Cognitive Behavioral Therapy + Recovery Coaching for Opioid Use Disorder

(OVERCOME 2 Trial)

Overseen By Ashley King, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Upstate

Must be taking: Buprenorphine

Disqualifiers: Severe disability, Pregnancy, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

92 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be currently receiving sublingual buprenorphine to participate.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy + Recovery Coaching for Opioid Use Disorder?

Research shows that combining medications for opioid use disorder with counseling and other services, like cognitive-behavioral therapy, improves treatment outcomes. Additionally, peer recovery coaching has been shown to help patients stay on their medication after leaving the hospital. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy combined with Recovery Coaching safe for treating opioid use disorder?

The combination of Cognitive Behavioral Therapy (CBT) and Recovery Coaching for opioid use disorder has been studied, and while specific safety data is not detailed, these therapies are generally considered safe. Buprenorphine, a medication often used in these treatments, is well-established for its safety and effectiveness in managing opioid use disorder. ^{3 6 7 8 9}

How does Cognitive Behavioral Therapy + Recovery Coaching for Opioid Use Disorder differ from other treatments?

This treatment is unique because it combines Cognitive Behavioral Therapy (CBT), which helps change negative thought patterns, with Recovery Coaching, providing personalized support, unlike standard treatments that often focus solely on medication or detoxification. ^{2 4 6 10 11}

What is the purpose of this trial?

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.

Research Team

Alain Litwin, MD

Principal Investigator

Prisma Health

Eligibility Criteria

Adults diagnosed with Opioid Use Disorder (OUD), currently on sublingual buprenorphine, and able to use a computer can join. They must be willing to be randomly assigned to a treatment group and have started buprenorphine within the last 30 days. Those with severe health or mental issues, pregnant or breastfeeding women, non-English speakers/readers, or those who've used prescribed buprenorphine in the past month cannot participate.

Inclusion Criteria

I started taking SL buprenorphine in the last 30 days.

I am currently taking SL buprenorphine/naloxone or buprenorphine HCL.

I am willing to be randomly assigned to a treatment group.

Exclusion Criteria

I have used a prescribed buprenorphine product in the last 30 days.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sublingual buprenorphine with or without CBT4CBT and peer recovery coaching for 8 weeks

8 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for retention to treatment and drug use at 1-, 3-, and 6-months after the end of treatment

6 months

3 visits (in-person or virtual)

Treatment Details

Interventions

• CBT4CBT
• RC
• Standard of Care

Trial Overview The trial tests if adding computer-based cognitive behavioral therapy (CBT4CBT) alone or combined with peer recovery coaching improves outcomes for those on standard opioid addiction treatment with sublingual buprenorphine. It measures drug use reduction over an 8-week period and checks how well patients stick to their treatments up to six months later.

Participant Groups

Group I: Standard of care + CBT4CBT+ RC Experimental Treatment 2 Interventions

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.

Group II: Standard of care + CBT4CBT Experimental Treatment 1 Intervention

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.

Group III: Standard of care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Clemson University

Collaborator

Trials

38

Recruited

8,200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study of 302 patients starting buprenorphine therapy for opioid use disorder, only 40.4% persisted with treatment for one year, highlighting a significant challenge in maintaining medication-assisted therapy.

Factors negatively impacting treatment persistence included the concurrent use of prescription opioids, care by an addiction specialist, and having Medicaid insurance, suggesting that addressing these issues could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Persistence Among Insured Patients Newly Starting Buprenorphine/Naloxone for Opioid Use Disorder. Shcherbakova, N., Tereso, G., Spain, J., et al.[2019]

Medications for opioid use disorders, such as methadone and buprenorphine, have significantly improved treatment outcomes compared to psychosocial treatment alone, especially for individuals with severe disorders.

The effectiveness of these medications is enhanced when combined with counseling and other support services, and there is growing evidence supporting supervised heroin injecting for those who do not respond to standard treatments, as seen in studies from Switzerland and other countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the treatment of opioid use disorders. Woody, GE.[2019]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

Opioid use disorder (OUD) significantly impacts individuals' psychological and social functioning, and is often linked with other psychiatric conditions that worsen its severity.

