Cannabis for Heart Rhythm Issues

Recruiting at 1 trial location

Overseen By Gregory M Marcus, MD, MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Anti-arrhythmics

Disqualifiers: Pregnancy, Atrial fibrillation, Heart failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Despite recreational cannabis now being legal in 23 states, where more than 100 million Americans reside, studies on the actual health effects are limited. This study is a randomized trial, where each participant will be instructed to consume or avoid cannabis on randomly assigned days during a 14-day monitoring period. The goal of this study is to answer the question: "Does cannabis use increase the frequency of 'early' and abnormal heart beats?" During the 14-day period, participants will wear an external heart monitor, a glucose monitor, and a fitness tracker to track heart rhythm, glucose levels, step counts, and sleep health. Participants will use a mobile app or a text messaging service for daily instructions/reminders on cannabis use, and short surveys. The investigators ask that participants smoke or vape cannabis at least once on days they are instructed to consume cannabis. Compelling evidence of heart and other health effects would be important to the clinical care of our patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anti-arrhythmic medications.

Is cannabis generally safe for people with heart rhythm issues?

Cannabis use has been linked to heart rhythm problems, such as arrhythmias (irregular heartbeats), especially in people with existing heart conditions. Some studies show that cannabis can cause changes in heart rate and increase the risk of serious heart-related events, even in young, healthy individuals. ^{1 2 3 4 5}

How does cannabis differ from other drugs for heart rhythm issues?

Cannabis is unique because it can cause both an increase and decrease in heart rate, depending on the dose, which is different from many standard heart rhythm drugs that typically aim to stabilize heart rate. Additionally, cannabis affects the heart through its active component THC, which interacts with the body's nervous system, potentially leading to arrhythmias (irregular heartbeats) that are not commonly seen with traditional heart medications. ^{1 2 3 4 6}

What data supports the effectiveness of the drug Cannabis for heart rhythm issues?

Research suggests that cannabis users may have lower odds of developing atrial fibrillation (a type of irregular heartbeat) compared to non-users, even when accounting for other health conditions and factors. ^{2 3 5 7 8}

Who Is on the Research Team?

Gregory M Marcus, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 21 who have used cannabis in the past month and can use a smartphone with specific apps. They should be willing to follow daily instructions on cannabis consumption for two weeks. People with heart conditions, pregnant women, or those on anti-arrhythmic meds cannot join.

Inclusion Criteria

I have used cannabis by inhaling it at least four times in one week in the past year.

I am 21 years old or older.

Have a smartphone

Exclusion Criteria

I have had a heart ablation procedure before.

I have a history of atrial fibrillation or heart failure.

Currently pregnant or trying to get pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are instructed to consume or avoid cannabis on randomly assigned days during a 14-day monitoring period while wearing monitors and using a mobile app for instructions and surveys.

2 weeks

Daily virtual check-ins via mobile app or text messaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Randomized instructions

Trial Overview The study tests if using cannabis affects heart rhythm by having participants consume or avoid it on random days while wearing health monitors. Data from heart, glucose monitors, fitness trackers, and surveys will help determine any changes in 'early' abnormal heartbeats.

How Is the Trial Designed?

Group I: Case-crossover Experimental Treatment 1 Intervention

Participants will be randomized in two-day blocks to consume then avoid cannabis ("Start: On Cannabis") or avoid then consume cannabis ("Start: Off Cannabis"). Using an case-crossover strategy delivered by the NIH-funded, UCSF-run Eureka platform utilizing a mobile smartphone-based application, or the Mosio text messaging software for clinical research, participants will receive instructions and answer questions to help researchers and physicians understand the relationship between inhaled cannabis and heart rhythm.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Among cardiac inpatients, 13.8% reported using cannabis in the past year, with younger patients and those with a history of tobacco or mental health issues being more likely to use it.

Most cannabis users among these patients engaged in higher-risk behaviors, such as smoking or vaping, and showed low intentions to quit, highlighting the need for further research on the cardiovascular effects of cannabis and the development of safer use guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence, Perceptions, and Patterns of Cannabis Use Among Cardiac Inpatients at a Tertiary-Care Hospital: A Cross-Sectional Survey. Walker, KL., Mackler, SA., Noble, SM., et al.[2023]

Among young adults aged 18-39 who are current or former cannabis users, there is a higher frequency of hospitalizations for acute myocardial infarction (AMI), arrhythmia, and stroke compared to non-users, indicating potential cardiovascular risks associated with cannabis use.

