Landmark study uses 22nd Century’s low-nicotine cigarettes

| October 5, 2015

The New England Journal of Medicine (NEJM) has published an article detailing a landmark study that used low-nicotine Spectrum cigarettes produced by 22nd Century, a leader in tobacco harm reduction.

The double-blind, parallel, randomized clinical trial was led by the Center for the Evaluation of Nicotine in Cigarettes and involved 840 smokers at 10 locations. Funded by the National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products, the study included six styles of 22nd Century’s Spectrum research cigarettes.

The cigarettes had nicotine contents ranging from 15.8 mg per gram of tobacco (similar to commercial brands) to 0.4 mg per gram (“very low nicotine”). The very low nicotine Spectrum cigarettes contain 95 percent less nicotine than conventional cigarettes, according to 22nd Century, which claims to be the only company in the world capable of growing tobacco with such low nicotine content.

The authors concluded that data from the study suggests 22nd Century’s proprietary low-nicotine Spectrum cigarettes were “associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.”

Researchers found that during the sixth and final week of the trial, participants who were assigned Spectrum cigarettes with 0.4 mg/g nicotine smoked fewer cigarettes per day (14.9) than those who were assigned to their usual brand of cigarettes (22.2). In addition, very low nicotine cigarettes were found to reduce exposure to, and dependence on, nicotine and to reduce cravings while adverse events were generally mild and similar among groups. In the 30 days following the trial, smokers of very low nicotine cigarettes reported that they attempted to quit smoking at a rate double that of participants who smoked cigarettes with 15.8 mg/gram nicotine (34.7 percent compared to 17 percent).

“The evidence is getting stronger that reducing nicotine reduces smoking and makes people less addicted to cigarettes and, in doing so, might make them more likely to quit,” Dr. Eric Donny, the study’s lead author, was quoted as saying in article posted on www.usatoday.com.

To further test that theory, Spectrum cigarettes are being used in a phase III clinical study that follows 1,250 smokers for five months.

The results of previous studies using very low nicotine cigarettes have demonstrated a variety of desirable outcomes, including reduced smoking, reduced nicotine exposure, reduce nicotine dependence, increased abstinence, reduced exposure to toxicants and few adverse events with little evidence of withdrawal-related discomfort or safety concerns.

Unlike “light” cigarettes, which reduce nicotine yields by diluting the smoke rather than by reducing the nicotine content of tobacco, very low nicotine cigarettes do not result in compensatory smoking.

“The current study by Donny and colleagues adds to a growing literature supporting the feasibility and potential benefits of a national nicotine reduction policy … ” public health policy reform advocates Drs. Michael Fiore and Timothy Baker explained in a separate article published in same issue of the NEJM. “Reducing the nicotine content of combustible tobacco to levels that will not sustain dependence seems to us to be the most promising regulatory policy option for preventing [at least] 20 million premature deaths.”

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Category: Breaking News

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