Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?
Brief Summary: SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control.

Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule.

Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD.

Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months.

Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).

Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate.

Expected benefits: This study might contribute to optimize the current use of varenicline.


Options:
A: Arm Label: group A; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: group B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline, Drug: placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): group A, group B | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): group B
B: Arm Label: Varenicline & nicotine patches; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Drug: Nicotine patches | Arm Label: Varenicline & placebo patches; Type: PLACEBO_COMPARATOR; Interventions: Drug: Varenicline, Drug: Placebo (nicotine patches) | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline & nicotine patches, Varenicline & placebo patches | Intervention Type: DRUG; Name: Nicotine patches; Assigned to Arm(s): Varenicline & nicotine patches | Intervention Type: DRUG; Name: Placebo (nicotine patches); Assigned to Arm(s): Varenicline & placebo patches
C: Arm Label: Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Sugar Pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sugar Pill
D: Arm Label: Cytisine plus behavioural support; Type: EXPERIMENTAL; Interventions: Drug: Cytisine, Behavioral: Behavioural support | Arm Label: Varenicline plus behavioural support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Behavioural support, Drug: Varenicline | Intervention Type: DRUG; Name: Cytisine; Assigned to Arm(s): Cytisine plus behavioural support | Intervention Type: BEHAVIORAL; Name: Behavioural support; Assigned to Arm(s): Cytisine plus behavioural support, Varenicline plus behavioural support | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline plus behavioural support

Answer: A