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

History of Changes

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 Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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


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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination
history of seizures
myocardial infarction within 6 months
current pregnancy or lactation, or inadequate contraception in women of childbearing potential
clinically significant suicidality
current or recent (past 3 months) DSM-IV substance abuse or dependence
illegal substance within 2 weeks of study initiation
initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline
initiation of a psychotropic medication within 2 months prior to study inclusion
previous treatment with naltrexone
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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):

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. doi: 10.1016/j.biopsych.2008.11.022. Epub 2009 Feb 12.


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
Study First Received:	May 30, 2006
Results First Received:	March 1, 2012
Last Updated:	April 9, 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

ClinicalTrials.gov processed this record on July 21, 2017

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