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Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (CBD)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102918
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cannabis Use Disorder
Interventions Drug: Cannabidiol
Drug: Placebo
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cannabidiol Placebo
Hide Arm/Group Description

Epidiolex

Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.

Placebo

Placebo: Participants will receive placebo over a 6-week treatment period.

Period Title: Overall Study
Started 5 5
Completed 4 5
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title Cannabidiol Placebo Total
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Epidiolex

Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.

Placebo

Placebo: Participants will receive placebo over a 6-week treatment period.

Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
33.6  (10.7) 28.0  (12.3) 30.8  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
3
  60.0%
3
  60.0%
6
  60.0%
Male
2
  40.0%
2
  40.0%
4
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  20.0%
0
   0.0%
1
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
0
   0.0%
1
  10.0%
White
3
  60.0%
5
 100.0%
8
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Self-report Cannabis Use during Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Inhalations per day
Number Analyzed 5 participants 5 participants 10 participants
26.03  (22.03) 21.03  (26.61) 23.53  (23.18)
[1]
Measure Description: Self-report via Timeline Followback of the number of inhalations per day during the Baseline time period
1.Primary Outcome
Title Self-report Instruments to Measure Cannabis Use
Hide Description Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback
Time Frame During Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the Cannabidiol arm was withdrawn from the study before Week 6 due to poor medication adherence.
Arm/Group Title Cannabidiol Placebo
Hide Arm/Group Description:

Epidiolex

Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.

Placebo

Placebo: Participants will receive placebo over a 6-week treatment period.

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: Inhalations of Cannabis Per Day
26.72  (26.96) 5.256  (4.34)
Time Frame Adverse event data was collected through-out the course of the study during each study visit. This is from baseline until Week 14 when the last follow-up visit was conducted.
Adverse Event Reporting Description Study staff collected any adverse event data during every study visit for each subject. This amounted to twice a week during the study.
 
Arm/Group Title Cannabidiol Placebo
Hide Arm/Group Description

Epidiolex

Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.

Placebo

Placebo: Participants will receive placebo over a 6-week treatment period.

All-Cause Mortality
Cannabidiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cannabidiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cannabidiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Due to the small sample size, more subjects would need to be included to be able to draw definitive conclusions from this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kevin Hill
Organization: Beth Israel Deaconess Medical Center
Phone: 617-667-1504
EMail: khill1@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03102918     History of Changes
Other Study ID Numbers: 2015P002013
First Submitted: March 31, 2017
First Posted: April 6, 2017
Results First Submitted: August 21, 2018
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019