Epidiolex in Obsessive Compulsive Disorder and Related Disorders

Last updated: May 2, 2025
Sponsor: University of Chicago
Overall Status: Active - Not Recruiting

Phase

2

Condition

Anxiety Disorders

Kleptomania

Obsessive-compulsive Disorder

Treatment

Cannabidiol

Clinical Study ID

NCT04978428
IRB21-1147
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women age 18-65

  • Primary diagnosis of OCD, Hoarding Disorder, Skin Picking Disorder,Trichotillomania, or Tourette Syndrome

  • YBOCS score of at least 18 at baseline

  • Ability to understand and sign the consent form.

Exclusion

Exclusion Criteria:

  • Unstable medical illness based on history or clinically significant abnormalities onbaseline physical examination or labs

  • Current pregnancy or lactation, or inadequate contraception in women of childbearingpotential

  • Subjects considered an immediate suicide risk based on the Columbia Suicide SeverityRating Scale (C-SSRS)

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

  • Illegal substance use based on urine toxicology screening

  • Initiation of psychological interventions within 3 months of screening

  • Use of any other psychotropic medication

  • Previous treatment with Epidiolex

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

Study Design

Total Participants: 4
Treatment Group(s): 1
Primary Treatment: Cannabidiol
Phase: 2
Study Start date:
April 14, 2022
Estimated Completion Date:
November 30, 2025

Study 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).

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

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