Marijuana and Acute Risk of Arrhythmia- Joint Abstinence and Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Change in PAC and PVC frequencies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Are currently taking insulin
- •Are unable to read or sign to provide informed consent
研究组 & 干预措施
Case-crossover
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.
干预措施: Randomized instructions (Behavioral)
结局指标
主要结局
Change in PAC and PVC frequencies
时间窗: 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.
次要结局
- Mean step count(2 weeks)
- Change in SVT episodes(Baseline and after completion of cannabis consumption, up to 2 weeks)
- Change in VT episodes(Baseline and after completion of cannabis consumption, up to 2 weeks)
- Mean daily glucose levels(2 weeks)
- Mean sleep duration(2 weeks)