Phase 2 N=7 Randomized Double-blind Treatment

Double-Blind Naltrexone in Compulsive Sexual Behavior

Compulsive Sexual Behavior

Bottom Line

View on ClinicalTrials.gov: NCT00467558 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS) — 8; 9.33 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Naltrexone (Drug); Sugar pill (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)	8; 9.33	—
SECONDARY Clinical Global Impression Scale - Severity	2.33; 2.67	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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;
initiation of a psychotropic medication within 2 months prior to study inclusion;
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00467558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.