4199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort Study
OBJECTIVES/GOALS: Precision care may engage smokers and providers in treatment but is understudied in the community. We piloted guideline-based care (GBC) alone or with Respiragene, a lung cancer polygenic risk score (PRS, 1-10), or metabolism-informed choice of medication using the nicotine metabol...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Cambridge University Press
2020-06-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866120003234/type/journal_article |
| _version_ | 1811155124688519168 |
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| author | Nicole Senft Maureen Sanderson Rebecca Selove William J. Blot Rachel F. Tyndale Quiyin Cai Karen Gilliam Suman Kundu Hilary A. Tindle |
| author_facet | Nicole Senft Maureen Sanderson Rebecca Selove William J. Blot Rachel F. Tyndale Quiyin Cai Karen Gilliam Suman Kundu Hilary A. Tindle |
| author_sort | Nicole Senft |
| collection | DOAJ |
| description | OBJECTIVES/GOALS: Precision care may engage smokers and providers in treatment but is understudied in the community. We piloted guideline-based care (GBC) alone or with Respiragene, a lung cancer polygenic risk score (PRS, 1-10), or metabolism-informed choice of medication using the nicotine metabolite ratio (NMR). METHODS/STUDY POPULATION: Daily smokers (n = 58) with stored biospecimens in the Southern Community Cohort Study were randomized 1:1:1 to GBC, PRS, or NMR, counseled to quit smoking, and co-selected FDA-approved cessation medication (nicotine replacement, varenicline) with a tobacco counselor. In PRS, precision motivational counseling was guided by PRS (i.e., lung cancer risk 10-40-fold that of never-smokers). In NMR, precision medication recommendations consisted of varenicline for faster metabolizers (NMR≥0.31) and nicotine replacement for slow metabolizers (NMR<0.31). Feasibility was defined as achieving at least 50% provider engagement (med prescription) and at least 50% patient engagement (self-reported med use). RESULTS/ANTICIPATED RESULTS: Participants were median age 59, 72% female, 81% Black, 60% with incomes <$15,000; median cigarettes/day was 15 (IQR 8-20) and 52% reported time-to-first cigarette <5 minutes, illustrating moderate nicotine dependence. Providers confirmed medication prescriptions for 40% of patients (32% GBC, 50% PRS, 37% NMR) and 83% of patients reported using medication (prescribed or unprescribed) during the study (90% GBC, 80% PRS, 79% NMR). At 6-month follow-up, 27% (n = 15) reported cessation (39% GBC, 16% PRS, 26% NMR). Among persistent smokers, 46% reported smoking at least 50% fewer cigarettes/day compared to baseline (45% GBC, 38% PRS, 57% NMR). Small sample size precluded statistical comparisons. DISCUSSION/SIGNIFICANCE OF IMPACT: Precision interventions to quit smoking are feasible for community smokers, who engaged at high rates. However, only 40% of providers supported patients’ quit attempts with medication prescriptions. Future research should test strategies to raise provider engagement in precision smoking treatment. CONFLICT OF INTEREST DESCRIPTION: R.F.T. has consulted for Quinn Emmanual and Apotex on unrelated topics. H.A.T. reported providing input on design for a phase 3 trial of cytisine proposed by Achieve Life Sciences and being a principal investigator of National Institutes of Health–sponsored studies for smoking cessation that include medications donated by the manufacturers. Other authors declare no potential conflicts of interest. |
| first_indexed | 2024-04-10T04:28:55Z |
| format | Article |
| id | doaj.art-d4030bf5164c4c3ca081bd1ab4256c30 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:28:55Z |
| publishDate | 2020-06-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-d4030bf5164c4c3ca081bd1ab4256c302023-03-10T08:51:34ZengCambridge University PressJournal of Clinical and Translational Science2059-86612020-06-01410510510.1017/cts.2020.3234199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort StudyNicole Senft0Maureen Sanderson1Rebecca Selove2William J. Blot3Rachel F. Tyndale4Quiyin Cai5Karen Gilliam6Suman Kundu7Hilary A. Tindle8Vanderbilt University Medical CenterMeharry Medical CollegeTennessee State UniversityVanderbilt University Medical CenterUniversity of TorontoVanderbilt University Medical CenterVanderbilt University Medical CenterVanderbilt University Medical CenterVanderbilt University Medical CenterOBJECTIVES/GOALS: Precision care may engage smokers and providers in treatment but is understudied in the community. We piloted guideline-based care (GBC) alone or with Respiragene, a lung cancer polygenic risk score (PRS, 1-10), or metabolism-informed choice of medication using the nicotine metabolite ratio (NMR). METHODS/STUDY POPULATION: Daily smokers (n = 58) with stored biospecimens in the Southern Community Cohort Study were randomized 1:1:1 to GBC, PRS, or NMR, counseled to quit smoking, and co-selected FDA-approved cessation medication (nicotine replacement, varenicline) with a tobacco counselor. In PRS, precision motivational counseling was guided by PRS (i.e., lung cancer risk 10-40-fold that of never-smokers). In NMR, precision medication recommendations consisted of varenicline for faster metabolizers (NMR≥0.31) and nicotine replacement for slow metabolizers (NMR<0.31). Feasibility was defined as achieving at least 50% provider engagement (med prescription) and at least 50% patient engagement (self-reported med use). RESULTS/ANTICIPATED RESULTS: Participants were median age 59, 72% female, 81% Black, 60% with incomes <$15,000; median cigarettes/day was 15 (IQR 8-20) and 52% reported time-to-first cigarette <5 minutes, illustrating moderate nicotine dependence. Providers confirmed medication prescriptions for 40% of patients (32% GBC, 50% PRS, 37% NMR) and 83% of patients reported using medication (prescribed or unprescribed) during the study (90% GBC, 80% PRS, 79% NMR). At 6-month follow-up, 27% (n = 15) reported cessation (39% GBC, 16% PRS, 26% NMR). Among persistent smokers, 46% reported smoking at least 50% fewer cigarettes/day compared to baseline (45% GBC, 38% PRS, 57% NMR). Small sample size precluded statistical comparisons. DISCUSSION/SIGNIFICANCE OF IMPACT: Precision interventions to quit smoking are feasible for community smokers, who engaged at high rates. However, only 40% of providers supported patients’ quit attempts with medication prescriptions. Future research should test strategies to raise provider engagement in precision smoking treatment. CONFLICT OF INTEREST DESCRIPTION: R.F.T. has consulted for Quinn Emmanual and Apotex on unrelated topics. H.A.T. reported providing input on design for a phase 3 trial of cytisine proposed by Achieve Life Sciences and being a principal investigator of National Institutes of Health–sponsored studies for smoking cessation that include medications donated by the manufacturers. Other authors declare no potential conflicts of interest.https://www.cambridge.org/core/product/identifier/S2059866120003234/type/journal_article |
| spellingShingle | Nicole Senft Maureen Sanderson Rebecca Selove William J. Blot Rachel F. Tyndale Quiyin Cai Karen Gilliam Suman Kundu Hilary A. Tindle 4199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort Study Journal of Clinical and Translational Science |
| title | 4199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort Study |
| title_full | 4199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort Study |
| title_fullStr | 4199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort Study |
| title_full_unstemmed | 4199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort Study |
| title_short | 4199 A pilot randomized controlled trial of precision care for smoking cessation in the Southern Community Cohort Study |
| title_sort | 4199 a pilot randomized controlled trial of precision care for smoking cessation in the southern community cohort study |
| url | https://www.cambridge.org/core/product/identifier/S2059866120003234/type/journal_article |
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