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Completed

NCT Number: NCT00467558

Double-Blind 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.

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Key information

Conditions

Compulsive Sexual Behavior Behavior Behavior, Addictive Compulsive Behavior Compulsive Sexual Behavior Disorder Disruptive, Impulse Control, and Conduct Disorders Impulsive Behavior Mental Disorders Sexual Dysfunctions, Psychological Sexual and Gender Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

Drug

daily

Other names: Revia

Sugar pill

Drug

daily

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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."

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2007
Registry last updated
May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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