Double-Blind Naltrexone in Compulsive Sexual Behavior - Full Text View

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00467558

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group 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:

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Compulsive Sexual Behavior Inventory (CSBI) [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Yale Brown Obsessive Compulsive Scale Modified for Compulsive sexual behavior (CSB-YBOCS) [ Time Frame: At each visit ] [ Designated as safety issue: No ]
Clinical Global Impression scale [ Time Frame: At each visit ] [ Designated as safety issue: No ]
Sheehan Disability Inventory [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
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:

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

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:	Jon E. Grant, M.D., University of Minnesota
ClinicalTrials.gov Identifier:	NCT00467558 History of Changes
Other Study ID Numbers:	0701M00804
Study First Received:	April 27, 2007
Last Updated:	December 2, 2010
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 February 09, 2012