Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?

• Status: Completed
• Trial end date: 2018-06-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Men or women aged ≥18 years

• Currently smoking 10 cigarettes per day or more

• Having smoked 5 py or more

• Presenting a CO level in expired air ≥ 10 ppm

• Personally motivated to reduce or stop smoking and indicating a willingness to follow through with protocol requirements

• Willing to sign a statement of informed consent

Exclusion Criteria:

• Myocardial infarction within the last 3 months

• Unstable angina

• Severe cardiac arrhythmia

• Pregnancy or breast feeding

• Use of any form of smokeless tobacco or nicotine substitution

• Having followed any smoking cessation programme during the last 3 months

• Alcohol or other drug addiction

• Use of any form of smokeless tobacco or nicotine substitution

• Participation in any clinical trial within the past 3 months

• Women in childbearing age not willing to use contraception until week 12 after QD