Grant Number:	5R01CA206193-05 Interpret this number
Primary Investigator:	Hawk, Larry
Organization:	State University Of New York At Buffalo
Project Title:	EVARQUIT: Extinguishing Cigarette Smoking Via Extended Pre-Quit Varenicline
Fiscal Year:	2021

PROJECT SUMMARY/ABSTRACT Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer duration of varenicline treatment prior to the target quit date (TQD) will yield greater decreases in the number of cigarettes smoked per day before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on our promising preliminary clinical data, we propose to test these hypotheses with a full-scale randomized clinical trial (RCT). Four hundred treatment-seeking smokers (200 female) will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit) and at long-term follow-up (weeks 8-26 and 8-52 post-quit). Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by converging behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). We predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. We further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: We aim to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.




Relationships Between the Nicotine Metabolite Ratio and Laboratory Assessments of Smoking Reinforcement and Craving Among Adults in a Smoking Cessation Trial.
Authors: Cooper R.K. , Mahoney M.C. , Tiffany S.T. , Colder C.R. , Tyndale R.F. , Hawk L.W. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2024-04-22 00:00:00.0; 26(5), p. 604-611.
PMID: 37996099
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Genetic Prediction of Smoking Cessation Medication Side Effects: A Genome-Wide Investigation of Abnormal Dreams on Varenicline.
Authors: Chenoweth M.J. , Kim Y.J. , Nollen N.L. , Hawk L.W. , Mahoney M.C. , Lerman C. , Knight J. , Tyndale R.F. .
Source: Clinical Pharmacology And Therapeutics, 2024-02-19 00:00:00.0; , .
EPub date: 2024-02-19 00:00:00.0.
PMID: 38369951
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A preliminary randomized trial of reinforcement contingencies to improve compliance with ecological momentary assessment.
Authors: Gass J.C. , Tonkin S. , Maguin E. , Colder C.R. , Mahoney M.C. , Tiffany S.T. , Hawk L.W. .
Source: Translational Behavioral Medicine, 2023-10-31 00:00:00.0; , .
EPub date: 2023-10-31 00:00:00.0.
PMID: 37904628
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A Psychometric Evaluation of the Stanford Expectations of Treatment Scale (SETS) in the Context of a Smoking Cessation Trial.
Authors: Ferkin A.C. , Tonkin S.S. , Maguin E. , Mahoney M.C. , Colder C.R. , Tiffany S.T. , Hawk L.W. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2022-11-12 00:00:00.0; 24(12), p. 1914-1920.
PMID: 35906990
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Effect of Extending the Duration of Prequit Treatment With Varenicline on Smoking Abstinence: A Randomized Clinical Trial.
Authors: Hawk L.W. , Tiffany S.T. , Colder C.R. , Ashare R.L. , Wray J.M. , Tyndale R.F. , Brandon T.H. , Mahoney M.C. .
Source: Jama Network Open, 2022-11-01 00:00:00.0; 5(11), p. e2241731.
EPub date: 2022-11-01 00:00:00.0.
PMID: 36367720
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Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.
Authors: Tonkin S.S. , Colder C. , Mahoney M.C. , Swan G.E. , Cinciripini P. , Schnoll R. , George T.P. , Tyndale R.F. , Hawk L.W. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2022-10-26 00:00:00.0; 24(11), p. 1803-1810.
PMID: 35639828
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Stability of Varenicline Concentration in Saliva Over 21 Days at Three Storage Temperatures.
Authors: Novalen M. , Chenoweth M.J. , Zhao B. , Hawk L.W. , Tyndale R.F. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2022-02-01 00:00:00.0; 24(2), p. 270-274.
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Transitioning to Remote Clinic Visits in a Smoking Cessation Trial During the COVID-19 Pandemic: Mixed Methods Evaluation.
Authors: Mahoney M.C. , Park E. , Schlienz N.J. , Duerr C. , Hawk L.W. .
Source: Jmir Formative Research, 2021-04-30 00:00:00.0; 5(4), p. e25541.
EPub date: 2021-04-30 00:00:00.0.
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The Perceived Impact of COVID-19 among Treatment-Seeking Smokers: A Mixed Methods Approach.
Authors: Rosoff-Verbit Z. , Logue-Chamberlain E. , Fishman J. , Audrain-McGovern J. , Hawk L. , Mahoney M. , Mazur A. , Ashare R. .
Source: International Journal Of Environmental Research And Public Health, 2021-01-09 00:00:00.0; 18(2), .
EPub date: 2021-01-09 00:00:00.0.
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The impact of three weeks of pre-quit varenicline on reinforcing value and craving for cigarettes in a laboratory choice procedure.
Authors: Lawson S.C. , Gass J.C. , Cooper R.K. , Tonkin S.S. , Colder C.R. , Mahoney M.C. , Tiffany S.T. , Hawk L.W. .
Source: Psychopharmacology, 2020-11-21 00:00:00.0; , .
EPub date: 2020-11-21 00:00:00.0.
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Making lemonade from SARS coronavirus-2 lemons: Transitioning a smoking cessation trial to a virtual platform.
Authors: Mahoney M.C. , Ashare R. , Schlienz N. , Duerr C. , Hawk L.W. .
Source: Journal Of Substance Abuse Treatment, 2020 10; 117, p. 108100.
EPub date: 2020-08-05 00:00:00.0.
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Withdrawal Symptom, Treatment Mechanism, and/or Side Effect? Developing an Explicit Measurement Model for Smoking Cessation Research.
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Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2018-12-11 00:00:00.0; , .
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