Date August 7, 2017
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What to expect: the FDA’s plan to limit nicotine in cigarettes

For years, researchers at Brown’s Center for Alcohol and Addiction Studies have been studying the potential impact of reducing nicotine in cigarettes, a policy that has now been formally introduced by the FDA.

PROVIDENCE, R.I. [Brown University] — When the U.S. Food and Drug Administration announced 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.

Q: What are some of the questions you and colleagues at Brown are asking now?

My colleagues in CAAS and I are testing how adolescents and vulnerable populations might respond to this policy. Given that people with psychiatric and substance-use disorder smoke almost half of the cigarettes consumed in the U.S., it’s important to examine whether this policy might have unintended negative consequences for these smokers. If so, we would have to figure out how to mitigate these consequences.

In my studies with post-doctoral fellow Mollie Miller, we’ve been testing responses to nicotine reduction in smokers with schizophrenia, depression and anxiety disorders. My CAAS colleagues Damaris Rohsenow and Rose Martin are testing responses in smokers with substance-use disorders, Rachel Cassidy is testing responses in adolescents, and Suzanne Colby and I will soon be starting a study that will examine how electronic cigarette availability and characteristics interact with cigarette nicotine reduction in adolescents.

Q: It’s surprising that some people might be adversely affected by what would seem to be a positive public health step. How might there be unintended consequences for certain groups?

There has long been a belief that a major reason for the high prevalence of smoking in people with psychiatric disorders is that nicotine helps with psychiatric symptoms — by improving negative mood and anxiety, for example. If so, these smokers might experience worsening of symptoms when nicotine is reduced. Similarly, rates of smoking are extremely high in people with substance-use disorders, who might increase their drug use if nicotine were reduced. So far what I’ve found is that smokers with elevated depression symptoms who switch to very low nicotine cigarettes do not experience increases in negative mood — in fact, their symptoms improve.

Q: Why will the pace at which nicotine is reduced be important?

If nicotine reduction does cause problematic levels of withdrawal symptoms or exacerbate psychiatric symptoms, it might be less disruptive to reduce nicotine slowly rather than all at once. The results of the recent study in over 1200 smokers that Rachel Denlinger-Apte has been involved will be helpful to the FDA as it considers how to best implement a nicotine reduction policy.

Q: In your opinion, what are the most important ways research can help further address the public health problem of smoking?

Finding effective treatments for vulnerable populations is an important priority. In addition to people with psychiatric and substance-use disorders, this includes people of color, people from low-income neighborhoods and LGBTQ communities, all of whom are disproportionately affected by tobacco. Reducing the nicotine content of cigarettes sold in the U.S. should help quite a bit, but we will still need to prioritize research aimed at developing effective cessation treatments for vulnerable populations and making those treatments available to all who want to quit.