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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help individuals reduce or stop using illegal drugs while on sublingual buprenorphine, a common treatment for opioid use disorder. Researchers compare three approaches: buprenorphine alone, buprenorphine with computer-based therapy (CBT4CBT), and buprenorphine with added peer recovery coaching (RC). The main goal is to determine which method best reduces drug use, as verified by saliva tests over eight weeks. Ideal participants are adults who have been on sublingual buprenorphine for less than 30 days and possess basic computer skills. As an unphased trial, this study allows participants to contribute to innovative approaches in addiction treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBT4CBT, a computer-based therapy, is generally safe for individuals with substance use issues. Studies have found it reduces substance use symptoms without major side effects. Participants typically find this therapy easy to use and effective.

Recovery coaching, which offers support from individuals who have overcome substance use, is also well-received. A review of studies indicates that recovery coaching can help individuals with opioid use disorder (OUD) remain engaged in treatment and enhance their recovery.

Both CBT4CBT and recovery coaching have been safely used in previous studies. These methods aim to support recovery without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for opioid use disorder because they integrate cognitive-behavioral therapy (CBT) with recovery coaching to offer a personalized approach. Unlike traditional care, these treatments use CBT4CBT, an 8-session digital program that focuses on key skills like coping with cravings and making better decisions, tailored specifically for opioid use and buprenorphine treatment. Additionally, the inclusion of peer recovery coaching provides nonclinical support from individuals who have successfully navigated recovery themselves, offering a unique blend of professional guidance and personal experience. This holistic approach aims to strengthen recovery outcomes by addressing both the psychological and social aspects of addiction.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that CBT4CBT, a computer-based therapy, can significantly reduce substance use. One study found that participants using CBT4CBT reduced their substance use more than those receiving only standard treatment. Another study confirmed that adding CBT4CBT to addiction treatment has lasting positive effects. In this trial, one arm will integrate the standard of care with CBT4CBT.

Regarding recovery coaching, studies indicate that recovery coaches, who are peers with personal recovery experience, play a crucial role in helping individuals stay on track. Research suggests that recovery coaching can enhance recovery by improving treatment adherence and reducing relapse rates. Participants who have worked with recovery coaches report high satisfaction and view them as essential to their care team. In this trial, another arm will combine the standard of care with both CBT4CBT and recovery coaching. ^{1 2 5 6 7}

Who Is on the Research Team?

Alain Litwin, MD

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5119533/

Cognitive Behavioral Therapy Improves Treatment ... Primary prescription opioid use patients assigned to PM-CBT had more than twice the mean number of weeks of abstinence for all drugs (7.6) than ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875924000080

Cognitive behavioral therapy for anxiety and opioid use ... Conclusions. These results support the feasibility and acceptability of a CBT protocol for co-occurring anxiety and OUD. However, in this small pilot trial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4042674/

Computer-Assisted Delivery of Cognitive-Behavioral Therapy This trial replicates earlier findings indicating CBT4CBT is an effective adjunct to addiction treatment with durable effects.

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2018.17090978

Randomized Clinical Trial of Computerized and Clinician ... Participants who received CBT or CBT4CBT reduced their frequency of substance use significantly more than those who received treatment as usual.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2767358

Combined Pharmacotherapy and Cognitive Behavioral ... Cognitive behavioral therapy did not perform better than another evidence-based modality in this context or as an add-on to combined usual care ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01645033

Computer-based Cognitive Behavioral Therapy for Risky ... The purpose of this study is to determine if a computerized version of Cognitive Behavioral Therapy (CBT) can improve high-risk sexual behaviors in patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12276506/

Computer-based training for cognitive behavioral therapy ... The results suggest that CBT4CBT is linked with a reduction in SUD symptoms and an increase in CBT skills, including change strategies and ...