E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tobacco addiction |
Ovisnost o duhanu, pušenje duhana |
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E.1.1.1 | Medical condition in easily understood language |
Tobacco addiction |
Ovisnost o duhanu, pušenje duhana |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess smoking behavior, awareness of and interest in using pharmacotherapy for smoking cessation in primary care patients in Croatia and Slovenia
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E.2.2 | Secondary objectives of the trial |
Implement a smoking cessation program using pharmacotherapy in a real-life setting, family medicine practices in Croatia and Slovenia
Investigate whether Cytisine is at least as feasible and effective as Varenicline in helping smokers to quit in a randomized non-inferiority trial
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be eligible for our study if they are aged 18 or older, are current smokers, indicate a desire to stop smoking, and an interest in pharmacotherapy. |
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E.4 | Principal exclusion criteria |
Younger than 18
Mental illness who cannot provide informed consent for the study
Pregnant or breastfeeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
Seven day abstinence from tobacco [ Time Frame: 12-weeks following target quit date ]
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Seven day abstinence from tobacco [ Time Frame: 12-weeks following target quit date ]
After the completion of the study |
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E.5.2 | Secondary end point(s) |
Seven day abstinence from tobacco country and practice [ Time Frame: 4-weeks following target quit date ]
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Seven day abstinence from tobacco [ Time Frame: 8-weeks following target quit date ]
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Seven day abstinence from tobacco [ Time Frame: 24-weeks following target quit date ]
Proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco.
Seven day abstinence from tobacco [ Time Frame: 4, 8, 12, and 24 weeks following target quit date ]
Repeated measures of proportion of patients in the varenicline and cytisine groups who self-report seven-day abstinence from tobacco
Continuous smoking cessation [ Time Frame: 4, 8, 12, and 24 weeks following target quit date ]
Proportion of patients who self-report continuous smoking cessation in the varenicline and cytisine groups (5 cigarettes allowed)
Medication adherence [ Time Frame: 1, 2, 3, 4, 8, 12 weeks following target quit date ]
Self report of adherence to assigned treatment protocol, including count of pills and stopping treatment (including reasons)
Side effects [ Time Frame: 4, 8, 12, and 24 weeks following target quit date ]
Self-report of any unintended sign, symptom, or other health-related issue that occurs during treatment with varenicline or cytisine |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Seven day abstinence from tobacco country and practice [ Time Frame: 4-weeks following target quit date ]
Seven day abstinence from tobacco [ Time Frame: 8-weeks following target quit date ]
Seven day abstinence from tobacco [ Time Frame: 24-weeks following target quit date ]
Seven day abstinence from tobacco [ Time Frame: 4, 8, 12, and 24 weeks following target quit date ]
Continuous smoking cessation [ Time Frame: 4, 8, 12, and 24 weeks following target quit date ]
Medication adherence [ Time Frame: 1, 2, 3, 4, 8, 12 weeks following target quit date ]
Side effects [ Time Frame: 4, 8, 12, and 24 weeks following target quit date ]
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
randomized controlled trial |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |