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.
|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|
- 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).
- 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."
|Study Start Date:||May 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Naltrexone
Naltrexone 50mg-150mg by mouth per day.
Other Name: Revia
Placebo Comparator: Placebo
Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Drug: Sugar pill
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Jon E Grant, M.D.||University of Minnesota - Clinical and Translational Science Institute|