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N-Acetyl Cysteine in Trichotillomania

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: NCT00354770
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : January 15, 2014
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania

Condition or disease Intervention/treatment Phase
Trichotillomania Drug: Placebo Drug: N-Acetyl Cysteine Phase 2

Detailed Description:
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania
Study Start Date : July 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: N-Acetyl Cysteine
N-Acetyl Cysteine
 Drug: N-Acetyl Cysteine
600mg capsules in varying doses for 12 weeks.
Other Name: NAC
Placebo Comparator: 2
Placebo
 Drug: Placebo
daily


Outcome Measures
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Primary Outcome Measures :
  1. Massachusetts General Hospital Hairpulling Scale [ Time Frame: Baseline and final visit after 12 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women age 18-65;
  • current DSM-IV trichotillomania

Exclusion Criteria:

  • unstable medical illness;
  • history of seizures;
  • myocardial infarction within 6 months;
  • current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
  • any thoughts of suicide;
  • lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
  • previous treatment with N-Acetyl Cysteine;
  • treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
  • 9) diagnosis of asthma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354770


Locations
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United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jon E Grant, MD, JD University of Minnesota
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00354770    
Other Study ID Numbers: 0604M85110
First Posted: July 20, 2006    Key Record Dates
Results First Posted: January 15, 2014
Last Update Posted: February 23, 2023
Last Verified: February 2023
Keywords provided by University of Chicago:
Trichotillomania
Hair-pulling
Additional relevant MeSH terms:
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Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
 Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes