Status:
COMPLETED
Double-Blind Naltrexone in Compulsive Sexual Behavior
Lead Sponsor:
University of Minnesota
Conditions:
Compulsive Sexual Behavior
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltre...
Detailed Description
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.
Eligibility Criteria
Inclusion
- men and women age 21-75;
- current diagnosis of compulsive sexual behavior
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 1 month) 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 :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00467558
Start Date
May 1 2007
End Date
June 1 2010
Last Update
May 18 2012
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55454