Status:
WITHDRAWN
Naltrexone in the Treatment of Pyromania
Lead Sponsor:
University of Minnesota
Conditions:
Pyromania
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.
Detailed Description
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in pyromania. Ten subjects with DSM-IV pyromania will receive 8 weeks of naltrexone or placebo. The hypothesis to be...
Eligibility Criteria
Inclusion
- men and women age 16-75;
- current DSM-IV pyromania
Exclusion
- unstable medical illness or clinically significant abnormalities on prestudy 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 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00467454
Start Date
June 1 2007
End Date
April 1 2010
Last Update
December 14 2011
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55454