Double-Blind Naltrexone in Kleptomania

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Kleptomania

Treatments: Drug: Placebo; Drug: Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT00332579

0602M82626

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Naltrexone

Treatment:

Drug: Naltrexone

B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo