Standard of CareOVERCOME 2NCT06102200
An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder
A study testing CBT4CBT, RC and Sandard of care in people with Standard of Care and Standard of Care + CBT4CBT, run by Prisma Health-Upstate at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Standard of Care, Standard of Care + CBT4CBT, Standard of Care + CBT4CBT + RC
- What is being tested?
- CBT4CBT, RC and Sandard of care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 6 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System
Greenville, South Carolina, 29605
About this study
Official title: Prisma Health Clemson University
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.
Read the detailed description
Buprenorphine has proven to be an effective pharmacologic strategy for treating OUD. However, buprenorphine is unlikely to give greater overall protection because of the shorter duration of treatment. There is a need for studies on interventions that could increase retention to buprenorphine, especially among those with ongoing illicit substance and polysubstance use.
Using a randomized controlled trial study design, the Overcome II study aims to investigate the incremental benefit in terms of reduction in illicit drug use and retention in standard of treatment due to providing the peer recovery coach and/or CBT4CBT interventions as a compliment to standard-of-treatment among persons receiving medication for opioid 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 CBT4CBT, (3) sublingual buprenorphine with CBT4CBT and peer recovery coaching. The primary outcome of interest is 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. The institutional review board at Prisma Health will provide the oversight for the ethical conduct of the study. Potential participants at Prisma Health will be screened for eligibility, will undergo the informed consent procedure, and eligible persons who consent to participation will be recruited into the study.
The participants will be randomized of one of the three treatment arms in a 1:1:1 ratio. The study will aim to recruit 30 participants per treatment arm. Study procedures will be conducted both virtually and at research facilities of the Prisma Health Addiction Medicine Center, in Greenville, SC. Participants will attend the research visits once a week during the first eight weeks (sessions 1 to 8), and 1-, 3-, and 6- months after the end of treatment.
- Being tested
- CBT4CBT, RC, Sandard of care
- Keywords
- CBT, Peer recovery coach, Opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT4CBTBehavioural
Also called CBT4CBT-Buprenorphine
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.
RCBehavioural
Also called Recovery Coaching
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.
Sandard of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: CBT4CBT; Behavioral: RC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use
The percentage of of saliva toxicology screens positive for all drugs during the 8 initial study weeks
Measured: 8 weeks
Secondary outcomes (13)
Buprenorphine retention at 3-month follow-up
Retention to buprenorphine
Measured: 20 weeks
Buprenorphine retention at 6-month follow-up
Retention to buprenorphine
Measured: 32 weeks
Drug use
The percentage of saliva toxicology screens positive for all drugs at 1 month follow-up
Measured: 12 weeks
Drug use
The percentage of saliva toxicology screens positive for all drugs at 3 month follow-up
Measured: 20 weeks
Drug use
The percentage of saliva toxicology screens positive for all drugs at 6 month follow-up
Measured: 32 weeks
Opioid use
The percentage of saliva toxicology screens positive for opioids during the 8 initial study weeks
Measured: 8 weeks
Opioid use
The percentage of saliva toxicology screens positive for opioids at 1 month follow-up
Measured: 12 weeks
Opioid use
The percentage of saliva toxicology screens positive for opioids at 3- month follow-up
Measured: 20 weeks
Opioid use
The percentage of saliva toxicology screens positive for opioids at 6- month follow-up
Measured: 32 weeks
Self-report drug use
Self-report drug use in the past 30 days (yes/no)
Measured: 8 weeks
Self-report drug use
Self-report drug use in the past 30 days (yes/no)
Measured: 12 weeks
Self-report drug use
Self-report drug use in the past 30 days (yes/no)
Measured: 20 weeks
Self-report drug use
Self-report drug use in the past 30 days (yes/no)
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start5 Oct 2023
- Primary completion5 Jun 2025
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Standard of CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral intervention
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alain H Litwin, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102200
- Sponsor's protocol ID
- 1930664-6
- Other IDs
- R34DA057662
- Acronym
- OVERCOME 2
- Status last verified
- Feb 2026
- First submitted
- 31 Aug 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35573387Pericot-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.
PubMed 41554331
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prisma Health Clemson University
- ClinicalTrials.gov ID
- NCT06102200
- Acronym / sponsor ID
- OVERCOME 2 / 1930664-6
- Keywords
- CBT, Peer recovery coach, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University, National Institute on Drug Abuse (NIDA)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Buprenorphine has proven to be an effective pharmacologic strategy for treating OUD. However, buprenorphine is unlikely to give greater overall protection because of the shorter duration of treatment. There is a need for studies on interventions that could increase retention to buprenorphine, especially among those with ongoing illicit substance and polysubstance use.
Using a randomized controlled trial study design, the Overcome II study aims to investigate the incremental benefit in terms of reduction in illicit drug use and retention in standard of treatment due to providing the peer recovery coach and/or CBT4CBT interventions as a compliment to standard-of-treatment among persons receiving medication for opioid 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 CBT4CBT, (3) sublingual buprenorphine with CBT4CBT and peer recovery coaching. The primary outcome of interest is 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. The institutional review board at Prisma Health will provide the oversight for the ethical conduct of the study. Potential participants at Prisma Health will be screened for eligibility, will undergo the informed consent procedure, and eligible persons who consent to participation will be recruited into the study.
The participants will be randomized of one of the three treatment arms in a 1:1:1 ratio. The study will aim to recruit 30 participants per treatment arm. Study procedures will be conducted both virtually and at research facilities of the Prisma Health Addiction Medicine Center, in Greenville, SC. Participants will attend the research visits once a week during the first eight weeks (sessions 1 to 8), and 1-, 3-, and 6- months after the end of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Behavioral intervention
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Behavioral: Sandard of careParticipants 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 + CBT4CBT | Experimental | Behavioral: CBT4CBTThis 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. |
| Standard of care + CBT4CBT+ RC | Experimental | Behavioral: CBT4CBT, Behavioral: RCThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT4CBTAlso: CBT4CBT-BuprenorphineThis 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. | Behavioural | Standard of care + CBT4CBT, Standard of care + CBT4CBT+ RC |
| RCAlso: Recovery CoachingPeer 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. | Behavioural | Standard of care + CBT4CBT+ RC |
| Sandard of careParticipants 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. | Behavioural | Standard of care |
Primary outcome
Drug use
Time frame: 8 weeks
The percentage of of saliva toxicology screens positive for all drugs during the 8 initial study weeks
13 secondary outcomes
Buprenorphine retention at 3-month follow-up
Time frame: 20 weeks
Buprenorphine retention at 6-month follow-up
Time frame: 32 weeks
Drug use
Time frame: 12 weeks
Drug use
Time frame: 20 weeks
Drug use
Time frame: 32 weeks
Opioid use
Time frame: 8 weeks
Opioid use
Time frame: 12 weeks
Opioid use
Time frame: 20 weeks
Opioid use
Time frame: 32 weeks
Self-report drug use
Time frame: 8 weeks
Self-report drug use
Time frame: 12 weeks
Self-report drug use
Time frame: 20 weeks
Self-report drug use
Time frame: 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 35573387Pericot-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.
- Derived from this study: PubMed 41554331Pericot-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain H Litwin, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT4CBT, RC and Sandard of care in people with Standard of Care and Standard of Care + CBT4CBT, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug use (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102200, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.