FINALLY! A REAL Clinical Trial on e-cigs!
Auckland University's Clinical Trials Research Unit has announced a six-month clinical trial of the safety and effectiveness of electronic cigarettes for smoking cessation! Currently in set-up phase, the trial has the cute name of END-IT.
END-IT: ELECTRONIC NICOTINE DEVICE INTERVENTION TRIAL
Funded by Health Research Council of New Zealand, the study will be a single-blind randomized control trial. Participants will be recruited from Auckland, NZ, and will receive a standard 8-week course of either a 16mg e-cig, a placebo 0mg e-cig, or nicotine patches, as well as behavioral support. They will be evaluated for continued tobacco abstinence after 6 months, as well as secondary outcomes, and for adverse events.
This study received funding in June 2010 and is currently in set-up phase, with study documents being prepared and ethics and regulatory approval being sought.
I have a few concerns over the study design. For one thing, it is designed to evaluate tobacco abstinence after an 8-week course of e-cigs, so will they count continued e-cig use after the 8 weeks as success or failure? Six months isn't really long enough, for another. And they gave no information on the size of the study.
But, it is a start. A start to the real solid research that we need. Blinded, randomized, placebo controlled, peer-reviewed and published, this will be a GREAT validation for our side when it is complete.