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
|Condition or disease||Intervention/treatment||Phase|
|Compulsive Sexual Behavior||Drug: Naltrexone Drug: Sugar pill||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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).
- 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."
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
|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|