The trial will run for one year, although the grant is active until 2016 (description here); the NCI has provided over $400,000 for the current fiscal year. The research is being directed by Matthew Carpenter, a psychiatrist at MUSC who previously published a pilot study demonstrating that Ariva and Stonewall dissolvable tobacco products are effective cigarette substitutes (described in this blog last January, here).
As with any clinical trial, outcomes will depend on the trial’s design; so far, few details are available. Will participants be provided with accurate information about the vastly lower health risks of Camel Snus? The answer isn’t clear, because the public description of the trial uses ambiguous terms. For example, Carpenter states that “a comprehensive risk profile [for smokeless tobacco] remains unclear”, despite numerous epidemiologic studies documenting minimal risks. In addition, he states, “The tobacco industry has developed a number of novel smokeless tobacco products that are purported to offer reduced health risks as compared to conventional cigarettes.” This implies that “reduced health risks” are unsubstantiated industry allegations; in fact, they are established scientific fact.
Carpenter describes the trial: “A population-based, nationwide sample of smokers will be proactively recruited through established methods, consented to enroll in a telephone-based cessation induction trial, and randomized to either a) provision of Camel Snus, or b) not.”
We don’t know how smokers will be recruited or enrolled, but we do know they will be randomized to receive Camel Snus, or not. While it is routine to offer one “treatment” in a clinical trial, this presents many problems when the outcome is a behavior. How do you study a product that is already available in stores nationwide? Will smokers who don’t receive Camel Snus be denied a product that is 98% safer than cigarettes? Will smokers who receive Camel Snus know its name? Will the products be provided free, or will smokers have to buy them? Which flavor of Camel Snus will be used? What happens if participants prefer another flavor, or prefer another smokeless product?
Previously, Carpenter found that Ariva and Stonewall had great potential as smoking cessation aids, but now only Camel Snus is being tested. If this trial is not a success, it may mean only that smokers are not enamored of Camel Snus.
Despite these questions, this trial is a landmark development for tobacco harm reduction. Its funding by the National Cancer Institute sends an unequivocal message that informing smokers about safer smokeless substitutes is ethical, credible and worthy of serious consideration.
5 comments:
To bad they went with Camel snus which is notoriously weak in nicotine. I started out using Camel snus several years ago but was not able to quit smoking until I started using Swedish snus. That is a common occurrence among snus users in the US.
In spite of that and the points you mentioned at least they are starting to look into products outside of the ineffective NRT's.
Yeah I think it would be worthwhile to do a cross comparison of other brands I think allowing snus with higher nicotine like thunder and general extra sterk would have a significant effect on the quitting rate and also having multiple brands, how is this supposed to be controlled for months anyway isn't it possible some of the people enrolled in the not qiven snus group will take an interest in what it is and find out you can get it online? I'd also be interested if at the end of the trial someone uses snus 98% percent of the time but smokes occasionally or smokes a cigar like once a month are they counted as part of the failed to quit group.
It's good to see some funding into alternative tobacco solutions, but this appears to be too little to late without a clear understanding of an existing product. I also don't believe there is a clear understanding of the difference between SNUS and Swedish snus as there are definite differences.
I personally don't believe I could have quit smoking using SNUS. As Stubby mentioned, the low nic content is an issue, but the sweetness of Camel flavors would have been an issue to me over time.
Swedish snus usage is very different than cigarette usage where one normally finds a brand and flavor that they enjoy and sticks with it. Ss users tend to purchase various flavors and use based on an interest in those different flavors.
Finally, as the blog suggests, a clinical trial setting? There are decades of usage information available in Sweden. The smoking cessation results are there. Yes, it's a different culture. However, other than the misguidance that the US has instilled in the minds of the population about the "dangers" of smokeless tobacco, smokers could find this to be a suitable alternative. I sure did.
If the National Cancer Institite funded this, it's gotta be good.
I hope they get good results but if they do not then we will know why. They should have included Snus that was has been shown to help people quit! Swedish Snus.
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