Naltrexone in the Treatment of Pyromania

December 13, 2011 updated by: University of Minnesota

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 73 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
daily
Active Comparator: 1
Naltrexone
daily
Other Names:
  • Revia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
Time Frame: At each visit
At each visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
Time Frame: At each visit
At each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jon E Grant, M.D., University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (Estimate)

April 30, 2007

Study Record Updates

Last Update Posted (Estimate)

December 14, 2011

Last Update Submitted That Met QC Criteria

December 13, 2011

Last Verified

December 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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