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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

Study Summary

This trial will study the safety and effectiveness of a drug called Epidiolex in adults with obsessive-compulsive and related disorders. The drug will be given for two weeks in an open-label fashion, meaning all participants will receive the medication.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline to week 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NIMH Symptom Severity Scale (for TTM or Skin Picking)
The Hoarding Rating Scale (HRS)
Yale Brown Obsessive Compulsive Scale (YBOCS)
+1 more
Secondary outcome measures
Clinical Global Impressions- Improvement Scale (CGI-I)
Hamilton Anxiety Rating Scale (HAM-A)
Hamilton Depression Rating Scale (HAM-D)
+2 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
38%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Diarrhea
7%
Nausea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control Group

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

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,835 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
466 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
85 Patients Enrolled for Obsessive-Compulsive Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the application process for this trial remain open?

"According to clinicaltrials.gov, this trail is actively enlisting volunteers and has been running since April 14th 2022 (with updates up until June 28th)."

Answered by AI

Does this experiment accommodate individuals who are 75 and older?

"This study's inclusion criteria mandates that potential participants should be between 18 and 65 years of age. For those younger than 18, there are 287 trials available; for seniors over the age of 65, 733 studies exist."

Answered by AI

What potential risks should be considered prior to administering Cannabidiol?

"The safety rating of Cannabidiol was estimated to be 2 on our scale, as this is a Phase 2 trial which has yielded data attesting to its risk profile but not its efficacy."

Answered by AI

How many participants are the researchers expecting to recruit for this experiment?

"Indeed, the information available on clinicaltrials.gov demonstrates that this research trial is currently in its recruitment phase. It began being advertised online on April 14th 2022 and has been recently updated as of June 28th 2022. This study requires 15 participants from a single site to be enrolled."

Answered by AI

Are there any preceding studies involving the usage of Cannabidiol?

"Currently, 79 trials are underway that focus on Cannabidiol. Of those studies, 16 have moved into Phase 3 of their research process. Despite the majority being based in Ribeirao Preto (Sao Paulo), there are a total of 290 sites working with this drug."

Answered by AI

What outcome is this research endeavor aiming to produce?

"The primary goal of this 8-week trial is to evaluate the efficacy of a treatment via changes in NIMH Symptom Severity Scale scores. Secondary objectives include gaugeing patient progress with Clinical Global Impressions- Improvement Scale, Hamilton Depression Rating Scale and Sheehan Disability Scale assessments at each visit."

Answered by AI

What criteria must one meet in order to be eligible for the research trial?

"This study is attempting to recruit 15 individuals aged 18-65 that present with Hoarding Disorder. In order to qualify for this trial, the patient must meet certain standards such as being of legal age and exhibiting a Young Brown Obsessive Compulsive Scale score of at least 18 upon initial assessment. Additionally, they must comprehend and agree to the terms outlined in the informed consent document."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
New York
Illinois
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
University of Chicago

Why did patients apply to this trial?

I have been pulling my hair for 60 years. I’ve suffered with Trichotillomania for 25 years. Tried multiple treatments with no relief.
PatientReceived 2+ prior treatments
I have tried multiple anxiety medications but never knew there were studies for anything so I thought I’d try.
PatientReceived no prior treatments
I have tried so many different medications, therapy and even flew to Utah for neurotherapy. Nothing has worked and it's debilitating. While searching for new treatments in 2023 I can across this study. I am hoping to find something that will help.
PatientReceived no prior treatments
We are currently in Habit Reversal Therapy for my daughter. Taking Prozac. Adderall. CBIT. Habitware Keen2. She is almost 15 and open to trials to help find some jobs for her Trich. Her Tourette’s comes with Comorbids of OCD (Trich) and ADHD, with huge executive functioning deficits affecting working memory, organizational skills, school retention and performance. Really neat kiddo who would like to find a solution.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How often will I need to drive to Chicago? When will I find out if I'm selected?
PatientReceived 1 prior treatment
Recent research and studies
~2 spots leftby Sep 2024