Naltrexone in the Treatment of Pyromania

Pyromania Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00467454
• Other study ID #: 0703M04084
• Status: Withdrawn
• Phase: Phase 2
• First received: April 27, 2007
• Last updated: December 13, 2011
• Start date: June 2007
• Est. completion date: April 2010

Study information

• Verified date: December 2011
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pyromania

Intervention

Drug:
• Naltrexone
daily
• Placebo
daily

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)		At each visit	No
Secondary	Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory		At each visit	No