Phase 2
Completed N=7
Double-Blind Naltrexone in Compulsive Sexual Behavior
Compulsive Sexual Behavior
Source: ClinicalTrials.gov NCT00467558 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS) — 8; 9.33 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.