CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

NCT ID: NCT04824404

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-12-06

Brief Summary

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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

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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.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Treatment As Usual (TAU)

Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly or bi-weekly visits (at the discretion of the provider) to the clinic to meet with their provider and provide a sample of blood.

Group Type NO_INTERVENTION

No interventions assigned to this group

CBT4CBT-Buprenorphine + Recovery Coach

This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional

Group Type EXPERIMENTAL

CBT4CBT-Buprenorphine + Recovery Coach

Intervention Type BEHAVIORAL

This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professionalCBT4CBT-Buprenorphine is an 8-session (module) system for teaching a wide range of CBT skills (understanding and changing patterns of substance use; coping with craving; refusing offers of drugs and alcohol; problem-solving skills; identifying and changing thoughts about drugs and alcohol; and improving decision-making skills)

Interventions

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CBT4CBT-Buprenorphine + Recovery Coach

This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professionalCBT4CBT-Buprenorphine is an 8-session (module) system for teaching a wide range of CBT skills (understanding and changing patterns of substance use; coping with craving; refusing offers of drugs and alcohol; problem-solving skills; identifying and changing thoughts about drugs and alcohol; and improving decision-making skills)

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT4CBT+ Recovery Coach

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clemson University

OTHER

Sponsor Role collaborator

Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Internal Medicine Recovery Clinic

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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87691

Identifier Type: -

Identifier Source: org_study_id

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