The MARY-JANE Cannabis and Heart Rhythm Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is designed as a case-crossover randomized trial, where each participant will be instructed to consume or avoid inhaled cannabis on randomly assigned days during a 14-day monitoring period. Participants will be asked to smoke or vape cannabis at least once on days they are instructed to consume cannabis. Participants will also wear an external electrocardiographic (ECG) monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application or text messaging service to receive daily instructions/reminders on cannabis use, and short surveys. The investigators will compare participant self-report of cannabis consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the relationship between acute cannabis consumption and heart rhythm changes. A total of 100 participants will be enrolled at the UCSF study site.

Official Title
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Marijuana and Acute Risk of Arrhythmia- Joint Abstinence and Exposure

Conditions
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Premature Atrial Contractions, Premature Ventricular Contractions

Intervention / Treatment
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* Behavioral: Randomized instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are age 21 or older Have a smartphone Are able to use the Eureka mobile application and Mosio text messaging software Have inhaled cannabis in the past month and on at least four different days in the same week in the past year Are willing to consume and abstain from inhaled cannabis for no more than two consecutive days as instructed over the 14-day trial period Exclusion Criteria: Currently pregnant or trying to get pregnant Have a medical reason to avoid cannabis Are unwilling to avoid all forms of cannabis consumption on days instructed to abstain from cannabis Are currently taking anti-arrhythmic medications Have a history of atrial fibrillation or heart failure Have congenital heart disease Have an implantable cardioverter-defibrillator or pacemaker Have had a previous cardiac ablation procedure

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case-crossover<br>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. | Behavioral: Randomized instructions<br>* Behavioral: Start: On Cannabis- In this two-day block, participants will be instructed to consume cannabis for one day and avoid cannabis the next day. Participants will be asked to smoke or vape cannabis at least once on days they are instructed to consume cannabis. Behavioral: Start: Off Cannabis- In this two-day block, participants will be instructed to avoid cannabis for one day and consume cannabis the next day. Participants will be asked to smoke or vape cannabis at least once on days they are instructed to consume cannabis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PAC and PVC frequencies | Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be change in premature atrial contraction (PAC) and PVC frequency due to cannabis consumption or avoidance during the monitoring period. | Baseline and after completion of cannabis consumption, up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SVT episodes | Participants will be wearing a continuously recording ECG monitor for two weeks. A secondary outcome will be change in supraventricular tachycardia (SVT) episodes due to cannabis consumption or avoidance during the monitoring period. | Baseline and after completion of cannabis consumption, up to 2 weeks | 
| Change in VT episodes | Participants will be wearing a continuously recording ECG monitor for two weeks. A secondary outcome will be change in ventricular tachycardia (VT) episodes due to cannabis consumption or avoidance during the monitoring period. | Baseline and after completion of cannabis consumption, up to 2 weeks | 
| Mean daily glucose levels | Participants will be wearing a continuous glucose monitor that will record serum glucose levels. A secondary outcome will be difference in mean daily glucose levels due to cannabis consumption or avoidance during the monitoring period. | 2 weeks | 
| Mean step count | Participants will be wearing a fitness tracker that will record step counts. A secondary outcome will be difference in mean step counts due to cannabis consumption or avoidance during the monitoring period. | 2 weeks | 
| Mean sleep duration | Participants will be wearing a fitness tracker that will record sleep duration. A secondary outcome will be difference in mean sleep duration due to cannabis consumption or avoidance during the monitoring period. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PACs, Cannabis, Marijuana, Weed, Arrhythmias, Cardiac Ectopy, PVCs, Heart Rhythm