A randomized clinical trial of counseling and nicotine replacement therapy for treatment of African American non-daily smokers: Design, accrual, and baseline characteristics
Introduction
Non-daily smokers (NDS) report smoking on some but not all days and constitute 8.9 million adults or 24.3% of all adult smokers in the US [1]. Prevalence of NDS has increased almost 30% in the last decade. NDS are at risk for the same health consequences of smoking as daily smokers (DS) [2,3], are nicotine dependent [4], and want to quit smoking [5], yet they are overlooked by health care providers and largely have been excluded from clinical trials. As a result, there is an almost complete paucity of information on effective treatments for this growing subgroup of smokers whose smoking patterns challenge traditional nicotine dependence treatment paradigms [5,6]. NDS average 15–20 smoking days per month and routinely abstain for periods of 5–10 days without experiencing significant withdrawal or craving [7,8], contributing to perceptions that NDS do not identify as smokers, are uninterested in quitting, are not addicted enough to warrant the use of smoking cessation medications, and concern that, if nicotine replacement therapy (NRT) is used, the amount of nicotine delivered could exceed the levels achieved through smoking [4,6,8]. These perceptions are not supported by the literature [6,9,10]; nonetheless, NDS are less likely than DS to be asked about their smoking status or advised to quit by a physician, have low utilization of smoking cessation pharmacotherapy or behavioral counseling, and experience difficulty in quitting; 73–82% of NDS who attempt to quit resume smoking within 90 days [5].
Racial/ethnic minorities are more likely to be NDS compared to non-Hispanic Whites (Whites) yet they bear a disproportionate burden of smoking-related diseases [[11], [12], [13]]. African Americans, in particular, have higher cardiovascular and cancer-disease risk at lower levels of smoking, including non-daily smoking [14,15]. Concentrations of NNAL, a metabolite of the potent lung carcinogen NNK, and cotinine, the primary metabolite of nicotine, are three to six times higher in African American NDS compared to White and Hispanic/Latino NDS [16,17]. This difference persists after adjustment for racial/ethnic variations in smoking level and nicotine metabolism, suggesting that African American NDS incur substantial risk from their intermittent pattern of smoking. African American NDS are also more likely than White and Hispanic/Latino NDS to have made a quit attempt in the past year and to intend to quit in the next 30 days [7], making the treatment of this high risk group a priority.
To date, only two small pilot studies have examined treatment of NDS [18,19]. The current study is one of three ongoing federally-funded (NIH, PCORI) smoking cessation randomized clinical trials (RCT) examining effective treatments for NDS and the only RCT focused exclusively on racial/ethnic minority NDS. The 3-year study is comparing the effectiveness of smoking cessation counseling alone or smoking cessation counseling in combination with participant's choice of NRT (i.e., nicotine patch, gum, lozenge) on abstinence in African American NDS interested in quitting. The primary aim is to test the hypothesis that 1) African American NDS randomized to C + NRT will have significantly higher biochemically verified smoking abstinence at 12 weeks (end of treatment) than African American NDS randomized to C. Secondary aims are: (2) test the hypothesis that African American NDS randomized to C + NRT will have significantly higher biochemically verified smoking abstinence at 26 weeks (end of follow-up) than African American NDS randomized to C, (3) test the hypothesis that AA NDS randomized to C + NRT will demonstrate significantly greater reductions in nicotine intake and carcinogen exposure and significantly more days abstinent, while experiencing no differences in side effects as participants randomized to C, and (4) identify predictors of successful quitting among African American NDS. Due to the exploratory nature of this aim, no specific hypotheses are proposed for this aim. This paper describes the study design, enrollment, and baseline characteristics of participants in the trial.
Section snippets
Study design
The study is an unblinded and open-label RCT of 278 African American NDS randomized to receive either 5 sessions of smoking cessation counseling in combination with 12 weeks of their choice of nicotine patch, gum, or lozenge (C + NRT) or 5 sessions of smoking cessation counseling alone (C). A 2:1 randomization schema was used; for every one patient randomized to C, two were randomized to C + NRT. The schedule of enrollment, intervention, and assessment activities is displayed in Table 1. The
Recruitment flow
The flow of participants into the study is shown in Fig. 1. Six-hundred and twenty-five African Americans initially identified as NDS out of 2528 African American smokers (24.7%) who were pre-screened as part of enrollment for this study and another ongoing study of African American daily smokers (data not shown). Of these, 63 (10.0%) were excluded after more in-depth screening indicated that they did not meet study criteria for non-daily smoking (smoked cigarettes on 4–27 days per month for
Discussion
A number of observations from the current study are worth noting to inform future cessation intervention studies with NDS. Nearly one-quarter of individuals screened met our NDS criteria. This is consistent with national prevalence data and reinforces the need for ongoing treatment studies with this growing subpopulation of smokers [1]. However, almost half of NDS who met our initial screening criteria did not keep their in-person appointment, possibly reflecting lower identity as a smoker and
Summary
Non-daily smoking is an increasing pattern of tobacco consumption in the US [1], yet a paucity of information exists on effective treatments for this growing subgroup of smokers. The current study will answer important questions about the comparative effectiveness of counseling only versus counseling in combination with NRT for smoking abstinence in African American NDS. Regardless of whether our hypothesis that counseling plus NRT will be more effective than counseling alone is supported, the
Trial status
The final participant was enrolled in May 2017. The active treatment and follow-up phases are ongoing, with the final week 26 follow-up visit scheduled for January 2018. Outcomes data have not been examined and will not be available until December 2018.
Competing interests
None to report.
Authors' contributions
Conception and design: NN, LC, MM, EE, JA.
Acquisition of data: NN, LC, MM, EE, MS.
Analysis and interpretation of data: NN, MM.
Writing, review, and revision of the manuscript: All authors.
Funding and acknowledgments
Research reported in this publication was supported funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (AD-1310-08709) and by a CTSA grant from NCATS awarded to the University of Kansas Medical Center for Frontiers: The Heartland Institute for Clinical and Translational Research # UL1TR000001. The statements in this publication are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute
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