Cannabidiol for Obsessive-Compulsive Disorder

Overseen by Jon E Grant, MD, JD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Chicago

Must not be taking: Psychotropic medications

Disqualifiers: Unstable illness, Pregnancy, Suicide risk, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the drug Epidiolex (CBD) for treating obsessive-compulsive disorder?

Research suggests that cannabidiol (CBD) may help with obsessive-compulsive disorder (OCD) by affecting pathways in the brain related to stress and inflammation. CBD has shown potential benefits in other conditions like anxiety and epilepsy, which indicates it might also be helpful for OCD. ^{1 2 3 4 5}

Is cannabidiol (CBD) generally safe for human use?

Cannabidiol (CBD), marketed as Epidiolex, is generally considered safe for human use, but it can cause side effects like sleepiness, diarrhea, and changes in appetite. It may also interact with other medications, so it's important to discuss its use with a healthcare provider, especially if you are taking other drugs. ^{2 6 7 8 9}

How is the drug Epidiolex unique for treating obsessive-compulsive disorder?

Epidiolex, which contains cannabidiol (CBD), is unique because it is derived from cannabis and works differently from traditional medications for obsessive-compulsive disorder by interacting with the body's endocannabinoid system, which may help regulate mood and anxiety. ^{10 11 12 13 14}

Research Team

Jon E Grant, MD, JD, MPH

Principal Investigator

University of Chicago

Eligibility Criteria

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

You have a score of at least 18 on the YBOCS test at the beginning of the study.

Ability to understand and sign the consent form.

Ability to understand and sign the consent form

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

Trial Timeline

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)

Treatment Details

Interventions

• Epidiolex (Cannabinoid)

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.

Participant Groups

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)

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

Findings from Research

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, 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]

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]

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) 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]

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), 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]

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]

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 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Possible actions of cannabidiol in obsessive-compulsive disorder by targeting the WNT/β-catenin pathway. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. [2020]

3. Italy pubmed.ncbi.nlm.nih.gov

Pharmacology and legal status of cannabidiol. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Translational Investigation of the Therapeutic Potential of Cannabidiol (CBD): Toward a New Age. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Drug-Drug Interactions Between Cannabidiol and Lithium. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Preclinical Assessment of the Abuse Potential of Purified Botanical Cannabidiol: Self-Administration, Drug Discrimination, and Physical Dependence. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]

9. United States 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. [2021]

10. Italy 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. [2013]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

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

13. Japan pubmed.ncbi.nlm.nih.gov

[Intravaginal administration of CDDP for adenocarcinoma]. [2013]

14. Japan 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]. [2013]