Naltrexone in the Treatment of Trichotillomania

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Brief Title

Naltrexone in the Treatment of Trichotillomania

Official Title

A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania

Brief Summary

      This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
    

Detailed Description

      The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania.
      Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone
      or placebo. The hypothesis to be tested is that Naltrexone 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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

National Institute of Mental Health Trichotillomania Symptom Severity Scale

Secondary Outcome

 Massachusetts General Hospital Hairpulling Scale

Condition

Trichotillomania

Intervention

Naltrexone

Study Arms / Comparison Groups

 1
Description:  Naltrexone

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

51

Start Date

August 2008

Completion Date

December 2012

Primary Completion Date

November 2012

Eligibility Criteria

        Inclusion Criteria:

          1. men and women age 18-75;

          2. current DSM-IV trichotillomania;

          3. hair-pulling primarily due to urges/cravings; and 4) pulling is reported as
             pleasurable the majority of time.

        Exclusion Criteria:

          1. unstable medical illness or clinically significant abnormalities on pre-study
             laboratory tests or physical examination;

          2. history of seizures;

          3. myocardial infarction within 6 months;

          4. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential;

          5. clinically significant suicidality;

          6. current or recent (past 3 months) DSM-IV substance abuse or dependence;

          7. illegal substance within 2 weeks of study initiation;

          8. initiation of psychotherapy or behavior therapy from a mental health professional for
             the treatment of trichotillomania within 3 months prior to study baseline;

          9. initiation of a psychotropic medication within 2 months prior to study inclusion;

         10. previous treatment with naltrexone; and

         11. 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;

         12. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any
             other DSM-IV psychotic disorder;

         13. current use of opiates.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jon E Grant, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00775229

Organization ID

0806M36061


Responsible Party

Principal Investigator

Study Sponsor

University of Chicago


Study Sponsor

Jon E Grant, M.D., Principal Investigator, University of Minnesota


Verification Date

January 2014