Smoking Cessation Clinical Trial Research Articles

Fine-mapping the CYP2A6 regional association with nicotine metabolism among African American smokers.

The nicotine metabolite ratio (NMR; 3'hydroxycotinine/cotinine) is a stable biomarker for CYP2A6 enzyme activity and nicotine clearance, with demonstrated clinical utility in personalizing smoking cessation treatment. Common genetic variation in the CYP2A6 region is strongly associated with NMR in smokers. Here, we investigated this regional association in more detail. We evaluated the association of CYP2A6 single-nucleotide polymorphisms (SNPs) and * alleles with NMR among African American smokers (N = 953) from two clinical trials of smoking cessation. Stepwise conditional analysis and Bayesian fine-mapping were undertaken. Putative causal variants were incorporated into an existing African ancestry-specific genetic risk score (GRS) for NMR, and the performance of the updated GRS was evaluated in both African American (n = 953) and European ancestry smokers (n = 933) from these clinical trials. Five independent associations with NMR in the CYP2A6 region were identified using stepwise conditional analysis, including the deletion variant CYP2A6*4 (beta = -0.90, p = 1.55 × 10-11). Six putative causal variants were identified using Bayesian fine-mapping (posterior probability, PP = 0.67), with the top causal configuration including CYP2A6*4, rs116670633, CYP2A6*9, rs28399451, rs8192720, and rs10853742 (PP = 0.09). Incorporating these putative causal variants into an existing ancestry-specific GRS resulted in comparable prediction of NMR within African American smokers, and improved trans-ancestry portability of the GRS to European smokers. Our findings suggest that both * alleles and SNPs underlie the association of the CYP2A6 region with NMR among African American smokers, identify a shortlist of variants that may causally influence nicotine clearance, and suggest that portability of GRSs across populations can be improved through inclusion of putative causal variants.

An Introduction and Practical Guide to Strategies for Analyzing Longitudinal Data in Clinical Trials of Smoking Cessation Treatment: Beyond Dichotomous Point-Prevalence Outcomes.

Conceptualizing tobacco dependence as a chronic relapsing condition suggests the need to use analytic strategies that reflect that premise. However, clinical trials for smoking cessation typically define the primary endpoint as a measure of abstinence at a single timepoint distal to the intervention, typically 3-12 months. This reinforces the concept of tobacco outcomes as a dichotomous state-one is, or is not, abstinent. Fortunately, there are several approaches available to handle longitudinal data that reflect the relapsing and remitting nature of tobacco use during treatment studies. In this paper, sponsored by the Society for Research on Nicotine and Tobacco's Treatment Research Network, we present an introductory overview of these techniques and their application in smoking cessation clinical trials. Topics discussed include models to examine abstinence outcomes (eg, trajectory models of abstinence, models for transitions in smoking behavior, models for time to event), models that examine reductions in tobacco use, and models to examine joint outcomes (eg, examining changes in the use of more than one tobacco product). Finally, we discuss three additional relevant topics (ie, heterogeneity of effects, handling missing data, and power and sample size) and provide summary information about the type of model that can be used based on the type of data collected and the focus of the study. We encourage investigators to familiarize themselves with these techniques and use them in the analysis of data from clinical trials of smoking cessation treatment. Implications Clinical trials of tobacco dependence treatment typically measure abstinence 3-12 months after participant enrollment. However, because smoking is a chronic relapsing condition, these measures of intervention success may not accurately reflect the common trajectories of tobacco abstinence and relapse. Several analytical techniques facilitate this type of outcome modeling. This paper is meant to be an introduction to these concepts and techniques to the global nicotine and tobacco research community including which techniques can be used for different research questions with visual summaries of which types of models can be used for different types of data and research questions.

The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial

IntroductionPeople who smoke cigarettes are more likely than people who do not to use cannabis, including blunts, a tobacco product containing nicotine and marijuana. Blunts represent a challenge for cessation trials because nicotine could make stopping cigarettes more difficult. Few studies have examined the impact of blunt use on individuals actively engaged in a cigarette quit attempt. MethodsBlunt use was assessed at baseline, Weeks 4, 8, 12, 16, and 26 among Black adult people who smoke enrolled in a double-blind, placebo-controlled, randomized trial of varenicline (VAR, n = 300) versus placebo (PBO, n = 200) for smoking cessation. Participants were categorized as ever blunt (blunt use reported at any timepoint) versus non-blunt (no blunt use reported). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at Weeks 12 and 26. Logistic regression examined the effects of treatment and blunt use on abstinence. Results75 participants (mean age 45.6 years (SD = 12.5, range: 22,80); 32 (42%) female) reported blunt use. Logistic regression analyses showed no treatment by blunt use interaction or significant main effect of blunt use on smoking abstinence at Weeks 12 or 26 (p > 0.05). After adjusting for treatment, those who used blunts had statistically similar odds of quitting at Week 12 (OR: 0.68, 95% CI: 0.31, 1.5) and Week 26 (OR: 0.84, 95% CI: 0.38, 1.87) as those who never used blunts during the study. DiscussionBlunt use had no statistically significant impact on cessation among participants in a smoking cessation clinical trial. Future trials are needed in which the target of cessation is all combustible products.

Patient-Reported Receipt of Oncology Clinician-Delivered Brief Tobacco Treatment (5As) Six Months following Cancer Diagnosis

Introduction: Smoking after a cancer diagnosis represents a modifiable health risk. It is recommended that oncology clinicians address tobacco use among their patients using the 5As brief model: Asking about use, Advising users to quit, Assessing willingness to quit, Assisting in quit attempts (counseling and medication), and Arranging follow-up. However, cross-sectional studies have found limited adoption of 5As (especially Assist and Arrange) in oncology settings. Further investigation is needed to understand changes in, and factors associated with, 5As delivery over time. Methods: Patients recently diagnosed with cancer and reporting current smoking (N = 303) enrolled in a smoking cessation clinical trial and completed three longitudinal surveys; at pre-intervention baseline and 3- and 6-month follow-up post-enrollment. Patient-level correlates of 5As receipt at baseline, 3 months, and 6 months were identified using multilevel regression models. Results: At baseline, patient-reported rates of 5As receipt from oncology clinicians ranged from 85.17% (Ask) to 32.24% (Arrange). Delivery declined from baseline to 6-month follow-up for all 5As, with the largest declines observed for Ask, Advise, Assess, and Assist-Counseling. Diagnosis of a smoking-related cancer was associated with greater odds of 5As receipt at baseline but lower odds at 6-month follow-up. At each time point, female gender, religiosity, advanced disease, cancer-related stigma, and smoking abstinence were associated with lower odds of 5As receipt, while reporting a recent quit attempt prior to enrollment was associated with higher odds of 5As receipt. Conclusion: Oncology clinicians’ 5As delivery declined over time. Clinician delivery of the 5As varied based on patients’ sociodemographics, clinical and smoking characteristics, and psychosocial factors.

Treatment adherence in a smoking cessation clinical trial for individuals with current or past major depressive disorder: Predictors and association with cessation

IntroductionIndividuals with major depressive disorder (MDD) exhibit high rates of tobacco use and lower responsiveness to tobacco cessation treatments. Treatment adherence is a strong predictor of treatment outcomes in the general population but has not been evaluated in this under-served community of smokers with MDD. MethodsWe used data from a randomized clinical trial on smoking cessation treatment among 300 smokers with MDD to examine the rate of adherence (medication and counseling), the association of adherence with cessation outcomes, and factors associated with adherence, including demographic and smoking characteristics, psychiatric characteristics, smoking cessation processes (e.g., withdrawal, reinforcers), and treatment-related side effects (e.g., nausea). ResultsOverall, 43.7% of participants were adherent with medication and 63.0% were adherent with counseling. Medication adherence was significantly associated with cessation, with 32.1% of adherent vs. 13.0% of non-adherent participants quitting smoking at EOT. Counseling adherence was also significantly associated with cessation, with 32.3% of adherent vs. 2.7% of non-adherent participants quitting smoking. Multivariate regression models showed that medication adherence was associated with higher engagement in complementary reinforcers and higher baseline smoking reward, while counseling adherence was associated with identifying as female, lower alcohol use and nicotine dependence, higher baseline smoking reward, and higher engagement in substitute and complementary reinforcers within the first weeks of medication use. ConclusionsAs with the general population of smokers, non-adherence to treatment in smokers experiencing depression is widespread and a significant barrier to cessation. Interventions that target reinforcers may improve rates of treatment adherence.

Abstract B004: Decídetexto: A mobile smoking cessation intervention among Puerto Ricans in the US

Abstract Background: Puerto Ricans report the highest smoking rate (28.5%) among women and men compared to other Latino subgroups. Puerto Rican smokers are less likely to use smoking resources and quit smoking. Objective: To assess smoking behaviors and sociodemographic characteristics related to smoking cessation outcomes among Puerto Ricans in the United States. Methods: The study is a secondary analysis of the Decídetexto text message smoking cessation clinical trial, including 457 Latino smokers with access to nicotine replacement therapy (NRT). The study included 111 Puerto Rican smokers (Decídetexto: 49; control: 62). Pearson Chi-squares were used for categorical dependent variables and point biserial correlation for continuous dependent associations with smoking cessation outcomes assessed at 6mo (quit attempts, number of cigarettes per day, quit attempts, and self-reported cessation). Results: Participants were largely middle-aged (49.6 years), women (52.3%), and more than half (69.4%) preferred the Spanish language. The mean number of cigarettes per day was 11.55 (SD=6.85), and they reported an average of 2.49 (SD=5.088) quit attempts in the last year. The majority of reported using menthol cigarettes (73.9%) and previously using medication (58.6%) and e-cigarettes (55%). A six-month, 7-day self-reported smoking abstinence was 24.3% (32.7% for Decídetexto and 17.7% for control). Previous quit attempts and education were significantly associated with the self-reported 7-day abstinence at six months year (rpb = .252, n = 111, p = .008; Χ2(4) = 10.772, p= .029 ). Age, gender, language preference, employment status, cigarettes per day, menthol cigarettes, and e-cigarette use were not related to 7-day self-reported smoking cessation. Conclusion: Decídetexto mobile smoking cessation is likely to facilitate smoking cessation among Puerto Ricans living in the US. Results from the present study will inform future randomized clinical trials for the understudied Puerto Rican Latino population with the highest smoking rate. Citation Format: Ruthmarie Hernández-Torres, Francisco Cartujano-Barrera, Arlette Chavez-Iñiguez, Deborah Ossip, M. Patricia Rivera, Eida M. Castro-Figueroa, Ana Paula Cupertino. Decídetexto: A mobile smoking cessation intervention among Puerto Ricans in the US [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B004.

The relationship between drinking and smoking in a clinical trial for smoking cessation and drinking reduction.

Heavy drinking smokers experience poorer smoking cessation outcomes. Less is known about the relationship between drinking and smoking among those who are trying to reduce or abstain from both substances. The present study used data from 115 heavy drinking smokers who completed a 12-week clinical trial comparing varenicline alone (1 mg/bid) versus varenicline (1 mg/bid) plus naltrexone (50 mg/day) for smoking cessation and drinking reduction. We tested whether drinking outcomes mediated the relationship between medication and cigarettes per smoking day (CPSD) during the active medication phase (Week 4, 8, and 12) and follow-up phase (Week 16 and 26). CPSD and drinking variables predicted respective use at subsequent time points (p's < .0001). Results revealed a nonsignificant mediation effect of our primary mediator drinks per drinking day (DPDD) at Week 12: 95% CI = [-1.03, .58] and Week 26: 95% CI = [-.09, .51], and our secondary mediators of percent heavy drinking days (PHDDs) and percent days abstinent (PDA) at Week 12: 95% CI = [-.14, .35] and Week 26: 95% CI = [-.15, .41]. Cross-lagged effects (e.g., Week 4 drinking predicting Week 8 smoking) were nonsignificant between DPDD and CPSD (p's ≥ .07), and PHDD and PDA and CPSD that met our a priori cutoff (p's ≥ .02). There was a significant relationship between drinking and smoking concurrently indicated by fixed error covariances (CPSD and DPDD: p < .01; CPSD and PDA p = .01). Our findings highlight an association between drinking and smoking behaviors, respectively, across the span of 6 months. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Interventions for Increasing Digital Equity and Access (IDEA) among rural patients who smoke: Study protocol for a pragmatic randomized pilot trial

BackgroundCigarette smoking prevalence is higher among rural compared with urban adults, yet access to cessation programming is reduced. The Increasing Digital Equity and Access (IDEA) study aims to evaluate three digital access and literacy interventions for promoting engagement with an online evidence-based smoking cessation treatment (EBCT) program among rural adults. MethodsThe pilot trial will use a pragmatic, three-arm, randomized, parallel-group design with participants recruited from a Midwest community-based health system in Minnesota, Wisconsin, and Iowa. All participants will receive an online, 12-week, EBCT program, and written materials on digital access resources. Participants will be stratified based on state of residence and randomly assigned with 1:1:1 allocation to one of three study groups: (1) Control Condition-no additional study intervention (n = 30); (2) Loaner Digital Device-Bluetooth enabled iPad with data plan coverage loaned for the study duration (n = 30); (3) Loaner Digital Device + Coaching Support–loaner device plus up to six, 15–20 min motivational interviewing-based coaching calls to enhance participants' digital access and literacy (n = 30). All participants will complete study assessments at baseline and 4- and 12-weeks post-randomization. Outcomes are cessation program and trial engagement, biochemically confirmed smoking abstinence, and patient experience. ResultsA rural community advisory committee was formed that fostered co-design of the study protocol for relevance to rural populations, including the trial design and interventions. ConclusionStudy findings, processes, and resources may have relevance to other health systems aiming to foster digital inclusion in smoking cessation and chronic disease management programs and clinical trials in rural communities.

Supplemental Material for The Relationship Between Drinking and Smoking in a Clinical Trial for Smoking Cessation and Drinking Reduction

Supplemental Material for The Relationship Between Drinking and Smoking in a Clinical Trial for Smoking Cessation and Drinking Reduction

Feasibility and Effectiveness of Recruiting Latinos in Decídetexto-A Smoking Cessation Clinical Trial from an Emergency Department Patient Registry.

There is an underrepresentation of Latinos in smoking cessation clinical trials. This study describes the feasibility and effectiveness of recruiting Latino smokers in the U.S. from an emergency department (ED) patient registry into a randomized smoking cessation clinical trial. Recruitment occurred from the Hackensack University Medical Center ED. Potential participants were contacted from a patient registry. The primary outcome was whether the participant responded to a call or text. Secondary outcomes included the best day of the week, week of the month, and time of day to obtain a response. Of the 1680 potential participants, 1132 were called (67.5%), while 548 (32.5%) were texted. For calls, response rate was higher compared to text (26.4% vs 6.4%; p < 0.001). More participants were interested in the study when contacted by calls compared to text (11.4% vs. 1.8%) and more participants were enrolled in the study when contacted by calls compared to text (1.1% vs. 0.2%). Regression models showed that ethnicity, age, time of day, and week of the month were not significantly associated with response rates. Recruitment of Latinos from an ED patient registry into a smoking cessation clinical trial is feasible using call and text, although enrollment may be low.

Recruiting racially and ethnically diverse smokers seeking treatment: Lessons learned from a smoking cessation randomized clinical trial

IntroductionRecruiting racial/ethnic minorities in smoking cessation trials is a priority. This study described lessons learned from recruiting a diverse sample of African American, White, and Hispanic/Latinx smokers in a smoking cessation trial. MethodsWe implemented a 42-month recruitment campaign utilizing reactive (e.g., word-of-mouth, newspaper, radio, online ads, flyers, community partnerships) and proactive (e.g., direct invitations) strategies. We included 821 participants in the analysis. We described our recruitment strategies’ implementation, their enrollment yield and rate (number enrolled/number screened) by race/ethnicity, and direct cost-per-participant (CPP: total cost/number of enrolled) for paid strategies. ResultsEnrollment yields were higher using reactive strategies than proactive strategies (94.3% vs. 5.7%). The top source of enrollment was word-of-mouth among African Americans (36%) and Whites (44%), and flyers among Hispanics/Latinxs (34%). Proactive recruitment, word-of-mouth, and flyers were more successful among African Americans than other groups. Newspaper and online ads were more successful among Hispanics/Latinxs than other groups (P < .05). Word-of-mouth was cost-free and yielded 23.1% of enrollment. The most economic method among paid strategies was flyer distribution (CPP = $47.6; yield 17.5%), followed by newspaper ($194.7; 23.7%) and online advertisements ($264.6; 24.0%). Radio and television ads were the most expensive and produced the least participant yield ($4,755.6; 0.8%). ConclusionRecruiting racially/ethnically diverse samples into smoking cessation clinical trials requires implementing multiple strategies and adjusting these strategies based on their enrollment yield and cost. Word-of-mouth, flyers, and newspaper and online ads were more successful among racial/ethnic minorities. Flyers and newspaper ads were the most economic methods for recruitment.

Stability of Varenicline Concentration in Saliva Over 21 Days at Three Storage Temperatures.

Varenicline is the most efficacious drug for smoking cessation; saliva varenicline concentrations can be useful for the evaluation of adherence in smoking cessation trials. Saliva is a useful noninvasive matrix for mail-in specimen collection, if stable. We investigated the stability of varenicline in saliva at different storage temperatures simulating the time it takes to mail in a sample. We evaluated the concentrations of varenicline, nicotine, cotinine, 3'-hydroxycotinine, and 3'-hydroxycotinine/cotinine (3HC/COT) ratio in quality control saliva samples (and after repeated freezing and thawing), and in smokers' saliva samples, stored for up to 21 days at room temperature (~25°C), 4°C, and -80°C. In saliva quality control samples, concentrations of varenicline, nicotine, cotinine, 3'-hydroxycotinine, and 3HC/COT remained unchanged and showed little within-sample variation (CV ≤ 5.5%) for up to 21 days at the three storage temperatures; they were also not altered after three thaw-freeze cycles. In smokers' saliva, a significant main effect of storage duration, but not temperature, was observed for varenicline, cotinine, and 3'-hydroxycotinine, but not for nicotine or the 3HC/COT ratio. However, these changes were within analytical (i.e., equipment) variation resulting in little within-sample variation (CV ≤ 5.8%) for all analytes in smokers' saliva. Varenicline, the other analytes, and the 3HC/COT ratio remained stable in saliva during storage for 21 days at all temperatures tested and after repeated freezing and thawing with only minor changes in concentration over time. These findings support the potential use of mail-in approach for saliva samples in varenicline smoking cessation clinical trials. Assessing saliva varenicline concentrations can be useful for the evaluation of adherence in smoking cessation trials. Saliva is a noninvasive matrix suitable for mail-in specimen collection. This is the first investigation of stability of varenicline in saliva. Varenicline, nicotine, cotinine, 3'-hydroxycotinine, and 3HC/COT were stable in saliva for up to 21 days at room temperature (~25°C), 4°C, and -80°C, supporting the use of a mail-in approach for saliva specimen in smoking cessation trials.

Transitioning to Remote Clinic Visits in a Smoking Cessation Trial During the COVID-19 Pandemic: Mixed Methods Evaluation

BackgroundThe pandemic of SARS-CoV-2, which causes COVID-19, has caused disruptions in ongoing clinical trials and is expected to accelerate interest in conducting research studies remotely.ObjectiveA quasi-experimental, mixed methods approach was used to examine the rates of visit completion as well as the opinions and experiences of participants enrolled in an ongoing clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or telephone conferencing due to the COVID-19 pandemic.MethodsFor quantitative comparisons, we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, COVID-19 cohort) to a comparable cohort of participants followed over a similar time period in the calendar years 2018 and 2019 (n=51, pre–COVID-19 cohort) to examine the rates of completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from in-person to remote visits.ResultsParticipants in the COVID-19 cohort completed an average of 83.6% of remote clinic visits (95% CI 73.1%-91.2%), which was not significantly different than the in-person completion rate of 89.8% in the pre–COVID-19 cohort. Participants in the COVID-19 cohort returned an average of 93.2% (95% CI 83.5%-98.1%) of saliva specimens for remote clinic visits completed, which was not significantly different than the in-person saliva specimen completion rate of 100% in the pre–COVID-19 cohort. Two broad themes emerged from the qualitative data: (1) the benefits of remote visits and (2) the challenges of remote counseling compared to in-person counseling. Despite limited experience with telehealth prior to this transition, most participants expressed a willingness to engage in remote visits in the future.ConclusionsEven in the context of a rapid transition from in-person to remote visits necessitated by the COVID-19 pandemic, rates of visit completion and return of biospecimens remained high. Participants were generally accepting of the transition. Further research is needed to identify the optimal mix of in-person and remote visits beyond the pandemic context and to better understand how these changes may impact study outcomes.Trial RegistrationClinicalTrials.gov NCT03262662; https://clinicaltrials.gov/ct2/show/study/NCT03262662

Python Package abstcal: An Open-Source Tool for Calculating Abstinence From Timeline Followback Data.

In smoking cessation clinical trials, timeline followback (TLFB) interviews are widely used to track daily cigarette consumption. However, there are no standard tools for calculating abstinence based on TLFB data. Individual research groups have to develop their own calculation tools, which is not only time- and resource-consuming but might also lead to variability in the data processing and calculation procedures. To address these issues, we developed a novel open-source Python package named abstcal to calculate abstinence using TLFB data. This package provides data verification, duplicate and outlier detection, missing-data imputation, integration of biochemical verification data, and calculation of a variety of definitions of abstinence, including continuous, point-prevalence, and prolonged abstinence. We verified the accuracy of the calculator using data derived from a clinical smoking cessation study. To improve the package's accessibility, we have made it available as a free web app. The abstcal package is a reliable abstinence calculator with open-source access, providing a shared validated online tool to the addiction research field. We expect that this open-source abstinence calculation tool will improve the rigor and reproducibility of smoking and addiction research by standardizing TLFB-based abstinence calculation. Abstinence calculation is an essential task in any smoking intervention study. However, there have not been standard open-source tools available to the researchers. This commentary describes a Python-based package called abstcal that can calculate abstinence from TLFB data, a common methodology to collect smoking consumption data in research settings. The package supports the calculation of point-prevalence, prolonged, and continuous abstinence. Importantly, the package has a web app interface that allows researchers to use the tool without any coding experience. This tool will facilitate smoking research by providing a standardized and easy-to-use abstinence calculation tool.

Nicotine metabolite ratio: Comparison of the three urinary versions to the plasma version and nicotine clearance in three clinical studies

BackgroundVariation in CYP2A6 activity influences tobacco smoking behaviors and smoking-related health outcomes. Plasma Nicotine Metabolite Ratio (NMR) is a robust phenotypic biomarker of CYP2A6 activity and nicotine clearance. In urine, the NMR has been calculated as a ratio of free trans-3’-hydroxycotinine to free cotinine (NMRF/F), total trans-3’-hydroxycotinine to free cotinine (NMRT/F), or total trans-3’-hydroxycotinine to total cotinine (NMRT/T). We evaluated these three urinary NMR versions relative to plasma NMR and nicotine clearance and elucidated mechanisms of discrepancies among them. MethodsBaseline plasma and urine biomarker data were available from two smoking cessation clinical trials and one nicotine pharmacokinetic study (total N = 768). NMRs were compared using Pearson correlations, linear regressions and ANOVA analyses. UGT2B10 and UGT2B17 were genotyped. ResultsUrinary NMRT/F was the most highly related to plasma NMR (R2 = 0.70, P <2.2e-16) followed by NMRF/F (R2 = 0.68, P <2.2e-16), while NMRT/T was less strongly related (R2 = 0.60, P <2.2e-16); consistent across study, ethnicity, sex, heaviness of smoking, and analyte analysis. Controlling for cotinine glucuronidation, as a phenotype or UGT2B10 genotype, corrected the NMRT/T discordance with plasma NMR (Panova<0.001). Similar findings were obtained for relationships of nicotine clearance with plasma NMR > urinary NMRT/F > NMRF/F > NMRT/T (R2 = 0.41 > 0.37 > 0.35 > 0.25 respectively). ConclusionUrinary NMRT/F followed by NMRF/F are the best urinary alternatives to plasma NMR or nicotine clearance. NMRT/T has the least utility as it is influenced substantially by variation in cotinine glucuronidation. ImpactThis work highlighted the variation in urinary NMRs, and identified mechanisms for disparities among them, which facilitates their use in predicting smoking-related outcomes.

COVID-19 Challenges Confronted by Smoking Cessation Clinical Trials for People Living With HIV: The Experience of Grantees of the US National Cancer Institute.

COVID-19 Challenges Confronted by Smoking Cessation Clinical Trials for People Living With HIV: The Experience of Grantees of the US National Cancer Institute.

Determining Optimal Cutoffs for Exhaled Carbon Monoxide and Salivary Cotinine to Identify Smokers among Korean Americans in a Smoking Cessation Clinical Trial.

Introduction It is critical to accurately identify individuals who continue to smoke even after treatment, as this may prompt the use of more intensive and effective treatment strategies to help them attain complete abstinence. Aims This study examined optimal cutoffs for exhaled carbon monoxide (CO) and salivary cotinine to identify smokers among Korean Americans in a smoking cessation clinical trial. Methods CO and cotinine were measured three to four times over 12 months from the quit day. Statistical analysis was conducted using Receiver Operating Characteristic (ROC) curves. Results A CO cutoff of 5 parts per million provided robust sensitivity (80.8-98.3%) and perfect specificity (100%), and a salivary cotinine cutoff of level 2 (30-100 ng/ml) provided the best sensitivity (91.2-95.6%) and perfect specificity (100%). Using these cutoffs, the agreement between self-reports and the two biomarkers ranged from 88.6% to 97.7%. The areas under ROC curves (AUCs) of exhaled CO ranged from 0.90 to 0.99, all of which were significant (all p values < 0.001), and the AUCs of salivary cotinine ranged from 0.96 to 0.98 (all p values < 0.001). Conclusion Exhaled CO and salivary cotinine are complementary, and they should be used together to verify smoking abstinence for smokers in a clinical trial.

Examining the effects of problematic alcohol use on cigarette abstinence in recently diagnosed cancer patients enrolled in a cessation trial: A secondary analysis

AimsAmong people with cancer, dual alcohol and tobacco use increases risk for morbidity and mortality. Most smoking cessation clinical trials with this patient population have excluded individuals with problematic alcohol use. This investigation examined whether problematic alcohol use affects smoking cessation in cancer patients. MethodsMixed-methods secondary analysis of data from the Smokefree Support Study, a randomized-controlled trial examining the efficacy of Intensive (IT; n = 153) vs. Standard Treatment (ST; n = 150) for smoking cessation in newly diagnosed cancer patients. Problematic alcohol use was assessed at enrollment using the Cut-Down-Annoyed-Guilty-Eye-Opener (CAGE), weekly frequency of alcohol use and binge drinking measures. Alcohol use was categorized as: no current alcohol use, moderate and problematic use. The primary outcome was biochemically-confirmed cigarette abstinence at 6-months. A subset of patients (n = 72) completed qualitative exit-interviews. ResultsAmong all participants, biochemically-confirmed cigarette abstinence rates were 25% (n = 32), 28% (n = 27), and 36% (n = 20) for participants reporting no current alcohol use, moderate use, and problematic use, respectively (p = 0.33). In logistic regression analysis, neither problematic alcohol use (AOR = 0.96, 95% CI = 0.35–2.67, p = .94) nor the problematic use by study arm interaction (AOR = 2.22, 95% CI = 0.59–8.39, p = .24) were associated with biochemically-confirmed 6-month abstinence. Qualitatively, participants reported that drinking alcohol triggers urges to smoke. ConclusionNewly diagnosed cancer patients reporting problematic alcohol use were not less likely to quit smoking than those without. Additional research is needed to investigate whether problematic alcohol users may benefit from smoking and alcohol behavior change interventions at the time of cancer diagnosis.

Using the Cigarette Purchase Task to examine the relative reinforcing value of cigarettes among mothers with versus without opioid dependence.

The Cigarette Purchase Task (CPT), in which participants estimate the number of cigarettes they would smoke across increasing cigarette prices, measures the relative reinforcing value of cigarettes. Although opioid-dependent individuals are particularly vulnerable to tobacco addiction, more research is needed to elucidate whether and to what extent their motivation to smoke differs from not-opioid-dependent smokers controlling for potential sociodemographic differences. Participants were 173 women (65 opioid-dependent) in an ongoing clinical trial for smoking cessation. Baseline CPT responses were compared between opioid-dependent and not-opioid-dependent women using five demand indices: Demand Intensity; Omax; Pmax; Breakpoint (BP); and α, and two latent factors: Amplitude and Persistence. Final regression models adjusted for sociodemographic characteristics differing between the two groups. Opioid-dependent women had greater demand Intensity (i.e., number of cigarettes they would smoke if they were free) than not-opioid dependent women in the adjusted model, F(1, 156) = 6.93, p = .016. No other demand indices differed significantly. Regarding latent factors, demand Amplitude (i.e., volumetric consumption), but not Persistence (i.e., price insensitivity), was greater for opioid-dependent women in the adjusted model, F(1, 146) = 4.04, p = .046. These results further demonstrate that the CPT is a highly sensitive task that can illuminate potentially important individual and population differences in the relative reinforcing value of smoking. Greater demand Intensity and Amplitude differentiated smokers with comorbid opioid dependence; thus, decreasing smoking prevalence among opioid-dependent populations may require policies and interventions that can decrease cigarette demand Intensity and Amplitude. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Making lemonade from SARS coronavirus-2 lemons: Transitioning a smoking cessation trial to a virtual platform

Clinical trials represent an essential component of improving treatment for substance use disorders (SUD). The SARS coronavirus-2 pandemic disrupted our ongoing clinical trial of smoking cessation and forced us to rapidly implement changes to assure participants access to ongoing counseling and monitoring via telephone calls and/or video chat sessions. Our experiences suggest that this pandemic will lead to changes for both future clinical trial participants and project staff. While challenges remain, it will be important to assessing the impact of these changes with regard to participant experiences and treatment outcomes.