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 : July 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kleptomania | Drug: Naltrexone Drug: Placebo | Phase 2 |
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 |
Actual Study Start Date : | May 1, 2006 |
Actual Primary Completion Date : | September 1, 2008 |
Actual Study Completion Date : | September 1, 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A
Naltrexone
|
Drug: Naltrexone
daily
Other Name: Revia |
Placebo Comparator: B
Placebo
|
Drug: Placebo
daily |
- 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55454 |
Principal Investigator: | Jon E Grant, MD, JD | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00332579 |
Other Study ID Numbers: |
0602M82626 |
First Posted: | June 1, 2006 Key Record Dates |
Results First Posted: | May 4, 2012 |
Last Update Posted: | July 29, 2019 |
Last Verified: | July 2019 |
Compulsive Shoplifting Kleptomania Compulsive Stealing |
Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Naltrexone Alcohol Deterrents |
Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |