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ClinicalTrials.gov Identifier: NCT00332579
Recruitment Status :
First Posted : June 1, 2006
Results First Posted : May 4, 2012
Last Update Posted : May 4, 2012
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
Condition or disease
Drug: NaltrexoneDrug: Placebo
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.
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Ages Eligible for Study:
21 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
men and women age 21-75
current DSM-IV kleptomania.
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.