Phase 2 N=25 Randomized Double-blind Treatment

Double-Blind Naltrexone in Kleptomania

Kleptomania

Bottom Line

View on ClinicalTrials.gov: NCT00332579 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) — 3.83; 11.46 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Naltrexone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)	3.83; 11.46	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00332579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.