Double-Blind Naltrexone in Compulsive Sexual Behavior

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Compulsive Sexual Behavior

Treatments: Drug: Sugar pill; Drug: Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT00467558

0701M00804

Details and patient eligibility

About

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.

Full description

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

Enrollment: 7 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups, including a placebo group

Naltrexone

Active Comparator group

Description:

Naltrexone 50mg-150mg by mouth per day.

Treatment:

Drug: Naltrexone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Sugar pill