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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Tourette Syndrome; Trichotillomania (Hair-Pulling Disorder); Hoarding Disorder
• Intervention / Treatment: Drug: Cannabidiol

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidiolex; Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks)	Drug: Cannabidiol; Epidiolex oral solution (2.5 mg/kg and 5 mg/kg); Other Names: Epidiolex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Yale Brown Obsessive Compulsive Scale (YBOCS) Total Score	The primary outcome measure will be the change from baseline using the Yale Brown Obsessive Compulsive Scale (YBOCS). The YBOCS is a 10-item scale that assesses OCD symptoms during the last seven days. The first five items comprise the urge/thought subscale and items 6-10 comprise the behavior subscale. The change in scores from baseline to Week 2 will be reported. The scores from the subscales are summed together to reach a total score. The scale ranges from 0-40 with higher scores reflecting more severe symptoms.	Baseline to Week 2
Change in NIMH Symptom Severity Scale (for TTM or Skin Picking) Total Score	The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts two weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to Week 2 will be reported. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.	Baseline to Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Global Impressions- Severity Scale (CGI-S) Total Score	The entire study for the subject will last 2 weeks. The subject will complete the CGI once per week. The change in scores from baseline to Week 2 will be reported. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"	Baseline to Week 2
Change in Hamilton Depression Rating Scale (HAM-D) Total Score	The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered assessment of depression that will be assessed at all study visits. The HAM-D is a 17-item scale that assess depressive symptoms during the last seven days. The change in scores from baseline to Week 2 will be reported. The scale ranges from 0-52 with higher total scores indicating higher levels of depression, while a score of 0 would indicate no depressive symptoms.	Baseline to Week 2
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score	The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered assessment of anxiety that will be assessed at all study visits. The HAM-A is a 14 item scale that assess anxiety symptoms during the last fourteen days. The change in scores from baseline to Week 2 will be reported. The scale ranges from 0-56 with higher scores indicating higher levels of anxiety, with 0 being no symptoms of anxiety.	Baseline to Week 2
Change in Sheehan Disability Scale (SDS) Total Score	The Sheehan Disability Scale (SDS) is a self-report scale that subjects will complete the SDS at all visits. The SDS is a three item scale that measures functional impairment across work/school, social life, and family/home responsibilities during the past seven days. The change in scores from baseline to Week 2 will be reported. Each item ranges from 0-10, with higher scores indicating more impairment. However, only total score is reported which ranges from 0-30, with higher scores indicating more severe impairment. The total score is computed by summing the three scores from each domain. The scale itself assesses the level of disability from target disorder with higher scores indicating a more debilitating disorder.	Baseline to Week 2
Change in Quality of Life Inventory (QOLI) Total Score	The Quality of Life Inventory (QOLI) is a self-report assessment of patient perceived quality of life that will be assessed at each visit. The change in scores from baseline to Week 2 will be reported. The QOLI assesses both the importance and satisfaction of 16 life domains. Scores are calculated by multiplying the importance score by the satisfaction score which gives a weighted score for each domain. Each weighted score is then added together to get a total score which ranges from 0-100 with higher scores indicating a higher quality of life, whereas lower scores indicate a lower quality of life.	Baseline to Week 2

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Jon E Grant, MD, JD, MPH, University of Chicago

Publications and helpful links

General Publications

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
• HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
• Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.
• Frisch MB, Cornell J, Villaneuva M (1993). Clinical validation of the Quality of Life Inventory: a measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assess. 4:92-101.
• Ravizza L, Barzega G, Bellino S, Bogetto F, Maina G. Predictors of drug treatment response in obsessive-compulsive disorder. J Clin Psychiatry. 1995 Aug;56(8):368-73.
• Blanco C, Olfson M, Stein DJ, Simpson HB, Gameroff MJ, Narrow WH. Treatment of obsessive-compulsive disorder by U.S. psychiatrists. J Clin Psychiatry. 2006 Jun;67(6):946-51. doi: 10.4088/jcp.v67n0611.
• Grant JE. Clinical practice: Obsessive-compulsive disorder. N Engl J Med. 2014 Aug 14;371(7):646-53. doi: 10.1056/NEJMcp1402176.
• Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CBD; Obsessive Compulsive Disorder; Trichotillomania; Tourettes; Hoarding; Skin Picking Disorder; Body focused repetitive behaviors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Behavioral Symptoms; Neurodegenerative Diseases; Self-Injurious Behavior; Neurodevelopmental Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Anxiety Disorders; Tic Disorders; Disruptive, Impulse Control, and Conduct Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Hoarding Disorder; Excoriation Disorder; Obsessive-Compulsive Disorder; Tourette Syndrome; Trichotillomania; Hoarding; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Cannabidiol
• Other Study ID Numbers: IRB21-1147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No