Double-Blind Naltrexone in Compulsive Sexual Behavior

Phase 2

Completed

• Conditions: Compulsive Sexual Behavior
• Interventions: Drug: Naltrexone; Drug: Sugar pill

• Registration Number: NCT00467558
• Lead Sponsor: University of Minnesota

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 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

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

Study Timeline

• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Study Start: 2007-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2012-02-03
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-18
• Last Update Submitted: 2012-04-18
• Results First Posted: 2012-05-18
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. men and women age 21-75;
2. current diagnosis of compulsive sexual behavior

Exclusion Criteria

1. unstable medical illness or clinically significant abnormalities on prestudy 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 1 month) 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone	Naltrexone	Naltrexone 50mg-150mg by mouth per day.
Placebo	Sugar pill	Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)	Assessed at each visit (every two weeks) until participation in the study was done (Week 8)	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).

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression Scale - Severity	Assessed at each visit (every two weeks) until participation in the study was done (Week 8)	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."

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States