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The Food and Drug Administration has the authority to reduce the nicotine content of cigarettes. In this randomized trial, participants assigned to reduced-nicotine cigarettes smoked fewer cigarettes than those assigned to standard-nicotine cigarettes. Twenty years ago, Benowitz and Henningfield published a landmark commentary that coincided with initial attempts by the Food and Drug Administration (FDA) to regulate tobacco products. 1 They reasoned that if the nicotine content of cigarettes were limited to approximately 0.5 mg per cigarette (approximately 0.7 mg per gram of tobacco), cigarettes would be rendered nonaddictive. Although a reduction in nicotine content was endorsed by representatives of the medical community, 2 in 2000, the FDA lost its initial argument to regulate cigarettes in a hearing before the Supreme Court, and the proposal ultimately languished. 3 In the past 8 years, the prospect of . . .

Background: As the U.S. Food and Drug Administration considers a low nicotine product standard for cigarettes, it is important to examine how people who smoke, especially individuals from priority populations disproportionately affected by smoking, perceive low nicotine content (LNC) cigarettes and their relative risk perceptions of alternative nicotine delivery system (ANDS) products, including e-cigarettes and snus, and medicinal nicotine. Methods: Data are from Wave 4 (2016–2017) of the adult Population Assessment of Tobacco Use and Health (PATH) Study. We examined respondents’ absolute risk perceptions about nicotine, LNC cigarettes, ANDS products and medicinal nicotine; their relative risk perceptions of LNC cigarettes and ANDS products compared to conventional cigarettes; and their relative risk perceptions of medicinal nicotine compared to ANDS products. Results: The majority of respondents across priority smoking populations indicated snus, e-cigarettes, and LNC cigarettes were ‘about the same’ level of harmfulness or addictiveness as conventional cigarettes. The majority of respondents indicated e-cigarettes to be ‘about the same’ harmfulness as medicinal nicotine. Conclusions: Our study indicates that adults who smoke cigarettes generally have misperceptions about the harms of nicotine and the relative risks of ANDS products and such misperceptions exist regardless of their racial/ethnic identity, sexual orientation, and gender identity.

OBJECTIVES/GOALS: The prevalence of combusted cigarette (CC) smoking among older adults is stagnant, with zero declines attributable to e-cigarette (EC) use. Normative beliefs predict quitting and switching to ECs (a behavior likely to yield health benefits for those unable to quit), so this study seeks to characterize the role of age in norms about CC and EC use. METHODS/STUDY POPULATION: Data come from Wave 5 (2018-2019) of the adult Population Assessment of Tobacco Use and Health (PATH) study, a nationally-representative, U.S. longitudinal cohort. Analyses were restricted to people with established CC use (smoked CCs in the past year, currently smoke regularly, and smoked ≥100 lifetime CCs; n=8,590). Cross-sectional weighted estimates of the prevalence of normative beliefs about CCs and ECs were calculated by age using the Balanced Repeated Replication (BRR) method with Fay=0.3. We used chi-square tests to examine the association of age group (18-24, 25-34, 35-44, 45-54, 55-64, or ≥65) with the prevalence of 2 descriptive and 4 personal social norms. RESULTS/ANTICIPATED RESULTS: The prevalence of the normative belief that most people disapprove of CCs (p DISCUSSION/SIGNIFICANCE: Older adults are more likely than younger adults to endorse anti-tobacco norms, which prior work shows is associated with quitting smoking. These beliefs could be leveraged to create targeted communications towards older adults encouraging smoking cessation. More research is needed to assess age-related tobacco beliefs and switching from CC to EC.

The FDA recently acquired regulatory authority over tobacco products, leading to renewed interest in whether reducing the nicotine content of cigarettes would reduce tobacco dependence in the United States. Given the association between depressive symptoms and cigarette smoking, it is important to consider whether smokers with elevated depressive symptoms experience unique benefits or negative consequences of nicotine reduction. In this secondary analysis of a randomized clinical trial that examined the effects of cigarettes varying in nicotine content over a 6-week period in non-treatment-seeking smokers, we used linear regression to examine whether baseline depressive symptom severity (scores on the Center for Epidemiologic Studies Depression Scale [CES-D]) moderated the effects of reduced-nicotine content (RNC) cigarettes, relative to normal-nicotine content (NNC) cigarettes, on smoking rates, depressive symptom severity, and related subjective and physiological measures. Of the 717 participants included in this analysis, 109 (15.2%) had CES-D scores ≥ 16, indicative of possible clinical depression. Relative to NNC cigarettes, RNC cigarettes reduced smoking rates, nicotine dependence, and cigarette craving, and these effects were not significantly moderated by baseline CES-D score. A significant interaction between baseline CES-D score and cigarette condition on week 6 CES-D score was observed (p < .05); among those with CES-D scores ≥ 16 at baseline, those assigned to RNC cigarettes had lower week 6 CES-D scores than those assigned to NNC cigarettes. Among those in the lowest nicotine content conditions, biochemically confirmed compliance with the RNC cigarettes was associated with an increase in CES-D score for those with baseline CES-D scores < 16 and no change in CES-D score for those with baseline CES-D scores ≥ 16. These findings provide initial evidence that a reduced-nicotine standard for cigarettes may reduce smoking, without worsening depressive symptoms, among smokers with elevated depressive symptoms. This secondary analysis of a recent clinical trial examined whether depressive symptom severity moderated the effects of reduced-nicotine cigarettes on smoking and depressive symptoms. Results indicate that, regardless of baseline depressive symptoms, participants randomized to reduced-nicotine cigarettes had lower smoking rates, nicotine intake, nicotine dependence, and craving at week 6 post-randomization than those assigned to normal-nicotine cigarettes. In participants with higher baseline depressive symptoms, those assigned to reduced-nicotine cigarettes had lower week 6 depressive symptoms than those assigned to normal-nicotine cigarettes. These results suggest that a nicotine reduction policy could have beneficial effects for smokers, regardless of depressive symptom severity.

IntroductionThe prevalence of cigarette smoking among adults aged ≥55 has remained stagnant over the past decade. National data modelling suggests no reduction in cigarette smoking prevalence attributable to e-cigarette use in the USA among people aged ≥45. Misperceptions about the absolute risks (ie, cigarettes are not harmful) and relative risks (ie, e-cigarettes are more harmful than cigarettes) of tobacco products may contribute to sustained smoking prevalence and hesitancy to switch from cigarettes to e-cigarettes among older adults.MethodsParticipants reported cigarette use (n=8072) at Wave 5 (2018–2019) of the Population Assessment of Tobacco and Health Study. Weighted multivariable logistic regressions included six age categories (independent variable) and cigarette and e-cigarette risk perceptions (outcomes). Additional models assessed the associations between dichotomous age (≥55 vs 18–54), risk perceptions and an interaction term (independent variables) with past 12-month quit attempts and past-month e-cigarette use (outcomes).ResultsAdults aged ≥65 were less likely than adults aged 18–24 to rate cigarettes as very/extremely harmful (p<0.05). Odds of rating e-cigarettes as more harmful than cigarettes among adults aged 55–64 and ≥65 were 1.71 (p<0.001) and 1.43 (p=0.024) greater than for adults aged 18–24. This misperception was negatively associated with past-month e-cigarette use and was stronger among adults aged ≥55 (p<0.001) than adults aged <55 (p<0.001).DiscussionAdults aged ≥55 are more likely to have misperceptions about the absolute and relative risks of tobacco products, which may contribute to continued smoking. Health communications targeting this age group could modify beliefs about the perceived harms of tobacco products.

Understanding factors that render some individuals more vulnerable to smoking relapse during the early stages of a quit attempt is critical to tailoring treatment efforts. Development of laboratory models of relapse can provide a framework for identifying underlying mechanisms that may contribute to vulnerability. Here, we explored predictors of abstinence in a novel incentive-based model of relapse. Fifty-six nontreatment seeking daily smokers completed several nicotine dependence measures prior to participating in a 1-week abstinence incentive test. During the abstinence procedure, participants earned monetary reinforcement for each biochemically verified day of abstinence according to a descending schedule of reinforcement. Compliance with the procedure was excellent. All but 3 participants were able to initiate abstinence; nearly 70% lapsed as incentives were reduced. Scores on the Fagerström Test for Nicotine Dependence (FTND), number of cigarettes smoked per day, and self-reported craving on the first day of abstinence each independently predicted time to lapse. The single item of time to first cigarette in the morning on the FTND significantly predicted time to lapse, even when controlling for other significant predictors just listed. The Nicotine Dependence Syndrome Scale (NDSS) and Wisconsin Inventory of Smoking Dependence Motives did not predict lapse, but the NDSS did predict reinitiation of abstinence among those experiencing an initial lapse. These findings partially replicate those of previous full-scale clinical trials and support the feasibility and validity of an incentive-based model of relapse. The time-limited and laboratory-based nature of this model has the potential to further investigations of underlying mechanisms contributing to relapse.

