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Double-Blind Naltrexone in Kleptomania

Primary Purpose

Kleptomania

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kleptomania focused on measuring Compulsive Shoplifting, Kleptomania, Compulsive Stealing

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Naltrexone

Placebo

Outcomes

Primary Outcome Measures

Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
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).

Secondary Outcome Measures

Full Information

First Posted
May 30, 2006
Last Updated
July 10, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00332579
Brief Title
Double-Blind Naltrexone in Kleptomania
Official Title
A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2006 (Actual)
Primary Completion Date
September 1, 2008 (Actual)
Study Completion Date
September 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kleptomania
Keywords
Compulsive Shoplifting, Kleptomania, Compulsive Stealing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Naltrexone
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Revia
Intervention Description
daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
daily
Primary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
Description
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).
Time Frame
K-YBOCS is done at each visit by the investigator.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19217077
Citation
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.
Results Reference
derived

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Double-Blind Naltrexone in Kleptomania

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