Annie R Peng1, Mark Morales2, E Paul Wileyto3, Larry W Hawk4, Paul Cinciripini5, Tony P George6, Neal L Benowitz7, Nicole L Nollen8, Caryn Lerman9, Rachel F Tyndale10, Robert Schnoll11. 1. Department of Pharmacology & Toxicology, University of Toronto, 1 King's College Cir, Toronto, ON M5S 1A8, Canada. Electronic address: a.peng@mail.utoronto.ca. 2. Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, United States. Electronic address: mark.morales@uphs.upenn.edu. 3. Department of Biostatistics & Epidemiology, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, United States. Electronic address: epw@mail.med.upenn.edu. 4. Department of Psychology, State University of New York at Buffalo, 230 Park Hall, Buffalo, NY 14260-4110, United States. Electronic address: lhawk@buffalo.edu. 5. Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, 1155 Pressler St, Houston, TX 77030, United States. Electronic address: pcinciri@mdanderson.org. 6. Addictions Division, Centre for Addiction and Mental Health and Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, 250 College Street, Toronto, ON M5T 1R8, Canada. Electronic address: Tony.George@camh.ca. 7. Department of Medicine, University of California, San Francisco, 1001 Potrero Ave, San Francisco, CA 94110, United States; Department of Bioengineering & Therapeutic Sciences, University of California, San Francisco, 1001 Potrero Ave, San Francisco, CA 94110, United States. Electronic address: neal.benowitz@ucsf.edu. 8. Department of Preventive Medicine & Public Health, University of Kansas School of Medicine, 3901 Rainbow Blvd., Kansas City, KS 66160, United States. Electronic address: NNOLLEN@kumc.edu. 9. Department of Psychiatry, Annenberg School for Communication, Abramson Cancer Center, University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19104, United States. Electronic address: CLerman@mail.med.upenn.edu. 10. Department of Pharmacology & Toxicology, University of Toronto, 1 King's College Cir, Toronto, ON M5S 1A8, Canada; Addictions Division, Centre for Addiction and Mental Health and Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, 250 College Street, Toronto, ON M5T 1R8, Canada. Electronic address: r.tyndale@utoronto.ca. 11. Department of Psychiatry, Abramson Cancer Center, University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19104, United States. Electronic address: schnoll@mail.med.upenn.edu.
Abstract
INTRODUCTION: While adherence to medication in smoking cessation clinical trials is strongly associated with clinical outcome, very few studies have evaluated the validity of pill count as a measure of adherence relative to a biological assay, and evaluated a broad range of correlates of adherence. METHODS: In a smoking cessation clinical trial of varenicline, we compared pill counts collected over 4 different time periods to varenicline salivary levels taken after 2weeks of treatment, as well as evaluated predictors of adherence to varenicline. RESULTS: Using a binary measure of adherence based on salivary varenicline levels, adherence was higher among older, white, and more educated participants. Relative to 3, 7, and 14-day pill count, 12-week pill count was the only significant measure able to discriminate adherence as defined by salivary varenicline levels (assessed by area under the receiver operating characteristic curve; AUC=0.59, p=0.004). Seventy-two percent of participants who indicated adherence on 12-week pill count were classified as adherent based on varenicline saliva levels (sensitivity=0.80; specificity=0.40). There was modest variability in the relationship between 12-week pill count and varenicline levels across race and rate of nicotine metabolism. Lastly, General Estimating Equation models demonstrated that longitudinal changes in withdrawal, craving, negative and positive affect, and side effect count and severity were not related to adherence based on salivary varenicline levels. CONCLUSIONS: These results indicate that 12-week pill count was the best, albeit a relatively weak, measure of varenicline adherence; additional factors associated with treatment adherence need to be identified.
INTRODUCTION: While adherence to medication in smoking cessation clinical trials is strongly associated with clinical outcome, very few studies have evaluated the validity of pill count as a measure of adherence relative to a biological assay, and evaluated a broad range of correlates of adherence. METHODS: In a smoking cessation clinical trial of varenicline, we compared pill counts collected over 4 different time periods to varenicline salivary levels taken after 2weeks of treatment, as well as evaluated predictors of adherence to varenicline. RESULTS: Using a binary measure of adherence based on salivary varenicline levels, adherence was higher among older, white, and more educated participants. Relative to 3, 7, and 14-day pill count, 12-week pill count was the only significant measure able to discriminate adherence as defined by salivary varenicline levels (assessed by area under the receiver operating characteristic curve; AUC=0.59, p=0.004). Seventy-two percent of participants who indicated adherence on 12-week pill count were classified as adherent based on varenicline saliva levels (sensitivity=0.80; specificity=0.40). There was modest variability in the relationship between 12-week pill count and varenicline levels across race and rate of nicotine metabolism. Lastly, General Estimating Equation models demonstrated that longitudinal changes in withdrawal, craving, negative and positive affect, and side effect count and severity were not related to adherence based on salivary varenicline levels. CONCLUSIONS: These results indicate that 12-week pill count was the best, albeit a relatively weak, measure of varenicline adherence; additional factors associated with treatment adherence need to be identified.
Authors: Taneisha S Buchanan; Carla J Berg; Lisa Sanderson Cox; Niaman Nazir; Neal L Benowitz; Lisa Yu; Olivia Yturralde; Peyton Jacob; Won S Choi; Jasjit S Ahluwalia; Nicole L Nollen Journal: Nicotine Tob Res Date: 2012-02-24 Impact factor: 4.244
Authors: Ahmed Jamal; Brian A King; Linda J Neff; Jennifer Whitmill; Stephen D Babb; Corinne M Graffunder Journal: MMWR Morb Mortal Wkly Rep Date: 2016-11-11 Impact factor: 17.586
Authors: Jennifer B McClure; Gary E Swan; Lisa Jack; Sheryl L Catz; Susan M Zbikowski; Tim A McAfee; Mona Deprey; Julie Richards; Harold Javitz Journal: J Gen Intern Med Date: 2009-02-24 Impact factor: 5.128
Authors: Grace Crawford; Jessica Weisbrot; Joseph Bastian; Alex Flitter; Nancy C Jao; Allison Carroll; Ravi Kalhan; Frank Leone; Brian Hitsman; Robert Schnoll Journal: Nicotine Tob Res Date: 2019-07-17 Impact factor: 4.244
Authors: Annie R Peng; Robert Schnoll; Larry W Hawk; Paul Cinciripini; Tony P George; Caryn Lerman; Rachel F Tyndale Journal: Drug Alcohol Depend Date: 2018-06-26 Impact factor: 4.492
Authors: Rachel L Tomko; Erin A McClure; Lindsay M Squeglia; Hayley Treloar Padovano; Aimee L McRae-Clark; Nathaniel L Baker; Matthew J Carpenter; Kevin M Gray Journal: Curr Opin Psychol Date: 2019-01-28
Authors: Rebecca L Ashare; Morgan Thompson; Katrina Serrano; Frank Leone; David Metzger; Ian Frank; Robert Gross; Anita Hole; Karam Mounzer; Ronald G Collman; E Paul Wileyto; Robert Schnoll Journal: Drug Alcohol Depend Date: 2019-05-07 Impact factor: 4.492
Authors: Robert Schnoll; Frank Leone; Anna Veluz-Wilkins; Andrew Miele; Anita Hole; Nancy C Jao; E Paul Wileyto; Allison J Carroll; Ravi Kalhan; Jyoti Patel; Corey Langer; Su Fen Lubitz; Brian Hitsman Journal: Psychooncology Date: 2019-01-24 Impact factor: 3.894
Authors: Robert Schnoll; E Paul Wileyto; Robert Gross; Brian Hitsman; Larry W Hawk; Paul Cinciripini; Tony P George; Neal L Benowitz; Su Fen Lubitz; Rebecca Ashare; Rachel F Tyndale; Caryn Lerman Journal: Drug Alcohol Depend Date: 2020-03-20 Impact factor: 4.492
Authors: Mackenzie Hosie Quinn; Anna-Marika Bauer; Alex Flitter; Su Fen Lubitz; Rebecca L Ashare; Morgan Thompson; Frank Leone; Robert Gross; Robert Schnoll Journal: Addict Behav Date: 2019-10-22 Impact factor: 3.913
Authors: Annie R Peng; Walter Swardfager; Neal L Benowitz; Jasjit S Ahluwalia; Caryn Lerman; Nicole L Nollen; Rachel F Tyndale Journal: Addiction Date: 2019-11-05 Impact factor: 6.526
Authors: Grace Crawford; Nancy Jao; Annie R Peng; Frank Leone; Ravi Kalhan; Rachel F Tyndale; Jessica Weisbrot; Brian Hitsman; Robert Schnoll Journal: Addict Behav Rep Date: 2018-07-04