An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder
Completed · Not applicable
Conditions studied: Standard of Care, Standard of Care + CBT4CBT, Standard of Care + CBT4CBT + RC
In brief
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.
Key facts
- Study ID
- NCT06102200
- Run by
- Prisma Health-Upstate
- People needed
- 92
- Starts
- 2023-10-05
- Expected to finish
- 2025-12-06
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults (≥18 years of age);
- DSM-V diagnosis of OUD, confirmed via electronic medical record review;
- Currently receiving SL buprenorphine/ naloxone and/or buprenorphine HCL;
- Initiated SL buprenorphine within the last 30 days;
- Willing to accept a random assignment to either treatment arm:
- Adequate computer skills
You may not qualify if…
- Severe medical or psychiatric disability that could impair the ability to perform study related activities (determined by the clinician);
- Pregnancy, planning conception, or breast-feeding for female participants;
- Inability to independently read and/or comprehend the consent form or other study materials;
- Inability to read/speak English (inability to independently read and comprehend the consent form or other study materials);
- Current suicidal ideation based on the Patient Health Questionnaire-9
- Have taken or received any prescribed buprenorphine product within 30 days prior to the current treatment episode.
Where it is running
- Greenville Health System — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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