Epidiolex in Obsessive Compulsive Disorder and Related Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-Label treatment study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidiolex

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

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)

Interventions

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Cannabidiol

Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)

Intervention Type DRUG

Other Intervention Names

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Epidiolex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No