Phase 2
Completed N=3
Oral Cannabidiol for Opioid Withdrawal
Opioid Withdrawal · Opioid Craving · Opioid Use Disorder
Source: ClinicalTrials.gov NCT04238754 ↗
Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Safety as Assessed by Number of Adverse Events — 4; 5 Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Assessed by Number of Adverse Events |
4; 5 | — |
| PRIMARY Number of Participants Whose Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) Levels >3x Upper Limit of Normal |
0; 0 | — |
| PRIMARY Change in Withdrawal Scores From Baseline AfterReceiving Placebo |
15.8 | — |
| SECONDARY Initial Efficacy of Study Drug as Assessed by Area Under the Curve for the Subjective Opiate Withdrawal Scale (SOWS) Scores |
1334.7; 1591.5 | — |
| SECONDARY Acceptability Assessed by Number of Participants Who Would Recommend the Medication to a Family Member or Friend |
3; 2 | — |
| SECONDARY Acceptability Assessed by Visual Analog Ratings |
24.333; 17.5 | — |
| SECONDARY Acceptability Assessed by Rating of Medication Acceptance on a 5-point Acceptance Rating Scale |
4; 4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04238754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.