counseling (2 sessions) + Meds

Primary Outcome Measures

Name	Time	Method
Number of Missed Medication-related Visits - Past 30 Days	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.
Number of Missed Medication Doses - Past 30 Days	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.

Secondary Outcome Measures

Name	Time	Method
Fentanyl and Opiate-positive Urine Toxicology Screen	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)