Naltrexone in the Treatment of Trichotillomania

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-12-31

Brief Summary

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This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania

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Detailed Description

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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.

Conditions

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Trichotillomania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Naltrexone

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

pill, by mouth, 50mg-150mg/day for the duration of the study

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

pill, by mouth, daily

Interventions

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Naltrexone

pill, by mouth, 50mg-150mg/day for the duration of the study

Intervention Type DRUG

Placebo

pill, by mouth, daily

Intervention Type DRUG

Other Intervention Names

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ReVia also known as a 'sugar pill'

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No