Clinical trial NCT06102200: An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder
Official title: Prisma Health Clemson University
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Standard of Care
Standard of Care + CBT4CBT
Standard of Care + CBT4CBT + RC
Keywords: CBT
Peer recovery coach
Opioid
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Clemson University
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-10-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral intervention
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Drug use
timeFrame: 8 weeks
Secondary outcomes:
measure: Buprenorphine retention at 3-month follow-up
timeFrame: 20 weeks
measure: Buprenorphine retention at 6-month follow-up
timeFrame: 32 weeks
measure: Drug use
timeFrame: 12 weeks
measure: Drug use
timeFrame: 20 weeks
measure: Drug use
timeFrame: 32 weeks
measure: Opioid use
timeFrame: 8 weeks
measure: Opioid use
timeFrame: 12 weeks
measure: Opioid use
timeFrame: 20 weeks
measure: Opioid use
timeFrame: 32 weeks
measure: Self-report drug use
timeFrame: 8 weeks
measure: Self-report drug use
timeFrame: 12 weeks
measure: Self-report drug use
timeFrame: 20 weeks
measure: Self-report drug use
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Alain H Litwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.