Associations of educational and marketing messages with beliefs about nicotine and reduced nicotine cigarettes.

INTRODUCTION: Widespread misperceptions about nicotine may have unintended effects on public health. We examined associations between existing messages about nicotine or tobacco and beliefs about nicotine and reduced nicotine cigarettes (RNC). METHODS: 2962 U.S. 18-45-year-olds were randomized in a May 2022 web-based survey to view one of 26 text-based messages about tobacco or nicotine from three sources: ongoing research (n = 8), messages authorized by FDA for VLN cigarettes (n = 6), and FDA's "From Plant to Product to Puff" campaign (n = 12); six messages from FDA's campaign did not reference nicotine and were treated as the reference source. Analyses examined associations between messages, grouped by source and individually, with beliefs about nicotine and RNC addictiveness and harms. RESULTS: Relative to FDA messages that did not reference nicotine, all message sources were associated with greater odds of a correct belief about nicotine (Odds Ratios [ORs] = 1.40-1.87, p's < 0.01); VLN messages were associated with greater correct beliefs about RNC addictiveness (b = 0.23, p < .05). No campaign produced greater correct beliefs about RNC harms. At the individual level, only five messages were associated with a correct belief about nicotine (ORs = 2.12-2.56, p-values < .01), and one with correct beliefs about RNC harms (b = 1.09, p < .05), vs. the reference message. CONCLUSIONS: Few existing messages improved understanding of the risks of nicotine separately from the risks of combustible products. Communication research is needed to promote greater public understanding of nicotine while minimizing unintended effects on nicotine and tobacco use.

The impact of exposure to FDA e-cigarette authorization messages on product perceptions and interest - an experiment with adults who smoke and youth.

INTRODUCTION: In the United States, e-cigarettes have entered a new regulatory era, needing authorizations from FDA to remain on or enter the marketplace. This study explored the impact of e-cigarette authorization messages on product perceptions and interest. METHODS: We conducted an online experiment in June 2022 with nationally-representative samples of adults (21+) who smoke cigarettes (n=866) and youth ages 15-20 (n=859). They were randomized to one of five conditions: viewing an ad for a fictional e-cigarette brand with no reference to FDA (control), an ad with an "authorized for sale by FDA" claim in varying presentation styles (plain text, FDA "approved" stamp, FDA logo), or reading a fictional news excerpt about the product's authorization plus control ad. We compared group differences on product interest, susceptibility, harm perceptions and message perceptions. RESULTS: Among adults who smoke, there were no effects on product interest nor susceptibility, but ratings of the product's harmfulness compared to cigarettes were lower among those in the news versus control condition (ß=-0.25, p=.04). Among youth, odds of susceptibility were higher among ever e-cigarette users who viewed the ad with the FDA logo authorization message relative to the control ad (OR=6.3, 95% CI:1.67-23.9, p<0.01). About 40% of all participants agreed the authorization claim makes them think the product is safe to use, but fewer (14-19%) agreed it makes them more interested in trying it. CONCLUSIONS: FDA e-cigarette authorization messages may impact some beliefs about product harm. More research is needed to track potential impacts on product use. IMPLICATIONS: This study provides new data about the potential impact of messages about FDA authorization of e-cigarette products (presented as ad claims or a news story) on authorized product perceptions, interest and susceptibility among adults who smoke cigarettes and youth. Our results suggest that FDA e-cigarette authorization messages may impact harm-related beliefs among adults who smoke and product susceptibility among youth who have ever used e-cigarettes before, though real-world effects are likely to be impacted by message type and format, and perceived message source and credibility. Authorization messages are likely to be misinterpreted as "FDA approval" by some; therefore, providing clarifications about authorization meaning and standards are relevant where possible.

Switching from cigarettes to IQOS: the relative importance of IQOS-associated reward, reinforcement and abstinence relief.

INTRODUCTION: This study investigated whether IQOS, a heated tobacco product, can fully substitute for combustible cigarettes and the factors that promote substitution. METHODS: Adults who smoked cigarettes daily (N=90; 21-65 years) completed a baseline ad-lib smoking period (days 1-5), two laboratory visits (days 6-7) and a 2-week period where they were instructed to switch from smoking cigarettes to using IQOS 3.0 (days 8-21). Mixed-effect modelling estimated the changes in cigarettes per day (CPD) and the percentage of baseline CPD substituted by HeatSticks during the switch period. Predictors included IQOS-associated subjective reward, relative reinforcing value, craving relief and withdrawal relief. RESULTS: Participants reduced their CPD to about 30% of their baseline smoking rate by the end of the 14-day switch period (p<0001). A lower versus higher reinforcing value of smoking relative to IQOS (RRV; break point <5 vs ≥5) predicted greater reductions in CPD (ß=-1.31 (95% CI -2.35 to -0.27) p=0.013). Initially, IQOS use was 72% of the baseline smoking rate (ß=71.64 (95% CI 42.79 to 100.48) p<0.0001) and climbed by 0.8% per day (ß=0.82 (95% CI 0.01 to 1.64) p=0.05), for an average substitution rate of 83%. The subjective reward of IQOS was the only predictor of a higher substitution rate (ß=4.26 (95% CI 1.03 to 7.50) p=0.01). CONCLUSIONS: IQOS fully substituted for cigarettes in ~20% of people who were not immediately interested in quitting smoking while the remainder significantly reduced their smoking. Positive reinforcing effects of IQOS foster use and the transition away from combustible cigarettes. TRIAL REGISTRATION NUMBER: NCT05076708.

Effects of IQOS health warnings and modified risk claims among young adult cigarette smokers and non-smokers.

INTRODUCTION: Heated tobacco products, including Marlboro IQOS, are available globally. In the USA, IQOS was authorised to be advertised with claims about reduced toxicant exposure relative to cigarettes. The effects of such modified risk claims and health warnings have not been studied among young adult cigarette smokers and non-smokers. METHODS: In 2020, US young adult (18-30 years, n=1328) cigarette smokers and non-smokers viewed an IQOS ad in a 4 (modified risk claim variations or none) by 3 (warning variations or none) between-subjects experiment. Outcome measures assessed perceived credibility and effectiveness of the health or risk message for discouraging IQOS use, perceived harms, efficacy beliefs, and IQOS use intentions. RESULTS: Smokers reported significantly higher (p<0.05) perceived credibility, lower perceived effectiveness, higher efficacy beliefs about switching to IQOS and higher intentions to use IQOS than non-smokers. Among smokers, health warnings increased perceived credibility (p<0.001) and effectiveness (p<0.05), but claims did not affect outcomes examined. Among non-smokers, warnings and claims increased perceived credibility, and warnings increased perceived effectiveness (p<0.003). The reduced exposure claim increased non-smokers' intentions to use IQOS (b=0.40, 95% CI 0.07 to 0.73). CONCLUSIONS: Among young adult smokers, health warnings increased perceived effectiveness at discouraging IQOS use and perceived credibility. Among non-smokers, warnings and claims increased perceived credibility and warnings increased perceived effectiveness, but the Food and Drug Administration-authorised reduced exposure claim increased intentions to use IQOS. Research is warranted to understand how the content of modified risk claims and health warnings for IQOS affects IQOS use in this population.

Influence of cigarillo packaging characteristics on young adults' perceptions and intentions: findings from three online experiments.

OBJECTIVES: Packaging is an important component of tobacco marketing that influences product perceptions and use intentions. However, little research exists on cigar packaging. We leveraged variability in existing Swisher Sweets cigarillo packaging to extend the evidence base. METHODS: Between 2017 and 2019, we conducted three online experiments with 774 young adult past-year cigar smokers recruited via Amazon Mechanical Turk. After viewing Swisher package images that differed by flavour descriptor and/or colour, participants rated them on perceptions and purchase intentions. In study 1, participants viewed one of four cigarillos ('Wild Rush Encore', 'Wild Rush Limited', 'Twisted Berry' and 'Strawberry'). In study 2, participants viewed two different watermelon rum-flavoured cigarillos ('Boozy Watermelon' and 'Island Madness'). In study 3, participants viewed two of three 'Wild Rush' cigarillo versions ('Encore' with or without an explicit flavour descriptor or 'Limited'). RESULTS: In study 1, more participants perceived 'Twisted Berry' and 'Wild Rush Limited' as tasting good and less harsh tasting compared with 'Wild Rush Encore'. In study 2, compared with 'Island Madness', more participants perceived 'Boozy Watermelon' as tasting good, less harsh tasting and used by younger users but less by masculine users; female participants were more likely to purchase 'Boozy Watermelon'. In study 3, participants perceived 'Wild Rush Encore' with the explicit flavour descriptor as tasting better than packages without and being used by younger users but less by masculine users. CONCLUSIONS: Variations in cigarillo packaging, even among cigarillos with the same flavour, may have differential consumer appeal, suggesting packaging features should be considered in cigar product regulation.

