Examination of the mechanism of action of two pre-quit pharmacotherapies for smoking cessation

BACKGROUND: There is substantial scope for improvement in the current arsenal of smoking cessation methods and techniques: even when front-line cessation treatments are utilized, smokers are still more likely to fail than to succeed. Studies testing the incremental benefit of using nicotine patch for 1–4 weeks prior to quitting have shown pre-quit nicotine patch use produces a robust incremental improvement over standard post-quit patch treatment. The primary objective of the current study is to test the mechanism of action of two pre-quit smoking cessation medications—varenicline and nicotine patch—in order to learn how best to optimize these pre-quit treatments. METHODS/DESIGN: The study is a three group, randomized, open-label controlled clinical trial. Participants (n = 216 interested quitters) will be randomized to receive standard patch treatment (10 weeks of patch starting from a designated quit day), pre-quit patch treatment (two weeks of patch treatment prior to a quit day, followed by 10 weeks post-quit treatment) or varenicline (starting two weeks prior to quit day followed by 10 weeks post-quit). Participants will use study-specific modified smart-phones to monitor their smoking, withdrawal symptoms, craving, mood and social situations in near real-time over four weeks; two weeks prior to an assigned quit date and two weeks after this date. Smoking and abstinence will be assessed at regular study visits and biochemically verified. DISCUSSION: Understanding how nicotine patches and varenicline influence abstinence may allow for better tailoring of these treatments to individual smokers. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12614000329662 (Registered: 27 March 2014).