Phase 3
N=50
Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors
Trichotillomania · Skin-Picking
Bottom Line
View on ClinicalTrials.gov: NCT03530800 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) — 12.38; 10.63 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dronabinol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) |
12.38; 10.63 | — |
| PRIMARY Skin Picking Symptom Assessment Scale (SP-SAS) |
24.44; 28.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03530800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.