Phase 3
Completed N=50
Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors
Trichotillomania · Skin-Picking
Source: ClinicalTrials.gov NCT03530800 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) — 12.38; 10.63 score on a scale
◆ Published Evidence
Emerging
17citations · ~4 / year
Tetrahydrocannabinol fails to reduce hair pulling or skin picking: results of a double-blind, placebo-controlled study of dronabinol.
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.
Linked Publications (2)
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Tetrahydrocannabinol fails to reduce hair pulling or skin picking: results of a double-blind, placebo-controlled study of dronabinol.
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Pharmacotherapy for trichotillomania.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.