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Premature Atrial ContractionsNCT06021613

The MARY-JANE Cannabis and Heart Rhythm Trial

A study testing Randomized instructions in people with Premature Atrial Contractions and Premature Ventricular Contractions, run by University of California, San Francisco at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
Randomized instructions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
2 sitesUnited States
Study dates
18 Jan 2024to 15 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UCSF Medical Center at Parnassus

    San Francisco, California, 94143

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Randomized instructions
Keywords
Cannabis, Marijuana, Weed, Arrhythmias, Cardiac Ectopy, PACs, PVCs, Heart Rhythm
Medical subject headings
Atrial Premature Complexes, Ventricular Premature Complexes, Marijuana Abuse, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Randomized instructionsBehavioural

    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.

Study groups in NCT06021613
Study groupRoleWhat they receive
Case-crossoverExperimentalParticipants 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.
Receives: Behavioral: Randomized instructions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (5)

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: 2 weeks

  4. 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.

    Measured: 2 weeks

  5. 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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2023
  2. Study start18 Jan 2024
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06021613
Sponsor's protocol ID
23-39656
Status last verified
Jul 2026
First submitted
28 Aug 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.

    PubMed 23831166

  • Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.

    PubMed 33501848

  • Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.

    PubMed 32125402

  • Marcus GM, Vittinghoff E, Whitman IR, Joyce S, Yang V, Nah G, Gerstenfeld EP, Moss JD, Lee RJ, Lee BK, Tseng ZH, Vedantham V, Olgin JE, Scheinman MM, Hsia H, Gladstone R, Fan S, Lee E, Fang C, Ogomori K, Fatch R, Hahn JA. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events. Ann Intern Med. 2021 Nov;174(11):1503-1509. doi: 10.7326/M21-0228. Epub 2021 Aug 31.

    PubMed 34461028

  • Lin AL, Nah G, Tang JJ, Vittinghoff E, Dewland TA, Marcus GM. Cannabis, cocaine, methamphetamine, and opiates increase the risk of incident atrial fibrillation. Eur Heart J. 2022 Dec 14;43(47):4933-4942. doi: 10.1093/eurheartj/ehac558.

    PubMed 36257330

  • Dewland TA, Vittinghoff E, Mandyam MC, Heckbert SR, Siscovick DS, Stein PK, Psaty BM, Sotoodehnia N, Gottdiener JS, Marcus GM. Atrial ectopy as a predictor of incident atrial fibrillation: a cohort study. Ann Intern Med. 2013 Dec 3;159(11):721-8. doi: 10.7326/0003-4819-159-11-201312030-00004.

    PubMed 24297188

  • Marcus GM, Dewland TA. Premature Atrial Contractions: A Wolf in Sheep's Clothing? J Am Coll Cardiol. 2015 Jul 21;66(3):242-244. doi: 10.1016/j.jacc.2015.04.069. No abstract available.

    PubMed 26184617

  • Dukes JW, Dewland TA, Vittinghoff E, Mandyam MC, Heckbert SR, Siscovick DS, Stein PK, Psaty BM, Sotoodehnia N, Gottdiener JS, Marcus GM. Ventricular Ectopy as a Predictor of Heart Failure and Death. J Am Coll Cardiol. 2015 Jul 14;66(2):101-9. doi: 10.1016/j.jacc.2015.04.062.

    PubMed 26160626

  • Marcus GM. Evaluation and Management of Premature Ventricular Complexes. Circulation. 2020 Apr 28;141(17):1404-1418. doi: 10.1161/CIRCULATIONAHA.119.042434. Epub 2020 Apr 27.

    PubMed 32339046

  • Marcus GM, Rosenthal DG, Nah G, Vittinghoff E, Fang C, Ogomori K, Joyce S, Yilmaz D, Yang V, Kessedjian T, Wilson E, Yang M, Chang K, Wall G, Olgin JE. Acute Effects of Coffee Consumption on Health among Ambulatory Adults. N Engl J Med. 2023 Mar 23;388(12):1092-1100. doi: 10.1056/NEJMoa2204737.

    PubMed 36947466

  • Elias A, Montenegro GC, Oo HH, Pena IJ, Lowe DA, Lee C, Tang J, Lynch KL, Lim L, Maamou M, Nguyen N, Springer ML, Marcus GM. Acute Effects of Cannabis Inhalation on Cardiac Ectopy, Physical Activity, Sleep, and Glucose. J Am Coll Cardiol. 2026 Jul 30:S0735-1097(26)07131-7. doi: 10.1016/j.jacc.2026.07.014. Online ahead of print.

    PubMed 42584385

Questions about this trial

What is this clinical trial studying?

A study testing Randomized instructions in people with Premature Atrial Contractions and Premature Ventricular Contractions, run by University of California, San Francisco at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PAC and PVC frequencies (time frame: Baseline and after completion of cannabis consumption, up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06021613, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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