Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

N-Acetyl Cysteine in Trichotillomania

This study has been completed.
Information provided by (Responsible Party):
Jon Grant, University of Chicago Identifier:
First received: July 18, 2006
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Trichotillomania
Interventions: Drug: Placebo
Drug: N-Acetyl Cysteine

  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
No text entered.

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
N-Acetyl Cysteine N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
Placebo Placebo pills

Participant Flow:   Overall Study
    N-Acetyl Cysteine     Placebo  
STARTED     25     25  
COMPLETED     22     22  
NOT COMPLETED     3     3  

  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.
No text entered.

Reporting Groups
N-Acetyl Cysteine N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
Placebo Placebo pills
Total Total of all reporting groups

Baseline Measures
    N-Acetyl Cysteine     Placebo     Total  
Number of Participants  
[units: participants]
  25     25     50  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     25     25     50  
>=65 years     0     0     0  
[units: years]
Mean ± Standard Deviation
  35.8  ± 13.6     32.7  ± 10.5     34.5  ± 11.5  
[units: participants]
Female     24     21     45  
Male     1     4     5  
Region of Enrollment  
[units: participants]
United States     25     25     50  

  Outcome Measures

1.  Primary:   Massachusetts General Hospital Hairpulling Scale   [ Time Frame: Beginning to end of study every 2 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 Chicago
phone: 773-834-1325

No publications provided by University of Chicago

Publications automatically indexed to this study:

Responsible Party: Jon Grant, University of Chicago Identifier: NCT00354770     History of Changes
Other Study ID Numbers: 0604M85110
Study First Received: July 18, 2006
Results First Received: March 1, 2012
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board