Clinical trial NCT06021613: The MARY-JANE Cannabis and Heart Rhythm Trial
Official title: Marijuana and Acute Risk of Arrhythmia- Joint Abstinence and Exposure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Premature Atrial Contractions
Premature Ventricular Contractions
Keywords: Cannabis
Marijuana
Weed
Arrhythmias
Cardiac Ectopy
PACs
PVCs
Heart Rhythm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Change in PAC and PVC frequencies
timeFrame: Baseline and after completion of cannabis consumption, up to 2 weeks
Secondary outcomes:
measure: Change in SVT episodes
timeFrame: Baseline and after completion of cannabis consumption, up to 2 weeks
measure: Change in VT episodes
timeFrame: Baseline and after completion of cannabis consumption, up to 2 weeks
measure: Mean daily glucose levels
timeFrame: 2 weeks
measure: Mean step count
timeFrame: 2 weeks
measure: Mean sleep duration
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Parnassus
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
Study officials:
affiliation: University of California, San Francisco
name: Gregory M Marcus, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.