7-day Point Prevalence Abstinence Research Articles

The MOHMQuit (Midwives and Obstetricians Helping Mothers to Quit Smoking) Trial: protocol for a stepped-wedge implementation trial to improve best practice smoking cessation support in public antenatal care services

Smoking during pregnancy is the most important preventable cause of adverse pregnancy outcomes, yet smoking cessation support (SCS) is inconsistently provided. The MOMHQUIT intervention was developed to address this evidence-practice gap, using the Behaviour Change Wheel method by mapping barriers to intervention strategies. MOHMQuit includes systems, leadership and clinician elements. This implementation trial will determine the effectiveness and cost-effectiveness of MOHMQuit in improving smoking cessation rates in pregnant women in public maternity care services in Australia; test the mechanisms of action of the intervention strategies; and examine implementation outcomes. A stepped-wedge cluster-randomised design will be used. Implementation of MOHMQuit will include reinforcing leadership investment in SCS as a clinical priority, strengthening maternity care clinicians' knowledge, skills, confidence and attitudes towards the provision of SCS, and clinicians' documentation of guideline-recommended SCS provided during antenatal care. Approximately, 4000 women who report smoking during pregnancy will be recruited across nine sites. The intervention and its implementation will be evaluated using a mixed methods approach. The primary outcome will be 7-day point prevalence abstinence at the end of pregnancy, among pregnant smokers, verified by salivary cotinine testing. Continuous data collection from electronic medical records and telephone interviews with postpartum women will occur throughout 32 months of the trial to assess changes in cessation rates reported by women, and SCS documented by clinicians and reported by women. Data collection to assess changes in clinicians' knowledge, skills, confidence and attitudes will occur prior to and immediately after the intervention at each site, and again 6 months later. Questionnaires at 3 months following the intervention, and semi-structured interviews at 6 months with maternity service leaders will explore leaders' perceptions of acceptability, adoption, appropriateness, feasibility, adaptations and fidelity of delivery of the MOHMQuit intervention. Structural equation modelling will examine causal linkages between the strategies, mediators and outcomes. Cost-effectiveness analyses will also be undertaken. This study will provide evidence of the effectiveness of a multi-level implementation intervention to support policy decisions; and evidence regarding mechanisms of action of the intervention strategies (how the strategies effected outcomes) to support further theoretical developments in implementation science. ACTRN12622000167763, registered February 2nd 2022.

Feasibility and Acceptability of a Telephone-Based Smoking Cessation Intervention for Qatari Residents

The steady increase in smoking rates has led to a call for wide-reaching and scalable interventions for smoking cessation in Qatar. This study examined the feasibility and acceptability of an evidence-based smoking cessation program delivered by telephone for Qatari residents. A total of 248 participants were recruited through primary care centers and received five weekly scheduled proactive behavioral counseling calls from personnel trained in tobacco cessation and navigation to obtain cessation pharmacotherapy from clinics. Outcomes were assessed at end of treatment (EOT), and 1- and-3-month follow up. The Mann-Whitney test was used to compare the average number of participants recruited per month pre- and post-COVID. We recruited 16 participants/month, the majority (85.5%) attended at least one counselling session, and 95.4% used some of pharmacotherapy. Retention rates were 70% at EOT, 64.4% and 71.7% at 1- and 3-month follow up, respectively; 86% reported being 'extremely satisfied' by the program. Our ITT 7-day point prevalence abstinence was 41.6% at EOT, 38.4% and 39.3% at 1-and 3-month, respectively. The average number of participants recruited per month was significantly higher for pre vs. post-COVID (18.9 vs. 10.0, p-value = 0.02). Average number of participants retained at EOT per recruitment month showed a slight decrease from 8.6 pre- to 8.2 post-COVID; average number who quit smoking at EOT per recruitment month also showed a decrease from 6 to 4.6. The study results indicated that our telephone-based intervention is feasible and acceptable in this population and presents a new treatment model which can be easily disseminated to a broad population of Qatari smokers.

Oklahoma Tobacco Helpline Utilization and Outcomes by Diabetes Status.

Diabetes and cigarette smoking are major causes of morbidity and mortality. Individuals with type 2 diabetes (T2D) who smoke are at an increased risk of smoking- and diabetes-related morbidity and mortality. We examined utilization patterns, satisfaction, and tobacco cessation outcomes among persons with T2D to determine whether the Oklahoma Tobacco Helpline is an equally effective intervention for tobacco users with T2D compared with those without diabetes. This study was a retrospective cohort design using registration and follow-up data from a state tobacco quitline. We examined Oklahoma Tobacco Helpline registration data from July 2015 to June 2021 to compare Helpline utilization among individuals who self-reported a previous diagnosis of T2D compared with those not reporting a diagnosis of diabetes. Oklahoma Tobacco Helpline registrants enrolled in a call program, either the single- or multiple-call program, who reported diabetes status at baseline. We compared tobacco use history, program enrollment, and services received for individuals self-reporting T2D with those without diabetes. We compared 30-day point-prevalence abstinence at 7 months and evaluated program satisfaction. Registrants with T2D were more likely to receive a higher intensity of services including the number of coaching calls and the amount of nicotine replacement therapy. At 7-month follow-up, 32.3% of registrants with T2D and 35.1% of those without diabetes reported 30-day point-prevalence abstinence, but the differences were not statistically significant. While findings demonstrate similar effectiveness, more research is needed to better understand why the prevalence of tobacco use remains high among individuals with T2D and how to improve cessation in this population.

Integrating Tobacco Treatment Into Oncology Care: Reach and Effectiveness of Evidence-Based Tobacco Treatment Across National Cancer Institute-Designated Cancer Centers.

Quitting smoking improves patients' clinical outcomes, yet smoking is not commonly addressed as part of cancer care. The Cancer Center Cessation Initiative (C3I) supports National Cancer Institute-designated cancer centers to integrate tobacco treatment programs (TTPs) into routine cancer care. C3I centers vary in size, implementation strategies used, and treatment approaches. We examined associations of these contextual factors with treatment reach and smoking cessation effectiveness. This cross-sectional study used survey data from 28 C3I centers that reported tobacco treatment data during the first 6 months of 2021. Primary outcomes of interest were treatment reach (reach)-the proportion of patients identified as currently smoking who received at least one evidence-based tobacco treatment component (eg, counseling and pharmacotherapy)-and smoking cessation effectiveness (effectiveness)-the proportion of patients reporting 7-day point prevalence abstinence at 6-month follow-up. Center-level differences in reach and effectiveness were examined by center characteristics, implementation strategies, and tobacco treatment components. Of the total 692,662 unique patients seen, 44,437 reported current smoking. Across centers, a median of 96% of patients were screened for tobacco use, median smoking prevalence was 7.4%, median reach was 15.4%, and median effectiveness was 18.4%. Center-level characteristics associated with higher reach included higher smoking prevalence, use of center-wide TTP, and lower patient-to-tobacco treatment specialist ratio. Higher effectiveness was observed at centers that served a larger overall population and population of patients who smoke, reported a higher smoking prevalence, and/or offered electronic health record referrals via a closed-loop system. Whole-center TTP implementation among inpatients and outpatients, and increasing staff-to-patient ratios may improve TTP reach. Designating personnel with tobacco treatment expertise and resources to increase tobacco treatment dose or intensity may improve smoking cessation effectiveness.

Effectiveness of an integrated smoking cessation service model on smoking status: A preliminary study.

Smoking cessation has been considered a benefit for smokers. This study aimed to investigate the effect of an integrated smoking cessation service model (ISCSM) on enhancing cessation among smokers in a community setting. The participants were 144 smokers allocated into two groups, experimental and control with 72 participants each. The ISCSM comprised two sessions: 1) smoking cessation service design and training smoking cessation capacity for the Community Health Workers (CHWs) by nurses; and 2) integrated smoking cessation service delivery. The CHWs offered brief advice for smoking cessation for smokers through home visits under supervision by nurses, then referred to proactive multisession intensive telephone counselling that was behavioral therapy with follow-up. In contrast, the control group received Thai therapy, which was mouthwash. The 7-day point prevalence abstinence (PPA) was assessed 30 days after the quit date. The probability of quitting between the experimental and control groups was calculated by the risk ratio (RR). Propensity score matching was performed to analyze the treatment effect after balancing the covariate factors. The probability of quitting smoking successfully among the participants in the experimental group was 7.5 times higher than the control group (χ2=46.18, RR=7.50, p<0.001). For the treatment effect tested by the PSM, the ISCSM efficiently impacted the 7-day PPA at 30 days among smokers in the experimental group after balancing the covariates (SS=0.281, MS=0.281, df=1, F=13.20, p<0.001). The findings of this study indicate that the ISCSM is an efficient, powerful intervention for enhancing smoking cessation.

Longitudinal analysis of peer social support and quitting Smoking: Moderation by sex and implications for cessation interventions

Social support predicts better health and lower mortality, but the benefits of peer social support for helping cigarette smokers quit are unclear. Moreover, sex as a moderating factor has not been investigated despite sex differences in social support processes. This study of smokers’ perceived availability of peer social support in quitting cigarette smoking is a secondary analysis of 1,010 individuals enrolled in an RCT that provided quitting assistance using tailored emails scheduled around a quit date. Participants completed measures of peer support for quitting cigarettes at enrollment (baseline), and at 1-, 3-, and 6-month follow-ups. Peer support at follow-ups was categorized as never-present, always-present, or mixed. A Generalized Estimating Equation (GEE) examined the association between peer support and 7-day point prevalence abstinence at follow-ups, controlling for baseline peer support, experimental condition, stress, depression, and sociodemographic and smoking behavior-related variables. Interactions of peer support × time, and peer support × sex, were tested. Results indicated that among women, always-present or mixed peer support was associated with, respectively, odds of abstinence that were 4.36 (95 % CI, 2.54–7.49, p = 0.0001), and 2.21 (OR = 2.21, 95 % CI, 1.27–3.85, p = 0.005) greater than among women reporting never-present peer support. Among men, peer support did not predict abstinence. Women who smoke may be especially receptive to the benefits of peer support when attempting to quit. Investigation of the basis of their perceptions, how they might be increased, and whether interventions to change them would be effective, is warranted.

Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial

BackgroundWith advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation treatment. Optimizing tobacco treatment delivery for PWH may increase engagement with evidence-based treatments and successful quit attempts.MethodsThe current study is a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out tobacco treatment intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. A total of 230 PWH who smoke will be recruited from an infectious diseases clinic at an academic medical center and will be randomized to receive (1) treatment as usual (TAU) or (2) Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Primary outcomes include: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (Weeks 9–12), and the number of 24-hour quit attempts at the end of study treatment (Week 12). Secondary outcomes include: participant reach (proportion reached out of contact attempts), implementation fidelity (including number of prescriptions written), participant adherence to prescribed pharmacotherapy, acceptability (participant and provider satisfaction with intervention delivery and content), and perceived barriers.DiscussionThis study will examine a novel approach to optimizing tobacco treatment delivery for PWH. Integrating effectiveness and implementation results will help define best practices for engaging PWH with evidence-based tobacco treatment interventions. The intervention is low-cost, has the potential to be highly scalable, and could be translatable to other ambulatory HIV clinic settings.Trial Registration ClinicalTrials.gov: NCT05019495 (August 24, 2021).

A pilot randomized controlled trial of smartphone-assisted mindfulness-based intervention with contingency management for smokers with mood disorders.

Adult smokers receiving outpatient psychiatric treatment for mood disorders were randomized to receive a smartphone-assisted mindfulness-based smoking cessation intervention with contingency management (SMI-CM, n = 25) or enhanced standard treatment (EST, n = 24) with noncontingent rewards. Participants in SMI-CM were prompted to practice audio-guided mindfulness five times per day for 38 days (vs. no comparison intervention in EST), and received monetary incentives for carbon monoxide (CO) ≤ 6 ppm. The primary outcome was biochemically verified 7-day point prevalence abstinence rates 2, 4, and 13 weeks after a target quit day. Of the 49 participants, 63.3% were Latinx and 30.6% Black; 75.5% reported household incomes < $25,000. Abstinence rates for SMI-CM were 40.0%, 36.0%, and 16.0% versus 4.2%, 8.3%, and 4.2% in EST at weeks 2, 4, and 13. A generalized estimating equations (GEE) model showed significant overall differences in abstinence rates in SMI-CM versus EST (adjusted odds ratio [AOR] = 8.12, 95% CI = 1.42-46.6, p = .019). Those who received SMI-CM reported significantly greater reduction in smoking-specific experiential avoidance from baseline to 3 days prior to quit date (β = -7.21, 95% CI = -12.1-2.33, p = .006). SMI-CM may increase cessation rates among smokers with mood disorders, potentially through reduced smoking-specific experiential avoidance. SMI-CM is a promising intervention, and warrants investigation in a fully powered randomized controlled trial (RCT). (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Varenicline for Tobacco-Dependent Adults Who Are Not Ready to Discontinue Use: A Systematic Review and Meta-Analysis.

Rationale: Not all individuals with tobacco dependence are ready to give up smoking. Research reveals behavioral differences between adults ready to discontinue tobacco use and those who are not. Thus, the interventions applied to these populations might differ. However, the evidence of using varenicline in individuals who are not ready to discontinue tobacco use is uncertain. Objectives: To determine if, in tobacco-dependent adults who report not being ready to discontinue tobacco use, clinicians should begin treatment with varenicline or wait until subjects are ready to discontinue tobacco use. Methods: We conducted a systematic review to assess the effectiveness and safety of treatment with varenicline in tobacco-dependent adults who are not ready to discontinue tobacco use. We systematically searched the Cumulative Index to Nursing and Allied Health Literature, Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials comparing varenicline versus placebo for individuals who were not ready to discontinue tobacco use. Outcomes of interest include point prevalence abstinence during treatment or at six months or longer, smoking reduction, motivation to quit, adverse events, and withdrawal symptoms. Two authors independently extracted data and assessed eligibility and risk of bias using a standardized data collection form. We followed the Grading of Recommendations, Assessment, Development and Evaluations approach to assess the certainty of evidence. Results: Five trials met our inclusion criteria. All 2,616 participants were adults who were not ready to discontinue tobacco use at study entry. For 7-day point prevalence abstinence at six months or longer, high-certainty evidence suggested that varenicline increased abstinence compared with placebo (relative risk, 2.00 [95% confidence interval (CI), 1.70-2.35]; absolute risk reduction, 173 more per 1,000 [95% CI, 121 more to 234 more]). We identified moderate-certainty evidence suggesting that varenicline increased serious adverse events (relative risk, 1.75 [95% CI, 0.98-3.13]; absolute risk reduction, 12 more per 1,000 [95% CI, 0 fewer to 35 more]). For withdrawal, low-certainty evidence suggested that varenicline treatment was associated with a lower symptom score (mean difference, 1.54 points lower; 95% CI, 2.15-0.93 points lower; low certainty) assessed using the Brief Questionnaire of Smoking Urges. Conclusions: In tobacco-dependent adults who are not ready to discontinue tobacco use, initiating varenicline treatment results in a large increase in abstinence and likely results in a slight increase in serious adverse events.

Insula deep rTMS and varenicline for smoking cessation: A randomized control trial study protocol.

Background: Current approved therapies for smoking cessation have modest long-term effects for abstinence. The insular cortex has been identified by preclinical and clinical studies as a critical target for addiction treatment. Insula functions can be modulated non-invasively using brain stimulation. It is unknown if deep repetitive transcranial magnetic stimulation (rTMS) of the insula can improve smoking cessation of smokers trying to quit using varenicline. Methods: This will be a randomized, double-blind, sham-controlled clinical trial with 50 nicotine dependent smokers looking to quit. They will be randomly assigned to receive either active (10 Hz) or sham insula deep rTMS. Deep rTMS will be administered for 4 weeks (5 days/week). All participants will receive open label varenicline for 12 weeks. The primary outcome measure will be the 7-day point prevalence abstinence at the end of 12 weeks. The secondary outcomes will be Fagerström Test of Nicotine Dependence, Minnesota Nicotine Withdrawal Scale, Tiffany Questionnaire of Smoking Urges, expired carbon monoxide measurements, cigarettes smoked per day, point prevalence abstinence at end of 4 weeks, prolonged and continuous abstinence at 6 months. The measures will be collected throughout the 3-month treatment period as well as at the 6-month follow up. Discussion: This trial will test for the first time the impact of deep insula rTMS on smoking cessation in smokers treated with varenicline. This trial will use an H-coil specific to the insula, while previous studies have targeted both the insula and prefrontal cortex. This trial will inform on the utility to combine insula deep rTMS with varenicline to improve smoking abstinence rates. Clinical Trial Registration: Trial registered at https://clinicaltrials.gov/ct2/show/NCT04083144 (Identifier: NCT04083144).

Web-delivered Acceptance and Commitment Therapy (ACT) for smoking cessation: Is it engaging and efficacious for US Hispanic/Latinx adult smokers?

Hispanic/Latinx adult smokers in the United States (US) face barriers to receiving and utilizing evidenced-based cessation treatments compared with other racial/ethnic groups. The lack of efficacious and accessible smoking cessation treatments for this population further contributes to such smoking disparities. In a secondary analysis, we explored the efficacy of an Acceptance and Commitment Therapy (ACT)-based website (WebQuit.org) versus a US Clinical Practice Guidelines (USCPG)-based website (Smokefree.gov) for smoking cessation in a subset of Hispanic/Latinx adult participants enrolled in the WebQuit trial. Of the 2,637 participants who were randomized in the parent trial, 222 were Hispanic/Latinx (n = 101 in WebQuit, n = 121 in Smokefree). Smoking cessation outcomes were measured at 3, 6, and 12-months. The primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Treatment engagement and satisfaction, change in acceptance of urges to smoke, and commitment to quitting smoking were compared across conditions. Retention rate was 88% at 12-months. WebQuit participants had higher odds of smoking cessation compared to Smokefree participants at 12-months (40% vs. 25%; OR = 1.93 95% CI: 1.04, 3.59). Findings were similar using multiple imputation. WebQuit participants engaged more with the website than Smokefree participants through multiple indicators of engagement, including spending more time using the website (IRR = 2.32; 95% CI: 1.68, 3.20). Although WebQuit participants engaged more with the website than Smokefree participants, there was no evidence that differences in quit rates were mediated by engagement level. This study provides initial empirical evidence that digital interventions may be efficacious for helping Hispanic/Latinx adults quit smoking.

Tailored text message and web intervention for smoking cessation in U.S. socioeconomically-disadvantaged young adults: A randomized controlled trial

The prevalence of cigarette smoking in young adults is higher among those with socioeconomic disadvantage than those without. Low treatment-seeking among young adult smokers is compounded by few efficacious smoking cessation interventions for this group, particularly socioeconomically-disadvantaged young adults (SDYA) who smoke cigarettes. The goal of this study was to test a tailored smoking-cessation intervention for SDYA. 343 SDYA aged 18–30 living in the U.S. (85% female) who smoke cigarettes with access to a smartphone and interest in quitting smoking in the next six months were recruited online in Spring 2020 and randomized to referral to online quit resources (usual care control; n = 171) or a 12-week tailored text message smoking-cessation program with a companion web-based intervention (n = 172). Intent to treat analyses examined associations between study condition, self-reported 30-day point prevalence abstinence (PPA), and confidence to quit smoking at 12 weeks, controlling for potential confounders. Intervention group participants had greater self-reported 30-day PPA at 12-weeks than controls (adjusted relative risk 3.93, 95% CI 2.14–7.24). Among those who continued smoking, the intervention increased confidence to quit (0.81 points, 95% confidence interval 0.08–1.53). Weekly engagement in the intervention predicted greater cessation. A tailored text message intervention for SDYA increased smoking abstinence and confidence to quit at the end-of-treatment. Findings may have been influenced by recruitment at the start of the COVID pandemic but suggest that text messaging is an acceptable and efficacious cessation strategy for SDYA smokers. Future studies should examine the impact on longer-term smoking-cessation and importance of intervention tailoring for SDYA.

A Smoking Cessation Mobile App for Persons Living With HIV: Preliminary Efficacy and Feasibility Study.

BackgroundThe prevalence of smoking in the United States general population has gradually declined to the lowest rate ever recorded; however, this has not been true for persons with HIV.ObjectiveWe conducted a pilot test to assess the feasibility and efficacy of the Lumme Quit Smoking mobile app and smartwatch combination with sensing capabilities to improve smoking cessation in persons with HIV.MethodsA total of 40 participants were enrolled in the study and randomly assigned 1:1 to the control arm, which received an 8-week supply of nicotine replacement therapy, a 30-minute smoking cessation counseling session, and weekly check-in calls with study staff, or to the intervention arm, which additionally received the Lumme Quit Smoking app and smartwatch.ResultsOf the 40 participants enrolled, 37 completed the follow-up study assessments and 16 used the app every day during the 56-day period. During the 6-month recruitment and enrollment period, 122 people were screened for eligibility, with 67.2% (82/122) deemed ineligible. Smoking criteria and incompatible tech were the major reasons for ineligibility. There was no difference in the proportion of 7-day point prevalence abstinence by study arm and no significant decrease in exhaled carbon monoxide for the intervention and control arms separately. However, the average exhaled carbon monoxide decreased over time when analyzing both arms together (P=.02).ConclusionsResults suggest excellent feasibility and acceptability of using a smoking sensor app among this smoking population. The knowledge gained from this research will enable the scientific community, clinicians, and community stakeholders to improve tobacco cessation outcomes for persons with HIV.Trial RegistrationClinicalTrials.gov NCT04808609; https://clinicaltrials.gov/ct2/show/NCT04808609

Feature-Level Analysis of a Smoking Cessation Smartphone App Based on a Positive Psychology Approach: Prospective Observational Study.

BackgroundSmoking cessation smartphone apps have emerged as highly accessible tools to support smoking cessation efforts. It is unknown how specific app features contribute to user engagement over time and relate to smoking outcomes.ObjectiveTo provide a feature-level analysis of the Smiling Instead of Smoking app (version 2) and to link feature use to subsequent smoking cessation.MethodsNondaily smokers (N=100) used the app for a period of 49 days (1 week before quitting and 6 weeks after quitting). Participants self-reported 30-day point-prevalence abstinence at the end of this period and at a 6-month follow up (the survey response rate was 94% and 89% at these points, respectively). Self-reported 30-day point prevalence abstinence rates were 40% at the end of treatment and 56% at the 6-month follow up. The app engaged users in both positive psychology content and traditional behavioral smoking cessation content. The app sent push notifications to prompt participants to complete prescribed content (ie, a “happiness exercise” every day and a “behavioral challenge” to use the app’s smoking cessation tools on 15 out of 49 days). Actions that participants took within the app were timestamped and recorded.ResultsParticipants used the app on 24.7 (SD 13.8) days out of the 49 prescribed days, interacting with the happiness content on more days than the smoking content (23.8, SD 13.8 days vs 17.8, SD 10.3 days; t99=9.28 [2-tailed]; P<.001). The prescribed content was frequently completed (45% of happiness exercises; 57% of behavioral challenges) and ad libitum tools were used on ≤7 days. Most participants used each ad libitum smoking cessation tool at least once, with higher use of personalized content (≥92% used “strategies,” “cigarette log,” “smoke alarms,” and “personal reasons”) than purely didactic content (79% viewed “benefits of quitting smoking”). The number of days participants used the app significantly predicted 30-day point-prevalence abstinence at the end of treatment (odds ratio [OR] 1.05, 95% CI 1.02-1.09; P=.002) and at the 6-month follow up (OR 1.04, 95% CI 1.008-1.07; P=.01). The number of days participants engaged with the happiness content significantly predicted smoking abstinence at the end of treatment (OR 1.05, 95% CI 1.02-1.08; P=.002) and at the 6-month follow up (OR 1.04, 95% CI 1.007-1.07; P=.02). This effect was not significant for the number of days participants engaged with the smoking cessation content of the app, either at the end of treatment (OR 1.04, 95% CI 0.996-1.08, P=.08) or at the 6-month follow up (OR 1.02, 95% CI 0.98-1.06; P=.29).ConclusionsGreater app usage predicted greater odds of self-reported 30-day point-prevalence abstinence at both the end of treatment and over the long term, suggesting that the app had a therapeutic benefit. Positive psychology content and prescriptive clarity may promote sustained app engagement over time.Trial RegistrationClinicalTrials.gov NCT03951766; https://clinicaltrials.gov/ct2/show/NCT03951766

Varenicline for Gradual Versus Abrupt Smoking Cessation in Poorly Motivated Smokers With COPD: A Prematurely Terminated Randomized Controlled Trial.

Although smoking is the leading cause of COPD, many patients with COPD smoke, highlighting the need for effective smoking cessation interventions in this population. This study examined the efficacy and safety of varenicline in increasing smoking cessation rates through "gradual" versus "abrupt" cessation in COPD patients with low motivation to quit smoking. Randomized, open label, 30-week, controlled trial (ClinicalTrials.gov identifier: NCT02894957) conducted between January 2019 and October 2020 at a center in Israel. Smokers with COPD, poorly motivated to quit, were randomized to 6 weeks of varenicline for smoking reduction and a target quit day (TQD) at the end of week 6 (gradual cessation group) or ad libitum smoking for 5 weeks, 1 week of varenicline, and a TQD at the end of week 6 (abrupt cessation group). After the pre-quit phase, both groups received 12-week regular varenicline treatment and 12-week follow-up. Primary outcome was biochemically-validated continuous abstinence for weeks 6-30. Secondary outcomes were (i) biochemically-confirmed 7-day point prevalence abstinence for weeks 4-30; (ii) efficient smoking reduction (≥50% in number of cigarettes/day) in the pre-quit phase; and (iii) number of cigarettes/day, motivation to quit, and changes in respiratory symptoms and spirometry from baseline through week 30. A drug recall issued by the study sponsor stopped the study after 70/242 (28.9%) patients had been enrolled. The gradual cessation group (n=29) had significantly higher continuous abstinence rates from TQD through week 30 vs the abrupt cessation group (n=41): 20.7% vs. 4.9% [OR=5.09; 95%CI 0.89-29.17; p=0.048] and higher 7-day point prevalence abstinence levels at all time points but week 18 [p= 0.027 at week 6, 0.056 at week 7 and 0.096 at week 9]. Motivation to quit increased (p=0.002) and the number of cigarettes/day decreased (p=0.002) over time in both groups. Respiratory symptoms, but not spirometry, improved in both groups at week 30. Treatment was safe and well tolerated. In poorly motivated smokers with COPD, using varenicline for a 6-week gradual smoking cessation before TQD, compared with abrupt cessation, significantly increased quit rates up to 6 months. Results were not affected by the smaller-than-expected sample size. Further studies are needed to confirm these data.

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

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

Pharmacist-led telehealth tobacco cessation services compared with usual care in a community health center

BackgroundPrevious studies regarding tobacco cessation services (TCS) concluded that pharmacist interventions lead to higher or similar quit rates compared with usual care; however, little is known about patient satisfaction with these services. ObjectivesThis study assessed 30-day point prevalence abstinence and patient satisfaction of TCS provided by pharmacists compared with primary care providers (PCPs) in a community health center. Secondary objectives assessed the number of encounters and time spent counseling and medications prescribed at each visit. MethodsPatients at the age of 18 years or older with tobacco use disorder and a new quit attempt were invited to complete a 9-question survey via e-mail, phone, and mail 7 months after their initial tobacco cessation visit. The survey assessed 30-day point prevalence abstinence and patient satisfaction. Chart reviews were conducted to assess time spent counseling and prescribing patterns. ResultsThe response rate was 38.8% (50/129) overall, 43.9% in the pharmacist group and 36.3% in the PCP group. A 30-day point prevalence abstinence was reached by 22.2% (4/18) in the pharmacist group and 9.4% (3/32) in the PCP group (P = 0.23). Patient satisfaction was significantly higher in the pharmacist group with regard to discussion around medications used to quit smoking (100% vs. 65.6%, P = 0.004), understanding how to properly use the medications (100% vs. 62.5%, P = 0.002), identifying behavioral changes to assist with quitting (94.4% vs. 65.6%, P = 0.036), and frequent follow-up visits (83.3% vs. 46.9%, P = 0.016). Pharmacists spent more time counseling patients and were more likely to prescribe dual nicotine replacement therapy and prescription medications. ConclusionsThere was not a statistically significant difference in abstinence rates, and patient satisfaction with TCS provided by pharmacists and PCPs was high. Pharmacists provide a more intensive service by spending more time counseling patients and providing more follow-ups and are more likely to diversify medications prescribed to quit smoking.

Effects of an Explicit Value Clarification Method With Computer-Tailored Advice on the Effectiveness of a Web-Based Smoking Cessation Decision Aid: Findings From a Randomized Controlled Trial.

BackgroundSmoking continues to be a driver of mortality. Various forms of evidence-based cessation assistance exist; however, their use is limited. The choice between them may also induce decisional conflict. Offering decision aids (DAs) may be beneficial; however, insights into their effective elements are lacking.ObjectiveThis study tested the added value of an effective element (ie, an “explicit value clarification method” paired with computer-tailored advice indicating the most fitting cessation assistance) of a web-based smoking cessation DA.MethodsA web-based randomized controlled trial was conducted among smokers motivated to stop smoking within 6 months. The intervention group received a DA with the aforementioned elements, and the control group received the same DA without these elements. The primary outcome measure was 7-day point prevalence abstinence 6 months after baseline (time point 3 [t=3]). Secondary outcome measures were 7-day point prevalence of abstinence 1 month after baseline (time point 2 [t=2]), evidence-based cessation assistance use (t=2 and t=3), and decisional conflict (immediately after DA; time point 1). Logistic and linear regression analyses were performed to assess the outcomes. Analyses were conducted following 2 (decisional conflict) and 3 (smoking cessation) outcome scenarios: complete cases, worst-case scenario (assuming that dropouts still smoked), and multiple imputations. A priori sample size calculation indicated that 796 participants were needed. The participants were mainly recruited on the web (eg, social media). All the data were self-reported.ResultsOverall, 2375 participants were randomized (intervention n=1164, 49.01%), of whom 599 (25.22%; intervention n=275, 45.91%) completed the DAs, and 276 (11.62%; intervention n=143, 51.81%), 97 (4.08%; intervention n=54, 55.67%), and 103 (4.34%; intervention n=56, 54.37%) completed time point 1, t=2, and t=3, respectively. More participants stopped smoking in the intervention group (23/63, 37%) than in the control group (14/52, 27%) after 6 months; however, this was only statistically significant in the worst-case scenario (crude P=.02; adjusted P=.04). Effects on the secondary outcomes were only observed for smoking abstinence after 1 month (15/55, 27%, compared with 7/46, 15%, in the crude and adjusted models, respectively; P=.02) and for cessation assistance uptake after 1 month (26/56, 46% compared with 18/47, 38% only in the crude model; P=.04) and 6 months (38/61, 62% compared with 26/50, 52%; crude P=.01; adjusted P=.02) but only in the worst-case scenario. Nonuse attrition was 34.19% higher in the intervention group than in the control group (P<.001).ConclusionsCurrently, we cannot confidently recommend the inclusion of explicit value clarification methods and computer-tailored advice. However, they might result in higher nonuse attrition rates, thereby limiting their potential. As a lack of statistical power may have influenced the outcomes, we recommend replicating this study with some adaptations based on the lessons learned.Trial RegistrationNetherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270International Registered Report Identifier (IRRID)RR2-10.2196/21772

Smartphone Application for Smoking Cessation (Quit with US): A Randomized Controlled Trial among Young Adult Light Smokers in Thailand.

This study aimed to determine the efficacy of a smartphone application named Quit with US among young adult smokers. An open-label, parallel, 2-group, randomized controlled trial with a 12-week follow-up was conducted between March and November 2020 among undergraduate students (18 to 24 years) in Chiang Mai Province, Thailand. A total of 273 participants were assigned by simple randomization procedure to the Quit with US intervention group (n = 137) or the control group (n = 136). All participants received pharmacists’ smoking cessation counseling at baseline and follow-ups. In addition, the intervention group’s participants were advised to use Quit with US. The baseline and 12-week follow-up assessments were conducted at a study unit, whereas other follow-ups were completed over the telephone. The primary abstinence outcome was the exhaled CO concentration level (≤6 ppm) verified 7-day point prevalence abstinence. At baseline, the participants’ mean (standard deviation) age was 21.06 (1.62) years. Most identified as daily smokers (57.9%, n = 158), consumed ≤10 cigarettes daily (89.4%, n = 244), and expressed low level of nicotine dependence as measured by Heaviness of Smoking Index score (86.1%, n = 235). Regarding intention-to-treat analyses, participants in the Quit with US intervention group achieved significantly greater smoking abstinence rate than those in the control group (58.4% (80/137) vs. 30.9% (42/136), risk ratio = 1.89, 95% confidence intervals = 1.42 to 2.52, p < 0.001). In conclusion, Quit with US integrated with pharmacists’ smoking cessation counseling significantly enhanced smoking abstinence rates among young adult light smokers consuming ≤ 10 cigarettes daily.

Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Type 2 Diabetes

Evidence of effective smoking cessation interventions in patients with diabetes is limited. The unique behavioral and metabolic characteristics of smokers with type 2 diabetes warrants a randomized clinical trial of the smoking cessation drug varenicline. To evaluate the efficacy and safety of varenicline in patients with type 2 diabetes with an intention to quit smoking. This multicenter, double-blind, placebo-controlled randomized clinical trial recruited patients from 6 outpatient clinics in 5 hospitals in Catania, Italy. Patients with type 2 diabetes, who were smoking at least 10 cigarettes a day, and who intended to quit smoking were screened for eligibility. Eligible patients were randomized to either varenicline or placebo treatment. The trial consisted of a 12-week treatment phase followed by a 40-week follow-up, nontreatment phase. Intention-to-treat data analysis was performed from December 2020 to April 2021. Varenicline, 1 mg, twice daily or matched placebo administered for 12 weeks. Patients in both treatment groups also received smoking cessation counseling. The primary efficacy end point of the study was the continuous abstinence rate (CAR) at weeks 9 to 24. Secondary efficacy end points were the CAR at weeks 9 to 12 and weeks 9 to 52 as well as 7-day point prevalence of abstinence at weeks 12, 24, and 52. A total of 300 patients (mean [SD] age, 57.4 [0.8] years; 117 men [78.0%] in varenicline group and 119 men [79.3%] in placebo group) were randomized to receive varenicline (n = 150) or placebo (n = 150). The CAR at weeks 9 to 24 was significantly higher for the varenicline than placebo group (24.0% vs 6.0%; odds ratio [OR], 4.95; 95% CI, 2.29-10.70; P < .001). The CARs at weeks 9 to 12 (31.3% vs 7.3%; OR, 5.77; 95% CI, 2.85-11.66; P < .001) and weeks 9 to 52 (18.7% vs 5.3%; OR, 4.07; 95% CI, 1.79-9.27; P < .001) as well as the 7-day point prevalence of abstinence at weeks 12, 24, and 52 were also significantly higher for the varenicline vs placebo group. The most frequent adverse events occurring in the varenicline group compared with the placebo group were nausea (41 [27.3%] vs 17 [11.4%]), insomnia (29 [19.4%] vs 19 [12.7%]), abnormal dreams (19 [12.7%] vs 5 [3.4%]), anxiety (17 [11.4%] vs 11 [7.3%]), and irritability (14 [9.4%] vs 8 [5.4%]). Serious adverse events were infrequent in both groups and not treatment-related. Results of this trial showed that inclusion of varenicline in a smoking cessation program is efficacious in achieving long-term abstinence without serious adverse events. Varenicline should be routinely used in diabetes education programs to help patients with type 2 diabetes stop smoking. ClinicalTrials.gov Identifier: NCT01387425.