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Marinol in Trichotillomania or Obsessive Compulsive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093976
First Posted: March 26, 2010
Last Update Posted: September 27, 2013
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.
Information provided by (Responsible Party):
Jon Grant, University of Chicago
Results First Submitted: March 1, 2012  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dronabinol Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks

Participant Flow:   Overall Study
    Dronabinol
STARTED   14 
COMPLETED   14 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dronabinol Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks

Baseline Measures
   Dronabinol 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   14 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.29  (8.86) 
Gender 
[Units: Participants]
 
Female   14 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures

1.  Primary:   Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score   [ Time Frame: Subjects were followed for their duration of participation in the study (12-weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: grant045@umn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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