Naltrexone in the Treatment of Pyromania

Phase 2

Withdrawn

• Conditions: Pyromania
• Interventions: Drug: Naltrexone; Drug: Placebo

• Registration Number: NCT00467454
• Lead Sponsor: University of Minnesota

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Study Start: 2007-06
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-13
• Last Update Posted: 2011-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Naltrexone	Naltrexone
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)	At each visit

Secondary Outcome Measures

Name	Time	Method
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory	At each visit

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States