Trial Outcomes & Findings for Oral Cannabidiol for Opioid Withdrawal (NCT NCT04238754)
NCT ID: NCT04238754
Last Updated: 2023-08-29
Results Overview
Number of Adverse Events reported across sessions with and without study drug. Adverse events were collected for the entire 57 hour session.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
through completion of the two study sessions, an average of 17 days
Results posted on
2023-08-29
Participant Flow
Participant milestones
| Measure |
Epidiolex Then Placebo
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.
|
Placebo Then Epidiolex
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.
|
|---|---|---|
|
First Intervention
STARTED
|
2
|
1
|
|
First Intervention
COMPLETED
|
2
|
1
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout - 1 Week
STARTED
|
2
|
1
|
|
Washout - 1 Week
COMPLETED
|
1
|
1
|
|
Washout - 1 Week
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
1
|
1
|
|
Second Intervention
COMPLETED
|
1
|
1
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Epidiolex Then Placebo
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.
|
Placebo Then Epidiolex
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.
|
|---|---|---|
|
Washout - 1 Week
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Oral Cannabidiol for Opioid Withdrawal
Baseline characteristics by cohort
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through completion of the two study sessions, an average of 17 daysNumber of Adverse Events reported across sessions with and without study drug. Adverse events were collected for the entire 57 hour session.
Outcome measures
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
Placebo
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
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
Epidiolex Adverse Events
|
5 Adverse Events
|
—
|
|
Safety as Assessed by Number of Adverse Events
Placebo Adverse Events
|
4 Adverse Events
|
—
|
PRIMARY outcome
Timeframe: End of residential stay, prior to dischargeNumber of participants whose AST/ALT levels \>3x upper limit of normal (ULN) at the end of a study session when they receive Epidiolex and Placebo. This will be used in the assessment of safety.
Outcome measures
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
Placebo
n=2 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|---|
|
Number of Participants Whose Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) Levels >3x Upper Limit of Normal
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, during residential session up to 57 hoursChange 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.
Outcome measures
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
Placebo
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|---|
|
Change in Withdrawal Scores From Baseline AfterReceiving Placebo
|
15.8 score on a scale
Standard Deviation 6.3
|
—
|
SECONDARY outcome
Timeframe: After first administration of study drug and up to 48 hoursWithdrawal symptom suppression during active and placebo conditions. Area Under the Curve (AUC) analyses will be calculated to characterize withdrawal on the Subjective Opiate Withdrawal Scale (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.
Outcome measures
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
Placebo
n=2 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|---|
|
Initial Efficacy of Study Drug as Assessed by Area Under the Curve for the Subjective Opiate Withdrawal Scale (SOWS) Scores
|
1334.7 scores on SOWS scale X hour
Standard Deviation 57.8
|
1591.5 scores on SOWS scale X hour
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: at the end of the 57-hour residential session, prior to dischargeNumber of participants who would recommend the medication to a family member or friend trying to taper down from opioid medications.
Outcome measures
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
Placebo
n=2 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|---|
|
Acceptability Assessed by Number of Participants Who Would Recommend the Medication to a Family Member or Friend
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at the end of the 57-hour residential session, prior to dischargeVisual 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.
Outcome measures
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
Placebo
n=2 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|---|
|
Acceptability Assessed by Visual Analog Ratings
|
24.333 units on a scale
Standard Deviation 9.0
|
17.5 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: at the end of the 57-hour residential session, prior to dischargeParticipant 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.
Outcome measures
| Measure |
All Participants
n=3 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
Placebo
n=2 Participants
Each participant will receive Epidiolex oral solution and Cherry syrup oral solution (placebo) in a randomized fashion.
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)
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|---|
|
Acceptability Assessed by Rating of Medication Acceptance on a 5-point Acceptance Rating Scale
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
Adverse Events
Epidiolex
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epidiolex
n=3 participants at risk
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)
|
Placebo
n=3 participants at risk
Cherry Syrup Oral Solution: 20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
33.3%
1/3 • Number of events 1 • through completion of the two study sessions, an average of 17 days
|
0.00%
0/3 • through completion of the two study sessions, an average of 17 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
66.7%
2/3 • Number of events 3 • through completion of the two study sessions, an average of 17 days
|
0.00%
0/3 • through completion of the two study sessions, an average of 17 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • through completion of the two study sessions, an average of 17 days
|
33.3%
1/3 • Number of events 1 • through completion of the two study sessions, an average of 17 days
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • through completion of the two study sessions, an average of 17 days
|
33.3%
1/3 • Number of events 1 • through completion of the two study sessions, an average of 17 days
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • through completion of the two study sessions, an average of 17 days
|
0.00%
0/3 • through completion of the two study sessions, an average of 17 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • through completion of the two study sessions, an average of 17 days
|
33.3%
1/3 • Number of events 1 • through completion of the two study sessions, an average of 17 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place