Racial/ethnic differences in the acute effects of reduced nicotine content cigarettes among adolescents who smoke.

OBJECTIVE: Reducing the nicotine content in cigarettes decreases their addictiveness and abuse liability, including among adolescents. Whether these effects differ by race/ethnicity is unknown. This study is a secondary analysis of previously published data collected between 2014-2017. We examined racial/ethnic differences in the effects of smoking cigarettes with varying nicotine content levels on subjective effects and tobacco withdrawal among adolescents who smoke daily. METHODS: Across two counterbalanced sessions, 50 adolescents recruited from Rhode Island (ages 15-19; 30 % Underrepresented Minorities [URM], 20 % Asians and Pacific Islanders [API]; 50 % Non-Hispanic Whites) self-administered a very low nicotine content (VLNC; 0.4 mg nicotine/g of tobacco) or normal nicotine content control (NNC; 15.8 mg/g) research cigarette following overnight abstinence. Subjective effects were reported post-administration and tobacco withdrawal outcomes were calculated from pre- to post-administration scores. Multilevel linear models tested main and interactive effects between cigarette nicotine content and race/ethnicity on all study outcomes. RESULTS: Participants reported lower positive subjective effects and reductions in smoking urges after smoking a VLNC cigarette relative to smoking an NNC cigarette (ps < 0.01). A main effect of race/ethnicity emerged, such that API (vs. URM and White) adolescents reported lower positive subjective effects, greater craving reduction, and higher cigarette aversion after smoking, regardless of nicotine content (ps < 0.05). Significant interactions were found between race/ethnicity and nicotine content for cigarette aversion, such that API adolescents rated VLNC (vs. NNC) cigarettes as less aversive than White and URM adolescents did (p = 0.03). CONCLUSIONS: Findings provide evidence that VLNC cigarettes may reduce abuse liability and tobacco withdrawal symptoms for adolescents across racial/ethnic groups and particularly for API youth.

Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.

Background: Reducing cigarette addictiveness has the potential to avert millions of yearly tobacco-related deaths worldwide. Substantially reducing nicotine in cigarettes decreases cigarette consumption, but no large clinical trial has determined the effects of reduced-nicotine cigarettes when other nicotine-containing products are available. The aim of this study was to examine the effects of reduced-nicotine cigarettes in the context of the availability of alternative nicotine delivery systems. Methods: In a U.S. six-site, open-label, parallel-arm study, smokers were randomized for twelve weeks to an experimental marketplace containing cigarettes with either 0.4 mg or 15.8 mg nicotine per gram of tobacco; all had access to non-combusted alternative nicotine delivery systems (e.g., e-cigarettes; medicinal nicotine). Group differences in the primary outcomes (cigarettes per day, number of smoke-free days) were examined using linear and negative binomial regression, respectively (Trial Registration: NCT03272685). Findings: Among 438 randomized participants (mean [standard deviation (SD), range] age, 44.5 [11.9, 20-73] years, 225 [51.4%] women, 282 [64.4%] White and 339 [77.4%] trial completers), those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention (mean [SD], 7.05 [7.88] vs. 12.95 [9.07], adjusted mean difference, -6.21 [95% CI, -7.66 to -4.75], P < 0.0001) and greater smoke-free days during intervention (mean [SD], 18.59 [27.97] vs. 5.06 [13.77], adjusted rate ratio, 4.25 [95% CI, 2.58-6.98], P < 0.0001). Interpretation: A reduced-nicotine cigarette standard in the context of access to other non-combusted nicotine products has the potential to benefit public health. Funding: U.S. NIH/FDA U54DA03165.

Differences in Normative Beliefs and Tobacco Product Use by Age Among Adults Who Smoke: Cross-Sectional Analysis of a Nationally Representative Sample.

BACKGROUND: The prevalence of combusted cigarette (CC) smoking among older adults is stagnant, with 0 declines attributable to e-cigarette (EC) use. Given that normative beliefs are associated with quitting and switching to ECs, we assessed cross-sectional associations between age, CC, and EC descriptive and injunctive norms and potential interactions with tobacco use behavior. METHODS: Data are from people with current, established (≥100 lifetime CCs) CC use (n = 8072) at Wave 5 (2018-2019) of the adult Population Assessment of Tobacco and Health Study. We used adjusted multivariable logistic regressions to model social norms as a function of age (18-24, 25-34, 35-44, 45-54, 55-64, ≥65 years). We also dichotomized age (≥55 vs 18-54) to investigate interactions between age and social norms on past 12-month CC quit attempts and past-month EC use. RESULTS: Older age was positively associated with pro- and anti-CC norms and anti-EC norms. Significant interactive effects revealed that being advised to quit smoking by a healthcare provider was more strongly associated with CC quit attempts among adults ≥55 years (adjusted odds ratio [aOR] [95% CI]: 2.12 [1.66, 2.71]) than adults <55 years (aOR: 1.63 [1.34, 2.00]). Reporting people close to you use ECs was also more strongly associated with EC use among adults ≥55 years (aOR: 4.37 [3.35, 5.69]) than among adults <55 years (aOR: 3.43 [2.89, 4.08]). CONCLUSIONS: This study identified modifiable risk factors for tobacco use that may be particularly beneficial for older adults. Behavioral and communication interventions that target normative beliefs may maximize smoking cessation, or harm reduction when cessation is not possible.

Reactions to using other nicotine and tobacco products instead of menthol cigarettes: A qualitative study of people who smoke menthol cigarettes in the United States.

The US Food and Drug Administration is considering banning menthol cigarettes, which could result in some people who smoke menthol cigarettes switching to other tobacco products (OTPs). This qualitative study explored reactions to using OTPs instead of menthol cigarettes. People who smoke menthol cigarettes (N=40) completed a behavioral economic assessment of the effects of menthol cigarette price increases on OTP purchasing. At the highest price, most participants could not afford menthol cigarettes. Instead, they could purchase non-menthol cigarettes, little cigars/cigarillos (LCCs), e-cigarettes, smokeless tobacco, or medicinal nicotine, or they could abstain from tobacco use. Participants used the OTPs they purchased for three days. During follow-up sessions, participants (n=35) completed semi-structured interviews discussing their purchasing-decisions and experiences using OTPs instead of menthol cigarettes. Interviews were analyzed using reflexive thematic analysis methods. Factors influencing purchasing decisions included flavor, price, prior use of OTPs, interest in trying new OTPs, and perceived ability to satisfy nicotine cravings. Participants described positive experiences using e-cigarettes including the "refreshing" menthol flavor, ability to use in places where cigarettes are prohibited, and convenience of use relative to smoking. Among those using non-menthol cigarettes, many reported they were acceptable but less satisfying products compared to menthol cigarettes while others reported negative reactions to them such as tasting like "cardboard". Reactions to smoking LCCs were mostly unfavorable but participants said it gave them "something to light". Multiple considerations may affect switching to OTPs in light of pending menthol cigarette regulation including the availability of menthol-flavored alternatives and (dis)satisfaction with OTPs.

Older age is associated with greater misperception of the relative health risk of e-cigarettes and cigarettes among US adults who smoke.

INTRODUCTION: The 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. METHODS: Participants 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). RESULTS: Adults 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). DISCUSSION: Adults 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.

Qualitative reactions to a low nicotine product standard for cigarettes from adolescents and young adults living in the United States who smoke.

The Biden Administration is considering a low nicotine product standard for cigarettes. This qualitative study examined reactions to a nicotine reduction policy among adolescents and young adults (AYA) who smoke cigarettes. After completing a lab study involving masked exposure either to low nicotine or normal nicotine research cigarettes and unmasked exposure to e-cigarettes varying in nicotine concentration and flavor, we conducted follow-up semi-structured interviews (N = 25) to explore participants' knowledge, attitudes, and perceptions of a low nicotine product standard and their anticipated tobacco use behavior after policy implementation. Interviews were audio-recorded, transcribed verbatim, double-coded, and analyzed using reflexive thematic analysis. Nearly half of participants supported the policy because they thought it would prevent young people from starting smoking and/or would help people quit. Reasons some participants opposed the policy included beliefs that adults should have the choice to smoke or that a nicotine reduction policy is counterintuitive because the government benefits from cigarette sales. Others believed the policy would be ineffective because youth could circumvent the policy (e.g., illicit market) or would increase their smoking to maintain the same nicotine level. Almost half of participants said they would quit smoking while the other half said they would continue smoking, although potentially reduce their smoking. Overall, our qualitative findings point to the need for pre-policy media campaigns targeting AYA who smoke to minimize negative reactions, dispel fears, and correct misperceptions as well as encourage quitting and provide information on accessing cessation resources.

Preliminary evidence on cigarette nicotine reduction with concurrent access to an e-cigarette: Manipulating cigarette nicotine content, e-liquid nicotine content, and e-liquid flavor availability.

The reinforcing characteristics of e-cigarettes could moderate the impact of reducing cigarette nicotine content. In this study, people who smoke daily were recruited from North Carolina and Pennsylvania (US) in 2018 and 2019. Within a randomized 2 × 2 × 2 factorial design, participants received investigational cigarettes and an e-cigarette for 12 weeks. Cigarette nicotine content was very low (0.4 mg/g of tobacco; VLNC) or normal (15.8 mg/g; NNC). E-liquids were 0.3% ("low") or 1.8% ("moderate") freebase nicotine, and available in tobacco flavors or tobacco, fruit, dessert and mint flavors. Study recruitment concluded before reaching the planned sample size (N = 480). Fifty participants were randomized and 32 completed the study. We found that randomization to VLNC, relative to NNC cigarettes, reduced self-reported cigarettes per day (CPD; mean difference: -12.96; 95% CI: -21.51, -4.41; p = 0.005); whereas e-liquid nicotine content and flavor availability did not have significant effects. The effect of cigarette nicotine content was larger in the moderate vs. low nicotine e-liquid groups and in the all flavors versus tobacco flavors e-liquid groups; tests of the interaction between e-liquid characteristics and cigarette nicotine content were not significant. Biomarkers of smoke exposure at Week 12 did not differ across conditions, which may reflect variability in adherence to only using VLNC cigarettes. In conclusion this study offers preliminary evidence that the extent to which cigarette nicotine reduction decreases smoking may depend on the reinforcing characteristics of alternative products, including the available nicotine contents and flavors of e-cigarettes.

Menthol preference moderates the relationship between cigarette nicotine content choice and reactions in young adults who smoke infrequently.

BACKGROUND: Half of young adults who smoke use menthol cigarettes, which is associated with continued smoking and greater nicotine dependence. Additionally, early subjective reactions to cigarettes predict future use. Menthol may blunt the sensory effects of nicotine. We investigated the moderating role of menthol on subjective reactions to, and choice of varied nicotine content cigarettes in young adults who smoke infrequently. METHODS: In three counterbalanced, double-blinded sessions, young adults who smoke ≤ 15 days/month smoked fixed doses from very low (VLNC), intermediate (INC), and normal (NNC) nicotine content cigarettes, which were menthol or non-menthol depending on preference. Participants chose their preferred cigarette in a final session. Positive and negative subjective reactions were measured in each session. ANOVA tests investigated the relationship between menthol preference, nicotine content, and subjective reactions. RESULTS: Participants (N = 87) were 18-25 years old and reported smoking 15.2 cigarettes per month over 8 days (35 % menthol). Non-menthol preferring participants had increased negative reactions with greater nicotine content (F(1, 55)= 10.76, p < .001); menthol preferring participants did not. Choice of higher nicotine cigarettes was associated with having reported a greater difference in positive reactions to NNC and VLNC for non-menthol preferring participants (F(1, 55)= 12.72, p < .001) but not for menthol preferring participants. CONCLUSIONS: Young adults who smoke infrequently are a priority tobacco control population given their high risk of transitioning to daily smoking. Results from this study in the form of subjective reactions indicate that a menthol ban is required for a nicotine reduction standard to be maximally effective in this vulnerable group.

Cigar Harm Beliefs and Associations with Cigar Use among Young Adults.

BACKGROUND: Cigar use, including little cigars and cigarillos (LCCs) and large traditional cigars, continues to harm young adults. Research on harm beliefs about cigars, particularly large cigars, is sparse. The current study examined cigar harm beliefs and associations with cigar use. Methods: Data are from a 2019 survey of a young adult cohort study recruited in fall 2010. Participants were asked questions about their beliefs about the harm of LCC and large cigar use. Those reporting ever use of cigars were asked how frequently they inhale the smoke into their lungs. Results: Participants (N = 1910) were 51.9% female with a mean age of 26.7 (SD = 0.6). Ever cigar use was 44.2% for large cigars and 43% for LCCs. Compared to those who have never used large cigars or LCCs, those reporting ever use of large cigars or LCCs reported lower harm beliefs about inhaling harmful chemicals and becoming addicted (ps <.0001). Those who reported higher harm beliefs also reported inhaling the smoke into their lungs more frequently for large cigars and LCCs (ps<.05). Conclusions: Cigar use harm beliefs were lower among participants reporting ever use of cigars compared to those reporting never use. Contrary to predictions, those reporting greater harm beliefs were more likely to report inhaling smoke more frequently than those with lower harm beliefs.

Effects of very low nicotine content cigarettes on smoking across vulnerable populations.

There has been long-standing interest in a reduced-nicotine product standard for combusted tobacco, which is within the regulatory purview of the Food and Drug Administration (FDA). In weighing whether to establish this standard, it is important to consider potential responses among people who are at elevated risk for tobacco-related health harms. In this narrative review, we summarize studies of very low nicotine content (VLNC) cigarettes conducted between 2010 and 2021 in groups that the FDA has identified as vulnerable populations. Studies conducted to date in adults with mental health conditions, adults with opioid use disorder, socioeconomically-disadvantaged adults, and youth or young adults indicate that immediate switching to VLNC cigarettes decreases smoking, with minimal or no unintended negative consequences. Few studies have investigated the effects of VLNC cigarettes in racial or ethnic minorities, people who smoke menthol cigarettes, and pregnant women, but initial findings suggest that responses of these individuals are similar to responses observed in other vulnerable populations. We are not aware of studies that have investigated VLNC cigarettes in military/veteran populations, sexual or gender minority individuals, or people living in underserved rural environments. Future research directions include understanding how to promote cessation in the context of a reduced-nicotine standard, and how to correct VLNC misperceptions in vulnerable populations. Nevertheless, the evidence to date indicates that a reduced-nicotine standard is likely to have the same beneficial effects on smoking reductions as it does in less vulnerable populations, which should provide some confidence in pursuing this regulatory approach.

Early Changes in Puffing Intensity When Exclusively Using Open-Label Very Low Nicotine Content Cigarettes.

INTRODUCTION: In response to reducing cigarette nicotine content, people who smoke could attempt to compensate by using more cigarettes or by puffing on individual cigarettes with greater intensity. Such behaviors may be especially likely under conditions where normal nicotine content (NNC) cigarettes are not readily accessible. The current within-subject, residential study investigated whether puffing intensity increased with very low nicotine content (VLNC) cigarette use, relative to NNC cigarette use, when no other nicotine products were available. AIMS AND METHODS: Sixteen adults who smoke daily completed two four-night hotel stays in Charleston, South Carolina (United States) in 2018 during which only NNC or only VLNC cigarettes were accessible. We collected the filters from all smoked cigarettes and measured the deposited solanesol to estimate mouth-level nicotine delivery per cigarette. These estimates were averaged within and across participants, per each 24-h period. We then compared the ratio of participant-smoked VLNC and NNC cigarette mouth-level nicotine with the ratio yielded by cigarette smoking machines (when puffing intensity is constant). RESULTS: Average mouth-level nicotine estimates from cigarettes smoked during the hotel stays indicate participants puffed VLNC cigarettes with greater intensity than NNC cigarettes in each respective 24-h period. However, this effect diminished over time (p < .001). Specifically, VLNC puffing intensity was 40.0% (95% CI: 29.9, 53.0) greater than NNC puffing intensity in the first period, and 16.1% (95% CI: 6.9, 26.0) greater in the fourth period. CONCLUSION: Average puffing intensity per cigarette was elevated with exclusive VLNC cigarette use, but the extent of this effect declined across four days. IMPLICATIONS: In an environment where no other sources of nicotine are available, people who smoke daily may initially attempt to compensate for cigarette nicotine reduction by puffing on individual cigarettes with greater intensity. Ultimately, the compensatory behavior changes required to achieve usual nicotine intake from VLNC cigarettes are drastic and unrealistic. Accordingly, people are unlikely to sustain attempts to compensate for very low cigarette nicotine content.

Longitudinal latent class analysis of tobacco use and correlates among young adults over a 10-year period.

