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Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES.

ABSTRACT: AIMS:To assess (1) how far the efficacies of front-line smoking cessation pharmacotherapies vary as a function of smoker characteristics and (2) associations between these characteristics and success of smoking cessation attempts. DESIGN:Prospective correlational study in the context of a double-blind randomized trial. The outcome was regressed individually onto each covariate after adjusting for treatment, and then a forward stepwise model constructed. Treatment moderator effects of covariates were tested by treatment × covariate interactions. SETTING:Health service facilities in multiple countries. PARTICIPANTS:Data came from 8120 smokers willing to make a quit attempt, randomized to varenicline, bupropion, nicotine replacement therapy (NRT) or placebo in Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) between 30 November 2011 and 13 January 2015. MEASUREMENTS:Smoker characteristics measured at baseline were country, psychiatric history, sex, age, body mass index (BMI), ethnic group, life-time suicidal ideation/behaviour, anxiety, depression, aggression, psychotropic medication, history of alcohol/substance use disorder, age of starting smoking, cigarette dependence [Fagerström Test for Cigarette Dependence (FTCD)] and prior use of study medicines. Outcome was biochemically confirmed continuous abstinence at weeks 9-24 from start of treatment. FINDINGS:No statistically significant treatment × covariate interactions were found. Odds of success were associated independently positively with age [odds ratio (OR) = 1.01; 95% confidence interval (CI) = 1.00, 1.01], BMI (1.01; 95% CI = 1.00, 1.02) and age of starting smoking (1.03; 95% CI = 1.02, 1.04). Odds were associated independently negatively with US (versus non-US) study site (0.53; 95% CI = 0.46, 0.61), black (versus white) ethnic group (0.57; 95% CI = 0.45, 0.72), mood disorder (0.85; 95% CI = 0.73, 0.99), anxiety disorder (0.71; 95% CI = 0.55, 0.90) and psychotic disorder (0.73; 95% CI = 0.50, 1.07), taking psychotropic medication (0.81; 95% CI = 0.68, 0.95), FTCD (0.89; 95% CI = 0.87, 0.92) and previous use of NRT (0.78; 95% CI = 0.67, 0.91). CONCLUSIONS:While a range of smoker characteristics-including psychiatric history, cigarette dependence and prior use of nicotine replacement therapy (NRT)-are associated with lower cessation rates, they do not substantially influence the efficacy of varenicline, bupropion or NRT.

SUBMITTER: West R

PROVIDER: S-EPMC6055735 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Project description:BackgroundPre-treatment factors that increase smokers' risk of experiencing neuropsychiatric adverse events (NPSAEs) when quitting smoking are unknown.ObjectiveTo identify baseline smoker characteristics beyond the history of mental illness that predict which participants were more likely to experience moderate to severe NPSAEs in EAGLES.DesignA prospective correlational cohort study in the context of a multinational, multicenter, double-blind, randomized trial.ParticipantsSmokers without (N = 3984; NPC)/with (N = 4050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N = 2882; 71%), anxiety (N = 782; 19%), and psychotic (N = 386; 10%) disorders.InterventionsBupropion, 150 mg twice daily, or varenicline, 1 mg twice daily, versus active control (nicotine patch, 21 mg/day with taper) and placebo for 12 weeks with 12-week non-treatment follow-up.Main measuresPrimary safety outcome was the incidence of a composite measure of moderate/severe NPSAEs. Associations among baseline demographic/clinical characteristics and the primary safety endpoint were analyzed post hoc via generalized linear regression.Key resultsThe incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%). Three baseline characteristics predicted increased risk for experiencing clinically significant NPSAEs when quitting regardless of carrying a psychiatric diagnosis: current symptoms of anxiety (for every ~ 4-unit increase in HADS anxiety score, the absolute risk of occurrence of the NPSAE endpoint increased by 1% in both PC and NPC); prior history of suicidal ideation and/or behavior (PC, 4.4% increase; P = 0.001; NPC, 4.1% increase; P = 0.02), and being of White race (versus Black: PC, 2.9% ± 0.9 [SE] increase; P = 0.002; and NPC, 3.4% ± 0.8 [SE] increase; P = 0.001). Among smokers with psychiatric disorders, younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity also predicted greater risk. There were no significant interactions between these characteristics and treatment. Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study.ConclusionsIrrespective of cessation pharmacotherapy use, smokers attempting to quit were more likely to experience moderate to severe NPSAEs if they reported current anxiety or prior suicidal ideation at baseline and were White. In smokers with a psychiatric history, female sex, younger age, and greater severity of nicotine dependence were also predictive.Trial registrationClinicalTrials.gov Identifier: NCT01456936.

Project description:Millions of Americans are forced to quit smoking as they enter tobacco-free prisons and jails, but most return to smoking within days of release. Interventions are needed to sustain tobacco abstinence after release from incarceration.To evaluate the extent to which the WISE intervention (Working Inside for Smoking Elimination), based on motivational interviewing (MI) and cognitive behavioral therapy (CBT), decreases relapse to smoking after release from a smoke-free prison.Participants were recruited approximately 8 weeks prior to their release from a smoke-free prison and randomized to 6 weekly sessions of either education videos (control) or the WISE intervention.A tobacco-free prison in the United States.A total of 262 inmates (35% female).Continued smoking abstinence was defined as 7-day point-prevalence abstinence validated by urine cotinine measurement.At the 3-week follow-up, 25% of participants in the WISE intervention (31 of 122) and 7% of the control participants (9 of 125) continued to be tobacco abstinent (odds ratio [OR], 4.4; 95% CI, 2.0-9.7). In addition to the intervention, Hispanic ethnicity, a plan to remain abstinent, and being incarcerated for more than 6 months were all associated with increased likelihood of remaining abstinent. In the logistic regression analysis, participants randomized to the WISE intervention were 6.6 times more likely to remain tobacco abstinent at the 3-week follow up than those randomized to the control condition (95% CI, 2.5-17.0). Nonsmokers at the 3-week follow-up had an additional follow-up 3 months after release, and overall 12% of the participants in the WISE intervention (14 of 122) and 2% of the control participants (3 of 125) were tobacco free at 3 months, as confirmed by urine cotinine measurement (OR, 5.3; 95% CI, 1.4-23.8).Forced tobacco abstinence alone during incarceration has little impact on postrelease smoking status. A behavioral intervention provided prior to release greatly improves cotinine-confirmed smoking cessation in the community.clinicaltrials.gov Identifier: NCT01122589.

Project description:ImportanceUnderstanding Black vs White differences in pharmacotherapy efficacy and the underlying reasons is critically important to reducing tobacco-related health disparities.ObjectiveTo compare pharmacotherapy efficacy and examine variables to explain Black vs White differences in smoking abstinence.Design, setting, and participantsThis study is a secondary analysis of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) double-blind, placebo-controlled, randomized clinical trial, which took place at clinical trial centers, academic centers, and outpatient clinics in 29 states in the US. US Black and White smokers who smoked 10 or more cigarettes per day with and without psychiatric comorbidity were enrolled between November 2011 and January 2015. Data analysis was performed from July 2019 to January 2020.InterventionsParticipants were randomized (1:1:1:1) in a double-blind, triple-dummy, placebo- and active-controlled (nicotine patch) trial of varenicline and bupropion for 12 weeks with follow-up through week 24.Main outcomes and measuresBiochemically verified continuous cigarette abstinence rate (CAR) from weeks 9 to 24. Baseline, postbaseline treatment, and safety characteristics were examined as variables to explain race differences in abstinence.ResultsOf the 1065 Black smokers enrolled, 255 were randomized to receive varenicline, 259 received bupropion, 286 received nicotine replacement therapy (NRT [ie, nicotine patch]), and 265 received placebo. Among the 3044 White smokers enrolled, 778 were randomized to receive varenicline, 769 received bupropion, 738 received NRT, and 759 received placebo. Participants were predominantly female (614 Black [57.7%] and 1786 White [58.7%] women) and heavy smokers (mean [SD] cigarettes per day, 18.2 [7.9] for Black and 20.0 [7.5] for White smokers), with a mean (SD) age of 47.2 (11.2) years for Black and 46.5 (12.7) years for White participants. Treatment and race were associated with CAR for weeks 9 to 24. The CAR was 4.9% lower for Black vs White participants (odds ratio [OR], 0.53; 95% CI, 0.41-0.69; P < .001); differences were found across all treatments. Pooling psychiatric and nonpsychiatric cohorts, varenicline (OR, 2.63; 95% CI, 1.90-3.63; P < .001), bupropion (OR, 1.75; 95% CI, 1.25-2.46; P = .001), and NRT (OR, 1.52; 95% CI, 1.07-2.16; P = .02) had greater efficacy than placebo for White participants. Only varenicline (OR, 2.63; 95% CI, 1.26-5.48; P = .01) had greater efficacy than placebo for Black participants. Baseline, postbaseline, and safety characteristics differed by race, but these variables did not eliminate the association of race with CAR. Black participants had 49% reduced odds of CAR for weeks 9 to 24 compared with White participants in the adjusted model (OR, 0.51; 95% CI, 0.39-0.66; P < .001).Conclusions and relevanceBlack and White smokers achieved the highest rate of abstinence while taking varenicline, suggesting that it is the best first-line therapy for these groups. However, Black smokers were less responsive to all therapies, including placebo. Understanding variables (eg, socioeconomic or biological) beyond those may lead to improved treatment outcomes for Black smokers.Trial registrationClinicalTrials.gov Identifier: NCT01456936.

