Diana A Hamilton1, Martin C Mahoney2, Maria Novalen3, Meghan J Chenoweth3, Daniel F Heitjan4, Caryn Lerman5, Rachel F Tyndale3, Larry W Hawk6. 1. Department of Psychology, University at Buffalo, SUNY, Buffalo, NY; 2. School of Public Health and Health Professions, University at Buffalo, SUNY, Buffalo, NY; Departments of Medicine and Health Behavior, Roswell Park Cancer Institute, Buffalo, NY; 3. Departments of Pharmacology and Toxicology, and Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada; 4. Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA; 5. Center for Interdisciplinary Research on Nicotine Addiction, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA. 6. Department of Psychology, University at Buffalo, SUNY, Buffalo, NY; lhawk@buffalo.edu.
Abstract
INTRODUCTION: The nicotine metabolite ratio (NMR), the ratio of 3-hydroxycotinine to cotinine, is a biomarker used in smoking cessation research, with several retrospective studies suggesting that NMR predicts treatment outcome. To be maximally useful in tailoring treatment, estimates of NMR should be stable over time. The present study is the first to examine the short-term test-retest reliability of NMR among treatment-seeking smokers. METHODS:Blood NMR was assessed at two time points, approximately 2-3 weeks apart and prior to intervention, among 72 healthy adult smokers (49% female; 35% non-White) enrolled in a cessation trial (http://ClinicalTrials.gov ID: NCT01314001). RESULTS:Mean NMR was stable from Time-1 to Time-2, with no significant change between assessments; test-retest reliability for NMR values was excellent (ICC[2,1] = 0.87). Test-retest reliability remained acceptable to high when NMR was categorized, as in recent clinical trials. Classification of participants as slow (quartile 1, NMR ≤ 0.24) or normal/fast NMR (quartiles 2-4, NMR ≥ 0.25) was consistent from Time-1 to Time-2 for 96% of participants (κ = 0.89). Though classification of participants into NMR quartiles was less consistent from Time-1 to Time-2 (67% agreement; weighted κ = 0.73), all reclassifications occurred between adjacent quartiles. CONCLUSIONS: Overall, these data support the use of a single NMR assessment for association studies with smoking phenotypes and in smokers seeking to quit, and they encourage large-scale efforts to determine optimal NMR cutpoints for tailoring treatment selection.
RCT Entities:
INTRODUCTION: The nicotine metabolite ratio (NMR), the ratio of 3-hydroxycotinine to cotinine, is a biomarker used in smoking cessation research, with several retrospective studies suggesting that NMR predicts treatment outcome. To be maximally useful in tailoring treatment, estimates of NMR should be stable over time. The present study is the first to examine the short-term test-retest reliability of NMR among treatment-seeking smokers. METHODS: Blood NMR was assessed at two time points, approximately 2-3 weeks apart and prior to intervention, among 72 healthy adult smokers (49% female; 35% non-White) enrolled in a cessation trial (http://ClinicalTrials.gov ID: NCT01314001). RESULTS: Mean NMR was stable from Time-1 to Time-2, with no significant change between assessments; test-retest reliability for NMR values was excellent (ICC[2,1] = 0.87). Test-retest reliability remained acceptable to high when NMR was categorized, as in recent clinical trials. Classification of participants as slow (quartile 1, NMR ≤ 0.24) or normal/fast NMR (quartiles 2-4, NMR ≥ 0.25) was consistent from Time-1 to Time-2 for 96% of participants (κ = 0.89). Though classification of participants into NMR quartiles was less consistent from Time-1 to Time-2 (67% agreement; weighted κ = 0.73), all reclassifications occurred between adjacent quartiles. CONCLUSIONS: Overall, these data support the use of a single NMR assessment for association studies with smoking phenotypes and in smokers seeking to quit, and they encourage large-scale efforts to determine optimal NMR cutpoints for tailoring treatment selection.
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