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1.
Am J Prev Med ; 2021 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-34756629

RESUMO

INTRODUCTION: With concerns about tobacco use being a risk factor for severe disease from COVID-19, understanding nicotine- and tobacco-use patterns is important for preventive efforts. This study aims to understand changes in combustible cigarette and E-cigarette use among U.S. adults. METHODS: In August 2020, a cross-sectional survey of a nationally representative sample of adults aged ≥18 years in the National Opinion Research Center's AmeriSpeak Panel who reported past 6-month use of combustible cigarettes or E-cigarettes was conducted. Multivariable logistic regression assessed the factors associated with increased product use and quit attempts since hearing about COVID-19. RESULTS: A total of 1,024 past 6-month cigarette smokers/E-cigarette users were surveyed. Among cigarette smokers, 45% reported no change in cigarette smoking, and 33% reported increased cigarette smoking since hearing about COVID-19. Higher stress was associated with increased cigarette smoking. Among E-cigarette users, 41% reported no change in E-cigarette use, and 23% reported increasing E-cigarette use. A total of 26% of cigarette smokers and 41% of E-cigarette users tried to quit because of COVID-19. Higher perceived risk of COVID-19 was associated with attempts to quit combustible cigarettes (AOR=2.37, 95% CI=1.59, 3.55) and E-cigarettes (AOR=3.14, 95% CI=1.73, 5.70). CONCLUSIONS: Cigarette and E-cigarette use patterns varied in response to the COVID-19 pandemic. Most cigarette smokers and E-cigarette users perceived product use as increasing COVID-19‒related health risks, and this was associated with attempts to quit. Some cigarette smokers, especially those reporting higher stress, increased product use. Proactive provision of cessation support to smokers and E-cigarette users may help mitigate the stress-related increases in product use during the COVID-19 pandemic.

2.
Contemp Clin Trials ; 111: 106586, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34606988

RESUMO

BACKGROUND: Integrating tobacco treatment services into lung cancer screening (LCS) has the potential to leverage a 'teachable moment' to promote cessation among long-term smokers and reduce disparities in tobacco treatment access. This protocol paper describes the Screen ASSIST (Aiding Screening Support In Stopping Tobacco) trial, which will identify how to best deliver evidence-driven tobacco treatment in the context of LCS. METHODS: Screen ASSIST is a randomized clinical trial with a 3-factor, fully crossed factorial design that enrolls current smokers (any cigarette use in the past 30 days) scheduled to attend LCS at multiple sites in the Mass General Brigham healthcare system. To maximize reach, recruitment is conducted at 3 time points: 1) at the time of LCS scheduling, 2) at the LCS visit, and 3) after the participant has received their LCS results. Participants are stratified by LCS study site and recruitment point and randomly assigned into 8 groups that test intervention components varying on telehealth counseling duration (4 weeks vs. 8 weeks), nicotine replacement therapy duration (2 weeks vs. 8 weeks), and systematic screening and referral for social determinants of health via a service named 'AuntBertha' (referral vs. no referral). The primary study outcome is self-reported past 7-day tobacco abstinence at 6-month follow-up. This trial will also assess systems integration and evaluate implementation of the intervention. DISCUSSION: Screen ASSIST will identify the most effective combination of tobacco cessation treatments within the LCS context, in order to improve the cost-effectiveness of LCS and quality of life among long-term heavy smokers.

3.
J Subst Abuse Treat ; : 108643, 2021 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-34716036

RESUMO

INTRODUCTION: Though telephone counseling is a modality commonly used to promote health behavior change, including tobacco cessation, specific counselor and participant behaviors that indicate engagement and therapeutic alliance remain poorly characterized in the literature. We sought to explore smokers' and counselors' engagement and rapport-building behaviors in telephone counseling for smoking cessation and patterns of these behaviors by smokers' psychiatric symptoms. METHODS: The study team transcribed, audio-recorded tobacco cessation counseling calls for the presence of engagement and rapport-building behaviors among recently hospitalized participants enrolled in a smoking cessation randomized controlled trial (RCT). The study used baseline data from the RCT to explore frequencies of counselors' and smokers' behaviors among smokers who had reported more (vs. fewer) symptoms of depression (PHQ8 ≥ 10) or anxiety (GAD7 ≥ 10) at study entry. RESULTS: Participants (n = 37) were mostly female (23/37), White (26/37), with a median age of 58. At study entry while hospitalized, moderate-to-severe symptoms of depression (18/37) and anxiety (22/37) were common. Participant-led engagement behaviors included referencing past quit attempts, asking questions, elaborating response to yes/no questions, expressing commitment to behavior change, and assigning importance to nonautomated calls. Counselor-led behaviors included building off prior interaction, empathy, normalizing challenges, reframing and summarizing, validating achievements, and expressing shared experience. Both participants and counselors engaged via general discussion and humor. Participant-led engagement behaviors appeared more often in call transcripts among patients with higher baseline depression and anxiety symptoms compared to those with lower symptom scores. CONCLUSIONS: This study classified participant-led, counselor-led, and shared engagement behaviors during tobacco cessation counseling calls. Increased engagement via telephone counseling may be important for individuals with psychiatric symptoms identified at the start of treatment.

