Overview

Naltrexone in the Treatment of Trichotillomania

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Chicago
Treatments:
Naltrexone
Criteria
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.