Trial Outcomes & Findings for Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (NCT NCT03102918)

NCT ID: NCT03102918

Last Updated: 2019-01-25

Results Overview

Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: During Week 6
• Results posted on: 2019-01-25

Participant Flow

Participant milestones

Measure	Cannabidiol Epidiolex Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.	Placebo Placebo Placebo: Participants will receive placebo over a 6-week treatment period.
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Cannabidiol Epidiolex Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.	Placebo Placebo Placebo: Participants will receive placebo over a 6-week treatment period.
Overall Study Protocol Violation	1	0

Baseline Characteristics

Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

Baseline characteristics by cohort

Measure	Cannabidiol n=5 Participants Epidiolex Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.	Placebo n=5 Participants Placebo Placebo: Participants will receive placebo over a 6-week treatment period.	Total n=10 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 10.7 • n=5 Participants	28.0 years STANDARD_DEVIATION 12.3 • n=7 Participants	30.8 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Self-report Cannabis Use during Baseline	26.03 Inhalations per day STANDARD_DEVIATION 22.03 • n=5 Participants	21.03 Inhalations per day STANDARD_DEVIATION 26.61 • n=7 Participants	23.53 Inhalations per day STANDARD_DEVIATION 23.18 • n=5 Participants

PRIMARY outcome

Timeframe: During Week 6

Population: One subject in the Cannabidiol arm was withdrawn from the study before Week 6 due to poor medication adherence.

Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback

Outcome measures

Measure	Cannabidiol n=4 Participants Epidiolex Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.	Placebo n=5 Participants Placebo Placebo: Participants will receive placebo over a 6-week treatment period.
Self-report Instruments to Measure Cannabis Use	26.72 Inhalations of Cannabis Per Day Standard Deviation 26.96	5.256 Inhalations of Cannabis Per Day Standard Deviation 4.34

Adverse Events

Cannabidiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kevin Hill

Beth Israel Deaconess Medical Center

Phone: 617-667-1504

Email: khill1@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place