Consolidated guidance for behavioral intervention pilot and feasibility studies.

BACKGROUND: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. METHODS: To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. RESULTS: A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. CONCLUSION: We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

Prevalence and perceptions of flavour capsule cigarettes among adults who smoke in Brazil, Japan, Republic of Korea, Malaysia and Mexico: findings from the ITC surveys.

INTRODUCTION: The global market of flavour capsule cigarettes (FCCs) has grown significantly over the past decade; however, prevalence data exist for only a few countries. This study examined prevalence and perceptions of FCCs among adults who smoke across five countries. METHODS: Cross-sectional data among adults who smoked cigarettes came from the International Tobacco Control Policy Evaluation Project Surveys-Brazil (2016/2017), Japan (2021), Republic of Korea (2021), Malaysia (2020) and Mexico (2021). FCCs use was measured based on reporting one's usual/current brand or favourite variety has flavour capsule(s). Perceptions of the harmfulness of one's usual brand versus other brands were compared between those who used capsules versus no capsules. Adjusted logistic regression models examined correlates of FCC use. RESULTS: There were substantial differences in the prevalence of FCC use among adults who smoke across the five countries: Mexico (50.3% in 2021), Republic of Korea (31.8% in 2021), Malaysia (26.5% in 2020), Japan (21.6% in 2021) and Brazil (6.7% in 2016/2017). Correlates of FCC use varied across countries. Capsule use was positively associated with being female in Japan and Mexico, younger age in Japan, Republic of Korea and Malaysia, high education in Brazil, Japan and Mexico, non-daily smoking in Republic of Korea, and having plans to quit in Japan and Republic of Korea. There was no consistent pattern of consumer perceptions of brand harmfulness. CONCLUSION: Our study documented the high prevalence of FCCs in some countries, pointing to the need to develop and implement regulatory strategies to control these attractive products.

Changes in substance use among adolescents before and during the COVID-19 pandemic in Guatemala.

Objectives: Due to the COVID-19 pandemic, on March 16th, schools had to be closed in Guatemala and went to online teaching. We sought to analyze the change in substance use among high school students in Guatemala associated with the lockdown. Methods: Data from two surveys (2019, n=2096, and 2020, n=1606) of a student cohort in private high schools in Guatemala City was used. Logistic models for past 30-day cigarette, e-cigarette, marijuana, and alcohol (including binge drinking) were used, regressing these on survey wave, while adjusting for sex, scholastic performance, high school year of student, parental education, substance use, and household member tobacco use. Results: Prevalence declined for smoking (10% to 3%, p<0.001), e-cigarette (31% to 14%, p<0.001), marijuana (4.3% to 1.9%, p<0.001), and alcohol use (47% to 38.5%, p<0.001), and binge drinking (24% to 13%, p<0.001). Adjusted models showed wave 2 associated with lower odds of using cigarettes (AOR=0.44, 95%CI=0.32-0.62), e-cigarettes (AOR=0.41, 95% CI=0.35-0.49, p<0.001), and binge drinking (AOR=0.73, 95%CI=0.59-0.89; p=0.002). Conclusion: Among Guatemalan adolescents, COVID-19 restrictions were associated with a significant decrease in smoking, e-cigarette use, and binge drinking.

Prevalence and correlates of flavored novel oral nicotine product use among a national sample of youth.

