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N-Acetyl Cysteine in Trichotillomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00354770
First received: July 18, 2006
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Massachusetts General Hospital Hairpulling Scale [ Time Frame: Beginning to end of study ] [ Designated as safety issue: No ]

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: 1
N-Acetyl Cysteine
 Drug: N-Acetyl Cysteine
daily
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354770

Locations
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

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

Responsible Party: Jon E. Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00354770     History of Changes
Other Study ID Numbers: 0604M85110
Study First Received: July 18, 2006
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Trichotillomania
Hair-pulling

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 19, 2013