Nicotine Delivery of a Menthol-Flavored Heat-not-Burn Tobacco Product During Directed Use.

INTRODUCTION: IQOS was authorized by the U.S. Food and Drug Administration (FDA) as a modified-risk tobacco product. We conducted a pharmacokinetic study evaluating the nicotine delivery and subjective effects of IQOS use among current menthol cigarette smokers to better understand if IQOS is an acceptable cigarette alternative in light of the proposed menthol cigarette ban. AIMS AND METHODS: Participants were adult smokers of >4 menthol cigarettes per day. After 14-hour nicotine abstinence, participants were provided an IQOS device and menthol heatstick to puff every 20 seconds for a total of 14 puffs. Blood samples were collected at baseline and during active use to calculate nicotine boost from baseline to peak concentration. Nicotine withdrawal symptoms were collected before and after IQOS use. In addition, a modified Product Evaluation Scale for IQOS was collected after use. RESULTS: Participants (n = 8) were a mean age of 43.9 years, 63% were female, 88% identified as White, and they smoked a mean of 17.1 menthol cigarettes per day. After IQOS use, the mean nicotine boost obtained was 15.96 ng/mL (SD = 6.91) (range 9.31 to 30.55 ng/mL). Most (75%) participants reported enjoying use of the product "a lot" or greater and more than half (62.5%) reported reduced cigarette cravings. Most participants reported no side effects after use; however, two experienced dry mouth, three experienced dizziness, one experienced throat irritation, and one experienced headache. CONCLUSION: We found that directed use (14 puffs) of menthol IQOS delivered a mean nicotine boost of 15.96 ng/mL which reduced craving for a cigarette. The majority of participants enjoyed use of IQOS and reported mild side effects. IMPLICATIONS: Menthol IQOS delivered a sufficient dose of nicotine perceived as satisfying by menthol cigarette smokers and it reduced craving with mild side effects. Menthol IQOS has potential to serve as a less harmful alternative for menthol cigarette smokers. The availability of modified risk products like IQOS should be considered by FDA's Comprehensive Plan for Tobacco and Nicotine Regulation.

A Comparison of Mental Health Symptoms among Adults Who Vape Nicotine, Cannabis, or Both.

OBJECTIVES: Dual use of combustible cannabis and nicotine is related to worse mental health symptoms (MHS); however, little is known about MHS among those who vape cannabis and nicotine. The current study aimed to determine if dual use of cannabis and nicotine vapes is associated with worse MHS compared to single use and to identify correlates of MHS for dual users. METHODS: We used Amazon Mechanical Turk to survey adults (N = 492) who used nicotine or cannabis vapes in the past 30 days on stress, anxiety, depression, vape use behaviors and sociodemographic information. We conducted hierarchical linear regressions to compare MHS between dual vs. single substance vape use and to identify correlates of MHS, including sociodemographic variables and vape use characteristics. RESULTS: The final sample was 37.6% female, 87.6% White, and 11% Hispanic/Latinx with a mean age of 34.15 years. After controlling for sociodemographic characteristics and combustible product use, dual users had significantly higher mean MHS severity than single users. For dual users, younger age and being married were associated with higher symptoms of depression and stress. Holding a medical cannabis card was associated with higher anxiety symptoms. CONCLUSION: The findings suggest that dual use of cannabis and nicotine vapes is associated with worse MHS severity compared to single substance use.

Growing Healthy Hearts: a single-arm feasibility study of a digitally delivered gardening, cooking, and nutrition intervention for adults with risk factors for cardiovascular disease.

