Trial Outcomes & Findings for Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine (NCT NCT04192370)
NCT ID: NCT04192370
Last Updated: 2023-05-18
Results Overview
Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being "not at all" and 10 being "extremely." Higher scores thus mean a "worse" outcome (i.e. more intense cravings/anxiety).
COMPLETED
PHASE2
8 participants
pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)
2023-05-18
Participant Flow
Participant milestones
| Measure |
Cannabidiol
As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days.
Cannabidiol 600mg: All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
Baseline characteristics by cohort
| Measure |
Cannabidiol
n=7 Participants
As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days.
Cannabidiol 600mg: All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.86 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)Population: Individuals with opioid use disorder who are currently receiving buprenorphine for treatment.
Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being "not at all" and 10 being "extremely." Higher scores thus mean a "worse" outcome (i.e. more intense cravings/anxiety).
Outcome measures
| Measure |
Cannabidiol
n=5 Participants
As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days.
Cannabidiol 600mg: All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
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|---|---|
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Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration
Cannabidiol
|
3.2 score on a scale
Standard Deviation .8
|
|
Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration
Pre-CBD
|
0.4 score on a scale
Standard Deviation 0.5
|
Adverse Events
Cannabidiol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place