Double-Blind Naltrexone in Kleptomania

Phase 2

Completed

• Conditions: Kleptomania
• Interventions: Drug: Placebo; Drug: Naltrexone

• Registration Number: NCT00332579
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2006-05-01
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-06-01
• Primary Completion: 2008-09-01
• Study Completion: 2008-09-01
• Results First Submitted: 2012-03-01
• Results First Submitted QC: 2012-04-09
• Results First Posted: 2012-05-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Placebo
A	Naltrexone	Naltrexone

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States