The objective of this study was “to determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction”1 in the precessation phase. The study design was a randomized, double-blinded, placebo-controlled, multinational clinical trial performed by Jon O. Ebbert et. This medication was given to smokers who were not willing or able to quit smoking within the next month but were willing to reduce smoking and make a quit attempt within the next 3 months. The time frame for this study was 52 weeks, where varenicline was given initially on a 24-week treatment period and 28-week follow-up. Trial design was a two arm parallel, the use of varenicline offers smokers an option to reduce smoking and improve …show more content…
This clinical trial had a cohesive study design which did include introduction, methods, results, discussion and conclusion. The following are examples of meeting the CONSORT checklist requirements. Eligibility criteria for participants was clearly defined as well as the exclusion criteria which applied to any subject with major psychotic or behavioral disorders, and chronic diseases (COPD, cardiovascular, cerebrovascular). Primary and secondary outcomes were identified based on decreased levels of carbon monoxide during the abstinence phase (weeks 12-24) and non-treatment phase (weeks 25-52). In the results section, a participant flow diagram was provided to delineate number of participants, randomization of participants, reasons for declined participants, and analyses of efficacy and safety. Sample size was determined by trying to detect a difference …show more content…
The median time from the 12 week reduction period to continuous abstinence (week 25-52) was 50 days compared to 85 days for placebo which was clinically significant. Also varenicline had clinical significance by increasing the 4 week point prevalence abstinence rate, reduced number of cigarettes smoked per day by 50% + or abstained completely, and reduced smoking by 75% + or abstained. Another point of interest was the safety of varenicline, assessed through incidence of adverse events. According to the study the adverse events were not significantly different to discontinue treatment. But there are three adverse events (nausea, abnormal dreams and constipation) in the trial indicating statistical significance but not clinical significance. These three adverse events may be attributed to the dopamine receptors in the chemo trigger zone, intestines (peristalsis) and central nervous system, but insufficient to discontinue use of