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Double-Blind Naltrexone in Kleptomania

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ClinicalTrials.gov Identifier: NCT00332579
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : May 4, 2012
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute

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

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

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
Study Start Date : May 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Naltrexone
Drug: Naltrexone
daily
Other Name: Revia
Placebo Comparator: B
Placebo
Drug: Placebo
daily



Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) [ Time Frame: K-YBOCS is done at each visit by the investigator. ]
    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).



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00332579


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, MD, JD University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon E. Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00332579     History of Changes
Other Study ID Numbers: 0602M82626
First Posted: June 1, 2006    Key Record Dates
Results First Posted: May 4, 2012
Last Update Posted: May 4, 2012
Last Verified: April 2012

Keywords provided by Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute:
Compulsive Shoplifting
Kleptomania
Compulsive Stealing

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