Naltrexone in the Treatment of Trichotillomania
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania|
- National Institute of Mental Health Trichotillomania Symptom Severity Scale [ Time Frame: This is the final score, measured at week 8 (final visit). ] [ Designated as safety issue: No ]Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.
- Massachusetts General Hospital Hairpulling Scale [ Time Frame: This is the final score, measured at week 8 (final visit). ] [ Designated as safety issue: No ]Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.
- Liver Function Tests [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: Yes ]Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).
|Study Start Date:||August 2008|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
pill, by mouth, 50mg-150mg/day for the duration of the study
Other Name: ReVia
Placebo Comparator: 2
pill, by mouth, daily
Other Name: also known as a 'sugar pill'
The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60615|
|Principal Investigator:||Jon E Grant, M.D.||University of Minnesota - Clinical and Translational Science Institute|