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Regulations limiting the sale of flavored e-cigarette products are controversial for their potential to interfere with e-cigarette use as a cessation aid in addition to curbing youth use. Limited research suggests that flavor might enhance the addictive potential of e-cigarettes; however, the acute effects of flavored aerosols on brain function among humans have not been assessed. The present study aimed to isolate and compare the neural substrates of flavored and unflavored e-cigarette aerosols on brain function among nine female daily smokers. Participants inhaled aerosolized e-liquid with 36 mg/mL of nicotine with and without a strawberry-vanilla flavor while undergoing functional magnetic resonance imaging. We used general linear modeling to compare whole-brain mean neural activation and seed-to-voxel task-based functional connectivity between the flavored and unflavored inhalation runs. Contrary to our hypothesis, the flavored aerosol was associated with weaker activation than the unflavored aerosol in the brain stem and bilateral parietal-temporal-occipital region of the cortex. Instead, the flavor engaged taste-related brain regions while suppressing activation of the neural circuits typically engaged during smoking and nicotine administration. Alternatively, functional connectivity between subcortical dopaminergic brain seeds and cortical brain regions involved in motivation and reward salience were stronger during the flavored compared to unflavored aerosol run. The findings suggest that fruity and dessert-flavored e-cigarettes may dampen the reward experience of aerosol inhalation for smokers who initiate e-cigarette use by inhibiting activation of dopaminergic brain circuits. These preliminary findings may have implications for understanding how regulations on flavored e-cigarettes might impact their use as cessation aids. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Menthol upregulates nicotinic acetylcholine receptors and is associated with tobacco dependence. The effects of menthol when smoking cigarettes with varying low nicotine content up to 98 % (e.g., non-addicting) less than commercial cigarettes is not well understood. The U.S. Food and Drug Administration is considering two tobacco product standards in cigarettes including banning menthol and reducing nicotine content. These new standards have the potential to significantly reduce smoking initiation and maintenance by limiting the mechanistic effects of nicotine and menthol on the brain.We conducted two parallel randomized clinical trials of gradually reduced nicotine in cigarettes from 11.6 mg down to 0.2 mg nicotine/cigarette (very low nicotine content; VLNC) vs. usual nicotine content (11.6 mg; UNC) over an 18-week period in people who smoke cigarettes with low socioeconomic status (SES) and mental health conditions.Compared to UNC, VLNC was associated with significant reductions in cotinine, cigarettes per day, expired carbon monoxide levels, nicotine dependence and symptomology. These associations did not differ between menthol and non-menthol cigarettes, except people who smoke menthol cigarettes had less of a cotinine reduction in the SES trial. The pooled odds ratio of being adherent with using only VLNC study cigarettes in the gradual nicotine reduction arm for people who smoke non-menthol vs. menthol cigarettes was 2.6 (95 % CI:1.0, 6.4; p-value: 0.04).When nicotine is lowered to non-addicting levels, the results indicate an independent effect of menthol on the need to sustain nicotine intake in addicted people who smoke cigarettes.

Introduction How nicotine dependence will be affected when current smokers initiate electronic cigarette (e-cigarette) use to reduce cigarette smoking is unknown. This study evaluated cigarette, e-cigarette, and total nicotine dependence more than 6 months among smokers reducing cigarette consumption by replacing with e-cigarettes. Aims and Methods Adult cigarette smokers were randomized to one of four conditions (36 mg/ml e-cigarette, 8 mg/ml e-cigarette, 0 mg/ml e-cigarette, or cigarette-substitute [CS] [provided at no cost]) and instructed to reduce their cigarette smoking by 75% at 1 month. Participants completed follow-up at 1, 3, and 6 months. The Penn State Nicotine Dependence Index (PSNDI) measured dependence on cigarettes (PSCDI) and e-cigarettes (PSECDI). Urine cotinine measured total nicotine exposure. Linear mixed effects models for each outcome were conducted and included interaction terms between visit and condition. Results Participants (n = 520) were 58.8% female, 67.3% White, and 48.0 years old. At baseline, the median number of cigarettes smoked per day was 17.3 and the mean PSCDI score was 13.4, with no significant differences between conditions. Participants in the e-cigarette conditions reported significantly lower PSCDI scores, compared with baseline, and with the CS condition at all follow-up visits. Those in the 36 mg/ml e-cigarette condition reported greater PSECDI scores at 6 months, compared with baseline and the 0 mg/ml and 8 mg/ml conditions. At all follow-up visits, there were no differences in total nicotine exposure compared to baseline, nor between any conditions. Conclusions E-cigarette use was associated with reduced cigarette dependence, compared to the CS, without significant increases in total nicotine exposure. Implications Initiation of electronic cigarette use while continuing to smoke could potentially increase nicotine dependence. In this randomized trial aimed at helping smokers to reduce their cigarette intake, we found that use of an e-cigarette was associated with a reduction in cigarette dependence and an increase in e-cigarette dependence (in the condition with the highest nicotine concentration only), with no long term increase in total nicotine dependence or nicotine exposure.

BACKGROUNDThe U.S. Food and Drug Administration and the government of New Zealand have proposed a reduction of the nicotine content in cigarettes to very low levels. This study examined the likely effects of this regulation in smokers with affective disorders.METHODSIn a randomized controlled trial conducted at two sites (Penn State Hershey and Massachusetts General Hospital, Boston) 188 adult smokers with a current or lifetime anxiety or unipolar mood disorder, not planning to quit in the next 6 months, were randomly assigned to smoke either Usual Nicotine Content (UNC) (11.6 mg nicotine/cigarette) cigarettes, or Reduced Nicotine Content (RNC) cigarettes where the nicotine content per cigarette was progressively reduced to 0.2 mg in five steps over 18 weeks. Participants were then offered the choice to either receive assistance to quit smoking, receive free research cigarettes, or resume using their own cigarette brand during a 12-week follow-up period. Main outcomes were biomarkers of nicotine and toxicant exposure, smoking behavior and dependence and severity of psychiatric symptoms.RESULTSAfter switching to the lowest nicotine content cigarettes, compared to smokers in the UNC group, the RNC group had significantly lower plasma cotinine (metabolite of nicotine), urine NNAL (metabolite of NNK, a lung carcinogen), exhaled carbon-monoxide, cigarette consumption, and cigarette dependence. There were no significant effects on psychiatric symptoms. At the end of the 12-week treatment choice phase, those randomized to the RNC group were more likely to have quit smoking (18% RNC v 4% UNC, p=0.004).CONCLUSIONReducing nicotine content in cigarettes to very low levels reduces toxicant exposure and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health.Trial registrationTRN: NCT01928758, registered August 21, 2013

