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NCT Number: NCT06021613

The MARY-JANE Cannabis and Heart Rhythm 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.

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Key information

Conditions

Premature Atrial Contractions Arrhythmias, Cardiac Atrial Premature Complexes Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Chemically-Induced Disorders Heart Diseases Marijuana Abuse Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Ventricular Contractions Substance-Related Disorders Ventricular Premature Complexes

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Medical Center at Mission Bay, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Are able to participate in a location where cannabis use would not break any established laws under any jurisdiction
  • Are able to self supply cannabis throughout the study duration

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
  • Are currently taking insulin
  • Are unable to read or sign to provide informed consent

Treatment and study plan

Randomized instructions

Behavioral

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.

Primary outcomes

  1. Change in PAC and PVC frequencies

    Time frame: Baseline and after completion of cannabis consumption, up to 2 weeks

    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.

Secondary outcomes

  1. Change in SVT episodes

    Time frame: Baseline and after completion of cannabis consumption, up to 2 weeks

    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.

  2. Change in VT episodes

    Time frame: Baseline and after completion of cannabis consumption, up to 2 weeks

    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.

  3. Mean daily glucose levels

    Time frame: 2 weeks

    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.

  4. Mean step count

    Time frame: 2 weeks

    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.

  5. Mean sleep duration

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Marijuana and Acute Risk of Arrhythmia- Joint Abstinence and Exposure

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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