Implementation, enrollment, and engagement in an opt-out telehealth pharmacist-assisted tobacco treatment program for patients seen in oncology outpatient clinics.

OBJECTIVE: To describe the workflow, reach, cost, and self-reported quit rates for an opt-out tobacco treatment program (TTP) for patients seen in 43 oncology outpatient clinics. METHODS: Between May 25, 2021, and December 31, 2022, adult patients (≥18 years) visiting clinics affiliated with the Medical University of South Carolina Hollings Cancer Center were screened for smoking status. Those currently smoking were referred to a telehealth pharmacy-assisted TTP. An attempt was made to contact referred patients by phone. Patients reached were offered free smoking cessation counseling and a 2-week starter kit of nicotine replacement medication. A random sample of 420 patients enrolled in the TTP were selected to participate in a telephone survey to assess smoking status 4 to 12 months after enrollment. RESULTS: During the reference period 35,756 patients were screened and 9.3% were identified as currently smoking. Among the 3319 patients referred to the TTP at least once, 2393 (72.1%) were reached by phone, of whom 426 (12.8%) were ineligible for treatment, 458 (13.8%) opted out of treatment, and 1509 (45.5%) received treatment. More than 90% of TTP enrollees smoked daily, with an average of 13.1 cigarettes per day. Follow-up surveys were completed on 167 of 420 patients, of whom 23.4% to 33.5% reported not smoking; if all nonresponders to the survey are counted as smoking, the range of quit rates is 9.3% to 13.3%. CONCLUSION: The findings demonstrate the feasibility of reaching and delivering smoking cessation treatments to patients from a diverse set of geographically dispersed oncology clinics.

Development of two novel treatments to promote smoking cessation: Savor and retrieval-extinction training pilot clinical trial findings.

Despite decades of progress, cigarette smoking remains a significant contributor to disease burden. This effect is especially pronounced for specific priority populations, such as individuals who live in rural communities, in that the burden of tobacco smoking is greater among these groups than in urban areas and the general population. The present study aims to evaluate the feasibility and acceptability of two novel tobacco treatment interventions delivered through remote telehealth procedures to individuals who smoke in the state of South Carolina. Results also include exploratory analyses of smoking cessation outcomes. Study I evaluated savoring, a strategy based on mindfulness practices, alongside nicotine replacement therapy (NRT). Study II evaluated retrieval-extinction training (RET), a memory-modification paradigm alongside NRT. In Study I (savoring), recruitment and retention data showed high interest and engagement in the intervention components, and participants who received this intervention decreased cigarette smoking throughout the course of the treatment (ps < .05). In Study II (RET), results showed high interest and moderate engagement in treatment, although exploratory outcome analyses did not demonstrate significant treatment effects on smoking behaviors. Overall, both studies showed promise in generating interest among individuals who smoke in participating in remotely delivered, telehealth smoking cessation interventions with novel therapeutic targets. A brief savoring intervention appeared to have effects on cigarette smoking throughout treatment, whereas RET did not. Gaining insight from the present pilot study, future studies may improve the efficacy of these procedures and incorporate the treatment components into more robust available treatments. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Smoking Cessation Pharmacotherapy Efficacy in Comorbid Medical Populations: Secondary Analysis of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) Randomized Clinical Trial.

INTRODUCTION: This study sought to compare medication efficacy in participants with medical comorbidities who smoke in the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) trial, a double-blind, triple-dummy, placebo- and active-controlled randomized controlled trial. AIMS AND METHODS: Participants were from the U.S. cohort of the main trial and randomized (1:1:1:1) to varenicline, bupropion, nicotine replacement therapy (NRT) patch, or placebo for 12 weeks with follow-up through week 24. Medical comorbidity data were derived from the baseline medical screening questionnaire and categorized into four subgroups (cardiac, respiratory, vascular, and diabetes). Within each comorbidity, generalized linear mixed models were used to assess the association between treatment and continuous abstinence rates from weeks 9-12 to 9-24. Similar models were used to test the effect of number of comorbidities on abstinence. RESULTS: Varenicline resulted in the highest week 12 abstinence rates across all pharmacotherapies and compared to placebo in all comorbidity subgroups: Cardiac (40.0% vs. 3.6%; odds ratios [OR] = 23.3 [5.1-107.1]), respiratory (24.7% vs. 12.8%; OR = 2.2 [1.3-3.8]), vascular (29.1% vs. 10.4%; OR = 3.6 [2.3-5.7]), and diabetes (30.9% vs. 8.3%; OR = 6.5 [2.3-19.0]). This was maintained at week 24 for those with cardiac (23.3% vs. 1.8%; OR = 21.7 [2.7-178.2]), vascular (18.9% vs. 7.1%; OR = 3.1 [1.8-5.3]), and diabetes (20.6% vs. 4.2%; OR = 8.4 [2.1-33.7]) comorbidities. Treatment contrasts within some comorbidity subgroups revealed superior efficacy of varenicline over other pharmacotherapies. All pharmacotherapies increased the odds of abstinence regardless of number of comorbidities. CONCLUSIONS: Varenicline is the most efficacious option for patients with manageable cardiac, respiratory, vascular, and diabetes conditions to quit smoking, supporting recent clinical practice guidelines that recommend varenicline as first-line pharmacotherapy. Bupropion and NRT demonstrated efficacy for some comorbidity subgroups. IMPLICATIONS: This secondary analysis of the EAGLES trial demonstrated that varenicline is the most efficacious option for patients with cardiac, respiratory, vascular, and diabetes diagnoses to quit smoking. This demonstration of varenicline efficacy among individuals with comorbid medical conditions supports recent clinical practice guidelines that recommend varenicline as a first-line pharmacotherapy for smoking cessation.

Shift From Smoking Cigarettes to Vaping Nicotine in Young Adults.

This survey study assesses trends in nicotine use among young adults in the US between 2013 and 2021.

Tobacco use and cancer-related symptom burden: Analysis of the US Population Assessment of Tobacco and Health Study.

BACKGROUND: Understanding the relationship between tobacco use and symptom burden may inform tobacco treatment interventions tailored to the needs of individuals with cancer. METHODS: The study included 1409 adult cancer survivors from Wave 5 of the US Food and Drug Administration Population Assessment of Tobacco and Health (PATH) Study. A multivariate analysis of variance controlling for age, sex, and race/ethnicity assessed the association of cigarette smoking and vaping on cancer-related symptom burden (fatigue, pain, emotional problems) and quality of life (QoL). Generalized linear mixed models controlling for the same factors were used to assess associations among symptom burden, QoL, and quit-smoking intentions, quit-smoking likelihood, and past 12-month smoking quit attempts. RESULTS: Weighted rates of current cigarette smoking and vaping were 14.21% and 2.88%, respectively. Current smoking was associated with greater fatigue (p < .0001; partial η 2  = .02), pain (p < .0001; partial η 2  = .08), emotional problems (p < .0001; partial η 2  = .02), and worse QoL (p < .0001; partial η 2  = .08). Current vaping was associated with greater fatigue (p = .001; partial η 2  = .008), pain (p = .009; partial η 2  = .005), and emotional problems (p = .04; partial η 2  = .003), but not worse QoL (p = .17). Higher cancer symptom burden was not associated with reduced interest in quitting, likelihood of quitting, or odds of past year quit attempts (p > .05 for each). CONCLUSIONS: Among adults with cancer, current smoking and vaping were associated with greater symptom burden. Survivors' interest in and intentions to quit smoking were not related to symptom burden. Future research should examine the role of tobacco cessation in improving symptom burden and QoL.

E-Cigarette Screening in Primary Care.

INTRODUCTION: Primary care visits present an opportune time to assess behaviors that contribute to patient health. Smoking, alcohol use, and illicit drugs are routinely documented in electronic health records, but less is known about screening for E-cigarette use and the prevalence of E-cigarette use in primary care settings. METHODS: Data include 134,931 adult patients who visited 1 of 41 primary care clinics within a 12-month period (June 1, 2021-June 1, 2022). Data on demographics, combustible tobacco, alcohol, illicit drug, and E-cigarette use were extracted from electronic medical records. Logistic regression was utilized to examine the variables associated with differential odds of being screened for E-cigarette use. RESULTS: Rates of E-cigarette screening (n=46,997; 34.8%) were significantly lower than that of tobacco (n=134,196; 99.5%), alcohol (n=129,766; 96.2%), and illicit drug (n=129,766; 92.6%) use. Of those assessed for E-cigarette use, 3.6% (n=1,669) reported current use. Of those with documented nicotine use (n=7,032), 17.2% (n=1,207) used mono E-cigarettes exclusively, 76.3% (n=5,364) used combustible tobacco exclusively, and 6.6% (n=461) reported dual use (both E-cigarette use and combustible tobacco use). Those who used combustible tobacco or illicit substances as well as younger patients were more likely to have been screened for E-cigarette use. CONCLUSIONS: Overall rates of E-cigarette screening were significantly lower than those of other substances. The use of combustible tobacco or illicit substances was associated with an increased likelihood of being screened. This finding may be because of the relatively recent proliferation of E-cigarettes, the recent addition of E-cigarette documentation to the electronic health record, or a lack of training on screening for E-cigarette use.

Interest in quitting e-cigarette use by device type and smoking history in US adults.

BACKGROUND: The use of e-cigarettes has been increasing, especially since the introduction of 'pod' devices to the marketplace since 2018. Most adults who vape report interest in quitting. The present study examined level of interest in e-cigarette cessation between users with varying cigarette smoking histories and device types. METHODS: Data obtained from wave 5 (2018-2019) of the Population Assessment of Tobacco and Health study (n=34 309). Analyses were conducted on adult current established e-cigarette users, categorised on cigarette smoking history (current, former or never) and device type (disposable, cartridge/pod, tank or mod). Participants reported if they planned to ever quit e-cigarettes, attempted to quit in the past year and attempted to quit by cutting back in the past year. RESULTS: Of the 2922 established e-cigarette users, 68.21% reported plans to quit vaping; 17.27% reported attempting to quit e-cigarettes in the past year; and 29.28% reported attempting to quit by cutting back in the past year. Cartridge users had higher odds of interest in quitting than tank and mod users. Disposable and cartridge users had higher odds of reporting a past year quit attempt than tank and mod users. Individuals with no smoking history had higher odds of reporting a past year quit attempt or cutting back relative to those reporting dual use (of both e-cigarettes and cigarettes) and former smoking. CONCLUSIONS: Tobacco control should consider the type of e-cigarette device that is being used, alongside users' cigarette smoking history, when developing interventions and other resources for vaping cessation.

E-cigarette cessation and transitions in combusted tobacco smoking status: longitudinal findings from the US FDA PATH Study.

BACKGROUND AND AIMS: Electronic nicotine delivery systems (ENDS) can help people to quit smoking combusted tobacco products (CTPs), but most current and former smokers who use ENDS also intend to quit ENDS. This analysis measured whether ENDS cessation among current and former CTP smokers is associated with changes in CTP smoking or abstinence. DESIGN: Regression analysis of a nationally representative cohort from waves 4 (W4) and 5 (W5) of the Population Assessment of Tobacco and Health Study (December 2016-November 2019). SETTING: United States. PARTICIPANTS: Adults (n = 1525) who reported W4 current or former use of ≥ 1 CTP and either currently using ENDS or quitting ENDS in the past year were included. MEASUREMENTS: Logistic regressions were performed separately among W4 current and former CTP smokers, controlling for demographic and tobacco use characteristics. First, we analyzed proximal outcomes by testing the association between ENDS quit status and CTP abstinence, both occurring during W5. Next, we analyzed long-term outcomes by testing W4 ENDS quit status as a predictor of CTP abstinence at W5, approximately 1 year later. FINDINGS: Among W4 current CTP smokers, there was no evidence that CTP smoking abstinence differed between those quitting or continuing using ENDS, both in our proximal [adjusted odds ratio (aOR) = 1.37, 95% confidence interval (CI) = 0.90, 2.10] and long-term (aOR = 0.90, 95% CI = 0.52, 1.53) analyses. Among former CTP smokers, quitting ENDS was associated with less CTP abstinence in our proximal analysis (aOR = 0.42, 95% CI = 0.20, 0.89), but there was no evidence that CTP smoking abstinence differed between those quitting or continuing using ENDS in our long-term analysis (aOR = 0.86, 95% CI = 0.44, 1.67). CONCLUSIONS: There is no evidence that ENDS cessation is associated with CTP abstinence among current smokers, although mixed findings among former smokers indicate a possible risk for relapse to smoking associated with quitting ENDS.

Nicotine replacement therapy for vaping cessation among mono and dual users: A mixed methods preliminary study.

Many adults express interest in e-cigarette cessation; however, there are few empirically tested interventions for quitting vaping. This study seeks to (1) evaluate reasons for quitting e-cigarettes in treatment-seeking adults, and (2) assess the feasibility and acceptability of nicotine replacement therapy (NRT) for e-cigarette cessation. Adult daily e-cigarette users completed qualitative interviews about quitting e-cigarettes, then were randomized to either 28-day supply of combination NRT (21 mg patches, 4 mg lozenges) + supportive booklet or Quitline referral. Primary aims were feasibility (number who enrolled) and acceptability (NRT use, adverse side effects). Exploratory aims evaluated abstinence (7-day point-prevalence) at end of treatment. Of the 30 participants who were enrolled, 50 % (n = 15) were dual users, and 50 % (n = 15) were mono-vapers, 26.6 % (n = 8) of whom were former smokers. Participants reported seeking treatment due to health concerns, dependence, stigma, and cost. Anticipated challenges of quitting vaping were withdrawal, negative mood, sensorimotor habits, and convenience. Most completed the end of treatment survey (n = 24; 80 %). Participants who received NRT reported using the patch M = 10.89 days and lozenges M = 6.39 days, with few days of adverse effects (M = 2.67). At end of treatment, 6/18 (33.3 %; 6 mono and 0 dual users) in the intervention group reported abstinence from vaping, compared to 0 in the control group (Fisher = 5.00, p =.057). In conclusion, adults are interested in quitting e-cigarettes due to negative consequences of use and are willing to use pharmacotherapy. Future research should confirm these results in a larger trial, address cigarette smoking in dual users, and aim to disseminate treatments.

Urgent Need for Novel Investigations of Treatments to Quit E-cigarettes: Findings from a Systematic Review.

E-cigarette use has been increasing globally over the past decade. Many use e-cigarettes as an alternative or method to quit cigarette smoking, whereas others use these products recreationally. As technology has advanced, many individuals have reported symptoms of dependence on these products and continue to use them beyond achieving abstinence from smoking. Despite individuals reporting interest in quitting, little is known about e-cigarette cessation. This systematic review sought to identify and evaluate all human subjects literature published on the outcome of e-cigarette cessation through September 2021. Of the 79 articles identified, 56 were cross-sectional, 6 were qualitative, 5 were cohort studies, 3 were experimental, 2 were mixed methods, and 7 reported intervention or case studies of e-cigarette cessation. Results showed youth generally had high intent to quit e-cigarettes, whereas results were mixed with adult samples. Youth were motivated to quit e-cigarettes by health concerns, whereas adults were motivated to quit e-cigarettes by cost, lack of satisfaction, and psychologic factors. Adults were more likely to report past e-cigarette quit attempts, most commonly "cold turkey." Few interventions tested strategies for e-cigarette cessation, with a majority targeted for youth. Given the lack of information on e-cigarette cessation, recommendations for future studies are outlined.

Tobacco Treatment Outcomes for Hospital Patients With and Without Mental Health Diagnoses.

Background: The prevalence of mental health conditions is higher in cigarette smokers than nonsmokers. However, those with diagnosed mental health disorders are understudied within general inpatient hospital settings. This study seeks to evaluate how having a mental health diagnosis influences response to a brief opt-out inpatient tobacco treatment intervention. Methods: Data included 4,153 admitted patients who completed a tobacco treatment visit. Post-discharge self-reported abstinence was obtained via response to an automated call 1-month after discharge. Mental health co-morbidities were assessed by reviewing electronic medical records. Logistic regression was used to assess associations between having a mental health diagnosis and patients' smoking history, interest in quitting smoking, and post-discharge abstinence. Results: Overall 34.1% of patients were diagnosed with mental health disorders, most commonly depression or substance use disorders. Patients with a diagnosed mental health disorder were more likely to report a history of long-term heavy smoking and were less likely to express an interesting in remaining abstinent from smoking after hospitalization. An intent-to-treat analysis using logistic regression analysis found lower rates of self-reported smoking abstinence in those with a mental health disorder compared to those without (9 vs. 13.2%, p < 0.001). Conclusions: Patients with a history of mental health diagnoses, such as depression or substance use disorders, was associated with lower rates of smoking abstinence in patients after hospitalization. Hospital based opt-out smoking cessation programs have shown to be generally effective and efficient. However, certain subpopulations may require tailored intervention in order to improve treatment outcomes. Future research is needed to develop brief, effective tobacco treatment for hospital patients with comorbid mental health diagnoses.

A pilot feasibility study of a behavioral intervention for nicotine vaping cessation among young adults delivered via telehealth.

BACKGROUND: Nicotine vaping among youth has increased, warranting concern from tobacco control proponents. Many youth who vape indicate interest in quitting; however, few empirically supported vaping cessation interventions exist. This pilot feasibility study adapted an established behavioral intervention, contingency management (CM), delivered via telehealth to promote vaping cessation among young adults. METHODS: Participants (N = 27; ages 17-21) vaping nicotine regularly were recruited via social media and digital advertisements from across the US (June 2020-January 2021). Participants were randomized at approximately 4:1 to CM or Monitoring control (22:5). CM was delivered through DynamiCare Health's smartphone app for 4 weeks, in which financial incentives were delivered contingent on abstinent cotinine samples after the quit day until the end of treatment (EOT; Days 7-28; 10 expected submissions). Control participants earned incentives for submitting cotinine, regardless of abstinence. Feasibility, acceptability, and abstinence was collected throughout treatment, at EOT, and at 1-month follow-up. RESULTS: The majority of enrolled participants completed treatment (Monitoring: 5/5; CM: 20/22), and intervention components were rated favorably overall (> 80%). CM participants submitted 112/220 (55%) abstinent cotinine samples throughout the quit attempt, while the Monitoring group submitted 4/50 (8%) negative samples. There were no differences in abstinence between groups at EOT or follow-up. CONCLUSION: This pilot study of a telehealth-based youth vaping cessation intervention demonstrated preliminary feasibility and acceptability. These results suggest that CM for young adult vaping cessation, delivered remotely, is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.

Reappraising Choice in Addiction: Novel Conceptualizations and Treatments for Tobacco Use Disorder.

The introduction of alternative nicotine and tobacco products (such as e-cigarettes, heat-not-burn devices, nicotine pouches) warrants an updated framework from which to conceptualize tobacco use disorder (TUD). The following review provides considerations for TUD within the context of novel products. Historically, the tobacco industry falsely claimed that cigarettes were not addictive or harmful and that those who smoked simply chose to do so. This generated an inaccurate lay perception that smoking is a free or informed choice. Research on nicotine pharmacology demonstrates the powerful addictive potential of nicotine, which is shaped by dose, speed of delivery, and other constituents generated. In addition, non-pharmacologic reinforcers motivate and maintain tobacco use behaviors for both traditional cigarettes and novel products. The negative consequences of combustible tobacco use are well known; however, these outcomes may differ for alternative products. Strategies used for combustible product cessation may be adapted for novel products, and treatment recommendations for TUD should be made within the context of a harm reduction framework wherein alternative product use may be the desired outcome. Providers must therefore be willing to modify their perceptions of products and treatment recommendations accordingly. Better public health outcomes are accomplished through promotion of abstinence from combustible smoking. For those who cannot wean from nicotine entirely, switching to less risky modes of delivery might be a secondary goal, with an eventual aim of stopping use of the alternative product. Implications: Given the advent of novel, alternative tobacco products, tobacco use disorder (TUD) must be conceptualized within a contemporary framework that includes harm reduction and alternative outcomes. The unique contributions of nicotine pharmacology, non-pharmacologic reinforcers, and consequences of use can be used to inform treatments for TUD with the ultimate goal of improving the health of individuals who use tobacco.

Distinct influences of nicotine and sensorimotor stimuli on reducing cravings to smoke and vape among dual users.

INTRODUCTION: When considering the clinical efficacy of e-cigarettes for smoking cessation, non-pharmacologic influences, such as conditioned reinforcers (e.g. sensorimotor stimuli), must be considered in addition to nicotine. The present study parsed the influences of nicotine delivery and sensorimotor stimuli (i.e, similarity to smoking) on cravings and other immediate outcomes of e-cigarette use. METHOD: Participants (N = 127 dual users) completed an experimental ad-lib vaping session in one of 4 conditions: Drug (open label nicotine vs non-nicotine e-cigarettes) crossed with delivery apparatus (normal e-cigarette vs altered sensorimotor apparatus). It was hypothesized that participants who were deprived of the usual vaping stimuli would report less craving reduction via vaping. Nicotine was hypothesized to enhance physiological outcomes. RESULTS: Moderate effects emerged for nicotine, whereas smaller effects were observed for the sensorimotor manipulation upon both cravings to smoke and cravings to vape. Contrary to the hypothesis, participants who vaped using the altered sensorimotor apparatus reported greater craving reduction compared to those who used normal e-cigarettes. Nicotine delivery also had moderate effects on psychological reward. Main effects were not moderated by gender, withdrawal, or dependence. CONCLUSIONS: Findings support the role of nicotine in reducing cravings via vaping. They also suggest that sensorimotor similarities to smoking may be less important among experienced vapers or dual users. Indeed, in this sample, the altered sensorimotor apparatus may have reduced craving via distraction or other mechanisms.

Associations between cancer diagnosis and patients' responses to an inpatient tobacco treatment intervention.

BACKGROUND: Diagnosis of a chronic illness, such as cancer may influence health behavior changes, such as smoking cessation. The present analyses examine associations between a cancer diagnosis (i.e., yes or no) and response to an opt-out smoking cessation bedside intervention provided to hospitalized patients. It was hypothesized that patients with a past or present cancer diagnosis would report higher motivation and engagement with quitting smoking, and higher rates of smoking abstinence after hospital discharge, compared to those without a cancer diagnosis. METHODS: Chart review was conducted on 5287 inpatients who accepted bedside treatment from a counselor and opted-in to automated follow-up calls from July 2014 to December 2019. RESULTS: At the time of inpatient assessment, those with a past or present cancer diagnosis (n = 419, 7.9%) endorsed significantly higher levels of importance of quitting than those without a cancer diagnosis (3.92/5 vs. 3.77/5), and were more likely to receive smoking cessation medication upon discharge (17.9% vs. 13.3%). Follow-up data from 30-days post-discharge showed those with a cancer diagnosis endorsed higher rates of self-reported abstinence (20.5%) than those without a cancer diagnosis (10.3%; p < 0.001). CONCLUSION: Being hospitalized for any reason provides an opportunity for smokers to consider quitting. Having a previous diagnosis of cancer appears to increase intention to quit and lead to higher rates of smoking cessation in patients who are hospitalized compared to patients without cancer. Future research needs to work toward optimizing motivation for smoking cessation while admitted to a hospital and on improving quit rates for all admitted patients, regardless of diagnosis.

Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial.

INTRODUCTION: Continued smoking following a cancer diagnosis has substantial health risks including increased overall and cancer-specific mortality, risk of secondary malignancies, cancer treatment toxicity and risk of surgical complications. These risks can be mitigated by quitting smoking. The preoperative period represents a prime opportunity in which to administer robust smoking cessation treatment to both improve health and support and improve surgical outcomes. We will conduct a randomised clinical trial to evaluate the effectiveness of financial incentives delivered contingent on biochemically verified smoking abstinence (contingency management (CM)) in patients with cancer undergoing surgery. METHODS AND ANALYSIS: The study will take place across two study sites, and participants (N=282) who smoke, are diagnosed with or suspected to have any type of operable cancer and have a surgical procedure scheduled in the next 10 days to 5 weeks will be randomised to receive standard care plus Monitoring Only or CM prior to surgery. All patients will receive breath carbon monoxide (CO) tests three times per week, nicotine replacement therapy and counselling. The CM group will also earn payments for self-reported smoking abstinence confirmed by CO breath test ≤4 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Point prevalence abstinence (PPA) outcomes (self-report of 7-day abstinence confirmed by CO≤4 ppm and/or anabasine ≤2 ng/mL) will be assessed on the day of surgery and 6 months after surgery. The effect of CM on 7-day PPA at the time of surgery and 6-month follow-up will be modelled using generalised linear mixed effects models. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the Medical University of South Carolina Institutional Review Board. We will disseminate our scientific results through traditional research-oriented outlets such as presentations at scientific meetings and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04605458.

Abstinence-related motivational engagement for smoking cessation: Longitudinal patterns and predictive validity.

The Abstinence-Related Motivational Engagement (ARME) scale was developed to assess motivation to remain abstinent after a smoking cessation attempt. The ARME demonstrated reliability and validity among a small sample of ex-smokers. This study expands the psychometric evaluation of the ARME and tests the ARME as a predictor of smoking status among a sample of participants quitting smoking. The parent trial tested the efficacy of a self-help smoking cessation intervention (N = 1874), with assessments every 6 months. Internal consistency and factor structure of the ARME was evaluated at each assessment to confirm use of the measure as designed. Discriminant validity was assessed by comparing the ARME to the Situation-specific Abstinence Self-Efficacy (SSE) scale via inter-correlations and prediction of future smoking status. Finally, the trajectories of both the ARME and SSE were compared among continuous abstainers and continuous smokers. A single-factor structure was observed at each assessment. Cronbach's alphas ranged from 0.88-0.91 for the total sample. Correlations between the ARME and the SSE ranged from 0.38-0.47 (ps <0.001) among smokers; and from 0.09-0.15 (most ps > 0.05) among abstainers. Among current smokers, the ARME and SSE were independent positive predictors of subsequent abstinence (AORs 1.28-2.29, ps <0.001). For those currently abstinent, only the SSE predicted subsequent abstinence (AORs 1.69-2.60, ps <0.05). GEE analyses showed different trajectories for the two measures, as well as between abstainers and smokers. In conclusion, the ARME is a reliable, valid measure with unique predictive utility for current smokers and a distinct trajectory among those who have successfully quit.