Cytisine for nicotine-containing electronic cigarette and tobacco cigarette cessation: a randomized placebo-controlled trial

Phase 1

Conditions: electronic cigarette cessation
Therapeutic area: Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Registration Number: CTIS2023-504708-27-00

Lead Sponsor: niversity of Rzeszow

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

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