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Double-Blind Naltrexone in Kleptomania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332579
First Posted: June 1, 2006
Last Update Posted: May 4, 2012
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.
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
  Purpose
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

Condition Intervention Phase
Kleptomania Drug: Naltrexone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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).


Enrollment: 25
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Naltrexone
Drug: Naltrexone
daily
Other Name: Revia
Placebo Comparator: B
Placebo
Drug: Placebo
daily

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.
  Eligibility

Information from the National Library of Medicine

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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.
  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): 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
  More Information

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 Submitted: May 30, 2006
First Posted: June 1, 2006
Results First Submitted: March 1, 2012
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