Cytyzyna w leczeniu uzależnienia od elektronicznych papierosów zawierających nikotynę i papierosów tytoniowych: randomizowane placebo- kontrolowane badanie

Kryteria włączenia kto może wziąć udział (14)

1. age >18 at the time of screening visit
2. willing to use mobile application during the treatment period (with the option to opt out during the study)
3. provides a valid mobile phone number and a valid e-mail address
4. 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
5. a daily access of the participant to a mobile phone
6. 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)
7. 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
8. willing to make a quit attempt using the study products (cytisine or placebo)
9. the ability and willigness to complete all study visits
10. acceptance of the study requirements and commitment to complete all study procedures
11. 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.
12. fertile man must practice barrier contraception along with application to the intercourse partner methods applicable to women with childbearing potential (WOCBP) indicated above
13. willing to use mobile application during the treatment period (with the option to opt out during the study)
14. provides a valid mobile phone number and a valid e-mail address