Project description:ImportancePatients with cancer who smoke after diagnosis risk experiencing reductions in treatment effectiveness, survival rates, and quality of life, and increases in complications, cancer recurrence, and second primary cancers. Smoking cessation can significantly affect these outcomes, but to date comprehensive treatment is not widely implemented in the oncologic setting.ObjectivesTo describe a potential model tobacco treatment program (TTP) implemented in a cancer setting, report on its long-term outcomes, and highlight its importance to quality patient care.Design, setting, and participantsA prospective cohort of smokers was treated in the TTP at a comprehensive cancer center from January 1, 2006, to August 31, 2015. Data analysis was performed from November 2017 to December 2018. Participants included 3245 patients (2343 with current cancer; 309 with previous cancer; 593 with no cancer history) drawn from a population of 5061 smokers referred for treatment in the TTP. Reasons for exclusion included follow-up for a noncancerous disease, no medical consultation, smoked less than 1 cigarette per day; or died before the 9-month follow-up.ExposuresTreatment consisted of an in-person medical consultation, 6 to 8 in-person and telephone follow-up counseling sessions, and 10 to 12 weeks of pharmacotherapy.Main outcomes and measuresPrimary outcome was 9-month 7-day point-prevalence abstinence evaluated using time-specific (3-, 6-, and 9-month follow-ups) and longitudinal covariate-adjusted and unadjusted regression models with multiple imputation, intention-to-treat, and respondent-only approaches to missing data. The Fagerström Test for Cigarette Dependence was used as a measure of dependence (possible range, 0-10; higher numbers indicate greater dependence).ResultsOf the 3245 smokers, 1588 (48.9%) were men, 322 (9.9%) were of black race/ethnicity, 172 (5.3%) were of Hispanic race/ethnicity, and 2498 (76.0%) were of white race/ethnicity. Mean (SD) age was 54 (11.4) years; Fagerström Test for Cigarette Dependence score, 4.41 (2.2), number of cigarettes smoked per day, 17.1 (10.7); years smoked, 33 (13.2); and 1393 patients (42.9%) had at least 1 psychiatric comorbidity. Overall self-reported abstinence was 45.1% at 3 months, 45.8% at 6 months, and 43.7% at 9 months in the multiply imputed sample. Results across all models were consistent, suggesting that, in comparison with smokers with no cancer history, abstinence rates within this TTP program did not differ appreciably whether smokers had current cancer, were a cancer survivor, or had smoking-related cancers, with the exception of patients with head and neck cancer; the rates were higher at 9 months (relative risk, 1.31; 95% CI, 1.11-1.56; P = .001) and in longitudinal models (relative risk, 1.24; 95% CI, 1.08-1.42; P = .002).Conclusions and relevanceIn this study, mean smoking abstinence rates did not differ significantly between patients with cancer and those without cancer. These findings suggest that providing comprehensive tobacco treatment in the oncologic setting can result in sustained high abstinence rates for all patients with cancer and survivors and should be included as standard of care to ensure the best possible cancer treatment outcomes.

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Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES.

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