A Pilot Clinical Trial of Varenicline for Smoking Cessation in Black Smokers

Nollen, Nicole L.; Cox, Lisa Sanderson; Nazir, Niaman; Ellerbeck, Edward F.; Owen, Ashli; Pankey, Sydni; Thompson, Nia; Ahluwalia, Jasjit S.

doi:10.1093/ntr/ntr063

Cited by 36 publications

(31 citation statements)

References 28 publications

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“…All five articles assessed the association between NRT use and abstinence; this research aim was explicitly stated in three studies (22,26,27) and addressed in sub-group analyses in the other two (28,29). Two articles presented secondary analyses of randomised controlled trials (22,27), and two articles provided data from prospective observational studies (26,28).…”

Section: Description Of Included Studiesmentioning

confidence: 99%

“…Two articles presented secondary analyses of randomised controlled trials (22,27), and two articles provided data from prospective observational studies (26,28).…”

Section: Description Of Included Studiesmentioning

confidence: 99%

“…One study was conducted in the United Kingdom (27), one in the United States (29), one enrolled patients in both countries (22), and the two remaining studies were from Switzerland (26) and Germany (28), respectively. Baseline sample sizes ranged from 92 to 1,030, study populations were predominantly white, the mean/median age of participants ranged from 40 to 47 years, 29% to 54% of participants were female, and the mean/median number of cigarettes smoked daily ranged from 20 to 25.…”

Section: Description Of Included Studiesmentioning

confidence: 99%

“…Smoking outcome was assessed as continuous abstinence and validated by exhaled carbon monoxide (CO) in four of the five studies (22,26,27,29). The association between adherence and abstinence was assessed by means of a logistic regression in four and by a χ 2 test in one study (28). Details of the 37 articles addressing the association between adherence and abstinence but not controlling for relapse as a cause for non-adherence are provided in Table S1 in the online supplement to this article.…”

Section: Description Of Included Studiesmentioning

confidence: 99%

“…4. Raupach et al (28) followed up 369 participants of a hospital-based smoking cessation programme for 6 months who had been encouraged to purchase NRT themselves. Participants provided self-reports of continuous abstinence and treatment duration at the sixmonth telephone follow-up.…”

Section: Summary Of the Evidencementioning

confidence: 99%

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A systematic review of studies assessing the association between adherence to smoking cessation medication and treatment success

et al. 2013

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Aims: Lack of adherence to smoking cessation medication regimens is assumed to play a significant role in limiting their effectiveness. This study aimed to assess evidence for this assumption.Methods: A systematic search was conducted, supplemented by expert consultation, of articles reporting on randomised trials and observational studies examining the association between adherence to cessation medication and the success of quit attempts. To rule out reverse causality, only studies where adherence was assessed prior to relapse were included.Five studies met the inclusion criteria and results were extracted independently by two researchers. Heterogeneity between studies precluded a pooled analysis of the data.Results: Studies varied widely with regard to both the definition of adherence and outcome measures. Included studies only addressed adherence to nicotine replacement therapy. One study of lozenge use found that amount of medication used between 1 and 2 weeks after the quit date predicted abstinence at 6 weeks (adjusted OR for 'high' versus 'low' lozenge use 1.25; 95% confidence interval (CI) = 1.05-1.50; p<0.02). Similarly, one study found a significant impact of oral nicotine consumption during the first week on abstinence at four weeks (adjusted OR per additional mg/d: 1.05%; CI = 1.01-1.10). Another study found that participants using nicotine replacement therapy for at least five weeks were significantly more likely to self-report continuous abstinence at 6 months. The remaining two studies failed to find a significant effect of treatment duration on outcome at one and two years but had very low power to detect such an effect. Conclusions:There is modest evidence to support the assumption that lack of adherence to nicotine replacement therapy regimens undermines effectiveness in clinical studies.

