PeRiopEratiVE SmokiNg CessaTion Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,720
- 试验地点
- 4
- 主要终点
- Smoking Cessation
研究概览
简要总结
PREVENT is a multicentre, 2x2 factorial, randomized clinical trial that aims to determine the effect of cytisine versus placebo, as well as the effect of video messaging to support smoking cessation versus standard of care in perioperative patients. This trial aims to investigate the effects of cytisine and text messaging on 6-month continuous abstinence rates. PREVENT will also assess secondary outcomes at 30 days, 56 days and 6 months post-randomization: 7-day point prevalence abstinence, urge to smoke, time to first lapse, time to relapse, number of cigarettes smoking if still smoking, pulmonary complications, vascular complications, wound and infectious complications, stroke, time in hospital and acute hospital care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are ≥18 years of age
- •are scheduled to undergo surgery within 28 days
- •are a current smoker and not currently using any smoking cessation treatment and,
- •have a smart mobile phone with an active, up to date data plan and with internet access
- •provide informed consent to participate.
排除标准
- •are pregnant or breastfeeding or expecting to become pregnant during the study follow-up period
- •are deemed unreliable for study procedures or follow-up
- •have a documented allergic reaction to cytisine, or its components (non-medicinal ingredients) or to the non-medicinal ingredients of the placebo.
- •had myocardial infarction, unstable angina, or stroke/transient ischemic attack within the preceding 2 weeks.
- •will have surgery with expected nil intake by mouth for 2 or more days
- •have previously participated in PREVENT
- •have a known diagnosis of untreated pheochromocytoma; Schizophrenia/bipolar psychiatric illness and currently psychotic; currently having suicidal ideation or risk of suicide as determined by the site physician, known history of moderate to severe depression; currently uncontrolled severe hypertension (≥180/120 mmHg) despite treatment; known history of uncontrolled hyperthyroidism (thyrotoxicosis), severe renal impairment i.e., creatinine clearance of less than 30 ml per minute (Cockcroft- Gault equation) or receiving long-term dialysis, or known diagnosis of severe liver disease as determined by the site physician or documented in the clinical history.
研究组 & 干预措施
Cytisine and Video Messaging
Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support through video messaging.
干预措施: Cytisine (Drug)
Cytisine and Video Messaging
Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support through video messaging.
干预措施: Video Messaging (Behavioral)
Placebo and Video Messaging
Administration of placebo (inactive drug) to patients on a set dose schedule with behavioural support through video messaging.
干预措施: Video Messaging (Behavioral)
Cytisine and No Video Messaging
Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support according to standard care such as a phone number for a self-help line.
干预措施: Cytisine (Drug)
结局指标
主要结局
Smoking Cessation
时间窗: 6 months
complete abstinence (smoking not more than 5 cigarettes) beginning on day 5 post randomization and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off \<10 parts per million \[ppm\]) measured with a carbon monoxide (CO) monitor
次要结局
- 7-day point-prevalence abstinence at 30 days(30 days)
- Time to first lapse(6 months)
- Death(6 months)
- Urge to smoke(baseline and 6-months)
- Wound complications(6 months)
- Number of cigarettes smoked daily if still smoking(30 days, 56 days and 6 months)
- Infectious complications(6 months)
- Non-fatal cardiac arrest(6 months)
- Acute hospital care since discharge(after hospital discharge for the study surgery to 6-month follow-up)
- 7-day point-prevalence abstinence at 56 days(56-days)
- 6 month continuous abstinence rate(6-months)
- Number of Patients with Proximal venous thrombo-embolism(6 months)
- Stroke(6 months)
- 7-day point-prevalence abstinence at 6-months(6-months)
- Time to relapse(6 months)
- Respiratory complications(6 months)
- Non-fatal Myocardial infarction(6 months)
- Length of hospital stay(time of hospital admission to time of discharge for surgical stay)