Naltrexone in the Treatment of Trichotillomania
|ClinicalTrials.gov Identifier: NCT00775229|
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Trichotillomania||Drug: Naltrexone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
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'
- National Institute of Mental Health Trichotillomania Symptom Severity Scale [ Time Frame: This is the final score, measured at week 8 (final visit). ]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). ]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) ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775229
|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|