Cannabidiol for Obsessive-Compulsive Disorder

Overseen By Laurie Avila, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: Psychotropic medications

Disqualifiers: Unstable illness, Pregnancy, Suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Epidiolex, a drug derived from cannabis, to determine its safety and effectiveness for individuals with obsessive-compulsive disorder (OCD) and similar conditions. Participants will take the drug for two weeks to help researchers understand its effects. The trial seeks adults with conditions like OCD, skin picking, or Tourette Syndrome that affect daily life. Those who have not recently taken similar medications may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any other psychotropic medications (drugs that affect your mind, emotions, or behavior) to participate in this trial.

Is there any evidence suggesting that Epidiolex is likely to be safe for humans?

Research has shown that Epidiolex, a type of cannabidiol (CBD), is usually well-tolerated. In animal studies, CBD reduced obsessive-compulsive behavior without noticeable side effects. While this is encouraging, results in animals don't always apply to humans.

In human studies, CBD has been linked to reduced anxiety symptoms, suggesting it might be safe and helpful for mental health issues. However, some people have experienced side effects like fatigue or changes in appetite.

The FDA has already approved Epidiolex for treating certain types of epilepsy, indicating it has met safety standards for those conditions. However, since this trial is in an early stage, the safety and effectiveness for obsessive-compulsive disorder (OCD) are still being tested. Always consult healthcare providers before joining a trial to receive tailored advice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for OCD?

Unlike the standard treatments for Obsessive-Compulsive Disorder (OCD), which typically include SSRIs like fluoxetine or cognitive-behavioral therapy, Epidiolex introduces a unique approach by utilizing cannabidiol (CBD) as its active ingredient. Epidiolex is derived from cannabis and works differently by potentially targeting the endocannabinoid system, which may help in modulating mood and anxiety. Researchers are excited about Epidiolex because it could offer a new mechanism of action with fewer side effects compared to traditional medications for OCD. Additionally, the potential for Epidiolex to show results relatively quickly adds to its appeal as a novel treatment option.

What evidence suggests that Epidiolex might be an effective treatment for obsessive-compulsive disorder?

Research has shown that Epidiolex, a type of cannabidiol (CBD), might help reduce symptoms of OCD. In one case, a 22-year-old with severe OCD improved significantly after using medical cannabis. Other studies suggest that CBD can help lower anxiety, which often accompanies OCD. The calming effects of CBD may ease obsessive thoughts and actions. This trial will evaluate the effects of Epidiolex on OCD symptoms, building on findings that suggest Epidiolex could benefit people with OCD and similar disorders. ^{1 3 6 7 8}

Who Is on the Research Team?

Jon E Grant, MD, JD, MPH

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to understand and sign the consent form.

Ability to understand and sign the consent form

Men and women age 18-65

Exclusion Criteria

You are taking other medications for mental health conditions.

You have recently expressed thoughts or behaviors that suggest you may harm yourself.

Current pregnancy or lactation, or inadequate contraception in women of childbearing potential

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

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

2 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Bi-weekly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Epidiolex

Trial Overview 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.

How Is the Trial Designed?

Group I: Epidiolex Experimental Treatment 1 Intervention

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

Epidiolex is already approved in United States, European Union for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidyolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

In a study of 36 patients with advanced non-small cell lung cancer, the combination of cisplatin and etoposide resulted in a 20% partial remission rate, while the combination with epirubicin showed no clinical response.

Both treatment regimens had mild side effects, suggesting they were relatively safe, but further research is needed to compare the efficacy of the weekly etoposide regimen against standard intermittent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II studies on weekly cisplatinum plus epirubicin or etoposide in the treatment of advanced non-small cell bronchogenic carcinoma. Lelli, G., Casadio, M., Giuliotti, C., et al.[2013]

A 47-year-old woman with lung metastases from breast cancer showed complete disappearance of metastatic lesions after receiving six cycles of modified EAP chemotherapy (Etoposide, Epiadriamycin, and CDDP) over seven months.

