Wednesday, May 11, 2011
National Cancer Institute Funds Camel Snus Quit-Smoking Study
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.