Double-Blind Naltrexone in Compulsive Sexual Behavior

NCT00467558 | Completed Phase 2 Results DMC

• 1 other identifier: 0701M00804
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Compulsive Sexual Behavior

Keywords

Impulse Control Disorder; Compulsive Sexual Behavior

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)

  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).

  Assessed at each visit (every two weeks) until participation in the study was done (Week 8)

Secondary Outcomes (1)

• Clinical Global Impression Scale - Severity

  Assessed at each visit (every two weeks) until participation in the study was done (Week 8)

Study Arms (2)

Naltrexone

ACTIVE COMPARATOR

Naltrexone 50mg-150mg by mouth per day.

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician

Drug: Sugar pill

Interventions

Naltrexone DRUG

daily

Also known as: Revia

Naltrexone

Sugar pill DRUG

daily

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women age 21-75;
• current diagnosis of compulsive sexual behavior

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Naltrexone; Sugars

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Sexual and Gender Disorders; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Jon E. Grant, MD
• Organization: University of Minnesota

grant045@umn.edu

612-273-9736

Study Officials

• Jon E Grant, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 18, 2012
• Results First Posted: May 18, 2012

Record last verified: 2012-04

Locations

US (1)