ClinicalTrials.gov
ClinicalTrials.gov Menu

Marinol in Trichotillomania or Obsessive Compulsive Disorder

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: NCT01093976
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Trichotillomania
Obsessive Compulsive Disorder
Intervention Drug: Dronabinol
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dronabinol
Hide Arm/Group Description Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Dronabinol
Hide Arm/Group Description Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
33.29  (8.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score
Hide Description The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28.
Time Frame Subjects were followed for their duration of participation in the study (12-weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Mean score reported below is the endpoint MGH-HPS score (at 12-weeks or last-observation carried forward).
Arm/Group Title Dronabinol
Hide Arm/Group Description:
Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.71  (5.48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dronabinol
Hide Arm/Group Description Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
All-Cause Mortality
Dronabinol
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dronabinol
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dronabinol
Affected / at Risk (%) # Events
Total   4/14 (28.57%)    
Psychiatric disorders   
Light-headed / dizziness *  4/14 (28.57%)  4
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Jon E. Grant
Organization: University of Minnesota
Phone: 612-273-9800
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT01093976     History of Changes
Other Study ID Numbers: 0909M72088
First Submitted: March 24, 2010
First Posted: March 26, 2010
Results First Submitted: March 1, 2012
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013