Naltrexone in the Treatment of Trichotillomania

The University of Chicago

Status and phase: Completed; Phase 2

Conditions: Trichotillomania

Treatments: Drug: Naltrexone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00775229

0806M36061

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Naltrexone

Treatment:

Drug: Naltrexone

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo