NCT04824404
Completed
Not Applicable
Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
ConditionsOpioid-use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid-use Disorder
- Sponsor
- Prisma Health-Upstate
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in drug use
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.
Detailed Description
In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adults (≥18 years)
- •having a DSM-V diagnosis of OUD
- •sublingual buprenorphine/naloxone and/or buprenorphine
- •having initiated maintenance treatment for OUD for at least 30 days before the screening
- •self-report or toxicology screening positive for any substance within 30 days of screening;
- •willing to accept a random assignment to either TAU/CBT4CBT-Buprenorphine + Recovery Coach;
- •having adequate computer skills
Exclusion Criteria
- •having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician)
- •being pregnant or breastfeeding;
- •being unable to independently read and/or comprehend the consent form or other study materials
- •being unable to read/speak English;
- •having current suicidal ideation based on the Patient Health Questionnaire-9.
Outcomes
Primary Outcomes
Change in drug use
Time Frame: 0-8 weeks
Using saliva toxicology tests
Secondary Outcomes
- Retention to buprenorphine(3 month follow up)
- Change in drug use(1 and 3 month follow up)
Study Sites (1)
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