Experimental cigarettes are needed to conduct studies examining the effects of varying doses of nicotine content on smoking behavior. The National Institute on Drug Abuse contracted with Research Triangle Institute to make such cigarettes available to researchers. The goal of this study was to determine whether cigarettes that vary in nicotine content produce an expected dose-response effect. Two studies were conducted. The first study recruited subjects from 3 sites and consisted of a single, within-subject laboratory session. Subjects first smoked 4 puffs on their usual-brand cigarette and then in double-blind, random-order, smoked 4 puffs on each experimental cigarette that contained either low nicotine (LN, 0.4 mg/g), intermediate nicotine (IN, 5.7-5.8 mg/g), or high nicotine (HN, 11.4-12.8 mg/g). Each puffing bout was separated by a 30-min interval. Subjects completed questionnaires and were assessed for vital signs after each cigarette. The second study involved 1 site and used a between-subject design in which subjects were assigned to 1 of the 3 experimental cigarettes for 1 week. Subjective responses and biomarkers of exposure were assessed. In the first study, significant dose-response effects were observed, particularly between the LN and HN cigarettes. The second study showed decreases in cigarette smoking and exposure biomarkers predominantly in the LN group, with no changes in the HN cigarette group. These results are similar to those observed in prior literature, confirming that these experimental cigarettes can be used safely and with the expected pharmacological effects.

People with facial movement disorders are instructed to perform various facial movements as part of their physical therapy rehabilitation. A difference in the movement of the orbicularis oris muscle has been demonstrated among people without facial nerve impairments when instructed to \"pucker your lips\" and to \"blow, as if blowing out a candle.\" The objective of this study was to determine whether the within-subject difference between \"pucker your lips\" and \"blow, as if blowing out a candle\" found in people without facial nerve impairments is present in people with facial movement disorders. People (N=68) with unilateral facial movement disorders were observed as they produced puckering and blowing movements. Automated facial image analysis of both puckering and blowing was used to determine the difference between facial actions for the following movement variables: maximum speed, amplitude, duration, and corresponding asymmetry. There was a difference between the amplitudes of movement for puckering and blowing. \"Blow, as if blowing out a candle\" produced a larger amplitude of movement. The findings demonstrate that puckering and blowing movements in people with facial movement disorders differ in a manner that is consistent with differences found in people who are healthy. This information may be useful in the assessment of and intervention for facial movement disorders affecting the lower face.

Understanding how smokers perceive reduced nicotine content cigarettes will be important if the FDA and global regulatory agencies implement reduced nicotine product standards for cigarettes. Prior research has shown that some smokers incorrectly believe \"light\" cigarettes are less harmful than regular cigarettes. Similar misunderstandings of health risk could also apply to reduced nicotine cigarettes. To date, most studies of reduced nicotine cigarettes have blinded subjects to the nicotine content. Therefore, little is known about how smokers experience reduced nicotine content cigarettes when they are aware of the reduced content, and how use may be impacted. The present study was a within-subjects experiment with 68 adult daily smokers who smoked two identical very low nicotine content Quest 3 (0.05 mg nicotine yield) cigarettes. Subjects were told that one cigarette contained \"average\" nicotine content, and the other contained \"very low\" nicotine content. After smoking each cigarette, subjects completed subjective measures about their smoking experience. Subjects rated the \"very low\" nicotine cigarette as less harmful to their health overall compared to the \"average\" nicotine cigarette; this effect held true for specific smoking-related diseases. Additionally, they rated the \"very low\" nicotine cigarette as having less desirable subjective effects than the \"average\" nicotine cigarette and predicted having greater interest in quitting smoking in the future if only the \"very low\" nicotine cigarette was available. Explicit knowledge of very low nicotine content changes smokers' perceptions of very low nicotine content cigarettes, resulting in reduced predicted harm, subjective ratings and predicted future use. Before a reduced nicotine product standard for cigarettes can be implemented, it is important to understand how product information impacts how smokers think about and experience very low nicotine content cigarettes. Prior research has shown that smokers incorrectly believed light cigarettes were less harmful products. As such, smokers may also misunderstand the health risks associated with smoking very low nicotine content cigarettes. This study highlights the importance of smokers' perceptions of nicotine content in cigarettes on the perceived health risks and the subjective effects of smoking very low nicotine content cigarettes.