Double-Blind Naltrexone in Compulsive Sexual Behavior

Study Overview
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Brief Summary
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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 naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Detailed Description
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The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Official Title
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A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior

Conditions
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Compulsive Sexual Behavior

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age 21-75; current diagnosis of compulsive sexual behavior Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naltrexone<br>Naltrexone 50mg-150mg by mouth per day. | Drug: Naltrexone<br>* daily<br>* Other names: Revia;|
| Placebo Comparator: Placebo<br>Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician | Drug: Sugar pill<br>* daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS) | The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale - Severity | The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = very much improved to 7 = very much worse. The CGI severity scale was used at each visit and ranges from 1 = not ill at all to 7 = among the most extremely ill. | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impulse Control Disorder, Compulsive Sexual Behavior