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NCT04240093 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Brown University.

Completed
Registry status
NA
Development phase
44
Enrollment target

NCT04240093 is a NA study that has completed, run by Brown University. The registered enrollment target is 44 participants.

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The verdict

NCT04240093, a NA study, has completed, sponsored by Brown University.

COMPLETED
Registry status
NA
Development phase
44 participants
Enrollment target

Study 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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2019-11-15
Est. Completion 2022-03-31
Phase NA

Sponsor

Brown University

231 total trials

What the Registry Record Tells You About NCT04240093

The ClinicalTrials.gov registry entry for NCT04240093 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Behavioral Activation (BA) Therapy is the first listed.

NCT04240093 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04240093 about?

NCT04240093 is a clinical study titled "CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder". 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 receivin...

What is the current status of trial NCT04240093?

This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2019-11-15. Estimated completion is 2022-03-31.

What interventions are being tested in trial NCT04240093?

The interventions under investigation include: Behavioral Activation (BA) Therapy (BEHAVIORAL), Substance Abuse and Health Navigation Counseling (BEHAVIORAL), Medications for Opioid Use Disorder (OTHER).

Who is sponsoring clinical trial NCT04240093?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.