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

NCT04240093 | Completed Results

• 3 other identifiers: 1906002463Junior Investigator Award5P20GM125507-02
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder; Medication Adherence; Health Care Utilization

Keywords

Medications for opioid use disorder; Methadone; Buprenorphine; Behavioral Activation

Outcome Measures

Primary Outcomes (2)

• Number of Missed Medication Doses - Past 30 Days

  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, 3 month follow-up, and 6 month follow-up

• Number of Missed Medication-related Visits - Past 30 Days

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

  Baseline, 3 month follow-up, and 6 month follow-up

Secondary Outcomes (1)

• Fentanyl and Opiate-positive Urine Toxicology Screen

  Baseline, 3 month follow-up, and 6 month follow-up

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds

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

Standard of Care

ACTIVE COMPARATOR

Substance Abuse and Health Navigation Counseling (2 sessions) + Meds

Behavioral: Substance Abuse and Health Navigation Counseling; Other: Medications for Opioid Use Disorder

Interventions

Behavioral Activation (BA) Therapy BEHAVIORAL

8 sessions of behavioral activation therapy

Experimental

Substance Abuse and Health Navigation Counseling BEHAVIORAL

2 standard substance abuse and health navigation counseling

Experimental; Standard of Care

Medications for Opioid Use Disorder OTHER

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

Experimental; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• Boston University: collaborator
• University of Massachusetts, Boston: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator
• Rhode Island Hospital: collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Links

• FRESH Research Lab

MeSH Terms

Conditions

Opioid-Related Disorders; Medication Adherence; Patient Acceptance of Health Care

Interventions

Therapeutics; Dosage Forms

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Patient Compliance; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Jaclyn White Hughto, PhD, MPH
• Organization: Brown University

jaclyn_hughto@brown.edu

401-863-6580

Study Officials

• Jaclyn W Hughto, PhD, MPH

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm RTC, randomized 1:1 to two arms: (1) the CoMBAT intervention (behavioral activation and substance abuse/health navigation) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent substance abuse/ health navigation counseling sessions.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: November 15, 2019
• Primary Completion: February 18, 2022
• Study Completion: March 31, 2022
• Last Updated: May 26, 2023
• Results First Posted: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The first time point at which outside investigators may request IPD will be after all of the baseline data has been collected and internal study staff have been offered the availability to write papers or give presentations on particular topics. A similar process will take place for outcome data following publication and release of the outcome paper(s). The PI will store the data indefinitely.
• Access Criteria: Raw data for additional analysis will be available to outside individuals by contacting the Principal Investigator (PI). The PI will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the PI will welcome this collaboration. The PI will allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the PI's web page (see below).

Locations

US (1)