Most adults who regularly use e-cigarettes or Electronic Nicotine Delivery Systems (ENDS) desire to discontinue use. ENDS use can result symptoms of nicotine withdrawal and dependence which can make it more difficult to discontinue use. Brief, valid assessment of nicotine dependence among adults who use ENDS is needed to guide treatment for nicotine dependence in this group. We sought to develop a brief, valid instrument to measure nicotine dependence among adults seeking to discontinue ENDS in a busy Quitline.In this cross-sectional design, we examined content, construct, and concurrent validity of the Roswell ENDS Nicotine Dependence Scale (Roswell eND Scale) and the Penn State E-Cigarette Dependence Index (Penn State eCDI). Participants who called the New York Quitline from November 2019 to June 2020 seeking to discontinue ENDS use were invited to participate. Construct validity was examined with exploratory and confirmatory factor analyses. Instrument and factor scores were then correlated with cotinine, a biomarker of nicotine exposure.All participants (n = 209) were highly dependent and co-used combustible cigarettes to varying degrees. Both instruments demonstrated content validity and construct validity, however only the 5-item Roswell eND Scale demonstrated criterion-related validity by showing a significant positive correlation with salivary cotinine levels.The 5-item Roswell eND Scale can briefly and effectively assess nicotine dependence among treatment-seeking adults who co-use ENDS and cigarettes. These preliminary psychometric findings have the potential to be generalizable to other adults seeking to discontinue ENDS use, many of whom currently or formerly smoked cigarettes.

Introduction The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). Methods A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. Results The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference −137 ng/mL; 95% CI −172, −102). The RNC group smoked fewer CPD (−4.1; 95% CI −6.44, −1.75) and had lower carbon monoxide levels (−4.0 ppm; 95% CI −7.7, −0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%). Conclusions This study supports a VLNC standard in cigarettes. Implications Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.

Research on electronic cigarette (e-cigarette) quit intentions and attempts is limited despite the potential health benefits of quitting, especially for long-term users. The current study aimed to investigate perceptions of harm and addictiveness and tobacco use characteristics associated with quit variables among users of a popular e-cigarette brand, JUUL.We surveyed 301 US adult JUUL users on their tobacco use characteristics, perceptions of JUUL harm and addictiveness, and quit variables at 3 time points, from July 2019 to April 2020. We used logistic regression models to assess demographic characteristics, smoking characteristics, and perceptions of JUUL harm and addictiveness as correlates of e-cigarette quit intentions, attempts, importance, and confidence.Twenty-three percent of the sample had intentions to quit using JUUL within the year, and 22.6% reported making a lifetime quit attempt. The average rating of quit importance was 4.1 and quit confidence was 5.8 on a Likert scale of 1 to 10. More than 90% of the sample indicated that JUUL was at least moderately addictive, whereas less than one-quarter indicated that JUUL was as harmful or more harmful than smoking. Higher levels of perceived JUUL addictiveness were associated with more quit intentions, attempts, and importance. Higher levels of perceived JUUL harm compared with smoking were associated with more quit importance.Our findings suggest that a small proportion of adult JUUL users are interested in quitting. Self-reported perceptions of JUUL's addiction potential may be related to more quit attempts. Findings highlight the need for evidence-based information on e-cigarette addictiveness and effective strategies for cessation.

Rationale: The use of electronic cigarettes (e-cigarettes) has rapidly increased in the United States, and thousands of e-cigarette flavors are available. However, there remains a dearth of evidence on e-cigarette flavor use patterns among older e-cigarette users. Objectives: This longitudinal study examined changes in flavor use patterns in long-term e-cigarette users, assessed self-reported adverse reactions, and evaluated users’ anticipated reactions to possible U.S. Food and Drug Administration e-cigarette flavor regulatory scenarios. Methods: The study population was 383 adult participants who completed two online e-cigarette surveys in 2012–2014 (baseline survey) and in 2017–2019 (follow-up survey). In both surveys, participants were asked, “Thinking about your preferred liquid, what is the name of this liquid flavor?” and to list all flavors used in the past 30 days. Flavor preference was classified using the Penn State Three-Step Flavor Classification method. Participants reported adverse events (open-ended description) with the associated flavor. Regulatory scenarios were presented, and participants selected perceived actions from among a list of 15 options. Results: Participants’ age averaged 44 ± 12 years; 86% were exclusive e-cigarette users, and 13% reported “poly-use” (i.e., e-cigarette and other tobacco product use). E-cigarette flavor preference migration occurred in all demographic groups: only 36–44% maintained a preference for their original flavor. Preference for tobacco and menthol or mint decreased over time (40% baseline vs. 22% follow-up); preference for fruit remained stable (23% baseline and follow-up), but chocolate/candy or other sweets preference significantly increased (16% baseline vs. 29% follow-up), and other flavors increased slightly. Migration to sweet flavors was more noticeable in younger adults (18–45 yr); exclusive e-cigarette users preferred sweet flavors more commonly than poly-users did (31% vs. 19%). Flavor-associated adverse reactions, mainly respiratory irritations, were reported by 26 (6.9%) participants. Nearly 50% of the participants reported that they would “find a way” to buy their preferred flavor or add flavoring agents themselves if nontobacco flavors were banned. Conclusions: Flavor migration toward sweet flavors occurred in long-term e-cigarette users, a trend most pronounced in younger and exclusive e-cigarette users. The anticipated maintenance of access to flavors despite regulation suggests an element of e-cigarette–related dependence that requires further evaluation. This information could help clinicians understand the health impacts of e-cigarette flavors, develop appropriate strategies for smoking cessation, and inform the U.S. Food and Drug Administration to plan future regulation of e-cigarette flavors.

Electronic nicotine delivery systems (ENDS) have the potential to help smokers living with HIV/AIDS (PLWHA) to reduce harms from tobacco use. However, little is known about ENDS use among people living with HIV/AIDS. This study’s aim was to evaluate the acceptability of two types of ENDS among PLWHA not planning to quit smoking. The study utilized a cross-over design where participants used two ENDS in a random order, a cigalike and a button-operated device, as smoking substitutes during two use periods separated by 7 days. Exhaled carbon monoxide (CO) was analyzed and participants reported daily cigarette and ENDS use and completed subjective ratings on ENDS acceptability. Paired t-tests were used to evaluate within-subject differences in CO, cigarettes per day (CPD), and subjective ratings from baseline to follow-up for each use period. Independent t-tests evaluated differences between ENDS devices. Participants (n=17) were a mean age of 49.1 years (SD=8.8), were 53% white, and 59% male. All participants had undetectable HIV RNA viral loads and their mean CD4 count was 765.1 cells/mm(3) (SD=281.6). Participants smoked a mean of 16.9 (SD=7.9) CPD at baseline. Overall, CPD significantly decreased during both ENDS use periods (p

In order to curb increasing youth electronic cigarette (e-cig) use, the United States Food and Drug Administration (FDA) banned the sale of flavored cartridge/pod-based products in February 2020. This mixed-methods study aimed to evaluate the impact of the FDA ban on adult JUUL users. The samples of current adult JUUL users were surveyed via Amazon Mechanical Turk at three time-points n = 76 (Sample 1), n = 128 (Sample 2), n = 86 (Sample 3) before and after the FDA flavored/pod ban. The participants were asked to report the JUUL flavored pod used most often and answer questions on purchasing generic pods or refilling (Quantitative). JUUL users were then interviewed in order to explore their perceptions and behaviors related to the FDA ban of flavored cartridge/pod-based products (Qualitative, n = 16). Quantitative data analysis evaluated the differences in variables by time-point. Qualitative data were coded into themes while using the constant comparative method. We found a significant decrease in the use of mint pods (43.4%, 22.7%, 16.3%) (p &lt, 0.01), while there was a significant increase in the use of menthol pods (6.6%, 26.6%, 37.2%) (p &lt, 0.01). Themes that emerged from the qualitative data included switching from mint to menthol pods, refilling pods, and switching to other products that are available in the desired flavors, such as generic pods or disposable e-cigs. Future research is needed in order to evaluate the impact of these behaviors on public health.

Introduction The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking is unclear. This exploratory analysis examined the effects of ENDS delivering different amounts of nicotine on cigarette abstinence up to 24-week follow-up, in comparison to placebo or a behavioral substitute. Methods This four-arm parallel-group, randomized, placebo-controlled trial took place at two academic medical centers in the United States (Penn State Hershey and Virginia Commonwealth University). Participants were current adult smokers (N = 520) interested in reducing but not planning to quit. They received brief advice and were randomized to one of four 24-week conditions, receiving either an eGo-style ENDS paired with 0, 8, or 36 mg/ml nicotine liquid (double-blind) or a cigarette-shaped tube, as a cigarette substitute (CS). Self-reported daily cigarette consumption and exhaled carbon monoxide (CO) were measured at all study visits. Outcomes included intent-to-treat, self-reported 7-day cigarette abstinence, biochemically confirmed by exhaled CO at 24 weeks after randomization. Results At 24 weeks, significantly more participants in the 36 mg/ml condition (14/130, 10.8%) than in the 0 mg/ml condition (1/130, 0.8%) and the CS condition (4/130, 3.1%) were abstinent (relative risk = 14 [95% CI = 1.9–104.9] and 3.5 [95% CI = 1.2–10.4], respectively). The abstinence rate in the 8 mg/ml condition was 4.6% (6/130). Conclusions When smokers seeking to reduce smoking tried ENDS, few quit smoking in the short term. However, if smokers continued to use an ENDS with cigarette-like nicotine delivery, a greater proportion completely switched to ENDS, as compared with placebo or a cigarette substitute. Implications The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking was unclear. This randomized trial found that ENDS with nicotine delivery approaching that of a cigarette are more effective in helping ambivalent smokers to quit cigarette smoking.

Background: Electronic delivery systems (e.g., vapes, e-cigarettes) are now popular modes of cannabis and nicotine administration that are often used by the same individuals; however, we still know little about dual nicotine and cannabis vaping. Materials & Methods: An online convenience sample of adult nicotine and/or cannabis vape users residing in the United States completed a 60 min survey on sociodemographic characteristics, cannabis and/or nicotine vape use behaviors and dependence, reasons for vape use, and perceptions of benefits and harms. After data cleaning, we compared dual vs. nicotine-only and cannabis-only vape users with univariate statistics and step-wise hierarchical linear regression analyses. Additionally, we assessed the factor structure, internal consistency, and criterion and convergent validity of the Penn State Cannabis Vaping Dependence Index (PSCVDI). Results: The final sample included 357 dual, 40 cannabis, and 106 nicotine vape users. Compared to nicotine- and cannabis-only vapers, dual vapers started using their nicotine and cannabis vapes at a younger age (p < 0.001), used them for more years (p < 0.001), and were less likely to use their nicotine vape to replace combustible cigarettes (p = 0.047). Dual users vs. single-substance users did not have significantly higher nicotine or cannabis vape dependence scores after controlling for sociodemographic and use behaviors. The PSCVDI showed adequate validity for measuring cannabis vape dependence. Conclusions: This survey is the first to highlight important differences in vape use behaviors and reasons for use between dual vs. cannabis- and nicotine-only vape users.

Summary Background Electronic nicotine delivery systems (ENDSs) are used by some smokers to reduce cigarette consumption, but their effectiveness is uncertain. We aimed to examine the extent to which ENDSs or a non-nicotine cigarette substitute influence tobacco-related toxicant exposure and cigarette consumption in smokers interested in smoking reduction. Methods We did a four-arm, parallel-group, randomised controlled trial at two sites in the USA (Penn State University, Hershey, PA, and Virginia Commonwealth University, Richmond, VA). We enrolled adults aged 21–65 years who smoked more than nine cigarettes per day (for at least the past year), with exhaled CO of more than 9 parts per million at screening, who were not currently using an ENDS, and who were interested in reducing smoking but not quitting. Participants were randomised (site-specific with allocation concealment; 1:1:1:1) to receive either a cartomiser-based, pen-style ENDS (eGo-style) paired with 0, 8, or 36 mg/mL liquid nicotine (participants and researchers masked to concentration) or a non-ENDS cigarette-shaped plastic tube that delivered no nicotine or aerosol (cigarette substitute; unmasked) for 24 weeks. Conditions were chosen to reflect a range of nicotine delivery including none (cigarette substitute and 0 mg/mL ENDS), low (8 mg/mL), and cigarette-like (36 mg/mL), and all conditions were paired with smoking reduction instructions. The primary outcome was concentration of the tobacco-specific carcinogen metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL; urinary total) collected at randomisation and at 4, 12, and 24 weeks. Multiple imputation with and without covariate adjustment was used in addition to sensitivity analyses. This trial is registered with ClinicalTrials.gov, NCT02342795. Findings Between July 22, 2015, and Nov 16, 2017, 684 individuals were screened and 520 (76%) were enrolled and randomised. 188 (36%) of 520 participants were lost to follow-up by week 24; attrition did not differ by study group (39 [30%] of 130 in the cigarette substitute group, 56 [43%] of 130 in the ENDS with 0 mg/mL nicotine group, 49 [38%] of 130 in the ENDS 8 mg/mL group, and 44 [34%] of 130 in the ENDS 36 mg/mL group). Urinary total NNAL at 24 weeks in the ENDS with 36 mg/mL nicotine group was 210·80 pg/mg creatinine (95% CI 163·03–274·42) compared with 346·09 pg/mg creatinine (265·00–455·32) in the cigarette substitute group (p=0·0061). No other significant differences between groups were observed for any time point for urinary total NNAL. Serious adverse event frequency was similar across groups (12 events in 12 participants [9%] in the ENDS with 36 mg/mL nicotine group, seven events in six participants [5%] in the 8 mg/mL group, 11 events in ten participants [8%] in the 0 mg/mL group, and 13 events in 13 participants [10%] in the cigarette substitute group), and all of these were deemed unrelated or unlikely to be related to study product use. There was one death between randomisation and 24 weeks (suicide; in the ENDS with 0 mg/mL nicotine group). Interpretation Use of an ENDS with cigarette-like nicotine delivery can reduce exposure to a major pulmonary carcinogen, NNAL, even with concurrent smoking. Future ENDS trials should involve products with well characterised nicotine delivery, including those with nicotine delivery approaching that of a cigarette. Funding National Institutes of Health, US Food and Drug Administration.

In this commentary, we review results from laboratory studies and randomized clinical trials that have examined the effects of very low–nicotine-content cigarette use in smokers with mental health conditions and socioeconomic disadvantages. On the basis of scientific evidence to date, we conclude that a reduced-nicotine standard for cigarettes would likely reduce cigarette smoking in these populations, without increasing psychiatric symptoms or compensatory smoking.

Introduction Little is known about the effects of long-term e-cigarette use, particularly the risks of relapse to cigarette smoking or increased dependence. Methods In a 2012–2014 baseline online e-cigarette survey, 1,863 respondents consented to participate in future research. A follow-up online survey was conducted in 2017–2018 to assess changes in e-cigarette use behaviors and e-cigarette–related dependence. For both surveys, exclusive e-cigarette use was defined as only using e-cigarettes in the past 7 days, and poly use was defined as using both e-cigarettes and other tobacco or nicotine products in the past 7 days. The Penn State Electronic Cigarette Dependence Index (PSECDI) score was calculated for each study subject and was used to evaluate e-cigarette dependence. Paired t-tests or Pearson correlation coefficients were used to examine changes in e-cigarette use behaviors or PSECDI scores between baseline and follow-up. Baseline and follow-up survey data were analyzed in January 2019. Results A total of 494 subjects provided complete data on both surveys. At baseline, 402 subjects (81.4%) were exclusive e-cigarette users, and 71 subjects (14.4%) were poly users. Among baseline exclusive e-cigarette users, the majority (88.3%) continued using e-cigarettes exclusively, but 37 users (9.2%) became poly users and 1 returned to cigarette smoking at follow-up. Among baseline poly users, 60.6% became exclusive e-cigarette users at follow-up. The mean PSECDI score remained similar over time (8.4 at baseline vs 8.3 at follow-up). Conclusions Findings suggest that the risk of relapse to cigarette smoking is low, and e-cigarette-related dependence remains stable in long-term e-cigarette users.

OBJECTIVES: Health advocates have been working to educate the public about the harms of smoking for more than 50 years. Recently, smoking rates have reduced more slowly among people with low incomes. The purpose of this study was to evaluate what low-income smokers may have learned from a lifetime of exposure to public health education and how this knowledge may have translated into smoking-related behaviors. METHODS: We used narrative inquiry and elicitation interview techniques. Interviews were recorded, transcribed verbatim, coded, and organized into themes using the constant comparative method. RESULTS: All the participants were aware of smoking-related harms to health but negative experiences with quitting, cessation medications, and healthcare professionals contributed to avoiding or rejecting educational messages. Participants’ perceptions of hypocritical societal tobacco control policies also led some to believe that the harms of tobacco use were exaggerated, or were being used to control or manipulate them. This contributed to a distrust of the government, public health advocates, and healthcare providers. CONCLUSIONS: Low-income smokers were aware of the harms of smoking and that quitting would improve their health. Public health advocates should consider developing messages that attempt to foster trust in healthcare professionals and are consistent with low-income adult smokers’ quitting experiences.

Electronic cigarettes (ECIGs) are a relatively new class of tobacco products and a subject of much debate for scientists and policymakers worldwide. Objective data that address the ECIG risk-benefit ratio for individual and public health are needed, and addressing this need requires a multidisciplinary approach that spans several areas of psychology as well as chemistry, toxicant inhalation, and physiology. This multidisciplinary approach would benefit from methods that are reliable, valid, and swift. For this reason, we formed a multidisciplinary team to develop methods that could answer questions about ECIGs and other potential modified risk tobacco products. Our team includes scientists with expertise in psychology (clinical, community, and experimental) and other disciplines, including aerosol research, analytical chemistry, biostatistics, engineering, internal medicine, and public health. The psychologists on our team keep other members focused on factors that influence individual behavior, and other team members keep the psychologists aware of other issues, such as product design. Critically, all team members are willing to extend their interests beyond the boundaries of their discipline to collaborate effectively with the shared goal of producing the rigorous science needed to inform empirically based tobacco policy. In addition, our trainees gain valuable knowledge from these collaborations and learn that other disciplines are accessible, exciting, and can enhance their own research. Multidisciplinary work presents challenges: learning other scientists' languages and staying focused on our core mission. Overall, our multidisciplinary team has led to several major findings that inform the scientific, regulatory, and public health communities about ECIGs and their effects. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Introduction E-cigarette dependence measures largely focus on e-cigarette use (“vaping”) that is linked to nicotine use, and measures assessing sensory aspects of vaping that may influence use (e.g., taste) are limited in scope. Thus, we developed the novel Sensory E-cigarette Expectancies Scale (SEES). Methods In Summer 2017, 610 adult e-cigarette users (48.7% male, 84.9% White, 37.41[±12.15] years old) completed an online survey that included 23 SEES items. Psychometric analyses included evaluating latent structure, internal consistency, measurement invariance, mean differences, and test-criterion relationships. Results Factor analyses supported a 9-item, 3-subscale structure (taste/smell, pleasure/satisfaction, vapor cloud production). Subscales evidenced internal consistency and scalar invariance by sex, race, smoking status (current/not), vaping status (daily/not), e-liquid nicotine content (yes/no), and device type (cig-a-likes/vape-pens/Advanced Personal Vaporizers [APVs]/Mods). Women and daily e-cigarette users reported stronger SEEs for taste/smell and pleasure than their counterparts. Non-white participants reported stronger SEEs for cloud production than White participants. Cig-a-like users reported the weakest SEEs for taste/smell and weaker SEEs linked to cloud production than APV/mod users. SEES scores evidenced convergence with nicotine dependence (mean r = .36). Finally, SEES scores predicted vaping frequency and habitual vaping concurrently and incrementally beyond nicotine dependence. Conclusions The SEES evidenced good psychometric properties, suggesting that the measure can be used to assess sensory vaping expectancies in adults. Importantly, SEES scores indicated that sensory expectancies are related, yet distinct, from nicotine dependence. Future research should evaluate how SEEs relate to product characteristic preferences and patterns of vaping including the development and maintenance of addiction.

Introduction Spectrum research cigarettes have been developed with varying nicotine content for use in studies evaluating the effects of a regulatory policy reducing the permissible nicotine content in cigarettes. This study aimed to characterize the nicotine pharmacokinetic profile of Spectrum cigarettes. Methods Twelve daily smokers attended four sessions and had blood nicotine, exhaled carbon monoxide, and subjective effects measured before and after smoking either a single cigarette of their preferred brand or high (10.9 mg/cigarette), medium (3.2 mg/cigarette), or low (0.2 mg/cigarette) nicotine content Spectrum research cigarettes, in a double-blind design with order counterbalanced. Results The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9, and 17.3 ng/mL for low-, medium-, and high-nicotine content Spectrum cigarettes. The high dose Spectrum had a similar nicotine boost to the “preferred brand” cigarettes (19 ng/mL). Subjects took longer puffs on the low nicotine cigarettes, but smoked these cigarettes faster than other cigarette types. High nicotine Spectrum cigarettes reduced the urge to smoke more than other cigarette types. Conclusions This study shows that Spectrum research cigarettes produce blood nicotine absorption in a dose-dependent manner, and therefore, are appropriate for use in studies of nicotine reduction in cigarettes. Implications This is the first study to determine the pharmacokinetic profile of Spectrum reduced nicotine content research cigarettes following an overnight abstinence. These data could provide evidence to regulatory agencies about the effects of reduced nicotine cigarettes when considering regulations on tobacco reduction.

OBJECTIVES: Cigarettes vary in rod length but are generally thought of as a constant unit. In this study, we evaluated whether the rod length of participants’ usual brand cigarettes affected their perceptions and smoking habits when switching to SPECTRUMs. METHODS: Data were analyzed for 341 participants smoking their own brand cigarettes for one week and after switching to normal nicotine content (11.6 mg) SPECTRUMs for 2 weeks. Changes in perceptions of cigarette attributes and biomarkers of smoke exposure were evaluated using linear mixed models among 3 groups: usual length short (ULS, 72 mm); medium/king (ULM, ~84 mm); and long (ULL ≥ 100 mm). RESULTS: Among the 3 cigarette length groups, only ULL smokers’ rated SPECTRUMs significantly less strong, harder to draw, lower in taste, and lower in enjoyment (p < .03) compared to usual brand. Among all groups, satisfaction was significantly lower for SPECTRUMs (p < .02). Cigarettes per day (CPD) increased significantly more for ULL (+4.75 CPD) as compared to ULM (+1.38 CPD) (p < .001). When switching to SPECTRUMs, cotinine-per-cigarette decreased among all groups, and exhaled carbon monoxide increased significantly in ULL and ULM smokers (p < .001). CONCLUSION: People who smoked long cigarettes had the largest changes in perceptions and use when switching to SPECTRUM research cigarettes.

Some electronic cigarette (e-cigarette) users are interested in quitting e-cigarette use, though few studies have assessed what factors contribute to this interest. This study aimed to identify factors associated with e-cigarette quitting interest and quitting behaviors in exclusive, long-term e-cigarette users. These e-cigarette users were surveyed in January 2017 (baseline) and June 2019 (follow-up), with an average follow-up period of 2.4 years. At baseline, the sample had been e-cigarette users for an average of 5.6 years. Among the 221 participants, 205 (92.8%) did not intend to quit using e-cigarettes at baseline. At follow-up, 196 (88.7%) continued exclusive e-cigarette use, 17 (7.7%) quit e-cigarettes, 8 (3.6%) became dual users, and none became exclusive smokers. At baseline, 16 users intended to quit e-cigarettes, 2 (12.5%) of whom quit at follow-up. Predictors of quitting e-cigarettes included no previous cigarette smoking (β = -3.7, OR = 0.021, p .01), lower Penn State Electronic Cigarette Dependence Index score (β = -0.21, OR = 0.81, p = .011), and lower number of devices used per day (β = -1.9, OR = 0.15, p = .015). Intending to quit e-cigarettes at baseline was not predictive of quitting at follow-up. At follow-up, 57 (25.8%) had tried to quit in the past. Overall predictors of trying to quit included interest in quitting at baseline (β = 1.7, OR = 5.3, p .01) and using a drip-fed atomizer (β = 1.0, OR = 2.7, p = .022). These results suggest that long-term exclusive e-cigarette users generally have little interest in stopping e-cigarette use, and that type of device used, smoking history, e-cigarette dependence, number of devices used, and intention to quit are associated with e-cigarette quitting behaviors.

Background The United States Food and Drug Administration has prioritized understanding the dependence potential of electronic cigarettes (e-cigs). Dependence is often estimated in part by examining frequency of use; however measures of e-cig use are not well developed because of varying product types. This study used an e-cig automatic puff counter to evaluate the value of self-reported e-cig use measures in predicting actual use (puffs). Methods Data were collected from a two-site randomized placebo-controlled trial evaluating the effects of e-cigs on toxicant exposure in smokers attempting to reduce their cigarette consumption. Participants randomized to an e-cig condition self-reported their e-cig frequency of use (times per day—one “time” consists of around 15 puffs or lasts around 10 minutes) on the Penn State Electronic Cigarette Dependence Index (PSECDI) and kept daily diary records of the number of puffs per day from the e-cig automatic puff counter. A linear mixed-effects model was used to determine the predictive value of the times per day measure. Correlations were used to further investigate the relationship. Results A total of 259 participants with 1165 observations of e-cig use were analyzed. Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p < .01). The Spearman correlation between measures was r equal to .58. Examination of individual participant responses revealed some potential difficulties reporting and interpreting times per day because of the difference in use patterns between cigarettes and e-cigs. Conclusion This study provides evidence that the self-reported PSECDI measure of times per day is a significant predictor of actual frequency of e-cig puffs taken. Implications Self-reported measures of e-cig frequency of use are predictive of actual use, but quantifying e-cig use in patterns similar to cigarettes is problematic.

COVID-19 has become a global pandemic, with over 81 million cases worldwide. To assess changes in tobacco use as a result of the pandemic, we surveyed a convenience sample of current tobacco users between April and June 2020. The sample was taken from a tobacco user research registry (n = 3396) from the Penn State College of Medicine in Hershey, Pennsylvania, USA. Participants who responded to the survey and were eligible for this study (n = 291) were 25.6% male, 93% white, and had a mean age of 47.3 (SD = 11.6) years. There were no reports of participants testing positive for COVID-19, but 21.7% reported experiencing symptoms associated with the virus. Most participants (67%) believed that their risk of contracting COVID-19 was the same as non-tobacco users, but 57.7% believed that their risk of serious complications, if infected, was greater compared to non-tobacco users. A total of 28% reported increasing their cigarette use during the pandemic. The most common reasons for increased use were increased stress, more time at home, and boredom while quarantined. Nearly 15% reported decreasing their tobacco use. The most common reasons for reduced use were health concerns and more time around non-smokers (including children). A total of 71 (24.5%) users reported making a quit attempt. Characterizing these pandemic-related changes in tobacco use may be important to understanding the full scope of subsequent health outcomes resulting from the pandemic. Tobacco cessation resources should be tailored to allow for safe, appropriate access for those interested in quitting.

BACKGROUND: JUUL is a popular electronic cigarette (e-cig) that is capable of delivering nicotine similarly to a cigarette. While known to deliver high doses of nicotine, there is little systematic evidence to show how the nicotine delivery of JUUL translates to user dependence. PURPOSE: The purpose of the study was to evaluate self-reported dependence of JUUL users and examine the relationship of dependence to user behaviors. METHODS: Current JUUL users were recruited via Amazon Mechanical Turk to complete an online survey about their use of JUUL. Participants were asked to complete the Penn State Electronic Cigarette Dependence Index (PSECDI) and to answer questions about their use patterns and other tobacco use. Means and frequencies were used to describe the sample. A linear regression model was used to predict user dependence. RESULTS: Participants (n = 76) were 65.4% male with a mean age of 31.9 (SD = 8.3) years. The mean PSECDI score was 7.8 (SD = 4.2) and ranged from no (15.8%) to high (14.5%) dependence. Overall predictors of a greater PSECDI score included reporting ever stealth vaping (β = 2.8, p < .01) and reporting greater use days in the past 30 (β = 3.5, p < .01). CONCLUSIONS: On average, JUUL users reported low to medium nicotine dependence on the PSECDI. JUUL user dependence may be more similar to e-cig user dependence than cigarette smoker dependence. These preliminary findings should be followed up in studies of larger samples of Juul users, collecting multiple measures of dependence, as well as biomarkers of nicotine intake (e.g. cotinine).

In 2018, the United States Food and Drug Administration (FDA) issued an advanced notice of proposed rulemaking to reduce nicotine in tobacco products to produce a minimally addictive or nonaddictive effect, but there was a research gap in the subjective responses of reduced-nicotine-content cigarettes. We compared the responses of the modified cigarette evaluation questionnaire (mCEQ) and cigarette-liking scale (CLS) between the gradually reduced nicotine content (RNC) group and the usual nicotine content (UNC) group. Linear mixed-effects models for repeated measures were used to analyze and compare the change over time for the mCEQ and CLS across the two treatment groups (RNC and UNC). We found that the change over time for the mCEQ and CLS was significant between the RNC and the UNC treatment groups at the beginning of visit 6 with 1.4 mg nicotine/cigarette. At visits 8 and 9, the RNC group reported significantly lower satisfaction scores compared to UNC. Subscale analysis showed that smoking satisfaction decreased in RNC while other measures, such as cigarette enjoyment, did not change. Understanding the impact of nicotine reduction on cigarette subjective responses through evaluation and liking scales would provide valuable information to the FDA on nicotine reduction policies for cigarettes. Published version

Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS. The CMS and procedures described have been field tested for the past three years and have dispensed over 160,000 cigarette packs to participants. The CMS can accommodate a range of practical issues with real-world study implementation making it a robust application that is scalable to any study.

Introduction Little cigars and filtered cigars are currently growing in popularity due to their low cost and wide variety of flavors while retaining an appearance similar to cigarettes. Given the health consequences associated with cigarette use, it is important to understand the potential harm associated with these similar products. This includes the potential harm associated with carbonyls (eg, acetaldehyde, acrolein, formaldehyde, etc.), an important class of toxicants and carcinogens in tobacco smoke. Our objective was to determine the carbonyl levels in mainstream smoke from little and filtered cigars compared to cigarettes. Methods We examined two brands each of little cigars and filtered cigars, as well as two research cigarettes for carbonyl delivery using the International Organization of Standards (ISO) and the Health Canada Intense (HCI) machine-smoking protocols. Results On a per puff basis, the levels of five of the seven carbonyls were higher from little cigars than filtered cigars and cigarettes (ISO: 56–116%; HCI: 39–85%; p < .05). On a per unit basis, most carbonyl levels were higher from both cigar types than cigarettes using the ISO method (ISO: 51–313%; p < .05) whereas only filtered cigars were higher using the HCI method (HCI: 53–99%; p < .05). Conclusion These findings suggest that cigar smokers can be exposed to higher levels of carbonyls per cigar than cigarette smokers per cigarette. Implications These data will increase our understanding of the relative harm from carbonyl exposure from little and filtered cigars both for cigar-only smokers and the cumulative harm among the growing population of cigarette–cigar multi-product smokers.

Introduction‘Stealth vaping’ is the practice of vaping discreetly in places where electronic cigarette (e-cigarette) use is prohibited. While anecdotal evidence suggests that stealth vaping is common, there have been no formal studies of the behaviour. The purpose of this study is to examine stealth vaping behaviour among experienced e-cigarette users.MethodsData were collected from the follow-up survey of a large longitudinal cohort study of adult experienced e-cigarette users conducted in January 2017. To measure stealth vaping behaviour, participants were asked ‘Have you ever ‘stealth vaped’, that is to say, used an e-cig in a public place where it was not approved and attempted to conceal your e-cig use? (yes/no)’. Participants indicating yes completed additional questions about the frequency of stealth vaping and were asked to select all the locations where they commonly stealth vape. Frequencies were used to examine the overall prevalence, frequency and common locations for stealth vaping. A logistic regression model was run to predict stealth vaping.ResultsApproximately two-thirds (64.3%, n=297/462) of the sample reported ever stealth vaping, of which 52.5% (n=156/297) reported stealth vaping in the past week. Among stealth vapers (n=297), 31% reported owning a smaller device solely for stealth vaping. The most common places to stealth vape included at work (46.8%), followed by bars/nightclubs (42.1%), restaurants (37.7%), at the movies (35.4%) and in airports/on airplanes (11.7%). Predictors of stealth vaping were greater dependence and owning a smaller device solely for stealth vaping.ConclusionsStealth vaping is a common behaviour for many experienced e-cigarette users. More research is needed to understand the reasons for stealth vaping and its potential health and safety implications. This information could help researchers and regulators to design interventions to minimise the public health impact of stealth vaping.

IntroductionAbout half of smokers relight their cigarette, a habit that is a risk factor for chronic bronchitis and possibly lung cancer. Little is known about the characteristics of smokers who relight and their dependence on nicotine. It is unknown whether relighting affects exposure to tobacco smoke constituents. This study examined the characteristics of relighters of usual brand cigarettes and whether relighting affects exposure to selected tobacco smoke constituents.MethodsWe explored relighting status and frequency, using baseline data from 248 adult smokers participating in studies of reduced nicotine cigarettes in relation to demographic and cigarette characteristics, smoking behaviors, nicotine dependence, biomarkers of exposure (exhaled carbon monoxide, blood cotinine), and biomarkers of oxidative stress (ratio of oxidized/reduced glutathione).Results69.4% (n = 172) of subjects reported relighting, and they relit an average of five cigarettes out of 20. Both relighters and non-relighters smoked a mean of 20 cigarettes per day (p = .6). Relighting was significantly associated with higher nicotine dependence, use of longer rod cigarettes, older age, lower income, and unemployment. There were no significant associations between relighting and blood cotinine, exhaled carbon monoxide or measures of oxidized/reduced blood glutathione.ConclusionsThe majority of subjects were relighters, who had higher levels of nicotine dependence than non-relighters. Relighters had similar levels of plasma cotinine and exhaled carbon monoxide to non-relighters.ImplicationsNo study has compared the cigarette characteristics and biomarkers of exposure of adult cigarette smokers who relight with those who do not. Relighting behavior was common in our sample and was associated with low income, not currently working, higher nicotine dependence, cigarette rod length, daily cigarette use years, and a lifetime history of depressed mood.

E-cigarette use rates are increasing among youth and adults, despite limited knowledge about the safety, risks, and potential for this product in substituting for or reducing other tobacco use. Understanding how to characterize and assess e-cigarette dependence will be important for evaluating the public health impact of e-cigarettes and considering prevention and intervention strategies. To provide an initial review of constructs to consider when assessing e-cigarette dependence, a content expert group within the Tobacco Center for Regulatory Science (TCORS) Measurement Workgroup engaged in a review of published manuscripts and 12 tobacco dependence measures, followed by review of suggested dependence domains by a 10-person external subject-matter expert panel. The final domains selected to be considered in the development of a measure of e-cigarette dependence included: 1) Quantity and frequency of use, 2) Tolerance, 3) Perceived benefits, 4) Withdrawal symptoms, 5) Craving/urge to use, 6) Use despite harm, 7) Impaired control, 8) Automaticity, 9) Preferred over competing rewards, and 10) Sensory dependence. Similarities and differences in potential features of e-cigarette dependence compared with dependence on other tobacco products is discussed. Future work will evaluate these dependence items and constructs in a sample of e-cigarette users with a goal of developing a valid, brief, standardized measure of e-cigarette dependence.

Resting state functional brain connectivity (rsFC) may be an important neuromarker of smoking behavior. Prior research has shown, among cigarette smokers, that nicotine administration alters rsFC within frontal and parietal cortices involved in executive control, as well as striatal regions that drive reward processing. These changes in rsFC have been associated with reductions in withdrawal symptom severity. We currently have a limited understanding of how rsFC is affected by the use of electronic cigarettes (ecigs), an increasingly popular class of products, the members of which deliver nicotine with varying effectiveness. The current study used fMRI to determine the effects of ecig use on rsFC and withdrawal symptoms. Independent component, dual regression, and permutation analyses were conducted on rsFC collected from ecig users before and after an ecig use episode (n=9) that occurred after 14 hours of nicotine abstinence. Similar to the known effects of nicotine administration, ecig use decreased rsFC of two clusters in the right frontal pole and frontal medial cortex with an attentional control salience network, and decreased rsFC of five clusters in the left thalamus, insula, and brain stem with a reward network encompassing the striatum. Ecig use increased inverse coupling between the prefrontal reward network and the right frontoparietal executive control network. Reductions in craving and difficulty with concentration were correlated with decreases in coupling strength between reward and executive control networks. These preliminary results suggest that the effects of ecig use on rsFC are similar to those seen with nicotine administration in other forms. In order to gain insight into the addictive potential of ecigs, further research is needed to understand the neural influence of ecigs across the range of nicotine delivery within this class of products.

Varenicline is a safe and effective aid to smoking cessation but most trials have involved frequent visits or intensive behavioral support unlike that typically provided in primary care. The current study examined if motivational text messages, sent via cellphone, would increase quit rates in smokers being treated with varenicline and 3 brief sessions in a family practice setting.This study was a randomized controlled, parallel-group smoking cessation trial. Intervention group participants (n = 74) received daily motivational text messages, additional texted tips in response to keywords, and weekly study questions while control group participants (n = 76) received only weekly study questions. Both groups received individualized counseling. Self-reported non-smoking and exhaled breath CO10ppm were used to validate smoking abstinence at 3 weeks and 12 weeks.Overall, 30.7% (46/150) of participants were abstinent at the 12 week follow-up and the abstinence rate did not differ between groups (INT 31.1% v. CON 30.3%, p = .91). The only predictor of abstinence at 12 weeks was use of varenicline during a previous quit attempt (p = .01). Intervention group participants were more likely to rate the text messaging program as good or excellent (p .01), to recommend a similar program to family or friends (p .01), and to complete positive smoking cessation activities (p = .04), when compared with the control group.Although there were no differences in quit rates between the intervention and control group, intervention group participants rated the text messaging system more favorably, were more likely to recommend the program to others, and were more likely to complete positive smoking cessation activities.

