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Completed

NCT Number: NCT00332579

Double-Blind Naltrexone in Kleptomania

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

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Key information

Conditions

Kleptomania Disruptive, Impulse Control, and Conduct Disorders Mental Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone

Drug

daily

Other names: Revia

Placebo

Drug

daily

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 1, 2006
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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