Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in trichotillomania and other body-focused repetitive behaviors such as skin-picking disorder. 50 subjects with DSM-5 trichotillomania or skin-picking disorder will receive 10 weeks of double-blind dronabinol or placebo. The hypothesis to be tested is that dronabinol will be effective and well tolerated in patients with trichotillomania and/or skin-picking disorder compared to placebo. The proposed study will provide needed data on the treatment of disabling disorders that currently lacks a clearly effective treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• current DSM-5 trichotillomania

• ability to understand and sign the consent form

Exclusion Criteria:

• Unstable Medical illness based on history of clinically significant abnormalities on baseline physical examination

• Current pregnancy or lactation, or inadequate contraception in women of childbearing potential

• Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

• Past 12-month DSM-5 psychiatric disorder other than trichotillomania

• Illegal substance use based on urine toxicology screening

• Use of any other psychotropic medication (except a PRN hypnotic)

• Previous treatment with dronabinol

• Cognitive impairment that interferes with the capacity to understand and self administer medication or provide written informed consent