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N-Acetyl Cysteine in Trichotillomania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354770
First Posted: July 20, 2006
Last Update Posted: December 16, 2016
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
  Purpose
This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania

Condition Intervention Phase
Trichotillomania Drug: Placebo Drug: N-Acetyl Cysteine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jon Grant, University of Chicago:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
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
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon Grant, Professor of Psychiatry, 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
Last Verified: October 2016

Keywords provided by Jon Grant, University of Chicago:
Trichotillomania
Hair-pulling

Additional relevant MeSH terms:
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