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Naltrexone in the Treatment of Pyromania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00467454
Recruitment Status : Withdrawn (Funding allocation to different clinical trials.)
First Posted : April 30, 2007
Last Update Posted : December 14, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.

Condition or disease Intervention/treatment Phase
Pyromania Drug: Naltrexone Drug: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
Study Start Date : June 2007
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Naltrexone
Drug: Naltrexone
daily
Other Name: Revia
Placebo Comparator: 2
Placebo
Drug: Placebo
daily


Outcome Measures

Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS) [ Time Frame: At each visit ]

Secondary Outcome Measures :
  1. Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory [ Time Frame: At each visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00467454     History of Changes
Other Study ID Numbers: 0703M04084
First Posted: April 30, 2007    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Firesetting Behavior
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents