Cytisine for nicotine-containing electronic cigarette and tobacco cigarette cessation: a randomized placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 23
- 主要终点
- Biochemically verified (negative urine cotinine and NNAL concentration) continuous EC containing nicotine and TC abstinence for 26 weeks preceding the 30-week follow-up (from 4 week to 30 week) post the start of treatment.
研究概览
简要总结
To evaluate the effectiveness of cytisine plus behavioural support compared to placebo plus behavioural support for cessation of single use of EC containing nicotine (electronic cigarettes, vaping) or dual use of EC containing nicotine and TC (tobacco cigarettes, smoking) in participants who are motivated to quit EC containing nicotine or dual use of EC containing nicotine and TC. The study will compare biochemically verified continuous abstinence rates (i.e., vaping and smoking) for 26 weeks preceding the 30-week follow-up from the start of treatment between two groups of single users of EC or dual users (EC and TC) allocated to either:
- Intervention arm: a 12-week course of 1.5 mg cytisine tablets plus behavioural support
- Comparator arm: a 12-week course of placebo tablets (appearance is like cytisine tablets) plus behavioural support
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •age >18 at the time of screening visit
- •acceptance of the study requirements and commitment to complete all study procedures
- •female subjects of childbearing potential must practice a highly effective method of birth control throughout the study. Contraceptive measures will be reviewed with patients during the informed consent process. Females applying hormonal contraception must agree to use additional barrier contraception. The following methods of birth control are considered highly effective: ▪ oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study drug administration; or ▪ implants of levonorgestrel inserted for at least 1 month prior to the study drug administration but not beyond the third successive year following insertion; or ▪ injectable progestogen administered for at least 1 month prior to study drug administration; or ▪ double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or ▪ an intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or ▪ estrogenic vaginal ring; or ▪ complete abstinence from intercourse; or ▪ percutaneous contraceptive patches.
- •fertile man must practice barrier contraception along with application to the intercourse partner methods applicable to women with childbearing potential (WOCBP) indicated above
- •willing to use mobile application during the treatment period (with the option to opt out during the study)
- •provides a valid mobile phone number and a valid e-mail address
- •willing to use mobile application during the treatment period (with the option to opt out during the study)
- •provides a valid mobile phone number and a valid e-mail address
- •the written, aware of consent to participate in the study including the consent to participate in the screening, baseline and follow-up visit after the trial accomplishment
- •a daily access of the participant to a mobile phone
- •single EC users: currently using EC containing nicotine and using it daily or at least five days per week for at least 1 month prior to the screening visit, screening semi-quantitative urine cotinine positive for recent nicotine use who did not use tobacco in any form in the past 3 months (verified carbon monoxide [CO] concentration in the exhaled air ≤ 5 ppm at the time of screening). Here, we define EC as handheld devices that heat a liquid to produce an aerosol for inhalation (this excluded heated tobacco products)
- •dual EC and TC users: currently using EC containing nicotine and using it daily or at least five days per week for at least 1 month prior to the screening visit who also smoke at least one TC [factory-made cigarettes and/or roll-your-own cigarettes] per day plus CO in the exhaled air > 5 ppm, screening semi-quantitative urine cotinine positive test for recent nicotine use
- •willing to make a quit attempt using the study products (cytisine or placebo)
- •the ability and willigness to complete all study visits
排除标准
- •pregnancy (including planning to become pregnant during the treatment phase of the study and 2 weeks after the last dose of study medication)
- •current participation in other clinical trials or smoking cessation programs
- •women who are of childbearing potential and are likely to become pregnant during the medication phase and are not willing to use a reliable form of contraception
- •breastfeeding
- •currently use any smoking cessation medication, including the nicotine-containing products and cytisine within at screening
- •a known hypersensitivity to cytisine or to any of the excipients
- •hospitalization for any of the following medical conditions in the previous 3 months: myocardial infarct/severe angina, stroke, severe arrhythmia or another severe heartrelated condition
- •self-report diagnosis of pheochromocytoma, heart failure (IV NYHA), untreated active peptic ulcer/gastroesophageal reflux disorder, moderate/severe renal insufficiency, epilepsy or untreated hyperthyroidism, uncontrolled hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg)
- •diagnosis of any non-treated and unstable psychotic disorders, including schizophrenia; If any subject becomes psychotic during the study, they must be removed from treatment and/or additional study visits.
- •malignancy that has not been in complete remission for at least three years
结局指标
主要结局
Biochemically verified (negative urine cotinine and NNAL concentration) continuous EC containing nicotine and TC abstinence for 26 weeks preceding the 30-week follow-up (from 4 week to 30 week) post the start of treatment.
