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Importance: Prohibiting the sale of commonly preferred e-cigarette flavors (eg, fruity and sweet) to discourage use among youths poses a risk of diminishing efforts to decrease smoking in adults., Objective: To compare reductions in smoking achieved in adults with psychiatric conditions or lower educational level using very low nicotine content (VLNC) cigarettes alone, combined with e-cigarettes limited to tobacco flavor (TF), or combined with e-cigarettes in participant-preferred flavors., Design, Setting, and Participants: Three randomized clinical trials were conducted for 16 weeks from October 2020 through November 2023 at the University of Vermont, Brown University, and Johns Hopkins University. Participants were adults who smoked daily and were not planning to quit in the next 30 days. These participants were from 3 at-risk populations: those with affective disorders, exemplifying mental illness; those with opioid use disorder, exemplifying substance use disorders; and females of reproductive age with a high-school education or less, exemplifying lower educational level. Participants were randomly assigned to 1 of 4 experimental conditions: (1) normal nicotine content (NNC) cigarettes only; (2) VLNC cigarettes only; (3) VLNC cigarettes plus e-cigarettes with classic TF (hereafter, VLNC + TF); and (4) VLNC cigarettes plus e-cigarettes with preferred flavors (hereafter, VLNC + PF)., Interventions: The NNC cigarettes contained 15.8 mg nicotine/g tobacco, the VLNC cigarettes contained 0.4 mg nicotine/g tobacco, the VLNC + TF had pods containing 5% nicotine by weight and only classic TF, and the VLNC + PF had pods containing 5% nicotine in 8 flavors (including fruity and sweet) from which participants selected 3 flavors., Main Outcomes and Measures: The primary outcome was mean total cigarettes smoked per day (CPD) during week 16. Tobacco-related biomarkers were assessed, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a tobacco-specific carcinogen., Results: A total of 326 participants (mean [SD] age, 40.09 [10.79] years; 243 females [74.5%]) from 3 randomized clinical trials were included. The VLNC cigarettes decreased total CPD, with least square (LS) means (SEMs) of 22.54 (1.59) in the NNC, 14.32 (1.32) in the VLNC, 11.76 (1.18) in the VLNC + TF, and 7.63 (0.90) in the VLNC + PF conditions. Each VLNC condition differed significantly from NNC, with an adjusted mean difference (AMD) of -8.21 (95% CI, -12.27 to -4.16; P < .001) in the VLNC, -10.78 (95% CI, -14.67 to -6.90; P < .001) in the VLNC + TF, and -14.91 (95% CI, -18.49 to -11.33; P < .001) in the VLNC + PF conditions. Participants in the VLNC + PF condition also decreased smoking below the VLNC and the VLNC + TF conditions (AMDs, -6.70 [95% CI, -9.84 to -3.55; P < .001] and -4.13 [95% CI, -7.05 to -1.21; P = .02]); the VLNC and VLNC + TF conditions did not differ significantly. Consistent with decreases in CPD, NNAL levels in the VLNC + PF condition were lower than in all other conditions, with AMDs (in pmol/mg creatinine) of -0.94 (95% CI, -1.41 to -0.47; P < .001) compared with the NNC condition, -0.47 (95% CI, -0.87 to -0.08; P = .03) compared with the VLNC condition, and -0.46 (95% CI, -0.83 to -0.10; P = .04) compared with the VLNC + TF condition., Conclusions and Relevance: These results provide further evidence that a reduced-nicotine standard for cigarettes has the potential to decrease smoking and tobacco-toxicant exposure in high-risk populations and that these effects may be enhanced when adults can access e-cigarettes in commonly preferred flavors., Trial Registration: ClinicalTrials.gov Identifiers: NCT04092387, NCT04090879, NCT04092101.

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., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

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., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

Research has linked specific COVID-19-related stressors to the mental health burden, yet most previous studies have examined only a limited number of stressors and have paid little attention to their clinical significance. This study tested the hypothesis that individuals who reported greater COVID-19-related stressors would be more likely to have elevated levels of anxiety, posttraumatic stress symptoms, and serious psychological distress., Methods: An online survey was administered to a convenience sample from 18 June to 19 July 2020, in US states that were most affected by COVID-19 infections and deaths at the time. Individuals who were 18 or older and residents of five Northeast US states were eligible to participate (N = 1079). In preregistered analyses, we used logistic regression models to test the associations of COVID-19 stressors with symptoms on the Generalized Anxiety Disorder-7 (GAD-7), Impact of Event Scale-Revised, and K6, adjusting for sociodemographic covariates., Results: COVID-19-related stressors (i.e., essential worker status, worry about COVID-19 infection, knowing someone hospitalized by COVID-19, having children under 14 at home, loneliness, barriers to environmental rewards, food insecurity, loss of employment) were associated with meeting thresholds (i.e., positive screening) for anxiety, posttraumatic stress, and/or serious psychological distress. Loneliness and barriers to environmental rewards were associated with all mental health outcomes., Limitations: We used a non-probability sample and cannot assume temporal precedence of stressors with regard to development of mental health symptoms., Conclusions: These findings link specific stressors to the mental health burden of the COVID-19 pandemic.

Background: Substance use is a risk factor for COVID-19 infection and adverse outcomes. However, reasons for elevated risk for COVID-19 in substance users are not well understood., Objective: The aim of this study was to evaluate whether alcohol or other drug use is associated with adherence to Centers for Disease Control and Prevention (CDC) guidelines for COVID-19 mitigation. Preregistered analyses tested the hypothesis that greater use of alcohol and other drugs would be associated with lower CDC guideline adherence. A secondary objective was to determine whether substance use was associated with the likelihood of COVID-19 testing or outcome., Methods: A cross-sectional web-based survey was administered to a convenience sample recruited through Amazon's Mechanical Turk platform from June 18 to July 19, 2020. Individuals aged 18 years or older and residing in Connecticut, Massachusetts, New Jersey, New York, or Rhode Island were eligible to participate. The exposure of interest was past 7-day use of alcohol, cigarettes, electronic cigarettes, cannabis, stimulants, and nonmedical opioids. The primary outcome was CDC guideline adherence measured using a scale developed from behaviors advised to reduce the spread of COVID-19. Secondary outcomes were likelihood of COVID-19 testing and a positive COVID-19 test result. All analyses accounted for the sociodemographic characteristics., Results: The sample consisted of 1084 individuals (mean age 40.9 [SD 13.4] years): 529 (48.8%) men, 543 (50.1%) women, 12 (1.1%) other gender identity, 742 (68.5%) White individuals, 267 (24.6%) Black individuals, and 276 (25.5%) Hispanic individuals. Daily opioid users reported lower CDC guideline adherence than nondaily users (B=-0.24, 95% CI -0.44 to -0.05) and nonusers (B=-0.57, 95% CI -0.76 to -0.38). Daily alcohol drinkers reported lower adherence than nondaily drinkers (B=-0.16, 95% CI -0.30 to -0.02). Nondaily alcohol drinkers reported higher adherence than nondrinkers (B=0.10, 95% CI 0.02-0.17). Daily opioid use was related to greater odds of COVID-19 testing, and daily stimulant use was related to greater odds of a positive COVID-19 test., Conclusions: In a regionally-specific, racially, and ethnically diverse convenience sample, adults who engaged in daily alcohol or opioid use reported lower CDC guideline adherence for COVID-19 mitigation. Any opioid use was associated with greater odds of COVID-19 testing, and daily stimulant use was associated with greater odds of COVID-19 infection. Cigarettes, electronic cigarettes, cannabis, or stimulant use were not statistically associated with CDC guideline adherence, after accounting for sociodemographic covariates and other substance use variables. Findings support further investigation into whether COVID-19 testing and vaccination should be expanded among individuals with substance-related risk factors., (©Mollie A Monnig, Hayley Treloar Padovano, Alexander W Sokolovsky, Grace DeCost, Elizabeth R Aston, Carolina L Haass-Koffler, Claire Szapary, Patience Moyo, Jaqueline C Avila, Jennifer W Tidey, Peter M Monti, Jasjit S Ahluwalia. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 09.11.2021.)

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.

The Center for Addiction and Disease Risk Exacerbation (CADRE) is a COBRE establishing a thematically linked, state-of-the-art, multidisciplinary Center investigating mechanisms where-by substance use (SU) increases the risk for or exacerbates chronic disease. It does so by employing a combination of behavioral and physiological laboratory-based approaches across several substances and across several diseases. COBRE projects investigate mechanisms underlying effects of opioids, cannabis, tobacco, and alcohol on risks for and progression of SU-related disease. Though linkages between SU and disease are well documented, physiological mechanisms underlying such associations are poorly understood, mainly because published studies use cross-sectional designs that do not allow for causal interpretations. Mechanisms studied in CADRE projects include systemic inflammation, immune system dysregulation, high blood pressure, pulmonary effects, and carcinogen exposure. A Clinical Laboratory Core provides infrastructure, resources, and scientific expertise and a center-wide database of risk factors associated with the development of SU and chronic disease.

Importance: This study is part of a programmatic effort evaluating the effects of reducing nicotine content of cigarettes to minimally addictive levels., Objective: To examine whether very low-nicotine-content (VLNC) cigarettes decrease smoking rates and dependence severity among smokers with psychiatric disorders or socioeconomic disadvantage., Design, Setting, and Participants: These 3 randomized clinical trials were performed at the University of Vermont, Brown University, and Johns Hopkins University between October 2016 and September 2019. Participants received 12 weeks of exposure to study cigarettes with nicotine content ranging from levels representative of commercial cigarettes (15.8 mg nicotine/g tobacco) to less than a hypothesized addiction threshold (2.4 mg/g and 0.4 mg/g). Daily smokers from 3 at-risk populations participated: individuals with affective disorders, exemplifying smokers with mental illness; individuals with opioid use disorder, exemplifying smokers with substance use disorders; and women with high school educations or less, exemplifying smokers with socioeconomic disadvantage. Data were analyzed from September 2019 to July 2020., Interventions: Random assignment to 1 of 3 study cigarettes provided weekly at no cost for 12 weeks., Main Outcomes and Measures: The primary outcome was between-group differences in mean total cigarettes smoked daily (CPD) during week 12; secondary outcomes included CPD for study and nonstudy cigarettes and dependence severity across weeks analyzed using analysis of covariance, random coefficients growth modeling, or repeated measures analysis of variance., Results: A total of 775 participants were included (mean [SD] age, 35.59 [11.05] years; 551 [71.10%] women [owing to 1 population being exclusively women]); participants smoked a mean (SD) of 17.79 (9.18) CPD at study intake. A total of 286 participants were randomized to 0.4 mg/g, 235 participants were randomized to 2.4 mg/g, and 254 participants were randomized to 15.8 mg/g. Participants randomized to VLNC cigarettes had decreased mean [SEM] total CPD during week 12 across populations (Cohen d = 0.61; P < .001). At week 12, mean (SEM) CPD decreased to 17.96 (0.98) CPD in the 0.4 mg/g group and to 19.53 (1.07) CPD in the 2.4 mg/g group, both of which were significantly different from the 15.8 mg/g group (25.08 [1.08] CPD at week 12) but not each other (0.4 mg/g adjusted mean difference: -7.54 [95%CI, -9.51 to -5.57]; 2.4 mg/g adjusted mean difference: -5.34 [95% CI, 7.41 to -3.26]). Several secondary outcomes differed across populations randomized to VLNCs, including mean total CPD across weeks, with linear trends lower in participants receiving 0.4 mg/g (-0.28 [95%CI, -0.39 to -0.18]; P < .001) and 2.4 mg/g (-0.13 [95%CI, -0.25 to -0.01]; P < .001) doses compared with those receiving the 15.8 mg/g dose (0.30 [95% CI, 0.19 to 0.41]). Fagerström Test of Nicotine Dependence mean total scores were significantly lower in participants who received VLNCs (Cohen d = 0.12; P < .001), with those who received the 0.4 mg/g dose (mean [SD] score, 3.99 [0.06]; P < .001 vs 15.8 mg/g) or 2.4 mg/g dose (mean [SD] score, 4.07 [0.06]; P = .01 vs 15.8 mg/g) differing from those who received the 15.8 mg/g dose (mean [SD] score, 4.31 [0.06]) but not from each other., Conclusions and Relevance: These findings demonstrate that decreasing the nicotine content of cigarettes to very low levels reduced smoking rate and nicotine-dependence severity in these high-risk populations, effects that may facilitate successful cessation., Trial Registration: ClinicalTrials.gov Identifiers: NCT02232737, NCT02250664, NCT02250534.

