E-cigarette clinical trial

Despite preliminary evidence suggesting that e-cigarettes may be an effective smoking cessation aid, there is a lack of evidence to guide regulations, and to inform clinical practitioners and consumers. In the absence of evidence, an increasing number of Canadian smokers are nevertheless using e-cigarettes as a cessation aid. The quality and product standards of these products vary considerably, and there have been increasing calls from the public health community to regulate e-cigarettes as a drug-delivery device to ensure their safety and to provide guidance to the clinical practice community.To date, no clinical trials have been conducted in Canada, with only two published RCTs of e-cigarettes, both of which suffer from several methodological limitations, as described below. There is an urgent need for clinical trials to determine the efficacy, if any, of e-cigarettes in promoting smoking abstinence.

The overall objective of the current study is to conduct a randomized clinical trial (RCT) to determine the clinical efficacy of e-cigarettes products in promoting smoking cessation compared to nicotine replacement therapy. The study will address four primary research questions:

  • Are there differences in smoking abstinence rates and time-to-relapse among cigarette smokers attempting to quit using e-cigarettes versus conventional nicotine replacement therapy?
  • Are there differences in cigarette consumption and reductions in the number of cigarettes-per-day among cigarette smokers attempting to quit using e-cigarettes versus conventional nicotine replacement therapy?
  • Are there differences in treatment adherence among cigarette smokers attempting to quit smoking using e-cigarettes versus conventional nicotine replacement therapy?
  • To what extent is the prolonged use of e-cigarettes associated with adverse outcomes, relative to conventional nicotine replacement therapy?

The proposed study will consist of a two group open-label randomized control trial to examine the efficacy of e-cigarettes as a smoking cessation aid compared to the nicotine replacement therapy assessed by continuous abstinence measured at 1, 3 and 6-month follow-up. Participants in the e-cigarette condition will be randomized to use a refillable “tank” system. To our knowledge, this will be the first clinical trial to examine this type of e-cigarette.

The multi-centre trial will be conducted at University of Waterloo and University of Ottawa Heat Institute. Data collection is scheduled for early 2015.

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