NCT06102200

Brief Summary

The Overcome II study is a randomized controlled trial among adults receiving sublingual buprenorphine to help prevent or reduce illicit drug use. The study outcomes will be compared between three treatment arms: (1) sublingual buprenorphine only, which is the standard-of-treatment (2) sublingual buprenorphine with a computer-based cognitive behavior therapy for substance use disorders (CBT4CBT), (3) sublingual buprenorphine with CBT4CBT and peer recovery coaching. The primary outcome of interest is the reduction in the proportion of positive results for saliva toxicology screenings for any drug during the 8-week treatment period. Study participants will also be assessed for the outcomes of retention to standard-of-treatment and illicit drug use at 1-, 3-, and 6-months follow-ups after the end of treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

August 31, 2023

Last Update Submit

February 4, 2026

Conditions

Standard of CareStandard of Care + CBT4CBTStandard of Care + CBT4CBT + RC

Keywords

CBTPeer recovery coachOpioid

Outcome Measures

Primary Outcomes (1)

  • Drug use

    The percentage of of saliva toxicology screens positive for all drugs during the 8 initial study weeks

    8 weeks

Secondary Outcomes (13)

  • Buprenorphine retention at 3-month follow-up

    20 weeks

  • Buprenorphine retention at 6-month follow-up

    32 weeks

  • Drug use

    12 weeks

  • Drug use

    20 weeks

  • Drug use

    32 weeks

  • +8 more secondary outcomes

Study Arms (3)

Standard of care

ACTIVE COMPARATOR

Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly, bi-weekly or monthly visits (at the discretion of the provider) in-person or virtually. This condition will be matched with the other conditions in terms of the number of research visits.

Behavioral: Sandard of care

Standard of care + CBT4CBT

EXPERIMENTAL

This condition will integrate the standard of care and CBT4CBT interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs: (1) Introduction to functional analysis of substance use; (2) strategies for recognizing and coping with craving; (3) refusal skills and assertiveness; (4) training in problem-solving skills; (5) strategies for recognizing and changing thoughts; (6) decision-making skills; (7) how to use CBT skills to reduce HIV/ HCV risk. Each module takes 30 minutes to complete and has a format, which includes on-screen narration, animation, quizzes, and interactive exercises to teach and model effective use of skills. Modules end with a practice exercise.

Behavioral: CBT4CBT

Standard of care + CBT4CBT+ RC

EXPERIMENTAL

This condition will integrate the standard of care, CBT4CBT, and recovery coaching services with Assertive Community Engagement (ACE) model interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs Peer recovery coaching services involve a form of nonclinical, peer support aimed at helping individuals with substance use disorders to achieve and maintain recovery. Recovery coaches are individuals with experience with substance use and successful recovery. In addition to their lived experience, recovery coaches obtain formal training on substance use coaching and receive ongoing supervision. The recovery coaches use an assertive engagement approach to provide holistic, person-centered, and strength-based support.

Behavioral: CBT4CBTBehavioral: RC

Interventions

RCBEHAVIORAL

Peer recovery coaching services involve a form of nonclinical, peer support aimed at helping individuals with substance use disorders to achieve and maintain recovery. Recovery coaches are individuals with experience with substance use and successful recovery. In addition to their lived experience, recovery coaches obtain formal training on substance use coaching and receive ongoing supervision. The recovery coaches use an assertive engagement approach to provide holistic, person-centered, and strength-based support.

Also known as: Recovery Coaching
Standard of care + CBT4CBT+ RC
Sandard of careBEHAVIORAL

Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly, bi-weekly or monthly visits (at the discretion of the provider) in-person or virtually. This condition will be matched with the other conditions in terms of the number of research visits.

Standard of care
CBT4CBTBEHAVIORAL

This condition will integrate the standard of care and CBT4CBT interventions. The CBT4CBT is an 8-session (module) system for teaching with one module on the basics of buprenorphine and the other modules on the seven CBT core skills tailored around issues related to buprenorphine and OUD and other SUDs: (1) Introduction to functional analysis of substance use; (2) strategies for recognizing and coping with craving; (3) refusal skills and assertiveness; (4) training in problem-solving skills; (5) strategies for recognizing and changing thoughts; (6) decision-making skills; (7) how to use CBT skills to reduce HIV/ HCV risk. Each module takes 30 minutes to complete and has a format, which includes on-screen narration, animation, quizzes, and interactive exercises to teach and model effective use of skills. Modules end with a practice exercise.

Also known as: CBT4CBT-Buprenorphine
Standard of care + CBT4CBTStandard of care + CBT4CBT+ RC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years of age);
  • DSM-V diagnosis of OUD, confirmed via electronic medical record review;
  • Currently receiving SL buprenorphine/ naloxone and/or buprenorphine HCL;
  • Initiated SL buprenorphine within the last 30 days;
  • Willing to accept a random assignment to either treatment arm:
  • Adequate computer skills

You may not qualify if:

  • Severe medical or psychiatric disability that could impair the ability to perform study related activities (determined by the clinician);
  • Pregnancy, planning conception, or breast-feeding for female participants;
  • Inability to independently read and/or comprehend the consent form or other study materials;
  • Inability to read/speak English (inability to independently read and comprehend the consent form or other study materials);
  • Current suicidal ideation based on the Patient Health Questionnaire-9
  • Have taken or received any prescribed buprenorphine product within 30 days prior to the current treatment episode.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Related Publications (2)

  • Pericot-Valverde I, Perez A, Heo M, Coleman A, Ortiz E, Merchant K, Melling T, Litwin A. Rationale, design, and methodology of a randomized pilot trial of an integrated intervention combining computerized behavioral therapy and recovery coaching for people with opioid use disorder: The OVERCOME study. Contemp Clin Trials Commun. 2022 May 5;28:100918. doi: 10.1016/j.conctc.2022.100918. eCollection 2022 Aug.

    PMID: 35573387BACKGROUND

  • Pericot-Valverde I, Heo M, Byrne KA, Karasz A, Perez A, Lopes S, Groome M, Voss S, King A, Barnick K, Litwin AH. Rationale and design of a three-arm randomized clinical trial to improve drug use and retention in care of people with opioid use disorder on buprenorphine: OVERCOME II study. Contemp Clin Trials. 2026 Mar;162:108226. doi: 10.1016/j.cct.2026.108226. Epub 2026 Jan 17.

    PMID: 41554331DERIVED

Study Officials

  • Alain H Litwin, MD

    Prisma Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 31, 2023

First Posted

October 26, 2023

Study Start

October 5, 2023

Primary Completion

June 5, 2025

Study Completion

December 6, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)