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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Recruitment Status : Withdrawn (Funding allocation to different clinical trials.)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):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE April 27, 2007
First Posted Date  ICMJE April 30, 2007
Last Update Posted Date December 14, 2011
Study Start Date  ICMJE June 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS) [ Time Frame: At each visit ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory [ Time Frame: At each visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naltrexone in the Treatment of Pyromania
Official Title  ICMJE A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
Brief Summary The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pyromania
Intervention  ICMJE
  • Drug: Naltrexone
    daily
    Other Name: Revia
  • Drug: Placebo
    daily
Study Arms  ICMJE
  • Active Comparator: 1
    Naltrexone
    Intervention: Drug: Naltrexone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 19, 2010)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2007)
10
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467454
Other Study ID Numbers  ICMJE 0703M04084
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jon E Grant, M.D. University of Minnesota
PRS Account University of Minnesota
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP