An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder (OVERCOME 2)

February 4, 2026 updated by: Prisma Health-Upstate

Prisma Health Clemson University

The Overcome II study is a randomized controlled trial among adults receiving sublingual buprenorphine to help prevent or reduce illicit drug use. The study outcomes will be compared between three treatment arms: (1) sublingual buprenorphine only, which is the standard-of-treatment (2) sublingual buprenorphine with a computer-based cognitive behavior therapy for substance use disorders (CBT4CBT), (3) sublingual buprenorphine with CBT4CBT and peer recovery coaching. The primary outcome of interest is the reduction in the proportion of positive results for saliva toxicology screenings for any drug during the 8-week treatment period. Study participants will also be assessed for the outcomes of retention to standard-of-treatment and illicit drug use at 1-, 3-, and 6-months follow-ups after the end of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Buprenorphine has proven to be an effective pharmacologic strategy for treating OUD. However, buprenorphine is unlikely to give greater overall protection because of the shorter duration of treatment. There is a need for studies on interventions that could increase retention to buprenorphine, especially among those with ongoing illicit substance and polysubstance use.

Using a randomized controlled trial study design, the Overcome II study aims to investigate the incremental benefit in terms of reduction in illicit drug use and retention in standard of treatment due to providing the peer recovery coach and/or CBT4CBT interventions as a compliment to standard-of-treatment among persons receiving medication for opioid use. The study outcomes will be compared between three treatment arms: (1) sublingual buprenorphine only, which is the standard-of-treatment (2) sublingual buprenorphine with CBT4CBT, (3) sublingual buprenorphine with CBT4CBT and peer recovery coaching. The primary outcome of interest is reduction in the proportion of positive results for saliva toxicology screenings for any drug during the 8-week treatment period. Study participants will also be assessed for the outcomes of retention to standard-of-treatment and illicit drug use at 1-, 3-, and 6-months follow-ups after the end of treatment. The institutional review board at Prisma Health will provide the oversight for the ethical conduct of the study. Potential participants at Prisma Health will be screened for eligibility, will undergo the informed consent procedure, and eligible persons who consent to participation will be recruited into the study.

The participants will be randomized of one of the three treatment arms in a 1:1:1 ratio. The study will aim to recruit 30 participants per treatment arm. Study procedures will be conducted both virtually and at research facilities of the Prisma Health Addiction Medicine Center, in Greenville, SC. Participants will attend the research visits once a week during the first eight weeks (sessions 1 to 8), and 1-, 3-, and 6- months after the end of treatment.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults (≥18 years of age);
  2. DSM-V diagnosis of OUD, confirmed via electronic medical record review;
  3. Currently receiving SL buprenorphine/ naloxone and/or buprenorphine HCL;
  4. Initiated SL buprenorphine within the last 30 days;
  5. Willing to accept a random assignment to either treatment arm:
  6. Adequate computer skills

Exclusion Criteria:

