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Double-Blind Naltrexone in Kleptomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00332579
First received: May 30, 2006
Last updated: April 9, 2012
Last verified: April 2012

May 30, 2006
April 9, 2012
May 2006
September 2008   (final data collection date for primary outcome measure)
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) [ Time Frame: K-YBOCS is done at each visit by the investigator. ] [ Designated as safety issue: No ]
The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
Complete list of historical versions of study NCT00332579 on ClinicalTrials.gov Archive Site
Not Provided
Kleptomania Symptom Assessment Scale (K-SAS)
Not Provided
Not Provided
 
Double-Blind Naltrexone in Kleptomania
A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania

The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Kleptomania
  • Drug: Naltrexone
    daily
    Other Name: Revia
  • Drug: Placebo
    daily
  • Active Comparator: A
    Naltrexone
    Intervention: Drug: Naltrexone
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Grant JE, Kim SW, Odlaug BL. A double-blind, placebo-controlled study of the opiate antagonist, naltrexone, in the treatment of kleptomania. Biol Psychiatry. 2009 Apr 1;65(7):600-6. Epub 2009 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. men and women age 21-75
  2. current DSM-IV kleptomania.

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 for the treatment of kleptomania 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
  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.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00332579
0602M82626
Yes
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
April 2012

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