Naltrexone in the Treatment of Pyromania

Study Overview
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Brief Summary
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The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.

Detailed Description
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The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in pyromania. Ten subjects with DSM-IV pyromania will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to set fires patients with pyromania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Official Title
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A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania

Conditions
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Pyromania

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age 16-75; current DSM-IV pyromania 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 3 months) 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Naltrexone | Drug: Naltrexone<br>* daily<br>* Other names: Revia;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS) |  | At each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory |  | At each visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pyromania, Fire Setting, Compulsive Fire Setting