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Trial record 9 of 9 for:    "Impulse Control Disorder" | "Peripheral Nervous System Agents"

Double-Blind Naltrexone in Compulsive Sexual Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Compulsive Sexual Behavior
Interventions Drug: Naltrexone
Drug: Sugar pill
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description Naltrexone 50mg-150mg by mouth per day. Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Period Title: Overall Study
Started 4 3
Completed 2 3
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description Naltrexone 50mg-150mg by mouth per day. Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
3
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
27.67  (7.37) 35.67  (10.69) 31.87  (9.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
3
 100.0%
7
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)
Hide Description 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).
Time Frame Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
Naltrexone 50mg-150mg by mouth per day.
Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
8  (7) 9.33  (1.15)
2.Secondary Outcome
Title Clinical Global Impression Scale - Severity
Hide Description 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.”
Time Frame Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
Naltrexone 50mg-150mg by mouth per day.
Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.33  (1.53) 2.67  (0.58)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description Naltrexone 50mg-150mg by mouth per day. Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jon E. Grant, MD
Organization: University of Minnesota
Phone: 612-273-9736
EMail: grant045@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00467558     History of Changes
Other Study ID Numbers: 0701M00804
First Submitted: April 27, 2007
First Posted: April 30, 2007
Results First Submitted: February 3, 2012
Results First Posted: May 18, 2012
Last Update Posted: May 18, 2012