A five-year, first-in-Canada study, led by McGill cardiologist Dr. Mark Eisenberg, is exploring whether vaping really is the magic ticket to finally breathing free and easy.

By James Martin

Although the holidays may seem like a distant memory, statistically speaking, most of us are still sticking with our New Year’s resolutions. (For now. Let’s not talk about how many of us last until July.) For many, that means quitting smoking — and they’re hoping that electronic cigarettes will help. According to the U.S. Centers for Disease Control and Prevention, nearly half of all American smokers have tried e-cigarettes to help them kick the habit. But Dr. Mark Eisenberg wants to know: Is vaping really the magic ticket to breathing free and easy?

Dr. Eisenberg is passionate about getting people to butt out. He gives a lot of smoking cessation talks — just last month, he spoke at the Jewish General Hospital, where he is staff cardiologist — and has noticed that, invariably, reformed smokers come up to him afterward to sing the praises of e-cigarettes, those increasingly popular handheld battery-operated vaporizers that mimic conventional cigarettes.

“They say, ‘I smoked for decades and I’ve tried everything — nicotine gum, patches, Zyban, Champix — and I couldn’t stop. Then I picked up an e-cigarette and I never smoked again,’” recalls Eisenberg, who is also a professor in McGill’s Faculty of Medicine and director of the Joint MD/PhD program. “Anecdotally, we have many, many cases like this.”

What doctors don’t have, however, is hard data to back it up. That’s why, this month Eisenberg will start a five-year clinical trial to look at how effective e-cigarettes are at aiding smoking cessation. It’s not just smokers and physicians who are interested in such clarity — so are lawmakers. Under Canada’s Food and Drug Act, e-cigarettes containing nicotine cannot be imported, advertised or sold without Health Canada’s approval; nicotine-free e-cigarettes are not restricted. Although Health Canada has yet to grant such approval, nicotine-loaded e-cigarettes are nevertheless widely and openly available in Canada.

The study, which is funded by the Canadian Institutes of Health Research (CIHR), will follow 486 outpatient smokers at 19 sites across Canada. The smokers will be randomized into three groups. One group will be given e-cigarettes that contain nicotine and counselling. The second group will receive e-cigarettes that do not contain nicotine, and counselling. The third group will only receive counselling. The researchers will supply the smokers with e-cigarettes for 12 weeks, and then follow up with them after six months and a year, observing whether they graduate to total non-smoking, continue with the e-cigarettes, or return to conventional cigarettes. Although some reformed smokers may fall off the wagon after a smoke-free year, Eisenberg clarifies that “statistically significant results at 12 months would still be important evidence” for the efficacy of e-cigarettes as a cessation aid. All 486 patients will not be enrolled simultaneously, with the study expected to roll out over the course of five years.

“The ultimate goal is to use the e-cigarette as a transitional tool in going from smoking conventional cigarettes to not smoking at all,” says Eisenberg. He notes that, at least in the early stages, e-cigarettes are about “transferring the addiction. You’re getting people onto something else that is giving them their nicotine, so they may never quit. E-cigarettes also provide other physical and social aspects because they feel like a cigarette; a pack-a-day smoker makes that hand-to-mouth motion more than 70,000 times a year, for example. That’s a difficult thing to break away from, and a nicotine patch doesn’t provide it.

“We have great hopes that e-cigarettes will be helpful for people trying to quit smoking,” he adds. “Even if they just switch to smoking e-cigarettes that would be better than continuing to smoke conventional cigarettes for decades. I’m not saying that e-cigarettes are safe, but they’re much safer than conventional cigarettes. They’re not going to give you lung cancer. They’re not going to give you heart disease. They’re not going to give you emphysema.

“But what we’re really hoping for is that e-cigarettes lead people to not smoking altogether.”

(This particular study, Eisenberg notes, is not designed to investigate safety concerns, such as whether e-cigarette vapour contains trace elements of harmful substances. Other than their smoking habits, the trial’s participants are healthy, he explains, “so the chances that they’d have adverse effects over a short time like the course of one year are quite low.” The researchers will, however, track whether the smokers are hospitalized for any cardiopulmonary issues. They will also gather data about benign side effects, such as throat irritation.)

E-cigarettes are already big business, ringing up an estimated $500-plus million in sales in the U.S. alone — and that’s without being able to make any claims about helping smokers kick their habits. Eisenberg says that the e-cigarette industry itself isn’t clamouring to make such claims: “They don’t want to be regulated by the Food and Drug Administration [in the U.S.] and Health Canada, so they don’t want to support clinical trials,” he says. “And they don’t need to: Smokers are voting with their feet by buying e-cigarettes to help them quit smoking.” Governments, however, want more than anecdotal evidence.

“This study alone would not be enough for Health Canada to allow companies to market e-cigarettes as smoking cessation aids,” explains Eisenberg. “That said, if this trial shows that there is a substantial reduction in smoking traditional cigarettes, then Health Canada will have to rethink their policy.

“This is just a first step. Then we would need multiple big trials in multiple populations. We would need to use tapering [of nicotine levels] studies, and we would need to use interventions that are longer than 12 weeks. But the fact is that smoking is still the single most reversible cause of mortality in Canada — so it’s an important first step.”

Posted on Wednesday, February 3, 2016