Oral Cannabidiol for Opioid Withdrawal

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study will examine the safety of the cannabinoid cannabidiol (Epidiolex) in a human laboratory model of clinically relevant withdrawal. The study will be a residential within-subject comparison; all participants will receive placebo dosing and active cannabidiol. Results may be used to support an R01 grant application to more closely examine this hypothesis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Dalio Foundation
• Treatments: Cannabidiol; Epidiolex; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Medically cleared to take study medication

• Are not pregnant or breast feeding

• Willing to comply with the study protocol

• Provides urine that tests positive for methadone

• Maintained on 80-120 mg of daily methadone with no dose changes in the past 2 weeks (verified through a medical release with the participant's provider)

Exclusion Criteria:

• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for alcohol/substance use disorder other than opioid use disorder

• Previous adverse reaction to a cannabinoid product

• Self-report any illicit drug use or cannabinoid use in the past 7 days

• Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse events

• Past year suicidal behavior as assessed via the Columbia Suicide Severity Rating Scale

• History of seizure disorder

• Past 14 day use of any of the following contraindicated medications:

• Clobazam, Valproate

• Moderate or strong inhibitors of CYP3A4 or CYPC19 (with the exception of methadone, as outlined in the Protection Against CBD Risks section).

• Strong CYP3A4 or CYP2C19 inducers

• UGT1A9, UGT2B7, CYP1A2, CYP2C8, CYP2C9 and CYP2C19 substrates (with the exclusion of caffeine).

• Central nervous system (CNS) depressants that are contraindicated with Epidiolex

• Breathalyzer that tests positive for alcohol prior to session admission

• Self-reported consumption of grapefruit juice within 24 hours of session admission

• Have a history of clinically significant cardiac arrhythmias or vasospastic disease

• Have circumstances that the study investigators believe are contraindicated with study participation and/or would interfere with study participation (e.g., impending jail).

• Moderate-severe hepatic impairment as indicated by ALT or AST levels > 3x ULN and/or Bilirubin levels >2x ULN as evidenced by a blood test.