Premature Atrial Contractions, Premature Ventricular Contractions
Conditions
Keywords
Cannabis, Marijuana, Weed, Arrhythmias, Cardiac Ectopy, PACs, PVCs, Heart Rhythm
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.
Interventions
BEHAVIORALRandomized 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.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PAC and PVC frequencies | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SVT episodes | 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. |
| Change in VT episodes | 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. |
| Mean daily glucose levels | 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. |
| Mean step count | 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. |
| Mean sleep duration | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory M Marcus, MD, MAS
University of California, San Francisco
Outcome results
None listed