Double-Blind Naltrexone in Compulsive Sexual Behavior

Compulsive Sexual Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467558
• Other study ID #: 0701M00804
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2007
• Last updated: April 18, 2012
• Start date: May 2007
• Est. completion date: June 2010

Study information

• Verified date: April 2012
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Sexual Behavior

Intervention

Drug:
• Naltrexone
daily
• Sugar pill
daily

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No