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Cannabinoid

Epidiolex for Opioid Withdrawal Syndrome

Phase 1 & 2
Waitlist Available
Led By Kelly E Dunn, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, during residential session up to 57 hours
Awards & highlights

Study Summary

This trial will study if a marijuana-based drug is safe to use to treat withdrawal symptoms.

Eligible Conditions
  • Opioid Withdrawal Syndrome
  • Opioid Craving
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of residential stay, prior to discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of residential stay, prior to discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Withdrawal Scores From Baseline AfterReceiving Placebo
Number of Participants Whose Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) Levels >3x Upper Limit of Normal
Safety as Assessed by Number of Adverse Events
Secondary outcome measures
Acceptability Assessed by Number of Participants Who Would Recommend the Medication to a Family Member or Friend
Acceptability Assessed by Rating of Medication Acceptance on a 5-point Acceptance Rating Scale
Acceptability Assessed by Visual Analog Ratings
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Epidiolex (CBD) Then PlaceboExperimental Treatment2 Interventions
Participants first receive 8 mL of Epidiolex (800 mg of cannabidiol) + 16 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses) during which prescribed methadone is withheld. After 1 week, they receive 20 mL of inactive cherry syrup delivered every 12 hours for 48hours total (4 doses) during which prescribed methadone is withheld.
Group II: Placebo Then EpidiolexPlacebo Group2 Interventions
Participants first receive 20 mL of inactive cherry syrup delivered every 12 hours for 48hours total (4 doses) during which prescribed methadone is withheld. After 1 week washout, they receive 8 mL of Epidiolex (800 mg of cannabidiol) + 16 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses) during which prescribed methadone is withheld.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epidiolex
2020
Completed Phase 2
~380
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,162 Total Patients Enrolled
Dalio FoundationUNKNOWN
Kelly E Dunn, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Oral Cannabidiol for Opioid Withdrawal
2020. "Oral Cannabidiol for Opioid Withdrawal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04238754.
~1 spots leftby Apr 2025
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