The treatment was well-tolerated, with no major side effects like leukopenia or thrombocytopenia observed, and there has been no recurrence of metastases for 14 months, suggesting the efficacy and safety of the modified EAP regimen for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Remarkable effect of the combination therapy of etoposide, epiadriamycin, and CDDP (EAP) in the treatment of metachronous lung metastases of breast cancer--a case report]. Kawabe, T., Honda, I., Kawakami, Y., et al.[2013]

Cannabidiol (CBD) shows promise as a potential treatment for obsessive-compulsive disorder (OCD) by downregulating GSK-3β, which may help control oxidative stress, inflammation, and glutamatergic pathways involved in OCD.

Current first-line therapies, like cognitive-behavioral therapy, only benefit about 40% of patients, highlighting the urgent need for new treatment options such as CBD, which could address underlying mechanisms of the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible actions of cannabidiol in obsessive-compulsive disorder by targeting the WNT/β-catenin pathway. Vallée, A., Lecarpentier, Y., Vallée, JN.[2023]

Epidiolex® (CBD) is effective for treating epilepsy in patients over 2 years old, but it can interact with other medications, as seen in a case where it contributed to lithium toxicity in a patient with Lennox-Gastaut syndrome.

After discontinuing lithium due to toxicity, the patient improved and remained seizure-free on CBD and two other antiseizure medications, highlighting the importance of monitoring drug interactions when adding CBD to treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Drug Interactions Between Cannabidiol and Lithium. Singh, RK., Dillon, B., Tatum, DA., et al.[2020]

Cannabidiol (CBD) is a non-psychoactive compound from cannabis that can counteract the psychotropic effects of THC and has gained popularity in various therapeutic products, especially after the FDA approved Epidiolex® for treating severe epilepsy in children.

Despite its therapeutic potential, there is a lack of consistent international regulations governing the marketing and authorization of CBD products, which raises concerns about product safety and efficacy for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology and legal status of cannabidiol. Brunetti, P., Lo Faro, AF., Pirani, F., et al.[2021]

Cannabidiol (CBD) has demonstrated promising therapeutic properties, including anxiolytic, antipsychotic, and neuroprotective effects, making it a potential treatment for various neuropsychiatric conditions.

Current research is exploring CBD's applications in treating conditions such as epilepsy, schizophrenia, and depression, with ongoing clinical trials expected to provide further insights into its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational Investigation of the Therapeutic Potential of Cannabidiol (CBD): Toward a New Age. Crippa, JA., Guimarães, FS., Campos, AC., et al.[2023]

A patient experienced serious neurological and neuropsychological side effects after 2 years of treatment with o,p'-DDD for adrenal carcinoma, but showed complete recovery after stopping the drug.

This case suggests that while o,p'-DDD can cause significant side effects, further studies are needed to evaluate its long-term effects, and discontinuation of therapy may not be necessary even in the presence of serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversible mental deterioration and neurological disturbances with o,p'-DDD therapy. Bollen, E., Lanser, JB.[2019]

A single vaginal administration of cisplatin (CDDP) effectively eliminated a large adenocarcinoma tumor in the vaginal stump of a patient who had previously undergone surgery for uterine corpus carcinoma, demonstrating its efficacy in this specific case.

The treatment involved 15 applications of 75 mg CDDP, with only minor side effects reported, such as slight pain in the external genitalia, indicating a favorable safety profile for this localized treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intravaginal administration of CDDP for adenocarcinoma]. Nakayama, K., Nozawa, S., Yamaguchi, M.[2013]

In a study involving 78 adults with moderate to severe cocaine use disorder, daily administration of 800 mg of cannabidiol (CBD) did not significantly reduce drug-cue-induced cravings compared to a placebo.

