Oral Cannabidiol for Opioid Withdrawal

Launched by JOHNS HOPKINS UNIVERSITY · Jan 22, 2020

Keywords

ClinConnect Summary

Based on preclinical research and emerging human research, cannabidiol (CBD; a major constituent of the cannabis plant) is a promising pharmacotherapy for the treatment of opioid withdrawal. Most recently, CBD decreased cue-induced craving and anxiety (two common withdrawal symptoms) among abstinent heroin-dependent individuals relative to placebo. As of June 2018, Epidiolex, an oral formulation of plant-derived pure CBD, has been approved by the U.S. Food and Drug Administration (FDA) for treating severe forms of epilepsy and can be prescribed for other off-label indications. Epidiolex has...

Gender

ALL

Eligibility 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.