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Double-Blind Naltrexone in Compulsive Sexual Behavior

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00467558
First received: April 27, 2007
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Compulsive Sexual Behavior
 Drug: Naltrexone
Drug: Sugar pill
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Compulsive Sexual Behavior

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Clinical Global Impression Scale - Severity [ Time Frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8) ] [ Designated as safety issue: No ]
    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."


Enrollment: 7
Study Start Date: May 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00467558     History of Changes
Other Study ID Numbers: 0701M00804
Study First Received: April 27, 2007
Results First Received: February 3, 2012
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013