Naltrexone in the Treatment of Trichotillomania

Study Overview
=================
Brief Summary
-----------------
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania

Detailed Description
-----------------
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.

Official Title
-----------------
A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania

Conditions
-----------------
Trichotillomania

Intervention / Treatment
-----------------
* Drug: Naltrexone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women age 18-75; current DSM-IV trichotillomania; hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time. Exclusion Criteria: unstable medical illness or clinically significant abnormalities on pre-study 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 trichotillomania within 3 months prior to study baseline; initiation of a psychotropic medication within 2 months prior to study inclusion; previous treatment with naltrexone; and 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; lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; current use of opiates.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Naltrexone | Drug: Naltrexone<br>* pill, by mouth, 50mg-150mg/day for the duration of the study<br>* Other names: ReVia;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* pill, by mouth, daily<br>* Other names: also known as a 'sugar pill';|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | This is the final score, measured at week 8 (final visit). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Week 8 (last visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hair pulling