Epidiolex in Obsessive Compulsive Disorder and Related Disorders

The University of Chicago

Status and phase: Active, not recruiting; Phase 2

Conditions: Obsessive-Compulsive Disorder; Hoarding Disorder; Tourette Syndrome; Trichotillomania (Hair-Pulling Disorder)

Treatments: Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT04978428

IRB21-1147

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 criteria

• Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination or labs
• 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)
• 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 and self-administer medication or provide written informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Epidiolex

Experimental group

Description:

Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks)

Treatment:

Drug: Cannabidiol