At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 3 enrolled
Drug / intervention
Epidiolex +1 moredrug
Likely dose
Epidiolex 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Placebo-Controlled Evaluation of the Safety of Oral Cannabidiol in a Clinically Relevant Model of Opioid Withdrawal
In Brief
A Phase 2 clinical trial evaluating Epidiolex and Placebo for Opioid Withdrawal and 2 related conditions. Completed, enrolled 3 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Withdrawal, Opioid Craving, Opioid Use Disorder
CountriesUnited States
CollaboratorsDalio Foundation
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartNov 2020
Primary CompletionJun 2022
TodayJul 2026
First PostedJan 23, 2020
Enrollment StartNov 1, 2020
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.4 years ago
Interventions
Epidiolexdrug
Epidiolex 100 mg/mL Oral Solution
Placebodrug
Cherry syrup oral solution