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Naltrexone in the Treatment of Pyromania

This study has been withdrawn prior to enrollment.
(Funding allocation to different clinical trials.)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00467454
First received: April 27, 2007
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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 ]

Enrollment: 0
Study Start Date: June 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Naltrexone
 Drug: Naltrexone
daily
Other Name: Revia
Placebo Comparator: 2
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:

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

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jon E Grant, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00467454     History of Changes
Other Study ID Numbers: 0703M04084
Study First Received: April 27, 2007
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Pyromania
Fire Setting
Compulsive Fire Setting

Additional relevant MeSH terms:
Firesetting Behavior
Impulse Control Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013