Cannabidiol as Adjunctive Treatment for Opioid Use Disorder

Summary

Participation Requirements

Description

This will be a randomized, double-blind, placebo controlled, sequential, dose-ranging study of Cannabidiol Oral Solution (CBD) (700, 1400 mg/day) as an adjunctive therapy to buprenorphine + naloxone in patients who have Opioid Use Disorder and are receiving residential behavioral therapy, including ...

This will be a randomized, double-blind, placebo controlled, sequential, dose-ranging study of Cannabidiol Oral Solution (CBD) (700, 1400 mg/day) as an adjunctive therapy to buprenorphine + naloxone in patients who have Opioid Use Disorder and are receiving residential behavioral therapy, including cognitive behavioral therapy. The primary dependent variable will be cue-induced craving. Secondary measures will be reductions in spontaneous craving, opioid withdrawal, negative affective states, and relapse, as well as retention in treatment with buprenorphine + naloxone. The study will be conducted at the Semel Institute in the David Geffen School of Medicine at the University of California Los Angeles (UCLA). Administration of the study compounds and all test procedures, and analyses will be conducted at UCLA. Participants will be recruited from the Domiciliary Residential Rehabilitation Treatment Program of the Veterans Administration of Greater Los Angeles Health Center (the Dom). This 300-bed program serves veterans with a wide range of psychiatric and medical conditions. More than 90% of those admitted to the program have been diagnosed with a substance use disorder. The Dom is staffed with psychiatrists, psychologists, social workers, recreation therapists, primary care physicians, and vocational rehabilitation specialists. It provides a therapeutic community that utilizes peer and professional support services in a structured, residential environment with 24-h and 7-days-a-week monitoring by on-site nurses and health technicians, who serve the needs of the patients and maintain communication. At the Dom, treatment as usual (TAU) for patients with Substance Use Disorder is 4 hours of group programming. Groups consist of various modalities, including cognitive behavioral therapy (CBT) for relapse prevention, Seeking Safety for Posttraumatic Stress Disorder,process groups, and Dialectical Behavioral Therapy. Matrix Model CBT, incorporating relapse prevention, is one of the core groups. Sixty participants who meet all eligibility criteria will be randomized to receive CBD or placebo in each of two dose cohorts (30 participants per cohort): CBD 700 mg/day and 1400 mg/day. The cohorts will be studied sequentially according to ascending dose order to ensure safety. Within each cohort, participants will be randomized by baseline buprenorphine plasma level (either below or ? 2 ng/ml) so that 20 participants will receive active study medication and 10 will receive placebo. Thus, there will be 3 groups of 20 participants per treatment, including a group with 20 participants who receive placebo. The study will comprise three periods: a 2-week screening period while participants are stabilized on buprenorphine + naloxone), a 4-week treatment period when study medication will be administered, and a 4-week follow-up period after termination of treatment with medication. Laboratory sessions will be conducted at three times: Day 0 (baseline), Day 7(when a steady state of CBD should have been reached; half-life of CBD after oral administration is 18-32 h),14 and Day 28 (end of treatment). Adherence to medication in the trial will be assured as the participant will take the test medication (CBD or placebo) under supervision daily. Blood samples will be collected to determine plasma concentrations of CBD, buprenorphine and its metabolites as well as the endocannabinoids anandamide and 2-AG, which may contribute to the response to CBD, laboratory assessments of safety. Retention in treatment (this trial plus buprenorphine +naloxone) will be assessed over the 28-day medication (CBD or placebo) period and weekly follow-up assessments for the subsequent month (28-day follow-up period).

Tracking Information