Dronabinol for High Blood Pressure

Overseen By Nicholas Wozniak

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Mayo Clinic

Must not be taking: Antimicrobials, Chemotherapy, Anticoagulants, others

Disqualifiers: Psychiatric disorders, Seizures, Substance abuse, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Dronabinol to assess its effects on individuals with high blood pressure, specifically on their blood vessels and nerves. Two groups will be compared: one will take Dronabinol first, followed by a placebo, while the other will do the reverse. The study seeks participants who use cannabis occasionally (less than twice a week) and have no major health issues, such as heart, lung, or kidney problems. As a Phase 2 trial, this research measures Dronabinol's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use certain medications, including some antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs, as well as prescribed CYP2C9 and/or CYP3A4 inhibitors. If you are taking any of these, you may need to stop them to participate.

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

Research has shown that Dronabinol, a treatment being tested for high blood pressure, has mixed safety results. Studies have found that it can alter blood pressure, either increasing or decreasing it. Some individuals have experienced dizziness or fainting when standing up quickly. Common side effects include stomach pain, dizziness, euphoria, nausea, and extreme sleepiness, occurring in at least 3% of patients.

The FDA has already approved Dronabinol for other uses, such as alleviating nausea in cancer patients. This provides some existing safety information, but its impact on blood pressure remains under careful study. Participants in the trial will be closely monitored for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Unlike the standard treatments for high blood pressure, which often include ACE inhibitors, beta-blockers, or diuretics, Dronabinol offers a unique approach. Dronabinol is derived from cannabis and works by affecting the endocannabinoid system, which is not typically targeted by conventional blood pressure medications. Researchers are excited about this treatment because it could offer a new pathway to manage high blood pressure, potentially benefiting patients who do not respond well to existing medications.

What evidence suggests that Dronabinol might be an effective treatment for high blood pressure?

Studies have shown that Dronabinol can affect blood pressure. In some cases, it lowers the systolic blood pressure. Research indicates that high doses of Dronabinol have significantly reduced both systolic and diastolic blood pressure. However, Dronabinol can sometimes cause blood pressure to fluctuate, especially when starting the treatment or changing the dose. These effects suggest potential benefits for managing blood pressure but also highlight the need for careful monitoring. Participants in this trial will be divided into two groups: one group will take Dronabinol first and then a placebo, while the other group will take a placebo first and then Dronabinol. This design will help assess Dronabinol's effects on blood pressure. ^{1 2 4 6 7}

Who Is on the Research Team?

Virend Somers

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for men and women aged 21-40 who occasionally use cannabis (less than twice a week) and do not have a high BMI (>35 kg/m2). Participants should not be on certain medications, including antimicrobials or anticoagulants, nor have a history of substance abuse, seizures, psychiatric disorders, or uncontrolled diseases like cardiovascular issues.

Inclusion Criteria

I am either a biological male or female.

I am between 21 and 40 years old.

Recreational occasional Cannabis use (Consuming THC less than 2 times a week)

Exclusion Criteria

BMI > 35 kg/m2

I am not currently taking specific drugs like antibiotics, cancer treatments, blood thinners, diabetes medication, anti-inflammatories, mental health drugs, or allergy medicines.

I am taking medication that affects how my body processes drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dronabinol or Placebo for 30 days to assess effects on blood pressure and neurovascular physiology

4 weeks

Baseline and end of treatment visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol

Trial Overview The study is testing the effects of Dronabinol (synthetic THC) on blood pressure compared to a placebo. It aims to understand how this compound affects neurovascular physiology in individuals with occasional recreational cannabis use.

How Is the Trial Designed?

Group I: Dronabinol Group Active Control 2 Interventions

Patients taking Dronabinol first and Placebo second

Group II: Placebo Group Active Control 2 Interventions

Patients taking Placebo first and Dronabinol second

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3335956/

Subjective, cognitive, and cardiovascular dose-effect ... Nabilone (2 mg) and dronabinol (10 mg) resulted in decreases in seated systolic blood pressure relative to placebo. There was no effect of medication condition ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07231965

NCT07231965 | Synthetic THC And Blood Pressure To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology. Official Title. Effects Of Cannabis Products On ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557531/

Dronabinol - StatPearls - NCBI Bookshelf - NIH As such, they may experience decreased or increased blood pressure, syncope, or rapid heart rate. Monitor for these changes after beginning treatment and ...

4. sciencedirect.com sciencedirect.com/science/article/am/pii/S0376871618301844

The effect of high-dose dronabinol (oral THC) maintenance ... high-dose dronabinol significantly reduced systolic and diastolic blood pressure ... Cannabis withdrawal scores, drug effects, adverse events, and blood pressure ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/018651s033lbl.pdf

marinol - accessdata.fda.gov Changes in your blood pressure. MARINOL may increase or decrease your blood pressure, especially when you start taking MARINOL or when your dose is changed.

6. mayoclinic.org mayoclinic.org/drugs-supplements/dronabinol-oral-route/description/drg-20063560

Dronabinol (oral route) - Side effects & dosage Dronabinol is used to treat nausea and vomiting caused by cancer medicines. It is used only when other kinds of medicine for nausea and vomiting did not work.

7. webmd.com webmd.com/drugs/2/drug-8774-1840/dronabinol-oral/dronabinol-solution-oral/details

Dronabinol (Marinol, Syndros) - Uses, Side Effects, and More Dronabinol can raise or lower your blood pressure. Changes in blood pressure can happen at any time during treatment, but are most likely to ...