Effects of advertising features on smokers' and non-smokers' perceptions of a reduced nicotine cigarette modified risk tobacco product.

INTRODUCTION: Research is needed to determine the impact of marketing on perceptions and use of reduced nicotine content (RNC) cigarettes, particularly as US regulators have permitted the sale of an RNC cigarette modified risk tobacco product (MRTP) that seeks further authorisation to advertise using modified risk claims. This study examined the effects of two advertising elements (product name and disclaimer content) on perceptions of an RNC cigarette MRTP. METHODS: Adult participants (n=807, 28.7% smokers, 58.2% male, 74.2% non-Latinx white) completed an online MTurk survey. Participants were randomised to view one of six RNC cigarette advertisements, using a 2×3 between-subject factorial design to manipulate product name ('Moonlight' vs 'Moonrise') and disclaimer content (industry-proposed: 'Nicotine is addictive. Less nicotine does NOT mean a safer cigarette' vs focused: 'Less nicotine does NOT mean a safer cigarette' vs no content), then completed recall and product perception questionnaires. RESULTS: All participants who viewed the industry-proposed disclaimer (vs no content) perceived greater addiction risk (p's<0.05). Non-smokers who viewed this disclaimer also perceived greater health risks and held fewer false beliefs (p's<0.05). Smokers who viewed Moonlight (vs Moonrise) ads perceived lower health risks (p<0.05). CONCLUSIONS: Disclaimer content may effectively inform consumers about addiction risk of a new RNC cigarette MRTP, and further inform non-smokers about health risks. This element, however, had little effect on perceived health risks among smokers, among whom the Moonlight product name was associated with health risk misperceptions similar to the banned 'light' descriptor.

Causal effects of point-of-sale cigarette promotions and subjective social status on cigarette craving: a randomised within-person experiment.

BACKGROUND: Cigarette smoking continues to be a leading cause of preventable deaths in the USA, in part because the USA has not adopted the WHO Framework Convention on Tobacco Control. One way the tobacco industry counteracts tobacco control policies is by heavily advertising cigarettes at the point of sale in retailers (eg, at the cash register) and by offering discounts on cigarettes. DESIGN: A within-subject experimental design with adults who smoke cigarettes daily (n=281) investigated whether: (1) exposure to images of cigarette promotions in an online experiment is associated with greater cigarette craving relative to viewing images of non-smoking cues, and (2) if exposure to images of point-of-sale cigarette promotions with a discount (vs without) increases cigarette craving. The study also examined how participants' subjective social status (compared with others in the USA) relates to cigarette craving after exposure to images of cigarette promotions with and without a discount. RESULTS: In an online experiment, exposure to images of smoking cues, including point-of-sale cigarette promotions, elicited greater craving relative to non-smoking cues (all p<0.001). In addition, images of promotions with a discount elicited higher levels of craving compared with those without a discount (b=0.09, p=0.001). Although participants with a higher (vs lower) subjective social status craved cigarettes less overall (b=-0.12, p=0.012), there was no difference in their craving between images of promotions with and without a discount, while craving was higher for images of promotions with a discount than without for participants with higher subjective social status (b=0.06, p=0.021). CONCLUSION: Viewing images of point-of-sale cigarette promotions can causally increase cravings to smoke, which may also apply to real-world retail settings that display cigarette promotions. Restricting point-of-sale promotions generally, and discounts specifically, could help reduce cigarette smoking and address tobacco use disparities in the USA.

Effect of nicotine corrective messaging on nicotine-related beliefs in US adults: a randomised controlled trial.

INTRODUCTION: Widespread misperceptions of the health risks of nicotine could undermine the public health benefits of the Food and Drug Administration's actions, including modified risk tobacco product authorisations and a reduced nicotine product standard for cigarettes. METHODS: 794 US adults (aged 18+) in NORC's AmeriSpeak panel participated in a randomised controlled trial in Spring 2021 to test the effect of three exposures to eight nicotine corrective messages (NCM) on beliefs about nicotine, nicotine replacement therapy (NRT), e-cigarettes and reduced nicotine content (RNC) cigarettes at 3-month follow-up. Analyses conducted in 2022 examined the effect of study condition (NCM (n=393) vs no message control (n=401)) on nicotine beliefs, use intentions and use of nicotine and tobacco products. RESULTS: Exposure to three NCM doses reduced nicotine (b=-0.33; 95% CI -0.60, -0.07), NRT (b=-0.49; 95% CI -0.85, -0.14), e-cigarette (b=-0.32; 95% CI -0.59, -0.05) and RNC cigarette false beliefs (b=-0.64; 95% CI -1.26, -0.02) compared with the control, controlling for baseline beliefs. Baseline tobacco use and concern about nicotine addiction attenuated intervention effects on false beliefs about RNC cigarettes. There were few intervention effects on intention or use of nicotine and tobacco products. CONCLUSIONS: Repeated exposure to NCM was necessary to reduce false beliefs about nicotine and tobacco products. Future studies will improve understanding of the dose and duration of nicotine education needed to shift intentions and behaviour, as well as tailored content for tobacco product users to achieve similar reductions in false beliefs as non-users. TRIAL REGISTRATION NUMBER: NCT04805515.

IQOS print magazine advertising characteristics and reach before and after FDA authorisation as a modified risk tobacco product.

INTRODUCTION: IQOS is a heated tobacco product that was authorised as a modified risk tobacco product (MRTP) in July 2020. While it was removed from the US market in 2021 for legal reasons, as the first tobacco product to receive an 'exposure modification' MRTP order, surveillance of IQOS marketing is needed to inform regulation and policy for future MRTPs. The purpose of this study is to expand the current research on IQOS advertising in the USA by examining content and readership characteristics of IQOS ads in print magazines before and after US Food and Drug Administration MRTP authorisation. METHODS: We merged content analysis data with Kantar Media data on magazine placement and expenditures. Magazine readership data were obtained from MRI-Simmons. We compared data from pre-MRTP authorisation with data post-MRTP authorisation. This study was conducted in 2021. RESULTS: There was one unique ad and there were 13 observations pre-MRTP, and eight unique ads and 132 observations post-MRTP. Compared with pre-MRTP ads, more post-MRTP ads featured Marlboro HeatSticks, including Amber HeatSticks, and featured people. All ads contained a warning label-most warning labels were cigarette specific. IQOS ads were featured in magazines that are especially popular among women. CONCLUSIONS: After receiving MRTP authorisation, IQOS increased ad expenditures in print magazines with a readership comprised of primarily women. If IQOS returns to the US market, it will be important for tobacco control to monitor their advertisement content, placement, and expenditures.

Effects of cigarette package colors and warning labels on marlboro smokers' risk beliefs, product appraisals, and smoking behavior: a randomized trial.

OBJECTIVE: Plain packaging and graphic warning labels are two regulatory strategies that may impact cigarette risk beliefs and reduce consumption, but data are needed to better understand how smokers respond to such regulations. METHODS: Adult, daily, Marlboro non-menthol smokers (Red [n = 141] or Gold [n = 43]) completed a mixed factorial randomized trial. Participants smoked their usual cigarettes during baseline (5-days) and were randomized to receive cigarette packs with a warning label manipulation (graphic vs. text-only). Within each warning label condition, participants completed three within-subjects pack color manipulations (red, gold, plain), each lasting 15 days. Participants were blinded to the fact that all packs contained their usual cigarettes. Mixed-effects models examined between- and within-subject differences on risk beliefs, product perceptions, and smoking behavior. RESULTS: Warning type and package color did not impact cigarette consumption or subjective ratings. However, use increased in all conditions (2.59-3.59 cigarettes per day) relative to baseline. While smokers largely held correct risk beliefs at baseline (Mean = 6.02, SE = 0.17, Range:0-8), the cumulative number of incorrect or uncertain cigarette risk beliefs increased from baseline in all pack color manipulations in the text (IRR range = 1.70-2.16) and graphic (IRR range = 1.31-1.70) warning conditions. Across all pack color periods, those in the graphic (vs. text) warning condition had reduced odds of reporting their study cigarettes as 'safer' than regular cigarettes (OR range = 0.22-0.32). CONCLUSIONS: Pack color modification may increase uncertainty about several key cigarette risk beliefs, though graphic warnings may attenuate these effects. Regulatory agencies could consider supporting policy changes with information campaigns to maximize public knowledge. TRIAL REGISTRATION: November 25, 2014; Registration number: NCT02301351.

Effects of reduced nicotine content cigarette advertising with warning labels and social media features on product perceptions among young adults.

This study sought to understand reactions to very low nicotine (VLN) cigarette advertising compared with conventional cigarette advertising with consideration of warning labels and social media context. The online experimental study recruited young adult cigarette smokers and nonsmokers (N = 1,608). Participants completed a discrete choice task with a 2 × 2 × 3 mixed design: brand, (VLN, Marlboro), context (Ad only, Ad on social media), and warning (Text-only, Well-known risk pictorial, or Lesser-known risk pictorial). Participants made choices about attention, appeal, harm, buying, and quitting intentions. Social media context increased attention and appeal. A well-known risk pictorial warning outperformed a text-only warning. Smokers had increased odds of quit intentions for VLN ads, yet nonsmokers had increased intentions to buy cigarettes on social media with a text-only warning. Results indicate differences in how young adults react to cigarette ads on social media, especially with the warnings they portray.

Mediational Effects on Motivation to Quit Smoking After Exposure to a Cigarette Pictorial Warning Label Among Young Adults.

BACKGROUND: Young adults are vulnerable to cigarette package marketing. Pictorial warning labels are recommended for tobacco control. Research should address questions raised in legal challenges including causal mechanisms. Evidence is mixed and understudied among young adults (e.g., discrete emotions and risk perceptions). PURPOSE: This study investigated mediators of pictorial warning label effects on motivation to quit smoking among young adult smokers. METHODS: This study analyzed data from a randomized trial with a 4 week exposure to a cigarette pictorial warning among young adult smokers (N = 229) aged 18-30 with assessments at baseline, immediately post-intervention, and 3 months. Mediation analyses used latent change scores to test the effects post-intervention on fear, anger, and risk perceptions. We also examined whether post-intervention measures predicted change in motivation to quit smoking at 3 months. The first model assessed aggregate risk perceptions and the second model assessed discrete risk perceptions (deliberative, affective). RESULTS: Pictorial warning label exposure led to increases in fear which led to increased motivation to quit smoking for the first (B = 0.12, 95% CI = 0.04, 0.26) and second (B = 0.12, 95% CI = 0.03, 0.25) model. Exposure modestly increased motivation to quit by way of fear and affective risk perceptions (B = 0.01, 95% CI = 0.00, 0.04). Exposure had a direct relationship on increased motivation to quit as well. CONCLUSIONS: Findings demonstrate factors contributing to change in motivation to quit smoking among young adult smokers after pictorial warning label exposure. Affective processes are mediators of pictorial warning label effects.

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

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

Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes.

The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerström Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes.

Educating the Public on the Health Risks of Very Low Nicotine Content Cigarettes: Results From a US-Based Convenience Sample.

INTRODUCTION: US FDA issued an advance notice of proposed rulemaking to reduce nicotine in cigarettes. To maximize the benefits of this potential standard, very low nicotine content (VLNC) cigarettes must be communicated in a way that does not result in misperceptions. AIMS AND METHODS: Adults (n = 567 who smoke; n = 610 non-smokers) from an online platform were randomized to a control message previously associated with accurate addictiveness perceptions of VLNC cigarettes but health misperceptions or to one of five messages that also included messaging on nicotine morbidity effects or VLNC cigarettes morbidity or mortality effects. p value <.01 was significant. RESULTS: In participants who smoke, perceived lung cancer risk (responses: 1, very little risk to 10, very high risk) if smoked VLNC cigarettes regularly was higher in conditions that communicated mortality effects of VLNC cigarettes compared to the control (7.12-7.18 vs. 5.97, p values < .01). In non-smokers, perceived lung cancer risk was higher in all five message conditions when compared with the control (7.58-8.22 vs. 6.35, p values < .01). Proportion who responded accurately (ie, False) to the statement Cigarettes with 95% less nicotine are safer than cigarettes with normal nicotine levels was higher in conditions describing VLNC morbidity or mortality effects when compared with the control in both participants who smoke (52.04-67.37% vs. 30.85%, p values < .01) and do not smoke (62.50-72.38% vs. 32.00%, p values < .01). CONCLUSIONS: Messaging on mortality effects of VLNC cigarettes (ie, cigarettes with 95% less nicotine are as deadly as current cigarettes) was associated with more accurate perceptions of the health risks of VLNC cigarettes than the control; however, misperceptions remained in one-third of participants. IMPLICATIONS: One approach to communicating a VLNC cigarette standard to the public is to include messaging on the mortality effects of VLNC cigarettes. However, further study and possible refinement of this message condition are recommended since approximately one-third of participants exposed to this message still perceived VLNC cigarettes to be safer than normal nicotine content cigarettes.

Progesterone Increases Nicotine Withdrawal and Anxiety in Male but Not Female Smokers During Brief Abstinence.

INTRODUCTION: Although exogenous progesterone may hold promise as a treatment for nicotine use disorders, it is unclear whether it is similarly effective in males and females. This study examined the effects of progesterone on nicotine use disorder comprehensively using behavioral, psychological, and neural measures in male and female smokers exposed to brief abstinence. AIMS AND METHODS: Thirty-three male and 33 female non-treatment-seeking smokers participated in a double-blind, randomized, placebo-controlled crossover study of 200 mg of progesterone or placebo daily over a four-day abstinence period. Smoking behavior and subjective effects of nicotine were assessed at baseline and after final drug administration. Nicotine withdrawal, smoking urges, mood states, and neural response to smoking cues were measured at baseline, after the first drug administration, and after the final drug administration. RESULTS: No main effect of drug (progesterone vs. placebo) emerged for any outcome. Significant sex by drug interactions emerged for nicotine withdrawal (p = .020), perceived strength of nicotine (p = .040), and perceived bad effects of nicotine (p = .029). Males receiving progesterone reported worse nicotine withdrawal (p = .046) and a trend towards decreased bad effects of nicotine (p = .070). Males on progesterone also reported greater tension and anxiety relative to placebo (p = .021). Females on progesterone perceived nicotine's effects as being stronger relative to placebo (p = .046). CONCLUSIONS: Progesterone causes sex-dependent effects on smoking-related outcomes during brief abstinence. Specifically, progesterone in males may increase rather than decrease nicotine withdrawal and negative affect during abstinence, potentially hindering efforts to quit smoking. IMPLICATIONS: In male and female smokers undergoing a brief period of abstinence, we examined the effects of progesterone on smoking outcomes. While progesterone had limited effects in female smokers, in males, it worsened nicotine withdrawal and negative affect. Our findings emphasize the importance of analyzing sex differences in future studies examining progesterone as a potential treatment and suggest that progesterone in males could potentially exacerbate aspects of nicotine dependence. CLINICALTRIALS.GOV REGISTRATION: NCT01954966. https://clinicaltrials.gov/ct2/show/NCT01954966.

The role of IQOS risk perceptions on cigarette smoking behaviours: results from a prospective pilot study.

BACKGROUND: IQOS is a heated tobacco product marketed as an alternative to combustible cigarette smoking. Little is known about cigarette smokers' IQOS health risk perceptions and if these risk perceptions impact IQOS use and cigarette smoking behaviour. METHODS: Adult, daily, non-treatment-seeking cigarette smokers (n=27), naïve to IQOS, were recruited from Philadelphia, Pennsylvania, USA. Participants were introduced to IQOS and then completed measures of risk perceptions. Participants were given an IQOS 2.4 holder, charger and HeatSticks, and asked to switch completely from cigarettes to IQOS for 14 days. The effects of risk perceptions on changes in IQOS use, cigarettes per day (CPD), the substitution of IQOS for cigarettes and motivation to quit smoking were evaluated. RESULTS: Over the 14-day switch period, CPD significantly decreased (B=-0.18, 95% CI=-0.26 to -0.09, p<0.0001), IQOS use significantly increased (B=0.02, 95% CI=0.00 to 0.03, p=0.042), as did the percentage IQOS HeatSticks that replaced CPD (B=0.02, 95% CI=0.01 to 0.03, p=0.005). Participants who perceived IQOS as less risky than cigarettes used fewer IQOS HeatSticks per day. A lower percentage of IQOS HeatStick substitution for cigarettes was observed for participants with higher versus lower risk perceptions (B=-0.14, 95% CI=-0.28 to -0.01, p=0.042). Motivation to quit increased from a mean of 5.53 to 6.79 on the contemplation ladder from baseline to day 14 (B=1.26, 95% CI=0.54 to 1.97, p<0.001). CONCLUSIONS: Smokers reduced their smoking rate and increased motivation to quit smoking while using IQOS. IQOS risk perceptions did not directly account for reductions in smoking, although they may contribute indirectly through increased IQOS use.

Shedding 'light' on cigarette pack design: colour differences in product perceptions, use and exposure following the US descriptor ban.

INTRODUCTION: Many countries removed misleading descriptors (eg, 'light,' 'mild') from cigarette packaging because they falsely conveyed messages of reduced risk. It is unclear if relabelled products currently promote misperceptions or differences in product use and toxicant exposure. We compared product perceptions, use and exposure between a US sample of Marlboro Gold (formerly 'light') and Red smokers. METHODS: 240 non-treatment-seeking adult daily Marlboro smokers (70% male, 71% White, mean cigarettes/day=16.4 (SD=8.3)) completed two laboratory sessions over a 5-day period. During sessions, participants smoked two cigarettes through a topography device to capture their puffing behaviour, provided precigarette and postcigarette carbon monoxide (CO) assessments, and completed risk perception and subjective rating questionnaires. Self-reported cigarettes per day were verified via daily filter collection; urine collected at the end of the period was assayed for nicotine metabolites. RESULTS: Gold (n=49) smokers were more likely than Red (n=191) to incorrectly believe their cigarettes had less nicotine and tar than regular cigarettes (ps<0.001), and rated them as weaker, less harsh, and mild tasting (ps<0.05). Differences between Red and Gold smokers in cigarettes per day and puffing behaviours trended towards significance (ps<0.1). Notably, there were no group differences on CO boost or total nicotine equivalents (ps>0.1). CONCLUSIONS: Misperceptions about nicotine and tar exist years after rebranding Marlboro Lights as Marlboro Gold. Biological results support that Gold smokers do not have lower toxicant exposure. The US should consider comprehensive packaging or product design regulations to properly inform smokers of product risks.Trial registeration number NCT02301351.

Tobacco minimum packaging policy to reduce cigarillo use among young people: results of an experimental study.

OBJECTIVE: The Food and Drug Administration has the authority to set a minimum for cigar pack size, a product feature linked to price. This study examined the effects of cigarillo package size and price on young adults' smoking and purchase intentions. DESIGN: Young adults (n=1032) 18-30 years old who smoked cigarillos in the past 12 months completed an online 3×2 within-subjects experiment testing the effects of cigarillo pack size (1, 2, 5) and price (actual price, standardised price per stick) on intentions to purchase and smoke cigarillos. We modelled the main effects and interactions of pack size and price on intentions to buy and smoke cigarillos overall and by cigarillo use frequency. RESULTS: Intentions to buy and smoke were strongest for lower priced singles and two packs compared with higher priced five packs. Under standardised price conditions, participants preferred larger packs, but under actual pricing conditions smaller packs, especially two packs, were preferred. Participants who smoked cigarillos less than monthly were more likely to buy and smoke the least expensive products (buy: singles actual price adjusted OR (aOR)=4.51, 95% CI 3.76 to 5.42; two packs actual price aOR=9.76, 95% CI 8.11 to 11.75; five packs standardised price aOR=3.17, 95% CI 2.89 to 3.48) with the strongest preference for two packs and singles. CONCLUSIONS: Young adult cigarillo smokers prefer smaller packs in conditions where pricing incentivises smaller packs. Minimum pack size policies may reduce the appeal of cigarillos among young adults, especially less frequent cigarillo smokers. Pack size policy should take into consideration price, and ideally these two factors should be addressed together.

Longitudinal effects of cigarette pictorial warning labels among young adults.

Young adults are influenced by cigarette package marketing. Pictorial warning labels are a recommended intervention. Evidence demonstrates pictorial warnings impact negative emotion, risk perceptions, and motivation to quit smoking, but there is limited research on their effects over time. This study analyzes data from a randomized trial of young adult smokers (N = 229) exposed to a pictorial or text-only cigarette warning. We assessed changes in fear, anger, risk perceptions, and motivation to quit smoking after 4 weeks using latent change score modeling and over 3 months using latent growth modeling. Latent change results showed exposure was associated with increases in fear, anger, and motivation to quit after 4 weeks. Latent growth showed exposure was associated with increases in motivation to quit smoking over 3 months, but not other outcomes. Findings suggest pictorial warning labels produce an emotional response and increase motivation to quit among young adult smokers.