BACKGROUND: Flavored novel oral nicotine products (ONP), such as pouches, gum, lozenges, tablets, and gummies, have recently entered the US market but have not been authorized for smoking cessation. This study assessed the prevalence and correlates of ONPs in a national sample of youth who smoked little filtered cigars or cigarillos (LCCs) or were susceptible to LCCs. METHODS: We conducted a national online survey from September-October 2022, as part of a study to develop cigar warnings among youth. Those aged 15-20 years old who reported using (ever or current) or susceptibility to little filtered cigars or cigarillos (LCCs) were eligible. Descriptive statistics and chi-square analyses assessed the prevalence of flavored ONP use and associations with other past 30-day tobacco product use and participant characteristics. RESULTS: Approximately one-fifth (17.1 %) of the sample (n = 680) reported past month flavored ONP use. Any past month tobacco use was correlated with past month flavored ONP use (ps < 0.001), increasing from 17.1 % in the overall sample to 26.8 % among those reporting e-cigarette use, 41.4 % (LCCs), 47.8 % (waterpipe tobacco), 61.8 % (large cigars), and 69.1 % (smokeless tobacco). The number of products used in the past month was significantly associated with higher odds of ONPs in the past month in a multivariable logistic regression model (aOR2.26; 95 % CI: 1.92, 2.65). DISCUSSION: Almost one-fifth of participants who use or are susceptible to cigar use in our national sample of youth use ONPs. Dual/poly use of other tobacco products and ONPs among youth suggests that many of these youth may be addicted to nicotine. Additional surveillance and regulation of ONPs that exhibit enticing characteristics, such as flavors, kid-friendly formulations, and targeted marketing/branding may be needed.

Factors Associated With the Changes in Smoking and Electronic cigarette use in Adolescents During the COVID-19 Pandemic: A Longitudinal Analysis.

PURPOSE: Explore the factors associated with the changes in smoking and electronic cigarette (e-cigarette) use and susceptibility among adolescents during the COVID-19 pandemic. METHODS: We surveyed a cohort of students (7th-12th grade) from private schools in Guatemala. Baseline (May-September 2019) was conducted in-person and follow-up (June-November 2020) online during the lockdown. Separate Generalized Estimating Equations logistic models regressed current smoking (n = 3,729), current e-cigarette use (n = 3,729), smoking susceptibility among never-smokers (n = 2,596), and susceptibility to e-cigarette use among never-users (n = 1,597) on online ad exposure, visiting stores, social network smoking/e-cigarette use, substance use (alcohol, marihuana, and cigarette or e-cigarette), perceived harm of using cigarettes/e-cigarettes, sociodemographic characteristics, and survey wave. Interactions were assessed between time and ad exposures, friends smoking and e-cigarette use. RESULTS: Frequency of store visits, exposure to online ads, and the use of cigarette and e-cigarette lowered at follow-up. Online e-cigarette ads, having family and friends who smoke, and current e-cigarette use increased the likelihood of being a current smoker. Frequent exposure to online e-cigarette ads, having family who use e-cigarettes, and being a current smoker were associated with higher likelihood of current e-cigarette use. Exposure to either online ads or having friends that smoke or use e-cigarettes, increased susceptibility to using either product. Interaction results showed that high exposure to online e-cigarette ads overtime increased the susceptibility to use e-cigarettes. DISCUSSION: Exposure to online ads and friends and family cigarette and e-cigarette use increased adolescent consumption and susceptibility during the pandemic.

Assessing transnational spillover effects of Mexico's front-of-package nutritional labeling system among Mexican Americans in the US.

OBJECTIVE: In 2020, Mexico implemented innovative front-of-package nutrition warning labels (FoPWLs) for packaged foods to increase the salience and understanding of nutrition information. This study evaluated Mexican Americans' self-reported exposure to Mexican FoPWLs and self-reported effects of FoPWLs on purchasing behavior. METHODS: The 2021 International Food Policy Study surveyed online panels of adult Mexican Americans in the US (n = 3361) to self-report on buying food at Mexican-oriented stores, noticing Mexican FoPWLs, and being influenced by FoPWLs to purchase less of eight different unhealthy foods (each assessed separately). After recoding the frequency of buying foods in Mexican stores and noticing FoPWLs (i.e., "often" or "very often" vs. less often), logistic models regressed these outcomes on sociodemographics, adjusting for post-stratification weights. RESULTS: Most participants (88.0%) purchased foods in Mexican stores. Of these, 64.1% reported noticing FoPWLs, among whom many reported that FoPWLs influenced them to buy fewer unhealthy foods (range = 32% [snacks like chips] - 44% [colas]). Participants were more likely to buy foods in Mexican stores and notice FoPWLs if they were younger, had ≥two children at home vs no children (AOR = 1.40, 95%CI = 1.15-1.71; AOR = 1.37, 95%CI = 1.03-1.80, respectively), and more frequently used Spanish (AOR = 1.91, 95%CI = 1.77-2.07; AOR = 1.87, 95%CI = 1.69-2.07). Also, high vs. low education (AOR = 1.51, 95%CI = 1.17-1.94) and higher income adequacy (AOR = 1.37, 95%CI = 1.25-1.51) were positively associated with noticing FoPWLs. Being female and more frequent Spanish use were consistently associated with reporting purchase of fewer unhealthy foods because of FoPWLs. CONCLUSIONS: Many Mexican Americans report both exposure to Mexican FOPWLs and reducing purchases of unhealthy foods because of them.

Smoking Dependence, Time-Discounting, and Sustained Cessation Behavior: A Longitudinal Study of Predominantly Light Smokers.

INTRODUCTION: This study aimed to assess whether two established psychosocial predictors of smoking abstinence, nicotine dependence and time-discounting, also apply to a population of predominantly cigarette light smokers, which is the dominant pattern of smoking in countries like Mexico. Relatively infrequent smoking is increasingly prevalent, yet still harmful, making it important to understand the predictors of cessation in this population. AIMS AND METHODS: Mexican adult smokers recruited from an online consumer panel were surveyed every 4 months between November 2018 and July 2020. We considered respondents who reported a quit attempt in between surveys (n = 1288). Dependence was measured with a 10-item version of the Wisconsin Inventory of Smoking Dependence Motives (WISDM). Time-discounting was assessed with five branching questions about hypothetical reward scenarios. Logistic models regressed sustained quit attempts (≥30 days of abstinence) at time t + 1 on study variables at time t. RESULTS: We found strong interitem reliability (α = 0.92) and intraindividual consistency of our brief WISDM (ρ = 0.68), but moderate intraindividual consistency of the time-discounting measure (ρ = 0.48). Forty-eight percent of the sample reported sustained quit attempts, and 79% were non-daily or light daily smokers (≤5 cigarettes per day). Smokers with higher WISDM-10 had lower odds of sustained quitting and this result remained when controlling for smoking frequency and the Heaviness of Smoking Index (adjusted odds ratio [AOR] = 0.768). Time-discounting was unassociated with sustained quitting. CONCLUSIONS: Our findings suggest that a brief, 10-item multidimensional measure of dependence is useful for predicting sustained quitting in a context of relatively light smoking; time-discounting appears less relevant, although our results are not conclusive because of the low test-retest reliability of our measure. IMPLICATIONS: Given the increase in non-daily and light daily cigarette smoking in many countries, including in Mexico, and the health risks this still poses, it is important to understand the predictors of cessation among relatively light smokers. The WISDM-10 multidimensional measure seems to be a good instrument to assess dependence and predict successful quitting in this population, and possibly more appropriate than physical dependence measures. As such, it could help design and target more suitable cessation treatments for non-daily and daily light cigarette smokers. While this study did not find time-discounting to be a relevant predictor of smoking abstinence, future studies should explore other measures.

Reactions to Messages About a Nicotine Reduction Policy: A Focus Group Study Among People Who Use Little Cigars and Cigarillos.

INTRODUCTION: The U.S. Food and Drug Administration (FDA) has proposed rulemaking to reduce the nicotine content in cigarettes and other combusted tobacco products to non-addictive levels. This qualitative study documents reactions to messages communicating this policy among people who use little cigars and cigarillos (LCCs). AIMS AND METHODS: We conducted eight focus groups with participants from four populations with the highest prevalence of cigar use (African American males and females, white males and females). Participants described their reactions to eight messages about the policy: Three messages about the equal risk of LCCs with regular and low nicotine levels; three quit efficacy messages about low nicotine LCCs being easier to quit; one "compensation" message to correct misperceptions about the policy causing people to smoke more to get desired nicotine; and one message about using alternative nicotine sources (eg, e-cigarettes). RESULTS: Participants perceived risk messages as the most motivating to quit, whereas efficacy messages made some participants feel that the policy would cause former users of LCCs to relapse. Many participants expressed favorable responses to the compensation message. The message about using alternative nicotine sources sparked intense responses, with many participants expressing outrage and mistrust of the message. Participants' beliefs that they were not addicted to LCCs dampened their perceptions of the effectiveness of the policy. CONCLUSIONS: Perceptions of the addictiveness and relative harms of LCCS influenced responses to policy messages. The FDA should consider using different messages to communicate with people who use LCCs because they perceive LCCs as different from cigarettes. IMPLICATIONS: This is the first study to document affective and cognitive responses to the FDA's reduced nicotine policy among people who use LCCs. The false belief that cigar products are less harmful than cigarettes may be influencing people's lack of support for the reduced nicotine policy and difficulty in understanding its potential positive impact. To maximize the public health benefit of the reduced nicotine policy, the FDA should include LCC products in the policy; however, it is crucial that they use educational messaging to clarify misperceptions regarding nicotine and harm as it applies to LCCs.

Combining Inserts With Warning Labels on Cigarette Packs to Promote Smoking Cessation: A 2-Week Randomized Trial.

BACKGROUND: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation. PURPOSE: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes. METHODS: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups. RESULTS: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes. CONCLUSIONS: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.

Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4­5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Self-reported decreases in the purchases of selected unhealthy foods resulting from the implementation of warning labels in Mexican youth and adult population.

Background: Front-of-package nutritional warning labels (WLs) are designed to facilitate identification and selection of healthier food choices. We assessed self-reported changes in purchasing different types of unhealthy foods due to WLs in Mexico and the association between the self-reported reductions in purchases of sugary beverages and intake of water and sugar-sweetened beverages. Methods: Data came from 14-17 year old youth (n=1,696) and adults ≥18 (n=7,775) who participated in the Mexican arm of the 2020-2021 International Food Policy Study, an annual repeat cross-sectional online survey. Participants self-reported whether the WLs had influenced them to purchase less of each of ten unhealthy food categories due to WLs. Among adults, a 23-item Beverage Frequency Questionnaire was used derive past 7-day intake of water and sugary beverages analyzed to determine the relationship between self-reported reductions in purchasing sugary drinks due to the WLs. Multilevel mixed-effects logistic regression models were fitted to estimate the percentage of participants who self-reported reducing purchases within each food group, and overall. Sociodemographic characteristics associated with this reduction were investigated as well. Results: Overall, 44.8% of adults and 38.7% of youth reported buying less of unhealthy food categories due to the implementation of WL, with the largest proportion reporting decreased purchases of cola, regular and diet soda. A greater impact of WLs on the reported purchase of unhealthy foods was observed among the following socio-demographic characteristics: females, individuals who self-identified as indigenous, those who were overweight, individuals with lower educational levels, those with higher nutrition knowledge, households with children, and those with a significant role in household food purchases. In addition, adults who reported higher water intake and lower consumption of sugary beverages were more likely to report reduced purchases of sugary drinks due to the WLs. Adults who reported greater water intake and lower sugary beverages intake were significantly more likely to report buying fewer sugary drinks due to the WLs. Conclusion: Our findings suggest that implementation of WLs has reduced purchases of unhealthy foods in Mexico. These results underscore the positive impact of the labeling policy particularly in subpopulations with lower levels of education and among indigenous adults.

Support for nicotine reduction in cigarettes: findings from the 2016 and 2020 ITC Four Country Smoking and Vaping Surveys.

INTRODUCTION: The USA and New Zealand have sought to establish a product standard to set a maximum nicotine level for cigarettes to reduce their addictiveness. This study examined support for very low nicotine cigarettes (VLNCs) in Australia, Canada, England and the USA between 2016 and 2020. METHODS: Repeated cross-sectional data were analysed from participants who currently smoke, formerly smoked or vaped and/or currently vape in the 2016 (n=11 150) and/or 2020 (n=5432) International Tobacco Control (ITC) Four Country Smoking and Vaping Survey. Respondents were asked if they would support a law that reduces the amount of nicotine in cigarettes to make them less addictive. Adjusted and weighted logistic regression analyses estimated the prevalence and predictors of support, such as country, age, sex, education, income, race and smoking/vaping status for VLNCs (support vs oppose/do not know). RESULTS: A majority of respondents supported a VLNC law, with support highest in Canada (69%; 2016 and 2020 combined), followed by England (61%), Australia (60%) and the USA (58%). Overall, support decreased from 62% in 2016 to 59% in 2020 (p=0.004), which did not differ by country. Levels of support differed by smoking/vaping status, where those who exclusively smoked daily showed the lowest level of support (59%) and those who exclusively vaped non-daily had the highest level of support (72%). CONCLUSION: More than half of respondents in all four countries-including those who smoked daily-supported a hypothetical VLNC standard to render cigarettes less addictive. It is important to examine if support is sustained after policies are implemented.

Cigarette Prices and Disparities in Cessation in the United States.

INTRODUCTION: Achieving cessation in people with established smoking patterns remains a challenge. Increasing cigarette prices has been one of the most effective strategies for lowering smoking rates. It remains unclear how effective it has been in encouraging cessation among adults in recent years and how the effectiveness varies by sociodemographic characteristics. METHODS: Using repeated cross-sectional data collected by the Tobacco Use Supplement of the Current Population Survey, we investigate the relationship between cigarette prices and cessation from 2003 to 2019 in adults 25+. We examine the associations between price and cessation in the population overall and by sex, race/ethnicity, and socioeconomic status. RESULTS: We found mixed support for associations between greater local prices and cessation. Unadjusted models showed that greater local prices were associated with greater odds of cessation, but the associations did not persist after controlling for sociodemographic characteristics. The associations did not significantly differ by respondent characteristics. Sensitivity analysis using alternative specifications and retail state price as the main predictor showed similar results. Sensitivity analysis with controls for e-cigarette use in the 2014-2019 period showed that greater local price was associated with cessation among adults with less than a high school degree. When stratified by year of data collection, results show that greater local prices were associated with cessation after 2009. CONCLUSIONS: Overall, the study adds to the conflicting evidence on the effectiveness of increasing prices on smoking cessation among adults with established smoking patterns. IMPLICATIONS: Higher cigarette prices have been one of the most effective tools for lowering smoking prevalence. It remains unclear how effective they are in encouraging adults with established smoking patterns to quit. Results show that greater local prices were associated with higher odds of cessation, but the association did not persist after sociodemographic adjustment. In a sensitivity analysis, greater local price was associated with cessation among people with less than a high school degree in models controlling for e-cigarette use. We also found evidence that greater local price was associated with cessation after 2009. More comprehensive smoke-free coverage was also associated with greater odds of cessation. The study's results highlight that encouraging cessation among adults with an established smoking pattern remains a challenging policy problem even when cigarette prices rise.

Chemicals in cigarette flavor capsules from Guatemala and Mexico.

BACKGROUND: The global market share for cigarettes with flavor capsules has grown exponentially over the last decade, particularly in Latin America. When smoking, consumers crush a liquid capsule in the filter that flavors the smoke. Little is known about the chemical constituents of the liquids in capsules or their potential health risks. METHODS: Based on consumer data and availability in Mexico and Guatemala, 31 flavor capsule brands were purchased (19 and 12, respectively) in 2020. Since some cigarettes included multiple capsules in a stick (up to 2) or pack (up to 4), the final analytic sample included 50 capsules. We conducted qualitative and quantitative analysis using gas chromatography with mass spectrometry (GC-MS, Agilent Technologies, Inc.). RESULTS: The qualitative analysis detected 296 compounds (range=9 to 67 per capsule), and all capsules contained menthol. Among the compounds detected in more than half the sample were limonene, menthone, benzaldehyde, eucalyptol and triacetin. Traces of nicotine were found in 22% of the capsules. In the quantitative analysis, menthol concentrations were 33 times greater than the next most common compound (limonene). Benzyl alcohol and vanillin were also found in high concentrations. Comparing same brand varieties across countries showed substantial variability in the concentration of menthol and other compounds. CONCLUSION: Menthol is an omnipresent constituent in capsule cigarettes, perhaps because of its anesthetizing and reinforcing addictive properties. Other compounds found are toxic, potentially carcinogenic, and may enhance addictiveness. Variance in the presence and concentrations of such compounds highlights the importance of product standards to regulate capsule content. IMPLICATIONS: This study evaluated the chemical content of capsule cigarettes from two Latin American countries that have two of the highest market shares for capsule cigarettes worldwide. Compared to other studies, our assessment included brand varieties from two countries to compare the differences in chemical content by country. Our results yield that menthol is found in all capsules, and that other chemicals found may prolong nicotine exposure and therefore reinforce the addictive properties of cigarettes.

Trends in E-Cigarette and Tobacco Cigarette Purchasing Behaviors by Youth in the United States, Canada, and England, 2017-2022.

Objectives: This paper describes trends in youth e-cigarette (EC) and tobacco cigarette (TC) purchasing behaviors in Canada, England, and the United States (US) in relationship to changing minimum legal age (MLA) laws. Methods: Data are from eight cross-sectional online surveys among national samples of 16- to 19-year-olds in Canada, England, and the US conducted from 2017 to 2022 (N = 104,467). Average wave percentage change in EC and TC purchasing prevalence and purchase locations were estimated using Joinpoint regressions. Results: EC purchasing increased between 2017 and 2022, although the pattern of change differed by country. EC purchasing plateaued in 2019 for the US and in 2020 for Canada, while increasing through 2022 for England. TC purchasing declined sharply in the US, with purchasing from traditional retail locations declining, while purchasing from social sources increased. Vape shops were the most common location for EC purchasing, although declining in England and the US. Conclusion: Trends in EC and TC purchasing trends in the US are consistent with the expected impact of the federal MLA law increasing the legal age to 21 years in December 2019.

Reduction in Depressive Symptoms in People who Inject Drugs who Are Cured of Hepatitis C Virus Infection: The HERO Study.

Background: Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome. Methods: We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone. Results: The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P = .004) and those with drug use at baseline (F(3478) = 5.11; P < .01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline. Conclusions: This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms.

Recruitment Methods, Inclusion, and Successful Participation in a Longitudinal Clinical Trial Using Ecological Momentary Assessment.

Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to protocols among these populations, particularly in longitudinal studies. Few studies have compared recruitment methods for longitudinal randomized trials testing health interventions, with even fewer having done so for trials involving ecological momentary assessment (EMA). As intervention research integrates EMA and other data collection approaches requiring substantial participant effort, it is critical to better understand the effectiveness and implications of strategies to improve the representativeness of health research. This secondary data analysis compared outcomes of proactive and reactive recruitment strategies (mobile lab intercepts and internet/flyer advertising, respectively) in study inclusion, task completion, and retention within a 14-day randomized controlled trial that used EMA to evaluate cigarette package health messages. Proactive recruitment resulted in higher proportions of participants with low income and education, limited health literacy, and of diverse racial/ethnic makeup. However, this recruitment method also resulted in lower task completion, especially in the second week of the trial period, and lower retention, although group differences were not explained by participant sociodemographic characteristics targeted by inclusion efforts. We conclude that proactive recruitment via intercepts is an effective strategy for health intervention research that aims to include stakeholders from historically marginalized groups but that researchers and funders must recognize these methods require additional resources, considerations, and capacity to address non-trivial challenges to successful participation.

Effects of front-of-package caffeine and sweetener disclaimers in Mexico: cross-sectional results from the 2020 International Food Policy Study.

OBJECTIVE: Front-of-package warning labels introduced in Mexico in 2020 included disclaimers that caution against allowing children to consume products with non-sugary sweeteners and caffeine. We examined the awareness and use of the disclaimers among Mexican adults and youth 1 month after the regulation was implemented. We also investigated their impact on the perceived healthfulness of industrialised beverages designed for children. DESIGN: Data on the awareness and use of the disclaimers were analysed. Two between-subjects experiments examined the effect of a sweetener disclaimer (Experiment 1, youth and adults) or a caffeine disclaimer (Experiment 2, only adults) on the perceived healthfulness of industrialised beverages. Interactions between experimental conditions and demographic characteristics were tested. SETTING: Online survey in 2020. PARTICIPANTS: Mexican adults (≥18 years, n 2108) and youth (10-17 years, n 1790). RESULTS: Most participants (>80 %) had seen the disclaimers at least rarely, and over 60 % used them sometimes or frequently. The sweetener disclaimer led to a lower perceived healthfulness of a fruit drink (adults: 2·74 ± 1·44; youth: 2·04 ± 0·96) compared with the no-disclaimer condition (adults: 3·17 ± 1·54; youth: 2·32 ± 0·96) (t's: >4·0, P values: <0·001). This effect was larger among older adults and male youth. The caffeine disclaimer did not affect adult's perceived healthfulness of a caffeinated drink (t = 0·861, P value = 0·3894). CONCLUSIONS: There were high awareness and use of the sweeteners and caffeine disclaimers shortly after the warning labels were implemented. The sweetener disclaimer appears to be helping consumers modify their perceptions regarding industrialised beverages for children. Findings may help decision-makers improve the regulation and better target communication strategies.

Perceived effectiveness of cigar warnings in discouraging blunt use.

INTRODUCTION: Many people remove the tobacco leaf from cigars and replace it with cannabis (i.e., blunts), but few studies have examined whether messages about the risks of cigars, like warnings on cigar packages, can affect blunt use. METHODS: Participants were 438 US adults who reported past 30-day cigar use and ever blunt use, recruited from a probability-based national panel to take an online survey. In a 2x2 experiment with a between-subjects design, we manipulated two cigar warning characteristics: 1) warning type: text-only vs. pictorial (i.e., text + image) and 2) warning size: 30% (smaller) vs. 50% (larger) of the product package. Participants then viewed 6 different warnings on a fictious cigarillo package, within their randomly assigned condition. After evaluating all stimuli, participants were asked the extent to which the warnings discouraged them from wanting to use cigars to smoke cannabis (i.e., blunt perceived warning effectiveness). Response options ranged from "not at all" (1) to "a great deal" (5). RESULTS: We observed no main effects of warning type or size on blunt perceived warning effectiveness. However, a significant interaction existed between the two experimental manipulations (p=0.009). Whereas adding images made no difference to blunt perceived warning effectiveness when warnings were smaller (simple effect: -0.22, p=0.28), images mattered for larger warnings. Specifically, adding images increased blunt perceived warning effectiveness when warnings were 50% of the product package (simple effect: 0.52, p=0.008). CONCLUSIONS: This experiment provides preliminary evidence that larger pictorial cigar warnings may discourage blunt use relative to larger but text-only warnings. IMPLICATIONS: Blunts, which are hollowed out cigars with tobacco leaf wrappers that are filled with cannabis leaf, are one of the most common ways in which tobacco and cannabis are used simultaneously, yet few studies have examined whether messages about the risks of cigars can affect blunt use. We conducted an online experiment concerning the perceived effectiveness of cigar warnings among people who use blunts recruited from a probability-based panel. Results provide novel, preliminary evidence that larger pictorial cigar warnings may discourage blunt use, relative to larger but text-only warnings. More research evaluating cigar warnings on blunt use is needed.

Preliminary Evidence of the Association between Time on Buprenorphine and Cognitive Performance among Individuals with Opioid Use Disorder Maintained on Buprenorphine: A Pilot Study.

People on buprenorphine maintenance treatment (BMT) commonly present cognitive deficits that have been associated with illicit drug use and dropout from buprenorphine treatment. This study has compared cognitive responses to the Stroop Task and the Continuous Performance Task (CPT) among individuals on BMT, with recent drug use, and healthy controls and explored the associations between cognitive responses and drug use, craving, and buprenorphine use among participants on BMT. The participants were 16 individuals on BMT and 23 healthy controls. All participants completed a 60 min laboratory session in which they completed the Stroop Task and the CPT, a saliva drug test, a brief clinical history that collected substance-use- and treatment-related information, and the Opioid Craving Scale. The results showed that the BMT participants presented more commission errors (MBMT participants = 2.49; Mhealthy controls = 1.38; p = 0.048) and longer reaction times (MBMT participants = 798.09; Mhealthy controls = 699.09; p = 0.047) in the Stroop Task than did the healthy controls. More days on buprenorphine were negatively associated with reaction time in the CPT (-0.52) and the number of commission errors (-0.53), simple reaction time (-0.54), and reaction time correct (-0.57) in the Stroop Task. Neither drug use nor craving was significantly associated with the results for the cognitive tasks. Relative to the control participants, the BMT individuals performed worse in terms of longer reaction times and more commission errors in the Stroop Task. Within the BMT participants, longer times on buprenorphine were associated with better cognitive results in terms of faster reaction times for both tasks and lower commission errors for the Stroop Task.

Improving Point-of-Sale Warnings for Single Cigars: Implications for Premium Cigars.

INTRODUCTION: For cigars sold individually without packaging, including many premium cigars, the US Food and Drug Administration (FDA) proposed that retailers display six warning statements on a sign at the point-of-sale (POS). AIMS AND METHODS: To examine the potential effectiveness of cigar warning signs, we conducted a between-subjects online experiment. Participants were 809 U.S. adults who reported using cigars (78% ever large cigar use, 49% past 30-day large cigar use) recruited from a probability-based panel. Participants viewed an image of a cigar store countertop with randomization to one of four conditions: (1) no warning sign, (2) a sign with six FDA proposed text-only warnings, (3) a sign with six novel text-only warnings, or (4) a sign with six novel text + image warnings. We used analysis of variance (ANOVA) models and post hoc Tukey tests to examine the results. RESULTS: The FDA-proposed text-only warning sign was perceived as less effective in discouraging participants from smoking cigars (M: 3.26, SD: 1.39; scale range: 1-5, where five indicates higher discouragement) compared with the novel text-only warning sign (M = 3.38, SD = 1.40) and the novel text + image warning sign (M = 3.65, SD = 1.34). The novel text + image warning sign increased discouragement from smoking cigars versus the FDA-proposed text-only warning sign (p = .02) and decreased the perceived satisfaction of smoking cigars versus no warning sign (p = .04). In a sensitivity analysis, the novel text + image warning sign decreased the perceived satisfaction of smoking cigars (p = .01), decreased cigar purchase intentions (p = .03), decreased the urge to smoke (p = .03), and increased discouragement from smoking cigars (p = .006) compared with all other study conditions. CONCLUSIONS: Results provide new evidence that policymakers, such as the FDA, could use when proposing POS warning signs for cigars. IMPLICATIONS: The US FDA proposed that retailers display a warning sign at the POS for cigars sold individually without packaging. We conducted an online experiment concerning the potential effectiveness of this regulatory policy with people who use cigars recruited from a probability-based panel. Results provide the first evidence that the FDA-proposed text-only warning sign was perceived as less effective than other types of warning signs and that adding images could potentially increase the effectiveness of warning signs. These findings are particularly relevant for premium cigars, which are often sold individually in brick-and-mortar retail settings.