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N-Acetyl Cysteine in Trichotillomania

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ClinicalTrials.gov Identifier: NCT00354770
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : January 15, 2014
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Trichotillomania
Interventions Drug: Placebo
Drug: N-Acetyl Cysteine
Enrollment 50

Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-Acetyl Cysteine Placebo
Hide Arm/Group Description N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day Placebo pills
Period Title: Overall Study
Started 25 25
Completed 22 22
Not Completed 3 3
Arm/Group Title N-Acetyl Cysteine Placebo Total
Hide Arm/Group Description N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day Placebo pills Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
35.8  (13.6) 32.7  (10.5) 34.5  (11.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
24
  96.0%
21
  84.0%
45
  90.0%
Male
1
   4.0%
4
  16.0%
5
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Massachusetts General Hospital Hairpulling Scale
Hide Description There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.
Time Frame Baseline and final visit after 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetyl Cysteine Placebo
Hide Arm/Group Description:
N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
Placebo pills
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
MGH-HPS Baseline 17.6  (4.64) 16.7  (5.28)
MGH-HPS Final Visit After 12 Weeks 10.4  (5.55) 16.0  (4.90)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-Acetyl Cysteine Placebo
Hide Arm/Group Description N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day Placebo pills
All-Cause Mortality
N-Acetyl Cysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
N-Acetyl Cysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-Acetyl Cysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      3/25 (12.00%)    
Gastrointestinal disorders     
Diarrhea   0/25 (0.00%)  0 2/25 (8.00%)  2
Nausea   0/25 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by 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 Chicago
Phone: 773-834-1325
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT00354770     History of Changes
Other Study ID Numbers: 0604M85110
First Submitted: July 18, 2006
First Posted: July 20, 2006
Results First Submitted: March 1, 2012
Results First Posted: January 15, 2014
Last Update Posted: December 16, 2016