4.
Cochrane Database Syst Rev ; 9: CD010216, 2021 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-34519354

RESUMO

BACKGROUND: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. Some people who smoke use ECs to stop or reduce smoking, but some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This is an update conducted as part of a living systematic review. OBJECTIVES: To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long-term smoking abstinence. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 May 2021, and reference-checked and contacted study authors. We screened abstracts from the Society for Research on Nicotine and Tobacco (SRNT) 2021 Annual Meeting.   SELECTION CRITERIA: We included randomized controlled trials (RCTs) and randomized cross-over trials, in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. Studies had to report abstinence from cigarettes at six months or longer or data on safety markers at one week or longer, or both. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included the proportion of people still using study product (EC or pharmacotherapy) at six or more months after randomization or starting EC use, changes in carbon monoxide (CO), blood pressure (BP), heart rate, arterial oxygen saturation, lung function, and levels of carcinogens or toxicants or both. We used a fixed-effect Mantel-Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in meta-analyses. MAIN RESULTS: We included 61 completed studies, representing 16,759 participants, of which 34 were RCTs. Five of the 61 included studies were new to this review update. Of the included studies, we rated seven (all contributing to our main comparisons) at low risk of bias overall, 42 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.53, 95% confidence interval (CI) 1.21 to 1.93; I2 = 0%; 4 studies, 1924 participants). In absolute terms, this might translate to an additional three quitters per 100 (95% CI 1 to 6). There was low-certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs were rare, but there was insufficient evidence to determine whether rates differed between groups due to very serious imprecision (RR 1.30, 95% CI 0.89 to 1.90: I2 = 0; 4 studies, 1424 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.94, 95% CI 1.21 to 3.13; I2 = 0%; 5 studies, 1447 participants). In absolute terms, this might lead to an additional seven quitters per 100 (95% CI 2 to 16). There was moderate-certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 1.06, 95% CI 0.47 to 2.38; I2 = 0; 5 studies, 792 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.61, 95% CI 1.44 to 4.74; I2 = 0%; 6 studies, 2886 participants). In absolute terms this represents an additional six quitters per 100 (95% CI 2 to 15). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was some evidence that non-serious AEs were more common in people randomized to nicotine EC (RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants), and again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 1.51, 95% CI 0.70 to 3.24; I2 = 0%; 7 studies, 1303 participants).  Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued use. Very few studies reported data on other outcomes or comparisons, hence evidence for these is limited, with CIs often encompassing clinically significant harm and benefit. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to NRT and compared to ECs without nicotine. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the effect size. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, with no difference in AEs between nicotine and non-nicotine ECs. Overall incidence of SAEs was low across all study arms. We did not detect  evidence of harm from nicotine EC, but longest follow-up was two years and the  number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates, but further RCTs are underway. To ensure the review continues to provide up-to-date information to decision-makers, this review is now a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar , Humanos , Agonistas Nicotínicos , Revisões Sistemáticas como Assunto , Dispositivos para o Abandono do Uso de Tabaco
5.
Lancet HIV ; 8(10): e652-e658, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34461050

RESUMO

Tobacco use is now a leading cause of death in people living with HIV in the USA. Increasing cessation rates in this group is a public health priority, yet the results of clinical trials aimed at optimising tobacco treatment strategies have been largely disappointing. Combinations of behavioural and pharmacological cessation therapies in people living with HIV have yielded increases in short-term quit rates, but few have shown long-term efficacy. Even with aggressive therapy combining intensive behavioural treatment with pharmacological agents, most smokers living with HIV continue to smoke. The generalised approach to tobacco treatment that prevails in guidelines and in clinical practices might do a disservice to these individuals, who represent a sizable segment of the population of people living with HIV. Harm reduction is a sensible and needed approach for smokers living with HIV who are unable or unwilling to quit. In this Viewpoint, we take an expansive view of harm reduction to include not only cutting down on cigarette intake for persistent smokers, but also reducing smoking's downstream health effects by increasing lung cancer screening and by controlling concurrent cardiovascular risk factors, especially hypertension and hyperlipidaemia.

7.
Am J Public Health ; 111(9): 1661-1672, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34410826

RESUMO

The topic of e-cigarettes is controversial. Opponents focus on e-cigarettes' risks for young people, while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking. Most US health organizations, media coverage, and policymakers have focused primarily on risks to youths. Because of their messaging, much of the public-including most smokers-now consider e-cigarette use as dangerous as or more dangerous than smoking. By contrast, the National Academies of Science, Engineering, and Medicine concluded that e-cigarette use is likely far less hazardous than smoking. Policies intended to reduce adolescent vaping may also reduce adult smokers' use of e-cigarettes in quit attempts. Because evidence indicates that e-cigarette use can increase the odds of quitting smoking, many scientists, including this essay's authors, encourage the health community, media, and policymakers to more carefully weigh vaping's potential to reduce adult smoking-attributable mortality. We review the health risks of e-cigarette use, the likelihood that vaping increases smoking cessation, concerns about youth vaping, and the need to balance valid concerns about risks to youths with the potential benefits of increasing adult smoking cessation.


Assuntos
Fumar Cigarros/prevenção & controle , Sistemas Eletrônicos de Liberação de Nicotina/estatística & dados numéricos , Prevenção do Hábito de Fumar/métodos , Fumar Tabaco/terapia , Vaping/prevenção & controle , Adolescente , Adulto , Humanos , Estados Unidos
9.
JMIR Form Res ; 5(6): e28952, 2021 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-34255651

RESUMO

BACKGROUND: Screen ASSIST is a cessation trial offered to current smokers at the point of lung cancer screening. Because of the unique position of promoting a prevention behavior (smoking cessation) within the context of a detection behavior (lung cancer screening), this study employed prospect theory to design and formatively evaluate a targeted recruitment video prior to trial launch. OBJECTIVE: The aim of this study was to identify which message frames were most effective at promoting intent to participate in a smoking cessation study. METHODS: Participants were recruited from a proprietary opt-in online panel company and randomized to a 2 (benefits of quitting vs risks of continuing to smoke at the time of lung screening; BvR) × 2 (gains of participating vs losses of not participating in a cessation study; GvL) message design experiment (N=314). The primary outcome was self-assessed intent to participate in a smoking cessation study. Message effectiveness and lung cancer risk perception measures were also collected. Analysis of variance examined the main effect of the 2 message factors and a least absolute shrinkage and selection operator (LASSO) approach identified predictors of intent to participate in a multivariable model. A mediation analysis was conducted to determine the direct and indirect effects of message factors on intent to participate in a cessation study. RESULTS: A total of 296 participants completed the intervention. There were no significant differences in intent to participate in a smoking cessation study between message frames (P=.12 and P=.61). In the multivariable model, quit importance (P<.001), perceived message relevance (P<.001), and affective risk response (ie, worry about developing lung cancer; P<.001) were significant predictors of intent to participate. The benefits of quitting frame significantly increased affective risk response (Meanbenefits 2.60 vs Meanrisk 2.40; P=.03), which mediated the relationship between message frame and intent to participate (b=0.24; 95% CI 0.01-0.47; P=.03). CONCLUSIONS: This study provides theoretical and practical guidance on how to design and evaluate proactive recruitment messages for a cessation trial. Based on our findings, we conclude that heavy smokers are more responsive to recruitment messages that frame the benefits of quitting as it increased affective risk response, which predicted greater intention to participate in a smoking cessation study.

10.
J Gen Intern Med ; 2021 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-34100230

RESUMO

BACKGROUND: Cigarette smoking is a risk factor for severe COVID-19 disease. Understanding smokers' responses to the pandemic will help assess its public health impact and inform future public health and provider messages to smokers. OBJECTIVE: To assess risk perceptions and change in tobacco use among current and former smokers during the COVID-19 pandemic. DESIGN: Cross-sectional survey conducted in May-July 2020 (55% response rate) PARTICIPANTS: 694 current and former daily smokers (mean age 53, 40% male, 78% white) who had been hospitalized pre-COVID-19 and enrolled into a smoking cessation clinical trial at hospitals in Massachusetts, Pennsylvania, and Tennessee. MAIN MEASURES: Perceived risk of COVID-19 due to tobacco use; changes in tobacco consumption and interest in quitting tobacco use; self-reported quitting and relapse since January 2020. KEY RESULTS: 68% (95% CI, 65-72%) of respondents believed that smoking increases the risk of contracting COVID-19 or having a more severe case. In adjusted analyses, perceived risk was higher in Massachusetts where COVID-19 had already surged than in Pennsylvania and Tennessee which were pre-surge during survey administration (AOR 1.56, 95% CI, 1.07-2.28). Higher perceived COVID-19 risk was associated with increased interest in quitting smoking (AOR 1.72, 95% CI 1.01-2.92). During the pandemic, 32% (95% CI, 27-37%) of smokers increased, 37% (95% CI, 33-42%) decreased, and 31% (95% CI, 26-35%) did not change their cigarette consumption. Increased smoking was associated with higher perceived stress (AOR 1.49, 95% CI 1.16-1.91). Overall, 11% (95% CI, 8-14%) of respondents who smoked in January 2020 (pre-COVID-19) had quit smoking at survey (mean, 6 months later) while 28% (95% CI, 22-34%) of former smokers relapsed. Higher perceived COVID-19 risk was associated with higher odds of quitting and lower odds of relapse. CONCLUSIONS: Most smokers believed that smoking increased COVID-19 risk. Smokers' responses to the pandemic varied, with increased smoking related to stress and increased quitting associated with perceived COVID-19 vulnerability.

11.
Artigo em Inglês | MEDLINE | ID: mdl-34069350

RESUMO

(1) Background: COVID-19 has substantially altered individual environments and behaviors. We aim to explore the impact of COVID-19 on the smoking behavior of individuals trying to quit tobacco. (2) Methods: This study presents a qualitative analysis of individual interviews focused on perceived impacts of the COVID-19 pandemic on tobacco use among 39 participants in the Helping HAND 4 (HH4) post-hospitalization smoking cessation trial (NCT03603496). (3) Results: Emergent impacts of COVID-19 included change in routine, isolation, employment changes, and financial challenges; these in turn were associated with boredom, altered cravings and triggers, and increased stress. The availability of effective coping mechanisms instead of smoking to deal with stress heavily influenced subsequent smoking behavior. These results were triangulated with the Transactional Model of Stress, providing a framework to elucidate connections between factors such as perceived control, self-efficacy, and dispositional coping style, and highlighting potential areas for intervention. (4) Conclusions: Results suggest that stress during the COVID-19 pandemic may undermine effective coping skills among individuals enrolled in a post-hospitalization smoking cessation trial. Strengthening effective coping skills (e.g., minimizing the use of tobacco as a default stress response) and increasing perceived control and self-efficacy are promising intervention targets.


Assuntos
COVID-19 , Abandono do Hábito de Fumar , Hospitalização , Humanos , Pandemias , SARS-CoV-2 , Fumar
12.
Prev Med Rep ; 23: 101402, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34094817

RESUMO

Introduction: Cancer patients who smoke report more stress and psychological distress than patients who do not smoke. It is unclear how these emotional symptoms may modify smoking behavior in cancer patients. We examined the influence of a smoking cessation intervention for cancer patients on stress and distress, and the effects of these symptoms on smoking abstinence. Methods: Mixed-methods secondary analysis of data from the Smokefree Support Study, a two-site 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. Stress coping, perceived stress, distress, and anxiety were self-reported at baseline, 3, and 6 months. Abstinence was biochemically-confirmed at 6 months. A subset of patients (n = 72) completed qualitative exit-interviews. Results: Patients were on average, 58 years old, 56% female, and smoked a median of 10 cigarettes/day. There were no significant treatment group × time interactions or main effects of treatment group on stress or distress measures (p's > 0.05), however there were significant main effects of time suggesting symptom improvements on each measure in both study groups (p's < 0.05). In adjusted logistic regression models, lower levels anxiety at 3 months predicted confirmed smoking abstinence at 6 months (p = .03). Qualitatively, at 6 months, patients reported their stress and smoking were connected and that the cessation counseling was helpful. Conclusions: Cancer patients enrolled in a smoking cessation trial report decreases in stress, distress and anxiety over time, and anxiety symptoms may impact smoking cessation success at follow-up resulting in an important intervention target.

13.
Nicotine Tob Res ; 23(12): 2037-2046, 2021 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-34077535

RESUMO

SIGNIFICANCE: Increased rates of smoking cessation will be essential to maximize the population benefit of low-dose CT screening for lung cancer. The NCI's Smoking Cessation at Lung Examination (SCALE) Collaboration includes eight randomized trials, each assessing evidence-based interventions among smokers undergoing lung cancer screening (LCS). We examined predictors of trial enrollment to improve future outreach efforts for cessation interventions offered to older smokers in this and other clinical settings. METHODS: We included the six SCALE trials that randomized individual participants. We assessed demographics, intervention modalities, LCS site and trial administration characteristics, and reasons for declining. RESULTS: Of 6285 trial- and LCS-eligible individuals, 3897 (62%) declined and 2388 (38%) enrolled. In multivariable logistic regression analyses, Blacks had higher enrollment rates (OR 1.5, 95% CI 1.2,1.8) compared to Whites. Compared to "NRT Only" trials, those approached for "NRT + prescription medication" trials had higher odds of enrollment (OR 6.1, 95% CI 4.7,7.9). Regarding enrollment methods, trials using "Phone + In Person" methods had higher odds of enrollment (OR 1.6, 95% CI 1.2,1.9) compared to trials using "Phone Only" methods. Some of the reasons for declining enrollment included "too busy" (36.6%), "not ready to quit" (8.2%), "not interested in research" (7.7%), and "not interested in the intervention offered" (6.2%). CONCLUSION: Enrolling smokers in cessation interventions in the LCS setting is a major priority that requires multiple enrollment and intervention modalities. Barriers to enrollment provide insights that can be addressed and applied to future cessation interventions to improve implementation in LCS and other clinical settings with older smokers. IMPLICATIONS: We explored enrollment rates and reasons for declining across six smoking cessation trials in the lung cancer screening setting. Offering multiple accrual methods and pharmacotherapy options predicted increased enrollment across trials. Enrollment rates were also greater among Blacks compared to Whites. The findings offer practical information for the implementation of cessation trials and interventions in the lung cancer screening context and other clinical settings, regarding intervention modalities that may be most appealing to older, long-term smokers.

14.
JAMA Psychiatry ; 78(8): 839-847, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-33950156

RESUMO

Importance: Smoking among individuals with serious mental illness (SMI) represents a major public health problem. Intervening during a psychiatric hospital stay may provide an opportunity to aid engagement in smoking cessation treatment and facilitate success in quitting. Objective: To examine the effectiveness of a multicomponent, sustained care (SusC) smoking cessation intervention in adults with SMI receiving inpatient psychiatric care. Design, Setting, and Participants: The Helping HAND 3 randomized clinical trial compared SusC with usual care (UC) among individuals with SMI who smoked daily and were receiving inpatient psychiatric care in Austin, Texas, in a single hospital. The study was conducted from July 2015 through August 2019. Interventions: The UC intervention involved brief smoking cessation information, self-help materials and advice from the admitting nurse, and an offer to provide nicotine replacement therapy during hospitalization. The SusC intervention included 4 main components designed to facilitate patient engagement with postdischarge smoking cessation resources: (1) inpatient motivational counseling; (2) free transdermal nicotine patches on discharge; (3) an offer of free postdischarge telephone quitline, text-based, and/or web-based smoking cessation counseling, and (4) postdischarge automated interactive voice response calls or text messages. Main Outcomes and Measures: The primary outcome was biochemically verified 7-day point-prevalence abstinence at 6-month follow-up. A secondary outcome was self-reported smoking cessation treatment use at 1, 3, and 6 months after discharge. Results: A total of 353 participants were randomized, of whom 342 were included in analyses (mean [SD] age, 35.8 [12.3] years; 268 White individuals [78.4%]; 280 non-Hispanic individuals [81.9%]; 169 women [49.4%]). They reported smoking a mean (SD) of 16.9 (10.4) cigarettes per day. Participants in the SusC group evidenced significantly higher 6-month follow-up point-prevalence abstinence rates than those in the UC group (8.9% vs 3.5%; adjusted odds ratio, 2.95 [95% CI, 1.24-6.99]; P = .01). The number needed to treat was 18.5 (95% CI, 9.6-306.4). A series of sensitivity analyses confirmed effectiveness. Finally, participants in the SusC group were significantly more likely to report using smoking cessation treatment over the 6 months postdischarge compared with participants in the UC group (74.6% vs 40.5%; relative risk, 1.8 [95% CI, 1.51-2.25]; P < .001). Conclusions and Relevance: The findings of this randomized clinical trial provide evidence for the effectiveness of a scalable, multicomponent intervention in promoting smoking cessation treatment use and smoking abstinence in individuals with SMI following hospital discharge. Trial Registration: ClinicalTrials.gov Identifier: NCT02204956.

16.
Cochrane Database Syst Rev ; 4: CD010216, 2021 04 29.
Artigo em Inglês | MEDLINE | ID: mdl-33913154

RESUMO

BACKGROUND: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. Some people who smoke use ECs to stop or reduce smoking, but some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This is an update of a review first published in 2014. OBJECTIVES: To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 February 2021, together with reference-checking and contact with study authors. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses. MAIN RESULTS: We included 56 completed studies, representing 12,804 participants, of which 29 were RCTs. Six of the 56 included studies were new to this review update. Of the included studies, we rated five (all contributing to our main comparisons) at low risk of bias overall, 41 at high risk overall (including the 25 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.70, 95% CI 1.03 to 2.81; I2 = 0%; 4 studies, 1057 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 11). These trials mainly used older EC with relatively low nicotine delivery. There was moderate-certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.60, 95% CI 0.15 to 2.44; I2 = n/a; 4 studies, 494 participants). Compared to behavioral support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.70, 95% CI 1.39 to 5.26; I2 = 0%; 5 studies, 2561 participants). In absolute terms this represents an increase of seven per 100 (95% CI 2 to 17). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs differed, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants; SAEs: RR 1.17, 95% CI 0.33 to 4.09; I2 = 5%; 6 studies, 1011 participants, very low certainty). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the size of effect, particularly when using modern EC products. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, though evidence indicated no difference in AEs between nicotine and non-nicotine ECs. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The evidence is limited mainly by imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information, this review is now a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Nicotina , Agonistas Nicotínicos , Abandono do Hábito de Fumar/métodos , Prevenção do Hábito de Fumar , Viés , Monóxido de Carbono/análise , Estudos de Coortes , Humanos , Pessoa de Meia-Idade , Nicotina/administração & dosagem , Agonistas Nicotínicos/administração & dosagem , Avaliação de Resultados em Cuidados de Saúde , Viés de Publicação , Ensaios Clínicos Controlados Aleatórios como Assunto , Fumar/epidemiologia , Abandono do Hábito de Fumar/estatística & dados numéricos , Dispositivos para o Abandono do Uso de Tabaco , Vaping
17.
Nicotine Tob Res ; 23(10): 1656-1663, 2021 08 29.
Artigo em Inglês | MEDLINE | ID: mdl-33847362

RESUMO

INTRODUCTION: Cytisinicline (known as cytisine), a nicotinic acetylcholine receptor partial agonist, is a smoking cessation aid currently marketed in Central and Eastern Europe using a 1.5-mg/tablet 25-day downward titration schedule. No prior studies have evaluated other doses or administration schedules. This study evaluated the effects of a higher dosage and simplified dosing schedule on drug efficacy and tolerability. METHODS: ORCA-1 was a double-blind, randomized, placebo-controlled clinical trial that provided cytisinicline or placebo tablets plus behavioral support for 25 days. Adult smokers (>10 cigarettes daily) committed to quitting smoking were randomized to compare 2 cytisinicline doses (1.5 mg and 3 mg) versus placebo, and 2 administration schedules [downward titration versus 3 times daily (TID)]. Primary outcome was a reduction in expected cigarettes smoked at end of treatment; secondary outcomes were biochemically confirmed 7-day abstinence at Week 4 and continuous abstinence from Weeks 5 to 8. RESULTS: Among 254 participants, those in cytisinicline arms (regardless of dose or schedule) had greater reductions in cigarettes smoked versus placebo, with differences observed in 3 cytisinicline arms statistically significant versus placebo. All cytisinicline arms had statistically significantly higher abstinence rates at Week 4 versus placebo. Both cytisinicline arms using TID schedules had statistically significantly higher continuous abstinence rates from Weeks 5 to 8 compared with placebo. Participants in the cytisinicline 3-mg TID arm had the highest abstinence rate. There were no safety concerns with either 1.5-mg or 3-mg cytisinicline. CONCLUSION: Based on simpler dose scheduling, excellent tolerability, and best-continued abstinence rate, cytisinicline 3-mg TID was selected for future Phase 3 studies. IMPLICATIONS: Although the 1.5-mg 25-day titration schedule has been marketed in Central and Eastern Europe for decades, this study explored using a higher dosage and a simplified dosing schedule for impact on cytisinicline efficacy and tolerability. Based on these results, a Phase 3 program was initiated using cytisinicline 3-mg tablets on a TID schedule for potential market approval in the United States.


Assuntos
Quinoxalinas , Fumantes , Adulto , Alcaloides , Azocinas , Benzazepinas , Método Duplo-Cego , Humanos , Quinolizinas , Resultado do Tratamento , Vareniclina
18.
Addict Behav ; 115: 106794, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33385757

RESUMO

AIMS: Among 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. METHODS: Mixed-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. RESULTS: Among 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. CONCLUSION: Newly 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.


Assuntos
Neoplasias , Abandono do Hábito de Fumar , Produtos do Tabaco , Humanos , Neoplasias/epidemiologia , Fumar/epidemiologia , Dispositivos para o Abandono do Uso de Tabaco
19.
Artigo em Inglês | MEDLINE | ID: mdl-33498834

RESUMO

The impact of the COVID-19 pandemic on US adults' smoking and quitting behaviors is unclear. We explored the impact of COVID-19 on smoking behaviors, risk perceptions, and reactions to text messages during a statewide stay-at-home advisory among primary care patients who were trying to quit. From May-June 2020, we interviewed smokers enrolled in a 12-week, pilot cessation trial providing text messaging and mailed nicotine replacement medication (NCT04020718). Twenty-two individuals (82% white, mean age 55 years), representing 88% of trial participants during the stay-at-home advisory, completed exit interviews; four (18%) of them reported abstinence. Interviews were thematically analyzed by two coders. COVID-19-induced environmental changes had mixed effects, facilitating quitting for some and impeding quitting for others. While stress increased for many, those who quit found ways to cope with stress. Generally, participants felt at risk for COVID-19 complications but not at increased risk of becoming infected. Reactions to COVID-19 and quitting behaviors differed across age groups, older participants reported difficulties coping with isolation (e.g., feeling disappointed when a text message came from the study and not a live person). Findings suggest that cessation interventions addressing stress and boredom are needed during COVID-19, while smokers experiencing isolation may benefit from live-person supports.


Assuntos
COVID-19 , Atenção Primária à Saúde , Abandono do Hábito de Fumar/psicologia , Adulto , Idoso , Humanos , Pessoa de Meia-Idade , Pandemias , Projetos Piloto , Estresse Psicológico , Dispositivos para o Abandono do Uso de Tabaco
20.
J Natl Cancer Inst ; 113(8): 1065-1073, 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-33484569

RESUMO

BACKGROUND: Guidelines recommend offering cessation interventions to smokers eligible for lung cancer screening, but there is little data comparing specific cessation approaches in this setting. We compared the benefits and costs of different smoking cessation interventions to help screening programs select specific cessation approaches. METHODS: We conducted a societal-perspective cost-effectiveness analysis using a Cancer Intervention and Surveillance Modeling Network model simulating individuals born in 1960 over their lifetimes. Model inputs were derived from Medicare, national cancer registries, published studies, and micro-costing of cessation interventions. We modeled annual lung cancer screening following 2014 US Preventive Services Task Force guidelines plus cessation interventions offered to current smokers at first screen, including pharmacotherapy only or pharmacotherapy with electronic and/or web-based, telephone, individual, or group counseling. Outcomes included lung cancer cases and deaths, life-years saved, quality-adjusted life-years (QALYs) saved, costs, and incremental cost-effectiveness ratios. RESULTS: Compared with screening alone, all cessation interventions decreased cases of and deaths from lung cancer. Compared incrementally, efficient cessation strategies included pharmacotherapy with either web-based cessation ($555 per QALY), telephone counseling ($7562 per QALY), or individual counseling ($35 531 per QALY). Cessation interventions continued to have costs per QALY well below accepted willingness to pay thresholds even with the lowest intervention effects and was more cost-effective in cohorts with higher smoking prevalence. CONCLUSION: All smoking cessation interventions delivered with lung cancer screening are likely to provide benefits at reasonable costs. Because the differences between approaches were small, the choice of intervention should be guided by practical concerns such as staff training and availability.

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