What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include Cognitive Behavioral Therapy (CBT) with exposure and response prevention, and serotonin reuptake inhibitors (SRIs) such as fluoxetine, sertraline, and clomipramine. Side effects of SRIs can include nausea, headache, insomnia, sexual dysfunction, and increased anxiety. Cannabidiol (CBD), which interacts with the endocannabinoid system, is being studied for its potential benefits in OCD. Known side effects of CBD can include fatigue, diarrhea, and changes in appetite and weight. While CBD is generally well-tolerated, more research is needed to fully understand its safety profile in the context of OCD treatment.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, and sertraline, as well as the tricyclic antidepressant clomipramine. While these treatments do not interact with the endocannabinoid system like Epidiolex (Cannabidiol), there is ongoing research into the potential benefits of cannabinoids for OCD. However, as of now, no cannabinoid-based treatments have received FDA approval specifically for OCD.

What other types of research exist?

Promising novel alternatives to Epidiolex for treating OCD in 2024 include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and escitalopram, which are well-established but continually optimized. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine may be considered, although more research is needed. Emerging treatments also include glutamate modulators like memantine and ketamine, which have shown potential in early studies. Behavioral and neuromodulation therapies, such as transcranial magnetic stimulation (TMS), are also gaining traction as adjunctive treatments.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 2 for reporting.

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 more

Secondary study objectives

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

29%

Tiredness

20%

Constipation

18%

Drowsiness

11%

Poor sleep

11%

Dizziness

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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®.