The study also found no difference in the time to relapse between participants taking CBD and those on placebo, indicating that CBD may not be an effective treatment for preventing relapse in cocaine use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. Mongeau-Pérusse, V., Brissette, S., Bruneau, J., et al.[2021]

Cannabidiol (CBD), specifically in its oral formulation Epidiolex, has been shown to have very low abuse potential and is unlikely to cause physical dependence, as demonstrated by studies in rats and nonhuman primates that showed no significant self-administration or withdrawal signs after chronic treatment.

The pharmacokinetic studies confirmed that the doses used in the experiments resulted in therapeutically relevant plasma levels, supporting the safety and efficacy of CBD for treating seizures in severe forms of epilepsy without the risks associated with addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Assessment of the Abuse Potential of Purified Botanical Cannabidiol: Self-Administration, Drug Discrimination, and Physical Dependence. Gray, RA., Heal, DJ., Maguire, DR., et al.[2022]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

A single intravenous injection of op'DDD in dogs leads to a rapid decrease in the adrenal cortex's response to adrenocorticotrophic hormone within 2 hours, indicating a significant impact on adrenal function.

The drug also inhibits glucose-6-phosphate dehydrogenase activity, which may help explain its effects on corticosteroid production in the adrenal cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action of 1,1,dichloro-2-p-chlorophenyl-2-o-chlorophenylethane on dog adrenal cortex. CAZORLA, A., MONCLOA, F.[2019]

A single oral dose of 750 mg of cannabidiol (CBD) showed significantly increased exposure when taken with a high-fat/calorie meal, with a 3.8-fold increase in overall exposure (AUC0-∞) and a 5.2-fold increase in maximum concentration (Cmax) compared to fasting.

CBD was well-tolerated with no severe adverse events reported, indicating its safety in healthy adults, while its absorption was also enhanced by low-fat meals, whole milk, and alcohol, albeit to a lesser extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. Crockett, J., Critchley, D., Tayo, B., et al.[2021]

Epidiolex, the only FDA-approved CBD-based drug, has been studied for its medicinal benefits and potential side effects across various clinical trials, focusing on both physiological and neurological conditions.

The review highlights that the outcomes of these trials can vary significantly based on the funding source, which may influence the reported efficacy and safety of Epidiolex and other CBD formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. Pauli, CS., Conroy, M., Vanden Heuvel, BD., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04978428

Epidiolex in Obsessive Compulsive Disorder and Related ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7396551/

Cannabis Improves Obsessive-Compulsive Disorder—Case ... Here we present the case of a 22-year-old male patient, who suffered from severe OCD since childhood and significantly improved after treatment with medicinal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124003342

Therapeutic potential of cannabidiol (CBD) in anxiety ... Our meta-analysis provides further support for the anxiolytic effects of CBD, revealing statistically significant reductions in anxiety symptoms across various ...

4. withpower.com withpower.com/trial/phase-3-compulsive-personality-disorder-8-2021-7e54f

Cannabidiol for Obsessive-Compulsive Disorder This trial aims to test if Epidiolex can safely and effectively reduce symptoms in adults with obsessive-compulsive and related disorders by calming the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7347041/

The Endocannabinoid System: A New Treatment Target for ... At the same time, some patients with OCD who smoke cannabis anecdotally report that it relieves their symptoms and mitigates anxiety, and several case reports ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7423713/

Acute Effects of Cannabinoids on Symptoms of Obsessive ... The data suggest that smoked cannabis, whether containing primarily THC or CBD, has little acute impact on OCD symptoms and yields smaller reductions in anxiety ...

7. mdpi.com mdpi.com/2813-1851/4/2/16

Medicinal Cannabis Use Among People with Obsessive ... A recent observational study highlighted that inhaled cannabis reduced the severity of compulsions by 60%, anxiety by 52%, and intrusions by 49% ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol The following study, which showed a positive effect of CBD on obsessive compulsive behavior in mice and reported no side effects, exemplifies the existing ...