Naltrexone in the Treatment of Trichotillomania

Phase 2

Completed

• Conditions: Trichotillomania
• Interventions: Drug: Placebo; Drug: Naltrexone

• Registration Number: NCT00775229
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Results First Submitted: 2013-10-09
• Results First Submitted QC: 2014-01-31
• Results First Posted: 2014-03-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. men and women age 18-75;
2. current DSM-IV trichotillomania;
3. hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.

Exclusion Criteria

1. unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. clinically significant suicidality;
6. current or recent (past 3 months) DSM-IV substance abuse or dependence;
7. illegal substance within 2 weeks of study initiation;
8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;
9. initiation of a psychotropic medication within 2 months prior to study inclusion;
10. previous treatment with naltrexone; and
11. 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;
12. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
13. current use of opiates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Naltrexone	Naltrexone

Primary Outcome Measures

Name	Time	Method
National Institute of Mental Health Trichotillomania Symptom Severity Scale	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.

Secondary Outcome Measures

Name	Time	Method
Massachusetts General Hospital Hairpulling Scale	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	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).

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States