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Naltrexone in the Treatment of Pyromania

NCT ID: NCT00467454

Last Updated: 2011-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-04-30

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.

Conditions

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Pyromania

Keywords

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Pyromania Fire Setting Compulsive Fire Setting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Naltrexone

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

daily

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

daily

Interventions

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Naltrexone

daily

Intervention Type DRUG

Placebo

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 16-75;
2. current DSM-IV pyromania

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 3 months) 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

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon E Grant, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0703M04084

Identifier Type: -

Identifier Source: org_study_id