Background: A mandated reduction in the nicotine content of cigarettes could reduce smoking rate and prevalence. However, one concern is that smokers may compensate by increasing the intensity with which they smoke each cigarette to obtain more nicotine. This study assessed whether smokers engage in compensatory smoking by estimating the mouth-level nicotine intake of low nicotine cigarettes smoked during a clinical trial., Methods: Smokers were randomly assigned to receive cigarettes with one of five nicotine contents for 6 weeks. An additional group received a cigarette with the lowest nicotine content, but an increased tar yield. The obtained mouth-level nicotine intake from discarded cigarette butts for a subset of participants (51-70/group) was estimated using solanesol as described previously. A compensation index was calculated for each group to estimate the proportion of nicotine per cigarette recovered through changes in smoking intensity., Results: There was no significant increase in smoking intensity for any of the reduced nicotine cigarettes as measured by the compensation index (an estimated 0.4% of the nicotine lost was recovered in the lowest nicotine group; 95% confidence interval, -0.1 to 1.2). There was a significant decrease in smoking intensity for very low nicotine content cigarettes with increased tar yield., Conclusions: Reductions in nicotine content did not result in compensatory changes in how intensively participants smoked research cigarettes., Impact: Combined with data from clinical trials showing a reduction in cigarettes smoked per day, these data suggest that a reduction in nicotine content is unlikely to result in increased smoke exposure., (©2020 American Association for Cancer Research.)

Background: Participant recruitment is often a challenge, particularly enrolling individuals with relatively rare characteristics. The wide reach of social media may provide a mechanism to overcome these challenges., Objective: This paper aimed to provide information to researchers who seek to recruit participants from rare populations using social media for studies with demanding protocols. We aimed to describe a pilot study protocol that identified and enrolled pregnant women (second or third trimester) who were exclusive users of electronic cigarettes (e-cigarettes). We have described the recruitment methods, time, and cost; examined advertisement types that were more or less successful; discussed participant retention and relationship management; and described the process of collecting biological data., Methods: In an open-access, nonrandomized pilot study, we placed Facebook advertisements that were selectively targeting women who were likely to be pregnant and interested in e-cigarettes or vaping. The advertisements invited individuals to complete a fully automated eligibility screener based on Qualtrics. Eligible participants were asked to (1) complete a Web-based survey that collected detailed information on the use of e-cigarettes, including the exact type of device and electronic liquid, (2) report the frequency and intensity of e-cigarette use for 3 months before pregnancy and during each trimester, and (3) provide a saliva specimen for a nicotine biomarker assay. We collected a photograph of each participant's e-cigarette device, 8 weeks after the mother's due date, to allow corroboration of the self-report and the baby's birth weight and gestational age from the participant's physician., Results: Participants were recruited between August 19 and October 26, 2017. We enrolled 20 participants in 2 months at a cost of US $3421.28. Baseline data were collected for all 20 participants. Of the 20 women enrolled, 16 provided a saliva sample, 4 provided a photo of the e-cigarette device, and 10 provided physician contact information. Of the 10 physicians contacted by mail, 6 responded with information on the participants and their babies., Conclusions: Study findings suggest that Facebook's targeting criteria should focus on e-cigarette users to maximize advertisement exposure of potentially eligible women. In addition, saliva sample collection was feasible among pregnant women (second or third trimester) who were exclusive e-cigarette users, but obtaining photographs and physician reports was problematic and called for further refinement. These lessons are likely useful to others who are seeking to use social media to recruit participants from rare populations into studies with demanding protocols., (©Harold H H Lee, Yuli Patrick Hsieh, Joe Murphy, Jennifer W Tidey, David A Savitz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.10.2019.)

Individuals with chronic health conditions persist in smoking despite the presence of smoking-related illness. The aim of this study was to examine whether chronic health conditions moderate response to reduced nicotine content cigarettes (0.4, 2.4, 5.2, 15.8 mg/g of tobacco). This is a secondary analysis of a controlled clinical laboratory study that examined the acute effects of cigarettes varying in nicotine content among individuals especially vulnerable to smoking and tobacco dependence. Participants in the present study were categorized as having 0, 1-2, or ≥3 smoking-related chronic health conditions (i.e., chronic condition severity, CCS). Repeated-measures analysis of variance was used to examine whether CCS moderated response to cigarettes across measures of addiction potential (i.e., concurrent choice testing between nicotine dose pairs, Cigarette Purchase Task (CPT) performance, positive subjective effects), tobacco withdrawal, cigarette craving, and smoking topography. No main effects of CCS or interactions of CCS and nicotine dose were observed for concurrent choice testing, positive subjective effects, tobacco withdrawal, or smoking topography. Main effects of CCS were noted on the CPT with greater CCS being associated with less persistent demand. There was an interaction of CCS and nicotine dose on Factor 1 of the Questionnaire on Smoking Urges with the effects of dose significant only among those with 1-2 chronic conditions. Overall, we see minimal evidence that chronic condition severity affects response to reduced nicotine content cigarettes. A policy that reduces the nicotine content of cigarettes to minimally addictive levels may benefit smokers already experiencing smoking-related chronic conditions.