Double-Blind Naltrexone in Compulsive Sexual Behavior

April 18, 2012 updated by: University of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)
Time Frame: 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).
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
Time Frame: 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."
Assessed at each visit (every two weeks) until participation in the study was done (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Jon E Grant, M.D., University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (Estimate)

April 30, 2007

Study Record Updates

Last Update Posted (Estimate)

May 18, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0701M00804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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