Cognitive Behavioral Therapy + Recovery Coaching for Opioid Use Disorder
(OVERCOME 2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Prisma Health-Upstate
Must be taking: Buprenorphine
Disqualifiers: Severe disability, Pregnancy, Suicidal ideation, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
36789How 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.
2461011Eligibility 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 am 18 years old or older.
I started taking SL buprenorphine in the last 30 days.
I am currently taking SL buprenorphine/naloxone or buprenorphine HCL.
+3 more
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
+3 more
Trial 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)
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Standard of care + CBT4CBT+ RCExperimental Treatment2 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 + CBT4CBTExperimental Treatment1 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 careActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Greenville Health SystemGreenville, SC
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Who Is Running the Clinical Trial?
Prisma Health-UpstateLead Sponsor
Clemson UniversityCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
Treatment Persistence Among Insured Patients Newly Starting Buprenorphine/Naloxone for Opioid Use Disorder. [2019]Persistence with medication-assisted therapy among patients with opioid use disorder has been associated with reduced likelihood of illicit opioid use.
Advances in the treatment of opioid use disorders. [2019]The development of medications for treating persons with opioid use disorders has expanded the number of evidence-based treatment options, particularly for persons with the most severe disorders. It has also improved outcomes compared to psychosocial treatment alone and expanded treatment availability by increasing the number of physicians involved in treatment and the settings where patients can be treated. The medications include methadone, buprenorphine, buprenorphine/naloxone, and extended-release injectable naltrexone. Studies have shown that they are most effective when used over an extended, but as-yet-unspecified, period of time and with counseling and other services, particularly for the many with psychosocial problems. Though controversial in some cultures, well-designed studies in Switzerland, the Netherlands, Germany, and Canada have demonstrated the efficacy of supervised heroin injecting for persons who responded poorly to other treatments, and this treatment option has been approved by Switzerland and a few other E.U. countries. The degree to which medication-assisted therapies are available is dependent on many variables, including national and local regulations, preferences of individual providers and their geographical location, treatment costs, and insurance policies. Greater availability of medication-assisted therapies has become a major focus in the U.S. and Canada, where there has been a marked increase in deaths associated with heroin and prescription opioid use. This paper provides a brief summary of these developments.
A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]Patients with opioid use disorder (OUD) are increasingly being hospitalized for acute medical illnesses. Despite initiation of medications for OUD (MOUDs), many discontinue treatment after discharge. To evaluate whether a psychosocial intervention can improve MOUD retention after hospitalization, we conducted a pilot randomized controlled trial of a peer recovery coach intervention.
Psychotherapies in opioid use disorder: toward a step-care model. [2023]Opioid use disorder (OUD) is characterized by a lack of control in opioid use, resulting in psychological distress and deficits in interpersonal and social functioning. OUD is often associated with psychiatric comorbidities that increase the severity of the disorder. The consequences of OUD are dramatic in terms of increased morbi-mortality. Specific medications and psychotherapies are essential tools not only in the treatment of OUD but also in the prevention of suicide and overdoses. In our review, we assess the different types of psychotherapies (counseling, motivational interviewing, contingency management, cognitive-behavioral therapy, and dialectical-behavior therapy) that are delivered to opioid users, either associated or un-associated with OUD medications and/or medications for psychiatric disabilities. We describe the application of these therapies first to adult opioid users and then to adolescents. This work led us to propose a stepped-care model of psychotherapies for OUD which provided information to assist clinicians in decision-making regarding the selection of psychotherapeutic strategies according to patients' OUD severity.
Quality of life and well-being following inpatient and partial hospitalization treatment for opioid use disorder. [2019]Treatment of opioid use disorder often begins with brief intensive inpatient or outpatient programs. Given the high relapse rates following intensive treatment, it is important to determine factors that lead to success post-discharge. Incorporating assessment during and early post-discharge may help determine such factors. The current study evaluated changes in quality of life among individuals during and after discharge from inpatient and partial hospitalization opiate treatment programs. Participants (n = 143) were recruited while in the programs and were re-assessed one month later (n = 113). Results found improvements in quality of life and reductions in rates of opiate use at follow-up. Individuals with greater improvements in Health, Substance Use, and Emotional Health domains were less likely to have relapsed. Treatment utilization post-discharge was not associated with relapse. Findings emphasize the importance of measurement-based care and suggest the need to assess indicators of treatment success beyond rates of relapse.
Treatment and Prevention of Opioid Use Disorder: Challenges and Opportunities. [2023]Treatment for opioid use disorder in the United States evolved in response to changing federal policy and advances in science. Inpatient care began in 1935 with the US Public Health Service Hospitals in Lexington, Kentucky, and Fort Worth, Texas. Outpatient clinics emerged in the 1960s to provide aftercare. Research advances led to opioid agonist and opioid antagonist therapies. When patients complete opioid withdrawal, return to use is often rapid and frequently deadly. US and international authorities recommend opioid agonist therapy (i.e., methadone or buprenorphine). Opioid antagonist therapy (i.e., extended-release naltrexone) may also inhibit return to use. Prevention efforts emphasize public and prescriber education, use of prescription drug monitoring programs, and safe medication disposal options. Overdose education and naloxone distribution promote access to rescue medication and reduce opioid overdose fatalities. Opioid use disorder prevention and treatment must embrace evidence-based care and integrate with physical and mental health care.
Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. [2023]Medications for opioid use disorder (MOUD) such as buprenorphine is effective for treating opioid use disorder (OUD). START NOW (SN) is a manualized, skills-based group psychotherapy originally developed and validated for the correctional population and has been shown to result in reduced risk of disciplinary infractions and future psychiatric inpatient days with a dose response effect. We investigate whether adapted START NOW is effective for treating OUD in a MOUD office-based opioid treatment (OBOT) setting in this non-inferiority clinical trial.
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]Opioid use disorder (OUD) has led to a staggering death toll in terms of drug-related overdoses. Despite the demonstrated benefits and effectiveness of buprenorphine, retention is suboptimal, and patients typically present with high rates of ongoing polysubstance use during treatment. A pilot trial provided preliminary support for the efficacy of computer-based cognitive-behavioral therapy (CBT4CBT) as an add-on to buprenorphine in reducing substance use. Recovery coaching services provided by individuals with substance use experience and successful recovery have also shown to positively influence recovery outcomes for people with OUD by increasing buprenorphine initiation and reducing opioid use.
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]A mindfulness-based intervention that reduces comorbid pain, anxiety, and substance use during office-based opioid treatment (OBOT) could enhance retention and prevent overdose. We conducted a pilot study of the Mindful Recovery OUD Care Continuum (M-ROCC), a 24-week trauma-informed program with a motivationally-sensitive curriculum.
A mental health professional survey of cognitive-behavioral therapy for the treatment of opioid use disorder. [2021]The objective of this survey was to obtain mental health professional perspectives on cognitive-behavioral therapy (CBT) for opioid use disorder (OUD) treatment.
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]Detoxification with psychosocial counseling remains a standard opioid-use disorder treatment practice but is associated with poor outcomes. This study tested the efficacy of a newly developed psychosocial intervention, Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T), relative to psychosocial treatment as usual (TAU), for improving treatment outcomes.