Despite the increased risk for certain cardiovascular events, cannabis users showed a lower frequency of hospitalizations for venous thromboembolic events (VTE), suggesting a complex relationship between cannabis use and cardiovascular health that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rising Trends in Hospitalizations for Cardiovascular Events among Young Cannabis Users (18-39 Years) without Other Substance Abuse. Desai, R., Fong, HK., Shah, K., et al.[2020]

In a study of 7,096 heart failure patients, those who used cannabis had lower odds of developing atrial fibrillation (AF) compared to non-users, with a significant reduction in AF diagnosis (19.08% vs 21.39%).

The protective effect of cannabis against AF was consistent even after accounting for factors like age, co-morbid conditions, insurance type, and socioeconomic status, suggesting a potential beneficial role of cannabis in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of Cannabis Use and Atrial Fibrillation Among Patients Hospitalized for Heart Failure. Adegbala, O., Adejumo, AC., Olakanmi, O., et al.[2019]

The rise in recreational cannabis use, particularly synthetic cannabinoids, has been linked to an increase in serious cardiovascular events, including sudden cardiac death and arrhythmias, especially among young men with few risk factors.

Older individuals and those with existing cardiovascular conditions may be at even greater risk, highlighting the need for further understanding of the complex interactions between cannabinoids and the cardiovascular system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Complications of Marijuana and Related Substances: A Review. Singh, A., Saluja, S., Kumar, A., et al.[2020]

This study aims to investigate the frequency of cardiac arrhythmias in hospitalized patients who use marijuana, addressing a gap in research regarding the potential cardiovascular effects of recreational marijuana use.

By utilizing the National Inpatient Sample (NIS) database, the research seeks to provide a comprehensive analysis of arrhythmia trends among marijuana users in a hospital setting, which has not been previously explored in detail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burden of arrhythmia in recreational marijuana users. Desai, R., Patel, U., Deshmukh, A., et al.[2022]

In a study of 502 THC-positive drivers, it was found that they had a significantly higher average pulse rate (82.8 beats/min) compared to a control group (75.6 beats/min), with 19.4% experiencing tachycardia, indicating a potential cardiovascular effect of THC.

The study also revealed that THC-positive drivers had a higher incidence of irregular heartbeats, particularly among those with lower blood THC concentrations, suggesting that even occasional cannabis use may lead to heart rate irregularities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and irregularity of heart rate in drivers suspected of driving under the influence of cannabis. Khiabani, HZ., Mørland, J., Bramness, JG.[2013]

In a study involving 61 participants (37 healthy controls and 24 with ischemic heart disease), cannabis use led to only mild increases in heart rate, which were less pronounced in individuals with ischemic heart disease.

The study found that while supraventricular tachycardia (SVT) was less frequent with increased cannabis use, nonsustained ventricular tachycardia (NSVT) was more common in those with ischemic heart disease, indicating a potential risk for arrhythmias in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arrhythmic Effects of Cannabis in Ischemic Heart Disease. Gillett, L., Johnson-Sasso, C., Miller, B., et al.[2023]

Cannabis use is linked to an increased risk of cardiac dysrhythmia, with 61% of studies reporting cannabis-induced tachycardia and various specific dysrhythmias such as atrial fibrillation and ventricular tachycardia.

While dysrhythmias are rare, they can be life-threatening, highlighting the need for healthcare providers to ask about cannabis use in patients with heart-related symptoms and to educate users, especially those with existing cardiac conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of cannabis use and cardiac dysrhythmias: a systematic review. Richards, JR., Blohm, E., Toles, KA., et al.[2021]

Citations

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

Prevalence, Perceptions, and Patterns of Cannabis Use Among Cardiac Inpatients at a Tertiary-Care Hospital: A Cross-Sectional Survey. [2023]

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

Rising Trends in Hospitalizations for Cardiovascular Events among Young Cannabis Users (18-39 Years) without Other Substance Abuse. [2020]

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

Relation of Cannabis Use and Atrial Fibrillation Among Patients Hospitalized for Heart Failure. [2019]

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

Cardiovascular Complications of Marijuana and Related Substances: A Review. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Burden of arrhythmia in recreational marijuana users. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Frequency and irregularity of heart rate in drivers suspected of driving under the influence of cannabis. [2013]

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

Arrhythmic Effects of Cannabis in Ischemic Heart Disease. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The association of cannabis use and cardiac dysrhythmias: a systematic review. [2021]