CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Integrated Intervention Combining 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.

Study Overview

• Status: Recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: CBT4CBT-Buprenorphine + Recovery Coach

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alain Litwin, MD; Phone Number: 8644556658; Email: alain.litwin@prismahealth.org
• Study Contact Backup: Name: Irene Pericot-Valverde, PhD; Phone Number: 8549998005; Email: iperico@clemson.edu

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Internal Medicine Recovery Clinic
      • Contact: Jessica Mavis; Phone Number: 864-455-8929; Email: Jessica.Mavis@prismahealth.org
      • Principal Investigator: Alain H Litwin, MD
      • Principal Investigator: Irene Pericot-Valverde, PhD
      • Principal Investigator: Angelica Perez, PhD
      • Sub-Investigator: Moonseong Heo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: CBT4CBT-Buprenorphine + Recovery Coach; This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional	Behavioral: 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); Other Names: CBT4CBT+ Recovery Coach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in drug use	Using saliva toxicology tests	0-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention to buprenorphine	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	3 month follow up
Change in drug use	Using saliva toxicology tests	1 and 3 month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Commission errors	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.	0-8 weeks
Selective attention	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."	0-8 weeks
Cognitive performance through Electroencephalogram	This outcome will be measured by alpha, the dominant frequency in the human scalp EEG of adults.	0-8 weeks

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Clemson University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): May 15, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 87691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No