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

Results First Received: February 3, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Compulsive Sexual Behavior
Interventions:	Drug: Naltrexone Drug: Sugar pill

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Naltrexone	Naltrexone 50mg-150mg by mouth per day.
Placebo	Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician

Participant Flow: Overall Study

	Naltrexone	Placebo
STARTED	4	3
COMPLETED	2	3
NOT COMPLETED	2	0
Lost to Follow-up	2	0

Baseline Characteristics

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Reporting Groups

	Description
Naltrexone	Naltrexone 50mg-150mg by mouth per day.
Placebo	Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Total	Total of all reporting groups

Baseline Measures

	Naltrexone	Placebo	Total
Number of Participants [units: participants]	4	3	7
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	4	3	7
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	27.67 ± 7.37	35.67 ± 10.69	31.87 ± 9.31
Gender [units: participants]
Female	0	0	0
Male	4	3	7
Region of Enrollment [units: participants]
United States	4	3	7

Outcome Measures

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1. Primary:

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) ]

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2. Secondary:

Clinical Global Impression Scale - Severity [ Time Frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Jon E. Grant, MD
Organization: University of Minnesota
phone: 612-273-9736
e-mail: grant045@umn.edu

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

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