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N-Acetyl Cysteine in Trichotillomania

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Trichotillomania

Intervention: Placebo (Drug); N-Acetyl Cysteine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Jon E Grant, MD, JD, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute

Summary

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

Clinical Details

Official title: A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Massachusetts General Hospital Hairpulling Scale

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

University of Minnesota Medical Center, Minneapolis, Minnesota 55454, United States
Additional Information

Starting date: July 2006
Last updated: July 7, 2014

Page last updated: August 23, 2015

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