Introduction Although the popularity of small cigar brands that resemble cigarettes, including both little cigars (LC) and filtered cigars (FC), has been on the rise, little is known about the delivery of nicotine from these products. Our objective was to determine the nicotine yields of small cigars in comparison to cigarettes. Methods Nicotine yields from LC, FC, and 3R4F and 1R6F research cigarettes were determined from mainstream smoke generated on a smoking machine under the International Organization of Standardization (ISO) and Canadian Intense (CI) methods. Market characteristics (price and package label) and physical features (filter ventilation, product weight and filter weight, product length, and diameter) were also determined for eight brands of small cigars. Results Nicotine yields in small cigars averaged 1.24 and 3.49 mg/unit on ISO and CI regimens, respectively, compared with 0.73 and 2.35 mg/unit, respectively, for the research cigarettes. Nicotine yields per puff were similar between small cigars and cigarettes. We also found that FC did not differ from LC in nicotine yields. FC and LC differ from each other in many physical design features (unit weight, filter weight, and filter length), but are similar in others (unit length, diameter, and filter ventilation). Conclusions Nicotine delivery from small cigars is similar to or greater than that from cigarettes. Thus, for future research and regulatory purposes, standard definitions need to be developed for small cigars, and FC and LC should be evaluated as separate entities. Implications Small cigars are similar to cigarettes in their design and use. Although nicotine yields per puff were similar between products, small cigars delivered substantially higher amounts of nicotine per unit than cigarettes. These findings support the growing body of evidence to justify regulating all small cigars, including LC and FC in a similar fashion as cigarettes.

Oxidative stress/damage resulting from exposure to cigarette smoke plays a critical role in the development of tobacco-caused diseases. Carbonyls and free radicals are two major classes of oxidants in tobacco smoke. There is little information on the combined delivery of these oxidants across different cigarette brands; thus, we set out to measure and compare their levels in mainstream smoke from popular US cigarettes. Mainstream smoke from 28 different cigarette brands produced by smoking (FTC protocol) was analyzed for five important, abundant carbonyls, and levels were compared to previously determined free radical for the same brands. Overall, there were large variations (3- to 6-fold) in carbonyl levels across brands with total carbonyl levels ranging from 275 to 804 μg/cigarette, which persisted even after adjusting for ventilation. Individual carbonyl levels were highly correlated with each other (r2: 0.40–0.95, P

Background The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. Methods/design Adults (N = 280) who have smoked five cigarettes or more per day for the past year, have not made a quit attempt in the prior month, are not planning to quit, and have less than 16 years of education are recruited into a two-arm, double-blinded randomized controlled trial. First, participants smoke their usual brand of cigarettes for 1 week and SPECTRUM research cigarettes containing a usual amount of nicotine for 2 weeks. During the experimental phase, participants are randomized to continue smoking SPECTRUM research cigarettes that contain either (1) usual nicotine content (UNC) (11.6 mg/cigarette) or (2) RNC (11.6 to 0.2 mg/cigarette) over 18 weeks. During the final phase of the study, all participants are offered the choice to quit smoking with nicotine replacement therapy, continue smoking the research cigarettes, or return to their usual brand of cigarettes. The primary outcomes of the study include retention rates and compliance with using only research cigarettes and no use of other nicotine-containing products. Secondary outcomes are tobacco smoke biomarkers, nicotine dependence measures, smoking topography, stress levels, and adverse health consequences. Discussion Results from this study will provide information on whether low SES smokers can maintain a course of progressive nicotine reduction without increases in incidence of adverse effects. Trial registration ClinicalTrials.gov, NCT01928719. Registered on 21 August 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2038-9) contains supplementary material, which is available to authorized users.

Since their introduction in the United States in 2007, electronic cigarettes (e-cigs) have risen in popularity. A nationally representative sample of adults showed that between 2010 and 2013, ever use of e-cigs increased from 1.8% to 13% (McMillen, Gottlieb, Shaefer, Winickoff, & Klein, 2015). While use is significantly higher in those who are current or former smokers (Delnevo et al., 2015), there is concern that e-cigs may appeal to never cigarette smokers and cause them to become nicotine dependent (Cobb, Hendricks, & Eissenberg, 2015). Based on 2014 data from the U.S. National Health Interview Survey, 2.8% of never cigarette smoking adults had tried e-cigs, and 0.4% were currently using them some days or every day (Delnevo et al., 2015). Although many cigarette smokers report using e-cigs as a smoking cessation or reduction tool (Foulds, Veldheer, & Berg, 2011), it is unclear why never cigarette smokers are using e-cigs. Never cigarette smoking e-cig users are important to understand as they have the potential to develop nicotine addiction through a new mode of delivery that has similarities to a cigarette (McMillen et al., 2015). While it is certainly possible that never tobacco users are initiating nicotine use with e-cigs, the majority of the literature focuses primarily on youth populations. Some studies have found evidence of e-cig uptake among never cigarette smoking adolescents, although rates of e-cig use are still higher in adolescent cigarette smokers (Bunnell et al., 2015; Camenga et al., 2014). They have also found there may be differences in risk factors for tobacco product use among adolescents using e-cigs vs. combustible cigarettes and those at intermediate levels of risk may engage in e-cig use when they would not have otherwise been susceptible to tobacco product use (Wills, Knight, Williams, Pagano, & Sargent, 2015). While these studies assume that adolescents are initiating nicotine use with e-cigs, a recent study has shown that a significant proportion of adolescent e-cig users are using e-cigs that do not contain nicotine (Miech, Patrick, O'Malley, & Johnston, 2016). Adults may differ from adolescents in their reasons for use and use patterns but there have been few studies that have examined e-cig use among adult never cigarette smokers. A comprehensive survey study conducted by Farsalinos et al. included an analysis of the use patterns of e-cig users who were never cigarette smokers, but it did not account for traditional tobacco product use aside from cigarettes (e.g. cigars, hookah, pipes, and chew) (Farsalinos, Romagna, Tsiapras, Kyrzopoulos, & Voudris, 2014). If the never cigarette smokers are current or past traditional tobacco product users taking up e-cigs as an alternative to traditional tobacco, it is not the case that they have initiated their nicotine addiction with e-cigs. For instance, Berg conducted a quantitative survey of young adult e-cig users including a full tobacco use history and found that more than 75% of never cigarette smokers had used at least one other tobacco product in their lifetime. Berg noted the need for qualitative research to more fully understand the reasoning behind e-cig use in this population (Berg, 2016). Because quantitative methods are most commonly used when studying e-cigs, it is useful to present quantitative data for comparability across studies. However, qualitative research is also useful when a phenomenon is not well understood because these methodologies allow for the illumination of contextual factors and details from the participant that would not otherwise be captured when using quantitative methods alone. Due to the limited data available on e-cig users who were never cigarette smokers, combining these methodologies using a mixed methods approach allows for strengthening of the quantitative results through the support of qualitative responses. Therefore, this study aims to utilize a mixed methods approach in order to gain a more comprehensive understanding of adult e-cig users who were never cigarette smokers with regard to their traditional tobacco product use, reasons for e-cig use and e-cig use patterns as well as to identify topics for future research within this population.