Double-Blind Naltrexone in Kleptomania
A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
1 other identifier
interventional
25
1 country
1
Brief Summary
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 30, 2006
CompletedFirst Posted
Study publicly available on registry
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
May 4, 2012
CompletedJuly 29, 2019
July 1, 2019
2.3 years
May 30, 2006
March 1, 2012
July 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
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).
K-YBOCS is done at each visit by the investigator.
Study Arms (2)
A
ACTIVE COMPARATORNaltrexone
B
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- men and women age 21-75
- current DSM-IV kleptomania.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Related Publications (1)
Grant JE, Kim SW, Odlaug BL. A double-blind, placebo-controlled study of the opiate antagonist, naltrexone, in the treatment of kleptomania. Biol Psychiatry. 2009 Apr 1;65(7):600-6. doi: 10.1016/j.biopsych.2008.11.022. Epub 2009 Feb 12.
PMID: 19217077DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jon E. Grant
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Jon E Grant, MD, JD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2006
First Posted
June 1, 2006
Study Start
May 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
July 29, 2019
Results First Posted
May 4, 2012
Record last verified: 2019-07