BACKGROUND: Food gardening may positively influence cardiovascular disease (CVD) risk-related behaviors. However, the vast majority of existing gardening interventions have used an in-person delivery model which has limitations for scalability. It is not known whether a digitally delivered gardening intervention would be feasible or acceptable to participants. The purpose of this pilot study was to assess the feasibility of a digitally delivered gardening intervention in three domains: participant acceptability, demand, and practicality. METHODS: A single-arm, pre-post-study design was used. Participants (n = 30) were aged 20 + with no plans to garden in the coming season and had at least 1 CVD risk factor. The intervention included ten 1-h video-conferencing sessions, written materials, and access to a study website. Content focused on gardening skills, cooking skills, and the Dietary Approaches to Stop Hypertension (DASH) diet. Feasibility outcomes included acceptability (post-program ratings), demand (session attendance rate), and practicality (ability to start a garden and grow F&V). The study was considered feasible if the following criteria were met: ≥ 70% rated the intervention as good or excellent, overall session attendance rate was ≥ 70%, and > 70% were able to start a garden and grow F&V. We also assessed pre-post-program changes in behavioral mediators (gardening confidence, gardening enjoyment, cooking confidence, and nutrition knowledge). Descriptive statistics were calculated. Pre-post differences were evaluated with means and 95% confidence intervals (95% CI). Effect sizes were calculated (Cohen's d). RESULTS: All feasibility criteria were met. A total of 93.3% of participants rated the intervention as good or excellent, 96% started a garden and grew F&V, and the overall session attendance rate was 81%. The largest mean pre-post changes were in gardening confidence (pre 7.1 [95% CI: 6.4, 7.9], post 9.0 [95% CI: 8.6, 9.5], Cohen's d = 1.15), gardening enjoyment (pre: 6.3 [95% CI: 5.9, 6.7], post: 7.5 [95% CI: 7.1, 7.9], Cohen's d = 1.69), and cooking self-efficacy (pre: 4.7 [95% CI: 4.3, 5.1], post: 7.7 [95% CI: 7.3, 8.0], Cohen's d = 3.0). CONCLUSION: A digitally delivered gardening intervention was feasible, acceptable to participants, and they had meaningful changes in behavioral mediators. The next step is to evaluate the impact of the intervention in a future randomized controlled trial.

Participant Preferences for the Development of a Digitally Delivered Gardening Intervention to Improve Diet, Physical Activity, and Cardiovascular Health: Cross-sectional Study.

BACKGROUND: Low dietary intake of fruits and vegetables and physical inactivity are 2 modifiable risk factors for cardiovascular disease. Fruit and vegetable gardening can provide access to fresh produce, and many gardening activities are considered moderate physical activity. This makes gardening interventions a potential strategy for cardiovascular disease risk reduction. Previously developed gardening interventions have relied on in-person delivery models, which limit scalability and reach. OBJECTIVE: The purpose of this study was to ascertain participant insight on intervention components and topics of interest to inform a digitally delivered, gardening-focused, multiple health behavior change intervention. METHODS: A web-based survey was delivered via Amazon Mechanical Turk (MTurk), including quantitative and open-ended questions. Eligible participants were aged ≥20 years, could read and write in English, were US residents, and had at least a 98% MTurk task approval rating. A multilevel screening process was used to identify and exclude respondents with response inattention, poor language fluency, or suspected automated web robots (bots). Participants were asked about their interest in gardening programming, their preferences for intervention delivery modalities (1-hour expert lectures, a series of brief <5-minute videos, or in-person meetings), and what information is needed to teach new gardeners. Comparisons were made between never gardeners (NG) and ever gardeners (EG) in order to examine differences in perceptions based on prior experience. Quantitative data were summarized, and differences between groups were tested using chi-square tests. Qualitative data were coded and organized into intervention functions based on the Behavior Change Wheel. RESULTS: A total of 465 participants were included (n=212, 45.6% NG and n=253, 54.4% EG). There was a high level of program interest overall (n=355, 76.3%), though interest was higher in EG (142/212, 67% NG; 213/253, 84.2% EG; P<.001). The majority of participants (n=282, 60.7%) preferred a series of brief <5-minute videos (136/212, 64.2% NG; 146/253, 57.7% EG; P=.16) over 1-hour lectures (29/212, 13.7% NG; 50/253, 19.8% EG; P=.08) or in-person delivery modes (47/212, 22.2% NG; 57/253, 22.5% EG; P=.93). Intervention functions identified were education and training (performing fundamental gardening and cooking activities), environmental restructuring (eg, social support), enablement (provision of tools or seeds), persuasion (offering encouragement and highlighting the benefits of gardening), and modeling (using content experts and participant testimonials). Content areas identified included the full lifecycle of gardening activities, from the fundamentals of preparing a garden site, planting and maintenance to harvesting and cooking. CONCLUSIONS: In a sample of potential web-based learners, participants were interested in a digitally delivered gardening program. They preferred brief videos for content delivery and suggested content topics that encompassed how to garden from planting to harvesting and cooking. The next step in this line of work is to identify target behavior change techniques and pilot test the intervention to assess participant acceptability and preliminary efficacy.

Effectiveness of smoking cessation interventions among persons with cancer: A systematic review.

OBJECTIVES: Continued smoking after cancer diagnosis is associated with worse outcomes, however, many persons diagnosed with cancer who smoke are unable to quit successfully. Effective interventions are needed to promote quitting in this population. The purpose of this systematic review is to understand the most effective interventions for smoking cessation among persons with cancer and to identify gaps in knowledge and methodology to suggest directions for future research. METHODS: Three electronic databases (The Cochrane Central Register of Controlled trials, MEDLINE, and EMBASE) were searched for studies of smoking cessation interventions among persons with cancer, published up to 1 July 2021. Title and abstract screening, full-text review, and data extraction was completed by two independent reviewers, via Covalence software, with any discordance resolved by a third reviewer. A quality assessment was completed using the Cochrane Risk of Bias Tool Version 2. RESULTS: Thirty-six articles were included in the review, including 17 randomized-controlled trials (RCTs) and 19 non-RCT studies. Of the 36 studies, 28 (77.8%) utilized an intervention that included both counseling and medication, with 24 (85.7%) providing medication to participants at no cost. Abstinence rates in the RCT intervention groups (n = 17) ranged from 5.2% to 75%, while the non-RCTs found abstinence rates ranging from 15% to 46%. Overall, studies met a mean of 2.28 out of seven quality items, ranging from 0 to 6. CONCLUSIONS: Our study highlights the importance of utilizing intensive combined behavioral and pharmacological interventions for persons with cancer. While combined therapy interventions seem to be the most effective, more research is needed, as current studies have several quality issues, including the lack of biochemical verification for abstinence.

A Comparison of Vaping Behavior, Perceptions, and Dependence among Individuals Who Vape Nicotine, Cannabis, or Both.

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.

Pilot randomized controlled trial evaluating the effect of random nicotine delivery on cigarettes per day and smoke exposure.

BACKGROUND: Many smokers report attempting to quit each year, yet most relapse, in part due to exposure to smoking-related cues. It is hypothesized that extinction of the cue-drug association could be facilitated through random nicotine delivery (RND), thus making it easier for smokers to quit. The current study aimed to evaluate the effects of RND on smoking cessation-related outcomes including cigarettes per day (CPD) and exhaled carbon monoxide (CO). METHODS: Participants were current smokers (>9 CPD) interested in quitting. Novel trans-mucosal, orally dissolving nicotine films, developed by Bionex Pharmaceuticals, were used in the study. The pharmacokinetic profile of these films was assessed in single (Experiment 1) and multiple-dose (Experiment 2) administrations prior to the smoking cessation study (Experiment 3). In Experiment 3, participants were randomized 1:1:1 to recieve 4 nicotine films per day of either: placebo delivery (0 mg), steady-state delivery (2 mg), or random nicotine delivery (RND) (0 mg or 4 mg). After two weeks, participants were advised to quit (target quit date, TQD) and were followed up 4 weeks later to collect CPD and CO and to measure dependence (Penn State Cigarette Dependence Index; PSCDI) and craving (Questionnaire of Smoking Urges; QSU-Brief). Means and frequencies were used to describe the data and repeated measures ANOVA was used to determine differences between groups. RESULTS: The pharmacokinetic studies (Experiment 1 and 2) demonstrated that the films designed for this study delivered nicotine as expected, with the 4 mg film delivering a nicotine boost of approximately 12.4 ng/mL across both the single and the multiple dose administration studies. The films reduced craving for a cigarette and were well-tolerated, overall, and caused no changes in blood pressure or heart rate. Using these films in the cessation study (Experiment 3) (n = 45), there was a significant overall reduction in cigarettes smoked per day (CPD) and in exhaled CO, with no significant differences across groups (placebo, steady-state, RND). In addition, there were no group differences in dependence or craving. Adverse events included heartburn, hiccups, nausea, and to a lesser extent, vomiting and anxiety and there were no differences across groups. CONCLUSION: Overall, this pilot study found that RND via orally dissolving films was feasible and well tolerated by participants. However, RND participants did not experience a greater reduction in self-reported CPD and exhaled CO, compared with participants in the steady-state and placebo delivery groups. Future studies to evaluate optimal RND parameters with larger sample sizes are needed to fully understand the effect of RND on smoking cessation-related outcomes.

Intentions and Attempts to Quit JUUL E-Cigarette Use: The Role of Perceived Harm and Addiction.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Evidence from an fMRI study that dessert-flavored e-cigarettes engage taste-related, but not smoking-related, brain circuitry for female daily smokers.

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) 2022 APA, all rights reserved).

