The MARY-JANE Cannabis and Heart Rhythm Trial

Last updated: February 7, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Treatment

Randomized instructions

Clinical Study ID

NCT06021613
23-39656
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 thesame week in the past year

  5. Are willing to consume and abstain from inhaled cannabis for no more than twoconsecutive days as instructed over the 14-day trial period

Exclusion

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 toabstain 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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Randomized instructions
Phase:
Study Start date:
January 18, 2023
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • UCSF Medical Center at Mission Bay

    San Francisco, California 94158
    United States

    Active - Recruiting

  • UCSF Medical Center at Parnassus

    San Francisco, California 94143
    United States

    Active - Recruiting

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