Oral Cannabidiol for Opioid Withdrawal
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04238754|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid Withdrawal Opioid Craving Opioid Use Disorder||Drug: Epidiolex 100 mg/mL Oral Solution Other: Cherry Syrup Oral Solution||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Within subject comparison of Epidiolex to placebo. The order of study drug (active Epidiolex or placebo) is randomized across participants. Epidiolex is flavor masked with cherry syrup|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Placebo-Controlled Evaluation of the Safety of Oral Cannabidiol in a Clinically Relevant Model of Opioid Withdrawal|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: All Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
Drug: Epidiolex 100 mg/mL Oral Solution
8 mL of Epidiolex (800 mg of cannabidiol) + 16 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
Other Name: cannabidiol
Other: Cherry Syrup Oral Solution
20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
- Safety as assessed by number of Adverse Events [ Time Frame: 57-hour residential session ]Number of Adverse Events reported across sessions with and without study drug
- Number of participants whose aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels >3x upper limit of normal [ Time Frame: 57-hour residential session ]Number of participants whose AST/ALT levels >3x upper limit of normal (ULN) at the end of a study session when they receive Epidiolex. This will be used in the assessment of safety.
- Feasibility of Spontaneous Withdrawal Model as assessed by change in withdrawal scores [ Time Frame: Baseline, 57-hour residential session when Epidiolex is received ]Change in withdrawal scores during laboratory evaluation of spontaneous withdrawal. Withdrawal is measured with the Subjective Opiate Withdrawal Scale (SOWS). That has a range of 0-64 where a mild score is represented by a score of 1-10, a moderate score is represented by a score of 11-20 and a severe score is considered anything greater than 21.
- Initial Efficacy of Study Drug as assessed by area under the curve for SOWS scores [ Time Frame: 57-hour residential session ]Withdrawal symptom suppression during active and placebo conditions. Area Under the Curve (AUC) analyses will be calculated to characterize withdrawal (SOWS) scores across time. SOWS AUC will be compared between the two conditions. AUC will range from 0 to 3072 where 0 represents no withdrawal during study drug administration and 3072 represents the most severe withdrawal during study drug administration.
- Acceptability assessed by percentage of participants who would recommend the medication to a family member or friend [ Time Frame: 57-hour residential session ]Percent of participants who would recommend the medication to a family member or friend trying to taper down from opioid medications.
- Acceptability assessed by visual analog ratings [ Time Frame: 57-hour residential session ]Visual analog ratings of the degree to which the medication suppressed opioid withdrawal symptoms. The visual analog ratings will be scored on a scale from 0-100 where 0 represents no suppression of withdrawal and 100 represents complete suppression of withdrawal.
- Acceptability assessed by rating of medication acceptance on a 5-point acceptance rating scale [ Time Frame: 57-hour residential session ]Participant rating of medication acceptance on a 5-point acceptance rating scale. The acceptance rating scale will range from 0-4 where 0 represents no acceptance of the medication and 4 represents complete acceptance of the medication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238754
|Contact: Cecilia L Bergeria, PhDemail@example.com|
|Contact: Kelly E Dunn, PhD||410-550-2254|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21224|
|Contact: Cecilia L Bergeria, PhD 540-604-4853 firstname.lastname@example.org|
|Principal Investigator:||Kelly E Dunn, PhD||Johns Hopkins University|