  1. Severe medical or psychiatric disability that could impair the ability to perform study related activities (determined by the clinician);
  2. Pregnancy, planning conception, or breast-feeding for female participants;
  3. Inability to independently read and/or comprehend the consent form or other study materials;
  4. Inability to read/speak English (inability to independently read and comprehend the consent form or other study materials);
  5. Current suicidal ideation based on the Patient Health Questionnaire-9
  6. Have taken or received any prescribed buprenorphine product within 30 days prior to the current treatment episode.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly, bi-weekly or monthly visits (at the discretion of the provider) in-person or virtually. This condition will be matched with the other conditions in terms of the number of research visits.
Behavioral: Sandard of care
Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly, bi-weekly or monthly visits (at the discretion of the provider) in-person or virtually. This condition will be matched with the other conditions in terms of the number of research visits.
Experimental: Standard of care + CBT4CBT
This condition will integrate the standard of care and CBT4CBT interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs: (1) Introduction to functional analysis of substance use; (2) strategies for recognizing and coping with craving; (3) refusal skills and assertiveness; (4) training in problem-solving skills; (5) strategies for recognizing and changing thoughts; (6) decision-making skills; (7) how to use CBT skills to reduce HIV/ HCV risk. Each module takes 30 minutes to complete and has a format, which includes on-screen narration, animation, quizzes, and interactive exercises to teach and model effective use of skills. Modules end with a practice exercise.
Behavioral: CBT4CBT
This condition will integrate the standard of care and CBT4CBT interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs: (1) Introduction to functional analysis of substance use; (2) strategies for recognizing and coping with craving; (3) refusal skills and assertiveness; (4) training in problem-solving skills; (5) strategies for recognizing and changing thoughts; (6) decision-making skills; (7) how to use CBT skills to reduce HIV/ HCV risk. Each module takes 30 minutes to complete and has a format, which includes on-screen narration, animation, quizzes, and interactive exercises to teach and model effective use of skills. Modules end with a practice exercise.
Other Names:
  • CBT4CBT-Buprenorphine
Experimental: Standard of care + CBT4CBT+ RC
This condition will integrate the standard of care, CBT4CBT, and recovery coaching services with Assertive Community Engagement (ACE) model interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs Peer recovery coaching services involve a form of nonclinical, peer support aimed at helping individuals with substance use disorders to achieve and maintain recovery. Recovery coaches are individuals with experience with substance use and successful recovery. In addition to their lived experience, recovery coaches obtain formal training on substance use coaching and receive ongoing supervision. The recovery coaches use an assertive engagement approach to provide holistic, person-centered, and strength-based support.
Behavioral: CBT4CBT
This condition will integrate the standard of care and CBT4CBT interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs: (1) Introduction to functional analysis of substance use; (2) strategies for recognizing and coping with craving; (3) refusal skills and assertiveness; (4) training in problem-solving skills; (5) strategies for recognizing and changing thoughts; (6) decision-making skills; (7) how to use CBT skills to reduce HIV/ HCV risk. Each module takes 30 minutes to complete and has a format, which includes on-screen narration, animation, quizzes, and interactive exercises to teach and model effective use of skills. Modules end with a practice exercise.
Other Names:
  • CBT4CBT-Buprenorphine
Behavioral: RC
Peer recovery coaching services involve a form of nonclinical, peer support aimed at helping individuals with substance use disorders to achieve and maintain recovery. Recovery coaches are individuals with experience with substance use and successful recovery. In addition to their lived experience, recovery coaches obtain formal training on substance use coaching and receive ongoing supervision. The recovery coaches use an assertive engagement approach to provide holistic, person-centered, and strength-based support.
Other Names:
  • Recovery Coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug use
Time Frame: 8 weeks
The percentage of of saliva toxicology screens positive for all drugs during the 8 initial study weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buprenorphine retention at 3-month follow-up
Time Frame: 20 weeks
Retention to buprenorphine
20 weeks
Buprenorphine retention at 6-month follow-up
Time Frame: 32 weeks
Retention to buprenorphine
32 weeks
Drug use
Time Frame: 12 weeks
The percentage of saliva toxicology screens positive for all drugs at 1 month follow-up
12 weeks
Drug use
Time Frame: 20 weeks
The percentage of saliva toxicology screens positive for all drugs at 3 month follow-up
20 weeks
Drug use
Time Frame: 32 weeks
The percentage of saliva toxicology screens positive for all drugs at 6 month follow-up
32 weeks
Opioid use
Time Frame: 8 weeks
The percentage of saliva toxicology screens positive for opioids during the 8 initial study weeks
8 weeks
Opioid use
Time Frame: 12 weeks
The percentage of saliva toxicology screens positive for opioids at 1 month follow-up
12 weeks
Opioid use
Time Frame: 20 weeks
The percentage of saliva toxicology screens positive for opioids at 3- month follow-up
20 weeks
Opioid use
Time Frame: 32 weeks
The percentage of saliva toxicology screens positive for opioids at 6- month follow-up
32 weeks
Self-report drug use
Time Frame: 8 weeks
Self-report drug use in the past 30 days (yes/no)
8 weeks
Self-report drug use
Time Frame: 12 weeks
Self-report drug use in the past 30 days (yes/no)
12 weeks
Self-report drug use
Time Frame: 20 weeks
Self-report drug use in the past 30 days (yes/no)
20 weeks
Self-report drug use
Time Frame: 32 weeks
Self-report drug use in the past 30 days (yes/no)
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Collaborators

National Institute on Drug Abuse (NIDA)
Clemson University

Investigators

  • Principal Investigator: Alain H Litwin, MD, Prisma Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2023

Primary Completion (Actual)

June 5, 2025

Study Completion (Actual)

December 6, 2025

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1930664-6
  • R34DA057662 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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