The MARY-JANE Cannabis and Heart Rhythm Trial

June 27, 2025 updated by: University of California, San Francisco

Marijuana and Acute Risk of Arrhythmia- Joint Abstinence and Exposure

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay
      • San Francisco, California, United States, 94143
        • UCSF Medical Center at Parnassus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Are age 21 or older
  2. Have a smartphone
  3. Are able to use the Eureka mobile application and Mosio text messaging software
  4. Have inhaled cannabis in the past month and on at least four different days in the same week in the past year
  5. Are willing to consume and abstain from inhaled cannabis for no more than two consecutive days as instructed over the 14-day trial period
  6. Are able to participate in a location where cannabis use would not break any established laws under any jurisdiction
  7. Are able to self supply cannabis throughout the study duration

Exclusion Criteria:

  1. Currently pregnant or trying to get pregnant
  2. Have a medical reason to avoid cannabis
  3. Are unwilling to avoid all forms of cannabis consumption on days instructed to abstain from cannabis
  4. Are currently taking anti-arrhythmic medications
  5. Have a history of atrial fibrillation or heart failure
  6. Have congenital heart disease
  7. Have an implantable cardioverter-defibrillator or pacemaker
  8. Have had a previous cardiac ablation procedure
  9. Are currently taking insulin
  10. Are unable to read or sign to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case-crossover
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after completion of cannabis consumption, up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after completion of cannabis consumption, up to 2 weeks
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.
Baseline and after completion of cannabis consumption, up to 2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Gregory M Marcus, MD, MAS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-39656

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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