Double-Blind Naltrexone in Compulsive Sexual Behavior

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Chronic Pain

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Detailed Description

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The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.

Conditions

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Compulsive Sexual Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Naltrexone

Naltrexone 50mg-150mg by mouth per day.

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

daily

Placebo

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

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

daily

Interventions

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Naltrexone

daily

Intervention Type DRUG

Sugar pill

daily

Intervention Type DRUG

Other Intervention Names

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Revia

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. clinically significant suicidality;
6. current or recent (past 1 month) DSM-IV substance abuse or dependence;
7. illegal substance within 2 weeks of study initiation;
8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
9. initiation of a psychotropic medication within 2 months prior to study inclusion;
10. previous treatment with naltrexone; and
11. 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No