Nicotine Reduction Strategy Research Articles

Potential Moderating Effects of Psychiatric Diagnosis and Symptom Severity on Subjective and Behavioral Responses to Reduced Nicotine Content Cigarettes.

IntroductionGiven FDA’s authority to implement a cigarette nicotine reduction policy, possible outcomes of this regulation must be examined, especially among those who may be most affected, such as those with comorbid psychiatric disorders.MethodsIn this secondary analysis of a multisite, randomized, clinical laboratory study, we used analyses of variance to examine the effects of nicotine dose (0.4, 2.4, 5.2, and 15.8 mg/g of tobacco), depressive and anxiety diagnoses (depression only, anxiety only, both, or neither), and depressive and anxiety symptom severity on cigarette choice, smoke exposure, craving, and withdrawal across three vulnerable populations: socioeconomically disadvantaged women of reproductive age, opioid-dependent individuals, and those with affective disorders (n = 169).ResultsDiagnosis and symptom severity largely had no effects on smoking choice, total puff volume, or CO boost. Significant main effects on craving and withdrawal were observed, with higher scores in those with both anxiety and depression diagnoses compared with depression alone or no diagnosis, and in those with more severe depressive symptoms (p’s < .001). These factors did not interact with nicotine dose. Cigarettes with <15.8 mg/g nicotine were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses (p’s < .01).ConclusionsReducing nicotine dose reduced measures of cigarette addiction potential, with little evidence of moderation by either psychiatric diagnosis or symptom severity, providing evidence that those with comorbid psychiatric disorders would respond to a nicotine reduction policy similarly to other smokers.ImplicationsThus far, controlled studies in healthy populations of smokers have demonstrated that use of very low nicotine content cigarettes reduces cigarette use and dependence without resulting in compensatory smoking. These analyses extend those findings to a vulnerable population of interest, those with comorbid psychiatric disorders. Cigarettes with very low nicotine content were less reinforcing, decreased total puff volume, and produced significant but lower magnitude and shorter duration reductions in craving and withdrawal than higher doses. These nicotine dose effects did not interact with psychiatric diagnosis or mood symptom severity suggesting that smokers in this vulnerable population would respond to a nicotine reduction strategy similarly to other smokers.

Modeling nicotine regulation: A review of studies in smokers with mental health conditions

Smokers with mental health conditions (MHCs) lose approximately 15 years of life relative to non-smokers without MHCs, of which two-thirds are attributable to smoking. The Food and Drug Administration (FDA) recently announced a new regulatory strategy for tobacco that includes a reduction in the nicotine content of cigarettes sold in the US to a minimally-addictive level. This action could improve cessation rates in smokers with MHCs by reducing their dependence on nicotine. However, nicotine reduction also could have unintended negative consequences in smokers with MHCs. Thus, it is important to conduct randomized controlled trials to investigate the potential effects of nicotine reduction in smokers with MHCs. Several studies of the acute or extended effects of nicotine reduction in smokers with emotional disorders or serious mental illness have been recently completed or are underway. Studies to date indicate that when smokers with MHCs are switched, under randomized, double-blind conditions, to cigarettes with very low nicotine content, they reduce their cigarette intake, with minimal or no effects on withdrawal, psychiatric symptoms, or compensatory smoking. However, some deleterious effects of nicotine reduction on cognitive performance measures in smokers with schizophrenia have been observed, which are offset by providing concurrent nicotine replacement. We review these studies and provide suggestions for potentially increasing the effectiveness of a nicotine reduction strategy for reducing smoking in people with MHCs. The research described was conducted in the United States in 2010–2018.

Nicotine Reduction Strategy: State of the science and challenges to tobacco control policy and FDA tobacco product regulation

Nicotine addiction is the proximate cause of disease and death from cigarette smoking. In 1994, we proposed reducing the nicotine content of cigarettes to non-addicting levels to reduce the risk of youth becoming addicted smokers and promoting quitting in established smokers. In 2009, the Family Smoking Prevention and Tobacco Control Act provided the authority to FDA to reduce nicotine levels as appropriate to benefit public health. Over the past 15 years, considerable research has determined that nicotine reduction is feasible and safe, resulting in reduced nicotine dependence with little evidence of compensatory over-smoking. The availability of acceptable non-combusted form of nicotine would provide support and enhance acceptability of nicotine reduction in tobacco. Most recently, the FDA promulgated a nicotine-based regulatory framework, which includes nicotine reduction combined with ready availability of noncombustible nicotine products. Nicotine reduction could contribute to a virtual end to the use of cigarette smoking, with enormous benefits to public health.

Commentary on Nardone et al. (2016): Satisfaction, dissatisfaction and complicating the nicotine-reduction strategy with more nicotine.

Commentary on Nardone et al. (2016): Satisfaction, dissatisfaction and complicating the nicotine-reduction strategy with more nicotine.

How Intravenous Nicotine Administration in Smokers Can Inform Tobacco Regulatory Science.

Reducing the negative health effects caused by tobacco products continues to be a public health priority. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the Food Drug Administration authority to pursue several new strategies, including regulating levels of nicotine and other ingredients in tobacco products. A nicotine reduction strategy proposed by Benowitz and Henningfield aims to reduce the nicotine content of tobacco products to an amount below a threshold that supports neither the development nor maintenance of addiction. Many factors must be considered to determine the viability and efficacy of this approach. For example, the policy should be based on precise information on the dose-dependent effects of nicotine on reinforcement and factors that contribute to individual differences in these effects. However, there have been few studies on these topics in humans. Here, we briefly review nicotine pharmacology and reinforcement then present several studies illustrating the application of intravenous (IV) nicotine delivery to study nicotine reinforcement in humans. We discuss how nicotine delivery by IV infusion may be uniquely suited for studying nicotine's dose-dependent effects, and how this can inform tobacco regulatory science to facilitate the development of effective tobacco control policies.

The case for the WHO Advisory Note, Global Nicotine Reduction Strategy

Cigarettes are the most addictive tobacco product and also the most deadly, causing the highest rates of tobacco-caused mortality and morbidity in most areas of the world.1 ,2 Although current...

Reducing the nicotine content to make cigarettes less addictive

Nicotine is highly addictive and is primarily responsible for the maintenance of cigarette smoking. In 1994, Benowitz and Henningfield proposed the idea of federal regulation of the nicotine content of...