Naltrexone in the Treatment of Pyromania - Full Text View

Sponsored by:	University of Minnesota
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00467454

Purpose

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

Condition	Intervention	Phase
Pyromania	Drug: Naltrexone Drug: Placebo	Phase II

MedlinePlus related topics: Fires

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS) [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	June 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Naltrexone	Drug: Naltrexone daily
2: Placebo Comparator Placebo	Drug: Placebo daily

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.

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467454

Contacts

Contact: Brian L Odlaug, B.A.	612-627-4363	odla0019@umn.edu
Contact: Jon E Grant, M.D.	612-273-9736	grant045@umn.edu

Locations

United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Brian L Odlaug, B.A. 612-627-4363 odla0019@umn.edu
Principal Investigator: Jon E Grant, M.D.

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator:

Jon E Grant, M.D.

University of Minnesota

More Information

Responsible Party:	University of Minnesota ( Jon E. Grant, M.D. )
Study ID Numbers:	0703M04084
Study First Received:	April 27, 2007
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00467454
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

Pyromania
Fire Setting
Compulsive Fire Setting

Study placed in the following topic categories:

Impulse Control Disorders
Mental Disorders
Naltrexone
Firesetting Behavior

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009