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Completed

NCT Number: NCT04824404

CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internal Medicine Recovery Clinic

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: CBT4CBT+ Recovery Coach

Primary outcomes

  1. Change in drug use

    Time frame: 0-8 weeks

    Using saliva toxicology tests

Secondary outcomes

  1. Retention to buprenorphine

    Time frame: 3 month follow up

    enrollment in and receiving buprenorphine and/or other effective medication treatment for OUD which will be verified by either report from the treatment clinic or electronic medical record

  2. Change in drug use

    Time frame: 1 and 3 month follow up

    Using saliva toxicology tests

Other outcomes

  1. Commission errors

    Time frame: 0-8 weeks

    This score indicates the number of times e client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity.

  2. Selective attention

    Time frame: 0-8 weeks

    This outcome will be measured by the Stroop Color and Word Test. This Stroop Test has three parts that generate simple and complex reaction times. Averaging the two complex reaction time scores from the Stroop Test generates a domain score for "reaction time."

  3. Cognitive performance through Electroencephalogram

    Time frame: 0-8 weeks

    This outcome will be measured by alpha, the dominant frequency in the human scalp EEG of adults.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Clemson University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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