- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332579
Double-Blind Naltrexone in Kleptomania
July 10, 2019 updated by: University of Minnesota
A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
Study Overview
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
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: B
Placebo
|
daily
|
Active Comparator: A
Naltrexone
|
daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
K-YBOCS is done at each visit by the investigator.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
May 30, 2006
First Submitted That Met QC Criteria
May 30, 2006
First Posted (Estimate)
June 1, 2006
Study Record Updates
Last Update Posted (Actual)
July 29, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0602M82626
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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