A Clarence cigarette company is at the heart of a new study suggesting that smoking cigarettes with very low levels of nicotine could help smokers quit.
The study, published Wednesday in the New England Journal of Medicine, used low-nicotine cigarettes made by 22nd Century Group, a Clarence-based cigarette manufacturer that has developed technology to manipulate the level of nicotine in tobacco.
The study offers hope that a trick proposed two decades ago – dialing back the nicotine that smokers get from their cigarettes – might help many quit, and steer others toward less dangerous means of feeding their addiction.
The new research also offers reassurance that smokers restricted to very low nicotine cigarettes will not simply smoke more, or inhale more deeply, to get the same dosage of nicotine.
Henry Sicignano III, 22nd Century’s president, said the study is an encouraging development for the company, which makes cigarettes at a factory it opened early this year in North Carolina.
22nd Century last month won a contract to sell 5 million of its low-nicotine Spectrum cigarettes to the U.S. government, which then provides the cigarettes to researchers studying the effects of smoking. The low-nicotine cigarettes are not sold to consumers.
The company, which lost $5.4 million during the first half of this year on sales of $2.9 million as it ramped up production at its North Carolina factory, is hoping to find even broader commercial uses for its low-nicotine cigarettes, which can be manipulated to have varying levels of nicotine. One potential use is as a prescription-based smoking cessation product.
22nd Century plans to seek a partner in the pharmaceutical industry to help fund the Phase 3 clinical studies that must be completed to win regulatory approval of its cigarettes that contain extremely low levels of tar for use a product to help smokers quit. Sicignano has estimated that those studies likely will cost $15 million to $20 million to complete.
The company also plans to seek permission from the U.S. Food and Drug Administration later this year for permission to put a “modified risk” label on its low-nicotine cigarettes. No other company has received such an authorization, and Sicignano estimates that the FDA review could take at least a year once 22nd Century submits its application.
“This is the value of our company. No one else in the world has this technology,” he said. “It’s been shown to have tremendous value to help people quit smoking.”
In an unusual clinical trial, longtime smokers who were assigned to smoke cigarettes with less than 15 percent of the nicotine in standard cigarettes saw their tobacco dependence drop by as much as 20 percent after six weeks.
Smokers getting their usual dose of nicotine did not reduce the number of cigarettes they smoked daily. But those who got low-nicotine cigarettes smoked 23 percent and 33 percent fewer cigarettes daily, with “minimal evidence of withdrawal-related discomfort,” the researchers reported.
The fear that slashing cigarettes’ nicotine would drive smokers into more dangerous habits has long discouraged U.S. health officials from rallying behind proposals to limit the amount of the chemical in combustible tobacco products.
That reluctance may be coming to an end.
A sweeping reduction of nicotine in smoked tobacco is “the most promising regulatory policy option” available for preventing the premature deaths of at least 20 million smokers, University of Wisconsin tobacco researchers Timothy Baker and Dr. Michael Fiore wrote in a commentary published with the study.
Such an initiative would need to cover all smoked tobacco products to ensure that people could not merely switch brands to get their fix, they wrote. And the research shows that nicotine limits need not be gradual to work, they added.
Smokers in the study were not told how much nicotine was in the cigarettes they received. However, many longtime smokers who got very-low-nicotine cigarettes suspected as much, said University of Pittsburgh psychologist Eric C. Donny, who led the study.
That wasn’t surprising, he said: In addition to its addictive properties, nicotine “contributes to that ‘hit’ in the back of the throat” when a smoker inhales.
What did surprise the researchers was that longtime smokers who got much smaller daily doses of nicotine than they were used to did not experience some of the extreme withdrawal symptoms – constipation, distraction, increased appetite – that cause many would-be quitters to turn back.
Donny invoked tobacco researcher Michael Russell’s 1976 observation that “people smoke for the nicotine, but they die from the tar.”
In the trial, all 780 subjects acknowledged they that had “no current interest in quitting” their smoking habit. Participants were randomly assigned to one of six groups. Five smoked study-provided cigarettes that ranged in nicotine strength from extremely low (0.4 mg per gram of tobacco) to levels typical of cigarettes sold in the U.S (15.8 mg per gram). The sixth group continued to smoke their own brand of cigarettes.
Nearly 35 percent of those assigned to smoke very low-nicotine cigarettes for six weeks said they had tried to quit in the 30 days after the study ended. Among those who had continued to get their full fix of nicotine, 17 percent – about half as many – reported that they had tried to quit.
Anti-smoking activists were enthusiastic.
“This is one of the most significant clinical studies related to tobacco done in decades,” said Matthew M. Myers, president of the Campaign for Tobacco-Free Kids. “This study not only demonstrates that it’s possible to reduce addictiveness, but provides solid evidence of the level of nicotine needed to accomplish that goal.”
The findings “should serve as a catalyst” for the Food and Drug Administration to set limits on the nicotine content of smoked tobacco sold in the United States, Myers said.
In addition to loosening tobacco’s grip on the nearly 18 percent of American adults who smoke, a nicotine limit would make cigarettes far less addictive to the 3,200 American kids who try smoking for the first time on any given day, Myers said.
Others were more skeptical.
“I’m always surprised at how strict regulations appeal to public health activists,” said Jeff Stier, a senior fellow and risk analyst at the National Center for Public Policy Research, a free-market-oriented think tank in Washington, D.C. Advocates of such regulation are often quick to overlook the unintended consequences of such sweeping changes, including smokers’ efforts to circumvent the limits, he said.
The Los Angeles Times contributed to this story. email: email@example.com