NCT04978428

Epidiolex in Obsessive Compulsive Disorder and Related Disorders

An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.

Detailed description

The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). OCRDs include obsessive compulsive disorder (OCD), trichotillomania, skin picking, tourettes disorder, and hoarding disorders. These disorders appear linked in terms of phenomenology and possibly biology. Fifteen subjects with OCRDs will be treated in an open-label fashion with Epidiolex (2.5 mg/kg twice daily for one week followed by 5mg/kg twice daily) for two total weeks of active treatment. The hypothesis to be tested is that Epidiolex will result in reduction in symptoms of OCRDs (improvement in symptoms will be indicated by lower scores on established outcome measures of OCRDs symptoms that have been used in prior studies).

Conditions

• Obsessive-Compulsive Disorder
• Trichotillomania (Hair-Pulling Disorder)
• Tourette Syndrome
• Hoarding Disorder

Interventions

Type	Name	Description
DRUG	Cannabidiol	Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)

Timeline

• Start date: 2022-04-14
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2021-07-27
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study