Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke.
- Resource Type
- Academic Journal
- Authors
- Nollen NL; Department of Population Health and the University of Kansas Cancer Center, University of Kansas School of Medicine, Kansas City, KS, USA.; Cox LS; Department of Population Health and the University of Kansas Cancer Center, University of Kansas School of Medicine, Kansas City, KS, USA.; Mayo MS; Department of Biostatistics & Data Science and the University of Kansas Cancer Center, University of Kansas School of Medicine, Kansas City, KS, USA.; Ellerbeck EF; Department of Population Health and the University of Kansas Cancer Center, University of Kansas School of Medicine, Kansas City, KS, USA.; Arnold MJ; Department of Population Health, University of Kansas School of Medicine, Kansas City, KS, USA.; Salzman G; Department(s) of Internal Medicine, Division of Respiratory and Critical Care, UMKC School of Medicine, Truman Medical Center, Kansas City, MO, USA.; Shanks D; Department of Family Medicine & Community Health, University of Kansas School of Medicine, Kansas City, KS, USA.; Woodward J; Department of Family Medicine & Community Health, University of Kansas School of Medicine, Kansas City, KS, USA.; Greiner KA; Department of Family Medicine & Community Health, University of Kansas School of Medicine, Kansas City, KS, USA.; Ahluwalia JS; Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.
- Source
- Publisher: Elsevier B.V Country of Publication: Netherlands NLM ID: 101671157 Publication Model: eCollection Cited Medium: Internet ISSN: 2451-8654 (Electronic) Linking ISSN: 24518654 NLM ISO Abbreviation: Contemp Clin Trials Commun Subsets: PubMed not MEDLINE
- Subject
- Language
- English
Background: The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality.
Methods: The current study is comparing the efficacy of optimized (OPT) versus enhanced usual care (UC) for smoking cessation in African Americans (AA) who smoke cigarettes. AAs who smoke (n = 392) are randomized 1:1 to OPT or UC. Participants in both groups receive 7 sessions of smoking cessation counseling and18-weeks of pharmacotherapy with long-term follow-up through Week 26. OPT participants receive nicotine patch and up to two pharmacotherapy adaptations to varenicline and bupropion plus patch based on carbon monoxide verified smoking status (≥6 ppm) at Weeks 2 and 6. UC participants receive patch throughout the duration of treatment. We hypothesize that OPT will be more effective than UC on the primary outcome of biochemically verified abstinence at Week 12.
Discussion: If effective, findings could broaden the scope of tobacco dependence treatment and move the field toward optimization strategies that impro ve abstinence for AA who smoke.
Trial Registration: NCT03897439.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JSA received sponsored funds for travel expenses as a speaker for the 2021 annual Global Tobacco and Nicotine Forum conference. JSA serves as a consultant and has equity in a start-up company Respira Technologies. Other authors have no competing interests to report.
(© 2022 The Authors.)