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Section: Description Of Included Studiesmentioning

confidence: 99%

“…Two articles presented secondary analyses of randomised controlled trials (22,27), and two articles provided data from prospective observational studies (26,28).…”

Section: Description Of Included Studiesmentioning

confidence: 99%

Section: Description Of Included Studiesmentioning

confidence: 99%

Section: Description Of Included Studiesmentioning

confidence: 99%

Section: Summary Of the Evidencementioning

confidence: 99%

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A systematic review of studies assessing the association between adherence to smoking cessation medication and treatment success

et al. 2013

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Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers

Cox

Nollen

Mayo

et al. 2022

JAMA

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Key PointsQuestionAmong African American individuals who are daily smokers, does the addition of varenicline to counseling improve rates of smoking cessation compared with counseling alone?FindingsIn this randomized clinical trial that included 500 African American adults, counseling plus 12 weeks of varenicline treatment, compared with counseling plus placebo, showed a statistically significant improvement in rates of 7-day point prevalence smoking abstinence at week 26 (15.7% vs 6.5%).MeaningThe findings support the use of varenicline added to counseling for promoting smoking cessation among African American adults who are daily smokers of all smoking levels.

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Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke

et al. 2023

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ImportanceAdapting to different smoking cessation medications when an individual has not stopped smoking has shown promise, but efficacy has not been tested in racial and ethnic minority individuals who smoke and tend to have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality.ObjectiveTo evaluate efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily.Design, Setting, and ParticipantsThis randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC) included non-Hispanic Black adults who smoke and was conducted from May 2019 to January 2022 at a federally qualified health center in Kansas City, Missouri. Data analysis took place from March 2022 to January 2023.InterventionsBoth groups received 18 weeks of pharmacotherapy with long-term follow-up through week 26. The ADT group consisted of 196 individuals who received a nicotine patch (NP) and up to 2 pharmacotherapy adaptations, with a first switch to varenicline at week 2 and, if needed, a second switch to bupropion plus NP (bupropion + NP) based on carbon monoxide (CO)-verified smoking status (CO ≥6 ppm) at week 6. The UC group consisted of 196 individuals who received NP throughout the duration of treatment.Main Outcomes and MeasuresAnabasine-verified and anatabine-verified point-prevalence abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points). The χ2 test was used to compare verified abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points) between ADT and UC. A post hoc sensitivity analysis of smoking abstinence at week 12 was performed with multiple imputation using a monotone logistic regression with treatment and gender as covariates to impute the missing data.ResultsAmong 392 participants who were enrolled (mean [SD] age, 53 [11.6] years; 224 [57%] female; 186 [47%] ≤ 100% federal poverty level; mean [SD] 13 [12.4] cigarettes per day), 324 (83%) completed the trial. Overall, 196 individuals were randomized to each study group. Using intent-to-treat and imputing missing data as participants who smoke, verified 7-day abstinence was not significantly different by treatment group at 12 weeks (ADT: 34 of 196 [17.4%]; UC: 23 of 196 [11.7%]; odds ratio [OR], 1.58; 95% CI, 0.89-2.80; P = .12), 18 weeks (ADT: 32 of 196 [16.3%]; UC: 31 of 196 [15.8%]; OR, 1.04; 95% CI, 0.61-1.78; P = .89), and 26 weeks (ADT: 24 of 196 [12.2%]; UC: 26 of 196 [13.3%]; OR, 0.91; 95% CI, 0.50-1.65; P = .76). Of the ADT participants who received pharmacotherapy adaptations (135/188 [71.8%]), 11 of 135 (8.1%) were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had CO-verified abstinence at week 2 had 4.6 times greater odds of being abstinent at week 12 (37 of 129 [28.7%] abstinence) than those who did not respond to treatment (19 of 245 [7.8%] abstinence; OR; 4.6; 95% CI, 2.5-8.6; P &lt; .001).Conclusions and RelevanceIn this randomized clinical trial of adapted vs standard of care pharmacotherapy, adaptation to varenicline and/or bupropion + NP after failure of NP monotherapy did not significantly improve abstinence rates for Black adults who smoke relative to those who continued treatment with NP. Those who achieved abstinence in the first 2 weeks of the study were significantly more likely to achieve later abstinence, highlighting early treatment response as an important area for preemptive intervention.Trial RegistrationClinicalTrials.gov Identifier: NCT03897439

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A Pilot Clinical Trial of Varenicline for Smoking Cessation in Black Smokers

Abstract: Studies are needed to examine the efficacy of varenicline among Black smokers. Interventions to facilitate adherence to pharmacotherapy warrant further attention as adherence is linked to improved tobacco abstinence.

Cited by 36 publications

References 28 publications

A systematic review of studies assessing the association between adherence to smoking cessation medication and treatment success

A systematic review of studies assessing the association between adherence to smoking cessation medication and treatment success

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers

Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke

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