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The MARY-JANE Cannabis and Heart Rhythm Trial

Primary Purpose

Premature Atrial Contractions, Premature Ventricular Contractions

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Randomized instructions
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Atrial Contractions focused on measuring Cannabis, Marijuana, Weed, Arrhythmias, Cardiac Ectopy, PACs, PVCs, Heart Rhythm

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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

Sites / Locations

  • UCSF Medical Center at Parnassus
  • UCSF Medical Center at Mission Bay

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Case-crossover

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 28, 2023
Last Updated
August 31, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT06021613
Brief Title
The MARY-JANE Cannabis and Heart Rhythm Trial
Official Title
Marijuana and Acute Risk of Arrhythmia- Joint Abstinence and Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Atrial Contractions, Premature Ventricular Contractions
Keywords
Cannabis, Marijuana, Weed, Arrhythmias, Cardiac Ectopy, PACs, PVCs, Heart Rhythm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case-crossover
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Randomized instructions
Intervention Description
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 Outcome Measure Information:
Title
Change in PAC and PVC frequencies
Description
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.
Time Frame
Baseline and after completion of cannabis consumption, up to 2 weeks
Secondary Outcome Measure Information:
Title
Change in SVT episodes
Description
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.
Time Frame
Baseline and after completion of cannabis consumption, up to 2 weeks
Title
Change in VT episodes
Description
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.
Time Frame
Baseline and after completion of cannabis consumption, up to 2 weeks
Title
Mean daily glucose levels
Description
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.
Time Frame
2 weeks
Title
Mean step count
Description
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.
Time Frame
2 weeks
Title
Mean sleep duration
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory M Marcus, MD, MAS
Phone
415-476-5706
Email
greg.marcus@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory M Marcus, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Medical Center at Parnassus
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23831166
Citation
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.
Results Reference
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PubMed Identifier
33501848
Citation
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.
Results Reference
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PubMed Identifier
32125402
Citation
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.
Results Reference
background
PubMed Identifier
34461028
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.
Results Reference
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PubMed Identifier
36257330
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.
Results Reference
background
PubMed Identifier
24297188
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.
Results Reference
background
PubMed Identifier
26184617
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.
Results Reference
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PubMed Identifier
26160626
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
36947466
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.
Results Reference
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The MARY-JANE Cannabis and Heart Rhythm Trial

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