Impact of a Prescription Produce Program on Diabetes and Cardiovascular Risk Outcomes.

OBJECTIVE: To evaluate the impact of a fruit and vegetable prescription program on diabetes and cardiovascular risk outcomes. DESIGN: Single-arm pre-post study. SETTING: Primary care clinic in a community-based hospital. PARTICIPANTS: Adults with type 2 diabetes (n = 97), aged > 18 years, with hemoglobin A1c (HbA1c) ≥ 7.0%, and a body mass index (BMI) of ≥ 25 kg/m2. INTERVENTION: Over 7 months, participants received monthly group-based diabetes self-management education (DSME) and monthly vouchers ($28-$140/month) redeemable for fruits and vegetables at local markets. ANALYSIS: Biomarker changes (HbA1c, BMI, and blood pressure) were assessed with paired t tests. Voucher distribution and redemption were tracked, and voucher redemption rates were calculated. Linear mixed-effect regression models tested associations between biomarkers, voucher redemption rates, and participant characteristics. RESULTS: There was a -1.3% (P < 0.001) postprogram change in HbA1c. Reduced HbA1c was associated with higher voucher redemption rates (P = 0.032) and a change in diabetes medications (P = 0.003). There were no associations with BMI, but blood pressure was positively associated with voucher redemption. CONCLUSIONS AND IMPLICATIONS: Fruit and vegetable prescription programs may improve diabetes outcomes by incentivizing DSME uptake and retention. Future randomized trials are warranted to identify strategies to improve DSME engagement and voucher redemption rates and assess mechanisms through which these programs influence health outcomes.

Tobacco Use Changes and Perceived Health Risks among Current Tobacco Users during the COVID-19 Pandemic.

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.

COVID-19 Vaccination Uptake and Hesitancy Among Current Tobacco Users.

Novel mRNA vaccines have been developed and were first distributed to high-risk individuals (including smokers) in the United States starting in December 2020 to combat the coronavirus (COVID-19) pandemic. Over one-half of the U.S. adult population has received at least 1 dose of a COVID-19 vaccine, but many others have reported hesitation about becoming vaccinated. We examined COVID-19 vaccine uptake and hesitancy from a convenience sample of Pennsylvanian adult smokers in April 2021, approximately 3 months after tobacco users were eligible to receive vaccination in the state. Participants (n = 231) were 23.4% male, 90.5% white, and had a mean age of 48.1 (SD = 11.9) years. All participants were current tobacco users, with the majority reporting current cigarette smoking (90.9%) with an average of 16 (SD = 8.1) cigarettes smoked per day. Nearly 60% (n = 137) reported receiving at least 1 dose of the vaccine and of those who did not (n = 94), 84% (n = 79) said they were somewhat or very unlikely to get a vaccine. Those who were unvaccinated were more likely to not consume news about COVID-19 (chi-square P-value < .01) and less likely to believe government news sources as reliable information for COVID-19 (chi-square P-value < .01). Qualitative responses among those who were vaccine hesitant expressed concerns about the lack of research on the vaccine, distrust of the safety of the vaccine, and fears about side effects. Understanding vaccine hesitancy among tobacco users can help develop targeted communication strategies and directly address concerns to promote vaccination among this population who may be at an increased risk of severe complications from COVID-19.

Growing Healthy Hearts: Gardening Program Feasibility in a Hospital-Based Community Garden.

OBJECTIVE: To assess feasibility in terms of acceptability, demand, and participant willingness to engage in gardening activities during an intervention delivered at a hospital-based community garden for patients at risk for cardiovascular disease (CVD). METHODS: In a pre-post study design, 15 adults with ≥1 CVD risk factor attended 5 education sessions over 12 weeks, tended garden beds, and completed questionnaires related to program acceptability and future gardening intentions. Interviews were used to identify areas for programmatic improvement. RESULTS: Most participants rated the intervention as good or excellent (93%), and 73% indicated that it was likely that they would garden next season. Areas for programmatic improvement included creating opportunities for group discussion, providing online materials, and offering more cooking and gardening content. CONCLUSIONS AND IMPLICATIONS: Gardening as an intervention for adult patients with CVD risk factors is feasible. Assessment of the effect of gardening on health outcomes and dietary intake is warranted.

Response to Flavored Cartridge/Pod-Based Product Ban among Adult JUUL Users: "You Get Nicotine However You Can Get It".

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 < 0.01), while there was a significant increase in the use of menthol pods (6.6%, 26.6%, 37.2%) (p < 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.