CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

NCT04824404 | Completed DMC

• 1 other identifier: 87691
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Change in drug use

  Using saliva toxicology tests

  0-8 weeks

Secondary Outcomes (2)

• Retention to buprenorphine

  3 month follow up

• Change in drug use

  1 and 3 month follow up

Other Outcomes (3)

• Commission errors

  0-8 weeks

• Selective attention

  0-8 weeks

• Cognitive performance through Electroencephalogram

  0-8 weeks

Study Arms (2)

Standard Treatment As Usual (TAU)

NO INTERVENTION

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.

CBT4CBT-Buprenorphine + Recovery Coach

EXPERIMENTAL

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

Behavioral: CBT4CBT-Buprenorphine + Recovery Coach

Interventions

CBT4CBT-Buprenorphine + Recovery Coach 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)

Also known as: CBT4CBT+ Recovery Coach

CBT4CBT-Buprenorphine + Recovery Coach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Clemson University: collaborator

Study Sites (1)

Internal Medicine Recovery Clinic

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 1, 2021
• Study Start: December 15, 2020
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)