Double-Blind Naltrexone in Kleptomania

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Naltrexone

Criteria

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.