INTRODUCTION: We assessed patterns and correlates, including demographic characteristics, psychological factors, and social role transitions, of young adults' tobacco use over time. METHODS: In the fall of 2010, we recruited a cohort of 3146 students from 11 colleges in North Carolina and Virginia. Participants completed baseline and at least two survey waves between 2010 and 2019. RESULTS: The sample was 49.8% female, 15.7% non-white, and 6.6% Hispanic. Longitudinal latent class analysis revealed a five-class model with distinct patterns and correlates of tobacco use. Limited Use (52.6% of sample) had minimal use. College-Limited Combustible Tobacco Users (18.6%) had moderate probability of cigarette, cigar, and waterpipe smoking, which decreased to no use post-college. Intermittent Sustained Polytobacco Users (10.9%) had low probability of use that continued post-college. College Polytobacco with Continued Cigarette and E-Cigarette Users (14.5%) had high probability of use of cigarette smoking and increasing probability of e-cigarette, both of which continued post-college. Sustained Polytobacco Users (5.7%) had moderate probability of use of tobacco products across all waves. CONCLUSIONS: Patterns of tobacco use varied considerably. In most classes, tobacco use was highest during freshman year and in three classes, use continued post-college. Prevention activities should focus on first-year students and target those at risk for post-college tobacco use.

"I think it's a good idea for the people that's young, the kids, but for someone like me it's a bad idea." - Interviews about a U.S. menthol cigarette ban with people who smoke menthol cigarettes.

OBJECTIVE: The US Food and Drug Administration recently announced its intention to pursue a federal ban on menthol cigarettes. This qualitative study assessed reactions to a potential menthol cigarette ban among people who smoke menthol cigarettes. METHODS: As part of a laboratory study examining menthol flavor regulations, we conducted follow-up interviews with participants who smoke menthol cigarettes (N = 35). We explored the following topics: (1) menthol cigarette risk perceptions; (2) knowledge, attitudes, and perceptions of menthol cigarette regulations; and (3) anticipated behavior if menthol cigarettes were banned. Interviews were audio-recorded, transcribed verbatim, double-coded, and analyzed using reflexive thematic analysis. RESULTS: Many participants thought menthol cigarettes carried more health risks than non-menthol cigarettes. Some participants said regulators wanted to ban menthol cigarettes because they appeal to youth. Others thought a ban would be good for public health because fewer people, particularly youth, would smoke. Several voiced skepticism about banning only menthol cigarettes rather than all cigarettes. Most said they would use other products, including electronic cigarettes or non-menthol cigarettes, but many also thought a menthol ban could motivate them or others to quit smoking. CONCLUSIONS: Banning menthol cigarettes could lead some people who smoke menthol cigarettes to switch to potentially less harmful products, like e-cigarettes, or quit smoking, which would likely benefit public health; however, others may simply transition to non-menthol cigarettes. As regulators move forward with banning menthol cigarettes, communication campaigns explaining the public health benefits, potentially focusing on the benefits for youth, should be part of the policy implementation plan.

Risk Perceptions of Low Nicotine Cigarettes and Alternative Nicotine Products across Priority Smoking Populations.

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.

Psychometric Analysis of a Microenvironment Secondhand Smoke Exposure Questionnaire.

BACKGROUND: We conducted a psychometric analysis of an adapted secondhand smoke (SHS) questionnaire by testing the three-component structure of the original scale that measures SHS exposure in home, work and social environments. METHODS: The 15-item questionnaire was administered to 839 daily smokers participating in a multi-site randomized controlled trial. Following parallel analysis, we conducted a confirmatory factor analysis specifying a three-factor structure. Cronbach's alphas and fit indices were calculated to assess internal consistency. Criterion validity was assessed by comparing the Social environments subscale to the Brief Wisconsin Inventory of Smoking Dependence Motives Social/Environmental Goads subscale. Predicative validity of the questionnaire was assessed using linear regressions and tobacco biomarkers of harm; NNAL, expired carbon monoxide and total cotinine. RESULTS: Five items did not load onto any factor and were dropped, resulting in a 10-item questionnaire. The Cronbach's alphas were (0.86), (0.77) and (0.67) for the Work, Social, and Home subscales, respectively. The WISDM subscale was moderately correlated with scores on the Social subscale (r = 0.57, p < 0.001). The questionnaire demonstrated predictive validity of smoke exposure above individual's own reported use as measured by cigarettes smoked per day. CONCLUSIONS: Three constructs emerged; results indicate that a shortened 10-item scale could be used in future studies.