This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
51
pill, by mouth, 50mg-150mg/day for the duration of the study
pill, by mouth, daily
University of Chicago
Chicago, Illinois, United States
National Institute of Mental Health Trichotillomania Symptom Severity Scale
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.
Time frame: This is the final score, measured at week 8 (final visit).
Massachusetts General Hospital Hairpulling Scale
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.
Time frame: This is the final score, measured at week 8 (final visit).
Liver Function Tests
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).
Time frame: Week 8 (last visit)
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