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Clinical Trials/NCT04824404
NCT04824404
Completed
Not Applicable

Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Prisma Health-Upstate1 site in 1 country38 target enrollmentDecember 15, 2020

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2020
End Date
December 6, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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