The review highlights various psychotherapies, such as cognitive-behavioral therapy and motivational interviewing, as essential components in treating OUD, and proposes a stepped-care model to help clinicians choose appropriate therapies based on the severity of the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapies in opioid use disorder: toward a step-care model. Durpoix, A., Rolling, J., Coutelle, R., et al.[2023]

A study involving 143 participants in opioid treatment programs showed significant improvements in quality of life and reductions in opiate use one month after discharge, indicating positive outcomes from treatment.

Greater improvements in specific health domains (Health, Substance Use, and Emotional Health) were linked to lower relapse rates, suggesting that focusing on these areas can enhance post-treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and well-being following inpatient and partial hospitalization treatment for opioid use disorder. Blevins, CE., Abrantes, AM., Kurth, ME., et al.[2019]

Opioid agonist therapies, such as methadone and buprenorphine, are recommended by authorities for treating opioid use disorder, as they help prevent rapid return to opioid use after withdrawal, which can be deadly.

In addition to medication, effective prevention and treatment strategies include public education, prescription monitoring, naloxone distribution for overdose emergencies, and integrating care for both physical and mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment and Prevention of Opioid Use Disorder: Challenges and Opportunities. McCarty, D., Priest, KC., Korthuis, PT.[2023]

In a study involving 137 participants, the adapted START NOW psychotherapy was found to be as effective as standard treatment-as-usual (TAU) for opioid use disorder, with similar attendance and drug use outcomes over 32 weeks.

START NOW psychotherapy is freely available and could be particularly beneficial in low-resource settings, making it a valuable option for treating opioid use disorder alongside medications like buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. Truong, A., Kablinger, A., Hartman, C., et al.[2023]

The OVERCOME study is a randomized clinical trial designed to evaluate the effectiveness of combining computer-based cognitive-behavioral therapy (CBT4CBT) with Recovery Coaching for individuals with opioid use disorder (OUD) who are receiving buprenorphine treatment.

This integrated intervention aims to reduce substance use and improve adherence to buprenorphine, potentially lowering the risk of mortality associated with OUD, as indicated by the study's focus on drug positivity rates and retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Pericot-Valverde, I., Perez, A., Heo, M., et al.[2022]

The Mindful Recovery OUD Care Continuum (M-ROCC) program, a 24-week mindfulness-based intervention, significantly reduced comorbid pain and anxiety in patients undergoing buprenorphine treatment, as evidenced by improved scores on various psychological scales and decreased substance use.

Participants showed a notable decrease in positive urine toxicology results for cocaine and benzodiazepines, indicating that M-ROCC may help enhance retention in treatment and prevent substance misuse during opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Schuman-Olivier, Z., Fatkin, T., Creedon, TB., et al.[2023]

Mental health professionals believe that key components of cognitive-behavioral therapy (CBT) for treating opioid use disorder (OUD) include building a strong treatment alliance, teaching coping skills, and using motivational interviewing, which were rated as the most effective strategies.

To enhance the effectiveness of CBT for OUD, professionals suggested incorporating mindfulness practices, peer support, and strategies for medication adherence, while also emphasizing the importance of addressing co-occurring mental health issues and life stressors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mental health professional survey of cognitive-behavioral therapy for the treatment of opioid use disorder. Lent, MR., Callahan, HR., Womer, P., et al.[2021]

The Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T) showed a moderate effect on improving treatment retention for opioid-dependent adults, particularly when the concerned significant other was a parent, where it had a significant impact (p<0.01).

CRAFT-T also significantly reduced opioid and other drug use among participants, indicating its potential efficacy as a treatment intervention for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. Brigham, GS., Slesnick, N., Winhusen, TM., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment Persistence Among Insured Patients Newly Starting Buprenorphine/Naloxone for Opioid Use Disorder. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Advances in the treatment of opioid use disorders. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]

4. Austria pubmed.ncbi.nlm.nih.gov

Psychotherapies in opioid use disorder: toward a step-care model. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Quality of life and well-being following inpatient and partial hospitalization treatment for opioid use disorder. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment and Prevention of Opioid Use Disorder: Challenges and Opportunities. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A mental health professional survey of cognitive-behavioral therapy for the treatment of opioid use disorder. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. [2021]