What to expect: the FDA’s plan to limit nicotine in cigarettes

PROVIDENCE, R.I. [Brown University] — When the U.S. Food and Drug Administrationannounced on July 28 a new push to substantially reduce and limit the amount of nicotine in cigarettes, the policy was informed by an evidence base developed with critical contributions from Brown University’s Center for Alcohol and Addiction Studies (CAAS) in the School of Public Health.

For years, a group of faculty members, postdoctoral researchers and students has been studying many dimensions of nicotine reduction, including the impact such a policy might have on smoking behavior in general and on specific populations of smokers, some of whom might face unintended consequences. Among those researchers is Jennifer Tidey, a professor of psychiatry and human behavior and of behavioral and social sciences, who co-authored a particularly influential paper in the New England Journal of Medicine in 2015.

In the wake of the news out of Washington, we asked Tidey to share thoughts on Brown’s nicotine-reduction research and its impact on the FDA’s new initiative.

Q: What can your 2015 study tell us about the FDA’s plan to lower nicotine levels in cigarettes?

This study was designed to model the potential effects — positive and negative — of a nicotine-reduction policy for cigarettes. More than 800 smokers at 10 sites across the country were randomly assigned to receive either their usual cigarette brand or research cigarettes with varying levels of nicotine for a six-week period. The nicotine content of the research cigarettes ranged from a level similar to commercial cigarettes down to having less than 5 percent of the nicotine content of a commercial cigarette.

After six weeks, participants who had received the very low nicotine cigarettes smoked fewer cigarettes per day, were less dependent, had less cigarette craving and had minimal withdrawal discomfort. Even though none of the participants was trying to quit at study outset, those who had used very low nicotine cigarettes were more likely to try to quit when the study ended. The study supports the idea that this policy could be an effective regulatory method of reducing tobacco dependence in the U.S., making it easier for people to quit if they want to.

Q: How else has recent research at Brown contributed to the evidence base for this policy? 

Rachel Denlinger-Apte, a doctoral student in the School of Public Health, is an investigator in a study with more than 1,200 smokers that has been comparing the effectiveness of reducing the nicotine content of cigarettes immediately or gradually over a number of months. That study was recently completed and results should be available soon. And along with our co-investigators from the 2015 study, we have been looking at other measures collected in that study to see, for example, how acceptable people find these cigarettes, how supportive they are of a nicotine-reduction policy, and whether nicotine reduction has deleterious effects on weight gain, alcohol use, cannabis use or depressive symptoms.

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