CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824404
• Other study ID #: 87691
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: May 15, 2022

Study information

• Verified date: July 2021
• Source: Prisma Health-Upstate
• Contact: Alain Litwin, MD
• Phone: 8644556658
• Email: alain.litwin[@]prismahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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)

Locations

Country	Name	City	State
United States	Internal Medicine Recovery Clinic	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Clemson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Cognitive performance through Electroencephalogram	This outcome will be measured by alpha, the dominant frequency in the human scalp EEG of adults.	0-8 weeks
Primary	Change in drug use	Using saliva toxicology tests	0-8 weeks
Secondary	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
Secondary	Change in drug use	Using saliva toxicology tests	1 and 3 month follow up