Status:
ACTIVE_NOT_RECRUITING
An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder
Lead Sponsor:
Prisma Health-Upstate
Collaborating Sponsors:
Clemson University
National Institute on Drug Abuse (NIDA)
Conditions:
Standard of Care
Standard of Care + CBT4CBT
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 tre...
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....
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06102200
Start Date
October 5 2023
End Date
May 31 2026
Last Update
August 28 2025
Active Locations (1)
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1
Greenville Health System
Greenville, South Carolina, United States, 29605