Biochemically verified (negative urine cotinine and NNAL concentration) continuous EC containing nicotine and TC abstinence for 26 weeks preceding the 30-week follow-up (from 4 week to 30 week) post the start of treatment.
Continuous EC containing nicotine cessation will be defined as self-reporting having remained quit for 26 weeks preceding follow-up at 30-week from the start of treatment and
Continuous EC containing nicotine cessation will be defined as self-reporting having remained quit for 26 weeks preceding follow-up at 30-week from the start of treatment and
allowing for no more than 5 vaping occasions, whether it be one puff or many while still holding the device (when the device is put away or after 10 min. the occasion is over, whichever comes first), with the additional criterion of no slip-ups (not even a puff) in the last week, and return of a negative biochemical test (cotinine and NNAL).
allowing for no more than 5 vaping occasions, whether it be one puff or many while still holding the device (when the device is put away or after 10 min. the occasion is over, whichever comes first), with the additional criterion of no slip-ups (not even a puff) in the last week, and return of a negative biochemical test (cotinine and NNAL).
Continuous TC cessation will be defined as self-reporting having remained quit for 26 weeks preceding follow-up at 30-week from the start of treatment (having smoked no more than five cigarettes in that time, i.e,. Russell standard) and return of a negative biochemical test.
Continuous TC cessation will be defined as self-reporting having remained quit for 26 weeks preceding follow-up at 30-week from the start of treatment (having smoked no more than five cigarettes in that time, i.e,. Russell standard) and return of a negative biochemical test.
Only participants self-reporting continuous abstinence at final follow-up will be biochemically verified.
Only participants self-reporting continuous abstinence at final follow-up will be biochemically verified.
A participant with urine concentration < 50 ng/mL and urine NNAL concentration < 10 pg/ml will be considered abstinent from EC containing nicotine and TC.
A participant with urine concentration < 50 ng/mL and urine NNAL concentration < 10 pg/ml will be considered abstinent from EC containing nicotine and TC.
A participant who vapes EC not containing nicotine (0 mg/mL) will be considered abstinent.
A participant who vapes EC not containing nicotine (0 mg/mL) will be considered abstinent.
Participants who will report abstinence but will be unable or unwilling to complete biochemical verification (urine cotinine) will be classified as using EC (treatment failure) for the primary outcome.
Participants who will report abstinence but will be unable or unwilling to complete biochemical verification (urine cotinine) will be classified as using EC (treatment failure) for the primary outcome.
. Participants who will report abstinence but will be unable or unwilling to complete biochemical verification (urine cotinine and NNAL) will be classified as using EC and TC (treatment failure) for the primary outcome.
. Participants who will report abstinence but will be unable or unwilling to complete biochemical verification (urine cotinine and NNAL) will be classified as using EC and TC (treatment failure) for the primary outcome.
次要结局
- Self-reported continuous EC containing nicotine abstinence defined as self-report of having vaped no EC containing nicotine allowing for no more than 5 vaping occasions, whether it be one puff or many while still holding the device (when the device is put away or after 10 min the occasion is over, whichever comes first), with the additional criterion of no slip-ups, not even a puff, in the last week for 26 weeks preceding follow-up at 30- week (from 4 week to 30 week) post the start of treatment
- Self-reported continuous EC containing nicotine abstinence at 2-week, 4-week, and 12- week post the start of treatment
- Self-reported continuous TC abstinence defined as self-report of having remained quit for 26 weeks preceding follow-up at 30-week from the start of treatment (having smoked no more than five cigarettes in that time, i.e., Russell standard)
- Self-reported continuous TC abstinence at 2-week, 4-week, and 12-week post the start of treatment
- Self-reported 7-day point prevalence abstinence defined as prevalence of abstinence (no TC, not a single vaping EC containing nicotine) during seven consecutive days immediately preceding 2-week, 4-week, 12-week, and 30-week interview
- Biochemically verified (negative urine cotinine and NNAL concentration) 7-day point prevalence abstinence defined as prevalence of abstinence (no TC, not a single vaping EC containing nicotine) during seven consecutive days immediately preceding 30-week interview
- Self-reported nicotine consumption from EC per day and week (strength and volume of eliquid/cartridge used per day) at 2-week, 4-week, 12-week, and 30-week post the start of treatment among those participants who continue EC using
- The proportion of SAEs and AEs compared across cytisine and placebo groups
研究者
Prof. Piotr Tutka
Scientific
University of Rzeszow