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Double-Blind Naltrexone in Compulsive Sexual Behavior

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ClinicalTrials.gov Identifier: NCT00467558
Recruitment Status : Completed
First Posted : April 30, 2007
Results First Posted : May 18, 2012
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Compulsive Sexual Behavior Drug: Naltrexone Drug: Sugar pill Phase 2

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior
Study Start Date : May 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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."



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467558


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jon E Grant, M.D. University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00467558     History of Changes
Other Study ID Numbers: 0701M00804
First Posted: April 30, 2007    Key Record Dates
Results First Posted: May 18, 2012
Last Update Posted: May 18, 2012
Last Verified: April 2012

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Impulse Control Disorder
Compulsive Sexual Behavior

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents