BridgeMD
Cytisine for nicotine-containing electronic cigarette and tobacco cigarette cessation: a randomized placebo-controlled trial
EU CTIS ID: 2023-504708-27-00
What this study is testing
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: 1) Intervention arm: a 12-week course of 1.5 mg cytisine tablets plus behavioural support 2) Comparator arm: a 12-week course of placebo tablets (appearance is like cytisine tablets) plus behavioural support
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.