Status:
COMPLETED
Naltrexone in the Treatment of Trichotillomania
Lead Sponsor:
University of Chicago
Conditions:
Trichotillomania
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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. Th...
Eligibility Criteria
Inclusion
- men and women age 18-75;
- current DSM-IV trichotillomania;
- hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.
Exclusion
- unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;
- history of seizures;
- myocardial infarction within 6 months;
- current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- clinically significant suicidality;
- current or recent (past 3 months) DSM-IV substance abuse or dependence;
- illegal substance within 2 weeks of study initiation;
- initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;
- initiation of a psychotropic medication within 2 months prior to study inclusion;
- previous treatment with naltrexone; and
- 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;
- lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- current use of opiates.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00775229
Start Date
August 1 2008
End Date
December 1 2012
Last Update
February 23 2023
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60615