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CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Primary Purpose

Opioid-use Disorder

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT4CBT-Buprenorphine + Recovery Coach

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Internal Medicine Recovery ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Treatment As Usual (TAU)

CBT4CBT-Buprenorphine + Recovery Coach

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in drug use

Using saliva toxicology tests

Secondary Outcome Measures

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

Change in drug use

Using saliva toxicology tests

Full Information

NCT ID

NCT04824404

First Posted

March 19, 2021

Last Updated

September 30, 2021

Sponsor

Prisma Health-Upstate

Collaborators

Clemson University

1. Study Identification

Unique Protocol Identification Number

NCT04824404

Brief Title

CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 15, 2020 (Actual)

Primary Completion Date

May 15, 2022 (Anticipated)

Study Completion Date

May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Prisma Health-Upstate

Collaborators

Clemson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Treatment As Usual (TAU)

Arm Type

No Intervention

Arm Description

Arm Title

CBT4CBT-Buprenorphine + Recovery Coach

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

CBT4CBT-Buprenorphine + Recovery Coach

Other Intervention Name(s)

CBT4CBT+ Recovery Coach

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change in drug use

Description

Using saliva toxicology tests

Time Frame

0-8 weeks

Secondary Outcome Measure Information:

Title

Retention to buprenorphine

Description

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

Time Frame

3 month follow up

Title

Change in drug use

Description

Using saliva toxicology tests

Time Frame

1 and 3 month follow up

Other Pre-specified Outcome Measures:

Title

Commission errors

Description

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.

Time Frame

0-8 weeks

Title

Selective attention

Description

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."

Time Frame

0-8 weeks

Title

Cognitive performance through Electroencephalogram

Description

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

Time Frame

0-8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alain Litwin, MD

Phone

8644556658

alain.litwin@prismahealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Irene Pericot-Valverde, PhD

Phone

8549998005

iperico@clemson.edu

Facility Information:

Facility Name

Internal Medicine Recovery Clinic

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Individual Site Status

Recruiting

Facility Contact: