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Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease: A Randomized Clinical Trial.

ABSTRACT: Importance:Smokers with chronic obstructive pulmonary disease (COPD) have particular difficulty quitting. Long-term nicotine replacement therapy (LT-NRT) might offer a strategy for reducing harm from cigarettes and provide a pathway for later cessation. Objective:To compare the effect of LT-NRT vs standard smoking cessation (SSC) on exposure to cigarette smoke, harm related to smoking, and cessation among smokers with COPD. Design, Setting, and Participants:This unblinded, randomized clinical trial recruited smokers who self-reported a diagnosis of COPD at any level of readiness to quit from May 23, 2014, through November 30, 2015. The 12-month follow-up was completed December 6, 2016. Patients were recruited at a clinical research unit of an academic medical center. Analysis was based on intention to treat and performed from March 8 through November 30, 2017. Interventions:Standard smoking cessation treatment included 10 weeks of NRT and 4 follow-up counseling sessions for those willing to make a quit attempt. Long-term NRT included 12 months of NRT and 6 follow-up counseling sessions regardless of initial willingness to quit. Overall, 198 patients were randomized to SSC, and 197 were included in the primary analysis; 200 patients were randomized to LT-NRT, and 197 were included in the primary analysis. Main Outcomes and Measures:The primary outcome was 7-day abstinence verified by carbon monoxide (CO) levels at 12 months. Secondary outcomes included cigarettes smoked per day (CPD), exposure to CO, urinary excretion of 4-methylnitrosamino-1-3-pyridyl-1-butanol (NNAL) (a smoking-related carcinogen), and adverse events. Results:Among 398 patients who were randomized (59.8% female; mean [SD] age, 56.0 [9.3] years), the mean (SD) CPD was 23.1 (12.3). Twelve-month follow-up was completed by 373 participants (93.7%), and 394 (99.0%) were included in the primary analysis. At 12 months, CO-verified abstinence occurred in 23 of 197 participants (11.7%) in the SSC arm and 24 of 197 (12.2%) in the LT-NRT arm (risk difference, 0.5%; 95% CI, -5.9% to 6.9%). Continuing smokers in the SSC and LT-NRT arms had similar, significantly reduced harms caused by smoking, including cigarette consumption by 12.4 and 14.5 CPD, respectively, exhaled CO level by 5.5 and 7.8 ppm, respectively, and mean urinary NNAL excretion by 21.7% and 23.0%, respectively. In multivariate analyses, continuing smokers with greater adherence to NRT experienced less reduction in NNAL exposure. The frequency of major adverse cardiac events was similar in both groups. Conclusions and Relevance:Similar rates of cessation and similar reductions in exposure to tobacco smoke resulted with LT-NRT and SSC. Among continuing smokers, ongoing use of NRT was not associated with reductions in smoke exposure. Trial Registration:ClinicalTrials.gov Identifier: NCT02148445.

SUBMITTER: Ellerbeck EF

PROVIDER: S-EPMC6324503 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease: A Randomized Clinical Trial.

Ellerbeck Edward F EF Nollen Nicole N Hutcheson Tresza D TD Phadnis Milind M Fitzgerald Sharon A SA Vacek James J Sharpe Matthew R MR Salzman Gary A GA Richter Kimber P KP

JAMA network open 20180907 5

<h4>Importance</h4>Smokers with chronic obstructive pulmonary disease (COPD) have particular difficulty quitting. Long-term nicotine replacement therapy (LT-NRT) might offer a strategy for reducing harm from cigarettes and provide a pathway for later cessation.<h4>Objective</h4>To compare the effect of LT-NRT vs standard smoking cessation (SSC) on exposure to cigarette smoke, harm related to smoking, and cessation among smokers with COPD.<h4>Design, setting, and participants</h4>This unblinded, ...[more]

PMID: 30646142

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Project description:BackgroundIncreased smartphone ownership has led to the development of mobile smoking cessation programs. Although the related body of evidence, gathered through the conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability.ObjectiveThe primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program, Pivot (intervention), versus QuitGuide (control). The secondary aims included comparison of other smoking-related behaviors, outcomes and participant feedback, and exploratory analyses of baseline factors associated with smoking cessation.MethodsIn this remote pilot RCT, cigarette smokers in the United States were recruited on the web. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via a web-based questionnaire with videoconference biovalidation in participants who reported 7-day point-prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire, NRT use, and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products, and continuous abstinence. PPA and continuous abstinence were biovalidated using witnessed breath carbon monoxide samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation.ResultsParticipants comprised 188 smokers (n=94, 50% in the Pivot group and n=94, 50% in the QuitGuide group; mean age 46.4, SD 9.2 years; n=104, 55.3% women; n=128, 68.1% White individuals; mean CPD 17.6, SD 9.0). Several cessation rates were higher in the Pivot group (intention to treat): self-reported continuous abstinence was 20% (19/94) versus 9% (8/94; P=.03) for QuitGuide, biochemically confirmed abstinence was 31% (29/94) versus 18% (17/94; P=.04) for QuitGuide, and biochemically confirmed continuous abstinence was 19% (18/94) versus 9% (8/94; P=.046) for QuitGuide. More Pivot participants (93/94, 99% vs 80/94, 85% in the QuitGuide group; P<.001) placed NRT orders (mean 3.3, SD 2.0 vs 1.8, SD 1.6 for QuitGuide; P<.001). Pivot participants had increased self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire (mean point increase 3.2, SD 7.8, P<.001 vs 1.0, SD 8.5, P=.26 for QuitGuide). QuitGuide participants made more mean quit attempts (7.0, SD 6.3 for Pivot vs 9.5, SD 7.5 for QuitGuide; P=.01). Among those who did not achieve abstinence, QuitGuide participants reported greater CPD reduction (mean -34.6%, SD 35.5% for Pivot vs -46.1%, SD 32.3% for QuitGuide; P=.04). Among those who reported abstinence, 90% (35/39) of Pivot participants and 90% (26/29) of QuitGuide participants indicated that their cessation program helped them quit.ConclusionsThis pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks.Trial registrationClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Project description:IntroductionMobile interventions enable personalized behavioral support that could improve smoking cessation (SC) in smokers ready to quit. Scalable interventions, including unmotivated smokers, are needed. We evaluated the effect of personalized behavioral support through mobile interventions plus nicotine replacement therapy sampling (NRT-S) on SC in Hong Kong community smokers.MethodsA total of 664 adult daily cigarette smokers (74.4% male, 51.7% not ready to quit in 30 days) were proactively recruited from smoking hotspots and individually randomized (1:1) to the intervention and control groups (each, n=332). Both groups received brief advice and active referral to SC services. The intervention group received 1-week NRT-S at baseline and 12-week personalized behavioral support through SC advisor-delivered Instant Messaging (IM) and a fully automated chatbot. The control group received regular text messages regarding general health at a similar frequency. Primary outcomes were carbon monoxide-validated smoking abstinence at 6 and 12 months post-treatment initiation. Secondary outcomes included self-reported 7-day point-prevalence and 24-week continuous abstinence, quit attempts, smoking reduction, and SC service use at 6 and 12 months.ResultsBy intention-to-treat, the intervention group did not significantly increase validated abstinence at 6 months (3.9% vs 3.0%, OR=1.31; 95% CI: 0.57-3.04) and 12 months (5.4% vs 4.5%, OR=1.21; 95% CI: 0.60-2.45), as were self-reported 7-day point-prevalence abstinence, smoking reduction, and SC service use at 6 and 12 months. More participants in the intervention than control group made a quit attempt by 6 months (47.0% vs 38.0%, OR=1.45; 95% CI: 1.06-1.97). Intervention engagement rates were low, but engagement in IM alone or combined with chatbot showed higher abstinence at 6 months (adjusted odds ratios, AORs=4.71 and 8.95, both p<0.05).ConclusionsPersonalized behavioral support through mobile interventions plus NRT-S did not significantly improve abstinence in community smokers compared to text only messaging. The suboptimal intervention engagement needs to be addressed in future studies.Trial registrationClinicalTrials.gov NCT04001972.

Project description:ImportanceSmoking cessation medications are routinely used in health care; it is vital to identify medications that most effectively treat this leading cause of preventable mortality.ObjectiveTo compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates.Design, setting, and participantsThree-group randomized intention-to-treat clinical trial occurring from May 2012 to November 2015 among smokers recruited in the Madison, Wisconsin, and Milwaukee, Wisconsin, communities; 65.5% of smokers offered the study (2687/4102) refused participation prior to randomization.InterventionsParticipants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups: (1) nicotine patch only (n = 241); (2) varenicline only (including 1 prequit week; n = 424); and (3) C-NRT (nicotine patch + nicotine lozenge; n = 421). Six counseling sessions were offered.Main outcomes and measuresThe primary outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence at 26 weeks. Secondary outcomes were carbon monoxide-confirmed self-reported initial abstinence, prolonged abstinence at 26 weeks, and point-prevalence abstinence at weeks 4, 12, and 52.ResultsAmong 1086 smokers randomized (52% women; 67% white; mean age, 48 years; mean of 17 cigarettes smoked per day), 917 (84%) provided 12-month follow-up data. Treatments did not differ on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 22.8% [55/241]; varenicline, 23.6% [100/424]; and C-NRT, 26.8% [113/421]) or at 52 weeks (nicotine patch, 20.8% [50/241]; varenicline, 19.1% [81/424]; and C-NRT, 20.2% [85/421]). At 26 weeks, the risk differences for abstinence were, for patch vs varenicline, -0.76% (95% CI, -7.4% to 5.9%); for patch vs C-NRT, -4.0% (95% CI, -10.8% to 2.8%); and for varenicline vs C-NRT, -3.3% (95% CI, -9.1% to 2.6%). All medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion.Conclusions and relevanceAmong adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks. The results raise questions about the relative effectiveness of intense smoking pharmacotherapies.Trial registrationclinicaltrials.gov Identifier: NCT01553084.

Project description:Many lifelong smokers establish smoking habits during young adulthood. A university can be an effective setting for early smoking cessation. We evaluated long-term predictors of smoking cessation among smokers in a university setting.We longitudinally followed a cohort of smokers enrolled in a university smoking cessation program in Seoul, South Korea. Sociodemographic factors, smoking-related variables, and changes in smoking habits were assessed during 6-week visit sessions and follow-up telephone interviews conducted 1 year or more later.A total of 205 participants were followed up (mean follow-up duration: 27.1 months). Cessation rates were 47.3% at the end of the visit sessions and 28.8% at follow-up. The long-term persistent smoking rate was significantly higher among individuals with peers who smoked (odds ratio [OR] = 8.64; 95% confidence interval [CI] = 1.75, 42.80), with family members who smoked (OR = 3.28; 95% CI = 1.20, 9.00), and who smoked 10 to 19 cigarettes/day (OR?=?4.83; 95% CI?=?1.49, 15.69). Conversely, persistent smoking was less likely among those who attended the program regularly (OR?=?0.84 per visit; 95% CI?=?0.72, 0.99) and attempted quitting more frequently (OR?=?0.93 per attempt; 95% CI?=?0.87, 0.99). Use of smoking cessation medications (varenicline or bupropion) was not significantly associated with long-term quitting (OR?=?0.71; 95% CI?=?0.26, 1.93).Peer influences were the strongest predictors of failure in long-term cessation among smokers who attempted to quit. Similarly, the existence of smokers in the family was negatively associated with successful quitting. Regular attendance at a smoking cessation program and a high number of attempts to quit were positively associated with successful quitting. Targeting peer and family smoking groups together rather than targeting individual smokers alone, implementing active cessation programs encouraging regular attendance, and providing comprehensive antismoking environments might be effective strategies in a university setting.

Project description:BackgroundCigarette smoking remains the leading cause of preventable illness and death, underscoring ongoing need for evidence-based solutions. Pivot, a US Clinical Practice Guideline-based mobile smoking cessation program, comprises a personal carbon monoxide breath sensor; a smartphone app; in-app, text-based human-provided coaching; nicotine replacement therapy; and a moderated web-based community. Promising Pivot cohort studies have established the foundation for comparative assessment.ObjectiveThis study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide, a US Clinical Practice Guideline-based smoking cessation smartphone app from the National Cancer Institute.MethodsIn this remote pilot randomized controlled trial, cigarette smokers in the United States were recruited on the web and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free nicotine replacement therapy. Data were self-reported via weekly web-based questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes toward quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app openings at 12 weeks. Cessation outcomes included self-reported 7- and 30-day point prevalence abstinence (PPA), abstinence from all tobacco products, and continuous abstinence at 12 and 26 weeks. PPA and continuous abstinence were biovalidated via breath carbon monoxide samples.ResultsParticipants comprised 188 smokers (94 Pivot and 94 QuitGuide): mean age 46.4 (SD 9.2) years, 104 (55.3%) women, 128 (68.1%) White individuals, and mean cigarettes per day 17.6 (SD 9.0). Engagement via mean "total app openings through 12 weeks" (primary outcome) was Pivot, 157.9 (SD 210.6) versus QuitGuide, 86.5 (SD 66.3; P<.001). Self-reported 7-day PPA at 12 and 26 weeks was Pivot, 35% (33/94) versus QuitGuide, 28% (26/94; intention to treat [ITT]: P=.28) and Pivot, 36% (34/94) versus QuitGuide, 27% (25/94; ITT: P=.12), respectively. Self-reported 30-day PPA at 12 and 26 weeks was Pivot, 29% (27/94) versus QuitGuide, 22% (21/94; ITT: P=.32) and Pivot, 32% (30/94) versus QuitGuide, 22% (21/94; ITT: P=.12), respectively. The biovalidated abstinence rate at 12 weeks was Pivot, 29% (27/94) versus QuitGuide, 13% (12/94; ITT: P=.008). Biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94; ITT: P=.03). Participant feedback, including ease of setup, impact on smoking, and likelihood of program recommendation were favorable for Pivot.ConclusionsIn this randomized controlled trial comparing the app-based smoking cessation programs Pivot and QuitGuide, Pivot participants had higher engagement and biovalidated cessation rates and more favorable user feedback at 12 and 26 weeks. These findings support Pivot as an effective, durable mobile smoking cessation program.Trial registrationClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Dataset Information

Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease: A Randomized Clinical Trial.

Publications

Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease: A Randomized Clinical Trial.

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