Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title: Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

Status Completed

Clinical Trial Summary

This research aims to determine the effects and safety of cannabidiol (CBD) (ATL5 softgel capsules) as an adjunctive therapy for patients, who have Opioid Use Disorder and are taking buprenorphine + naloxone or methadone. Buprenorphine + naloxone and methadone is an approved treatment for Opioid Use Disorder, but relapse to opioid misuse is common among patients who receive this treatment. Finding an adjunctive treatment that reduces relapse for these patients would be helpful.

We will recruit participants from the Tarzana Treatment Center (TTC) in the San Fernando Valley. They will be receiving buprenorphine + naloxone or methadone as part of residential therapy. Potential participants who pass initial screening and wish to continue in the study will provide written, informed consent and will complete a 2-day evaluation, including blood and urine tests, questionnaires about their mood, medical, psychiatric and drug use history and physical exam.

Up to 60 participants who meet all eligibility criteria will be invited to complete baseline assessments (blood and urine tests, questionnaires), and will be assigned randomly to receive CBD (600mg/day) or placebo, corresponding to two groups of up to 30 participants each.

After the baseline measurements, participants will take part in a 28-day treatment phase for 4 weeks. They will take the study medication under supervision (CBD 300 mg twice daily or placebo). Questionnaires on opioid craving, withdrawal, and mood symptoms will be administered daily during the treatment period excluding weekends. After the 28-day intervention, participants will complete the questionnaires and undergo urine drug tests in 4 weekly follow-up visits.

The study will last ~10 weeks, comprising three periods: a screening period (2-weeks when participants are stabilized on buprenorphine + naloxone or methadone in residential treatment at the Tarzana Treatment Center), a treatment period (4 weeks when study CBD or placebo is administered at Tarzana Treatment Center), and a follow-up period (4 weeks after termination of the test intervention).

Clinical Trial Description

This will be a randomized, double-blind, placebo controlled, study of Cannabidiol (CBD) (600mg/day) as an adjunctive therapy to buprenorphine + naloxone or methadone in patients who have Opioid Use Disorder and are receiving residential behavioral therapy, including cognitive behavioral therapy. The primary endpoint will be safety and tolerability of CBD in these patients, and it will be assessed via measurement of cardiovascular parameters (heart rate, blood pressure, and cardiac rhythm and conduction on EKG), other vital signs, liver enzymes, pulse oximetry, adverse events, and pharmacokinetics. Secondary measures will include cue-induced craving, reductions in spontaneous craving, opioid withdrawal, negative affective states, and relapse, as well as retention in treatment with buprenorphine + naloxone or methadone.

Patients will be recruited from the Tarzana Treatment Center (TTC) in the San Fernando Valley, where buprenorphine + naloxone or methadone (as part of their treatment) and CBD (as part of this protocol) will be administered. Tarzana Treatment Centers, Inc. is a community-based, private non-profit behavioral healthcare organization located in Southern California with several agency sites, including the one in the San Fernando Valley, where this protocol will be conducted. TTC delivers drug and alcohol use treatment, has been accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) since 1987, and has a workforce that includes physicians, psychologists, and nurses. TTC's substance use treatment approach includes residential programs that are overseen by a Program Director and are staffed by a clinical supervisor, operations supervisor, counselors, interns, nursing staff and 24/7 technicians. Groups and services include education group, process group, 12-step, family group, mental health services and recreation skills. Cognitive-behavioral treatment is used in both individual and group therapy to address craving and relapse issues and in the treatment of mental health problems.

Up to 60 participants who meet all eligibility criteria will be invited to complete baseline assessments (blood and urine tests, questionnaires), and will be assigned randomly to receive CBD or placebo, corresponding of two cohorts of up to 30 participants each. Within each cohort, participants will be randomized by baseline buprenorphine plasma level (either below or ≥ 2 ng/ml).

The study will comprise three periods: a multi (~7-14)-day 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. Cue-induced craving 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),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, and laboratory assessments of safety. Retention in treatment (this trial plus buprenorphine +naloxone or methadone) 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). ;

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

• NCT number: NCT03787628
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2022
• Completion date: March 12, 2024