Evaluation of nicotine patch adherence measurement using self-report and saliva cotinine among abstainers in a smoking cessation trial

• Published in: Drug and alcohol dependence 2020-05, Vol.210, p.107967-107967, Article 107967
• Main Authors: Schnoll, Robert, Paul Wileyto, E., Gross, Robert, Hitsman, Brian, Hawk, Larry W., Cinciripini, Paul, George, Tony P., Benowitz, Neal L., Fen Lubitz, Su, Ashare, Rebecca, Tyndale, Rachel F., Lerman, Caryn
• Format: Article
• Language: English
• Subjects: Adherence; Adult; Carbon monoxide; Cigarette smoking; Clinical research; Clinical trials; Collection; Cotinine; Cotinine - analysis; Drug addiction; Female; Humans; Male; Measurement; Medication Adherence - psychology; Metabolism; Middle Aged; Nicotine; Nicotine - administration & dosage; Nicotine metabolism; Nicotine patch; Nicotine patches; Nicotine sensitivity; ROC Curve; Saliva; Saliva - chemistry; Saliva cotinine; Self report; Self Report - standards; Smoking; Smoking cessation; Smoking Cessation - methods; Smoking Cessation - psychology; Tobacco Smoking - drug therapy; Tobacco Smoking - epidemiology; Tobacco Smoking - psychology; Tobacco Use Cessation Devices - trends; Transdermal medication; Validity
• ISSN: 0376-8716; 1879-0046
• DOI: 10.1016/j.drugalcdep.2020.107967

•Self-reported patch use and saliva cotinine were modestly correlated.•Self-reported 7-day and 3-week patch use is correlated with saliva cotinine after one week of treatment.•The optimal cotinine cut-point for adherence may vary by nicotine metabolism rate. Adherence to nicotine patches relates to cessation. This is the first study to examine the validity of self-reported nicotine patch adherence relative to saliva cotinine. We used data from 198 clinical trial participants who received 11 weeks of nicotine patches, self-reported patch use, had saliva cotinine 1-week after the start of treatment assessed, and were not smoking when saliva was collected (CO < 6). Self-reported patch adherence was defined as: 3-day (before saliva collection), 7-day (before saliva collection), 3-week use (7 days before, and 14 days after, saliva collection), and 11-week use (7 days before, and 10 weeks after, saliva collection). Analyses, including receiver operating characteristic curves, considered differences in nicotine metabolism. Sensitivity, specificity and positive (PPV) and negative predictive value (NPV) assessed optimal cotinine cut-point for adherence. Self-reported 7-day (r = 0.13) and 3-week (r = 0.13) patch use marginally correlated with week 1 cotinine (p’s = 0.08) but not 3-day or 11-week. Significant area under the curve (AUC) values of 0.67 (95 %CI: 0.55−0.79) and 0.72 (95 %CI: 0.57−0.88) were found using 7-day self-report for the overall sample and for slow metabolizers (p’s