Grant Details
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 |
Abstract
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.
Publications
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
Related Citations
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
Related Citations
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
Related Citations
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
Related Citations
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
Related Citations
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
Related Citations
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.
PMID: 34460924
Related Citations
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.
PMID: 33878020
Related Citations
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.
PMID: 33435462
Related Citations
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.
PMID: 33219852
Related Citations
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.
PMID: 32811627
Related Citations
Withdrawal Symptom, Treatment Mechanism, and/or Side Effect? Developing an Explicit Measurement Model for Smoking Cessation Research.
Authors: Tonkin S.S.
, Williams T.F.
, Simms L.J.
, Tiffany S.T.
, Mahoney M.C.
, Schnoll R.A.
, Cinciripini P.M.
, Hawk L.W.
.
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2018-12-11 00:00:00.0; , .
EPub date: 2018-12-11 00:00:00.0.
PMID: 30535357
Related Citations