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Cannabinoid
Cannabidiol for Obsessive-Compulsive Disorder
Phase 2
Recruiting
Led By Jon E Grant, MD, JD, MPH
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 2
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if Epidiolex can safely and effectively reduce symptoms in adults with obsessive-compulsive and related disorders by calming the brain and reducing anxiety. Epidiolex is a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD) that has been previously studied for its potential to be misused.
Who is the study for?
Adults aged 18-65 with a primary diagnosis of OCD, Hoarding Disorder, Skin Picking Disorder, Trichotillomania, or Tourette Syndrome can join. They must have certain symptom severity scores and be able to consent. Excluded are those on other psychotropic meds, at suicide risk, pregnant or not using contraception, using illegal substances, starting new psychological therapies recently or having cognitive impairments.
What is being tested?
The trial is testing the safety and effectiveness of Epidiolex (cannabidiol) for adults with obsessive compulsive and related disorders over two weeks in an open-label fashion where everyone knows they're getting the medication.
What are the potential side effects?
Possible side effects of Epidiolex may include sleepiness, decreased appetite, diarrhea, fever; however specific side effects for this trial haven't been listed but will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
NIMH Symptom Severity Scale (for TTM or Skin Picking)
The Hoarding Rating Scale (HRS)
Yale Brown Obsessive Compulsive Scale (YBOCS)
+1 moreSecondary study objectives
Clinical Global Impressions- Improvement Scale (CGI-I)
Hamilton Anxiety Rating Scale (HAM-A)
Hamilton Depression Rating Scale (HAM-D)
+2 moreSide effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761729%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EpidiolexExperimental Treatment1 Intervention
Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). SSRIs work by increasing the levels of serotonin in the brain, which helps regulate mood, anxiety, and compulsive behaviors.
CBT, particularly exposure and response prevention (ERP), helps patients confront their fears and reduce the compulsive behaviors associated with OCD. Cannabidiol (CBD), as studied in Epidiolex, interacts with the endocannabinoid system, which plays a role in regulating mood, anxiety, and stress responses.
This interaction may help reduce anxiety and compulsive behaviors in OCD patients, offering a potential alternative or adjunctive treatment to traditional therapies.
The Potential of Cannabinoid-Based Treatments in Tourette Syndrome.Pure delta-9-tetrahydrocannabinol and its combination with cannabidiol in treatment-resistant Tourette syndrome: A case report.Severe motor and vocal tics controlled with Sativex®.
The Potential of Cannabinoid-Based Treatments in Tourette Syndrome.Pure delta-9-tetrahydrocannabinol and its combination with cannabidiol in treatment-resistant Tourette syndrome: A case report.Severe motor and vocal tics controlled with Sativex®.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,043 Previous Clinical Trials
758,492 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
119 Patients Enrolled for Obsessive-Compulsive Disorder
Jon E Grant, MD, JD, MPHPrincipal InvestigatorUniversity of Chicago
9 Previous Clinical Trials
463 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
85 Patients Enrolled for Obsessive-Compulsive Disorder
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