Grant Number:	4R01CA165001-05 Interpret this number
Primary Investigator:	Schnoll, Robert
Organization:	University Of Pennsylvania
Project Title:	Extended Duration Varenicline for Smoking Among Cancer Patients: a Clinical Trial
Fiscal Year:	2016

DESCRIPTION (provided by applicant): Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke following diagnosis and treatment. Continued smoking by cancer patients reduces survival time, medical treatment efficacy, and quality of life (QOL). To date, studies of smoking cessation interventions for cancer patients have failed to yield significant treatment effects. As such, currently, there is no evidence-based treatment model for addressing tobacco use in this population. With medical advances in cancer care yielding a growing constituency of cancer survivors - close to 12 million today - addressing nicotine dependence in this population is a priority. A recent NCI meeting called for the evaluation of novel treatments for nicotine dependence among cancer patients which address the unique barriers to cessation evident in this population, including: a high level of nicotine dependence, high levels of psychological distress and cognitive impairment, and a protracted relapse timeline. While PHS guidelines recommend acute treatment durations with approved medications for tobacco use, we have shown that extending the duration of treatment beyond the standard treatment duration significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to abstinence following a lapse. Extended duration treatment is particularly efficacious for smokers with high levels of nicotine dependence and cognitive impairment, vs. standard duration treatment, and increases quit rates for smokers with high levels of psychological distress. Varenicline, vs. other medications for smoking, may be particularly effective for cancer patients given the drug's beneficial effects on affect ad cognition. Thus, using a double-blind placebo- controlled design with 374 cancer patients we will: 1) Compare standard varenicline treatment (12-weeks active + 12-weeks placebo) to extended varenicline treatment (24-weeks active) for increasing week 24 and week 52 biochemically-confirmed 7-day point prevalence abstinence~ 2) Assess the effects of extended varenicline therapy on QOL, including varenicline side effects~ and 3) Assess changes in affect and cognitive impairment as mediators of extended varenicline therapy's effect on quit rates. We will also explore potential moderators of the effect of extended varenicline treatment on quit rates (e.g., tumor site and stage, time since diagnosis, treatment history, level of nicotine dependence). This study is significant by addressing a population with high smoking rates, which has been under-studied in the area of nicotine dependence treatment, and is at risk for unique adverse tobacco-related health effects. This study is innovative by evaluating the efficacy of extended vs. standard duration varenicline treatment, which may more effectively address unique barriers to cessation in this population. This will also be the first study to use varenicline blood levels as a measure of adherence. There is widespread agreement that evidence-based treatment programs for nicotine dependence among cancer patients are needed. This study may help guide efforts to implement such programs and help determine the benefits of extended treatment duration for nicotine dependence more broadly.




Change in Health-Related Quality of Life Among Individuals With Cancer Undergoing Smoking Cessation Treatment Involving Varenicline.
Authors: May J.R. , Jao N.C. , McCarter K. , Klass E. , Pearman T. , Leone F. , Schnoll R.A. , Hitsman B. .
Source: Oncology nursing forum, 2021-01-04; 48(1), p. 112-120.
PMID: 33337436
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Longitudinal associations between smoking and affect among cancer patients using varenicline to quit smoking.
Authors: Carroll A.J. , Kim K. , Miele A. , Olonoff M. , Leone F.T. , Schnoll R.A. , Hitsman B. .
Source: Addictive behaviors, 2019 Aug; 95, p. 206-210.
EPub date: 2019-04-03.
PMID: 30978583
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Predictors of Varenicline Adherence Among Cancer Patients Treated for Tobacco Dependence and its Association With Smoking Cessation.
Authors: Crawford G. , Weisbrot J. , Bastian J. , Flitter A. , Jao N.C. , Carroll A. , Kalhan R. , Leone F. , Hitsman B. , Schnoll R. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2019-07-17; 21(8), p. 1135-1139.
PMID: 29955828
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A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence.
Authors: Schnoll R. , Leone F. , Veluz-Wilkins A. , Miele A. , Hole A. , Jao N.C. , Paul Wileyto E. , Carroll A.J. , Kalhan R. , Patel J. , et al. .
Source: Psycho-oncology, 2019 Mar; 28(3), p. 561-569.
EPub date: 2019-01-24.
PMID: 30680852
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The association between self-reported varenicline adherence and varenicline blood levels in a sample of cancer patients receiving treatment for tobacco dependence.
Authors: Crawford G. , Jao N. , Peng A.R. , Leone F. , Kalhan R. , Tyndale R.F. , Weisbrot J. , Hitsman B. , Schnoll R. .
Source: Addictive behaviors reports, 2018 Dec; 8, p. 46-50.
EPub date: 2018-07-04.
PMID: 29998189
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Factors Associated with Adherence to Transdermal Nicotine Patches within a Smoking Cessation Effectiveness Trial.
Authors: Handschin J. , Hitsman B. , Blazekovic S. , Veluz-Wilkins A. , Wileyto E.P. , Leone F.T. , Schnoll R.A. .
Source: Journal of smoking cessation, 2018 Mar; 13(1), p. 33-43.
EPub date: 2017-03-09.
PMID: 31223345
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Cancer-related disease factors and smoking cessation treatment: Analysis of an ongoing clinical trial.
Authors: Carroll A.J. , Veluz-Wilkins A.K. , Blazekovic S. , Kalhan R. , Leone F.T. , Wileyto E.P. , Schnoll R.A. , Hitsman B. .
Source: Psycho-oncology, 2018 Feb; 27(2), p. 471-476.
EPub date: 2017-08-04.
PMID: 28636795
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Cancer Patients Enrolled in a Smoking Cessation Clinical Trial: Characteristics and Correlates of Smoking Rate and Nicotine Dependence.
Authors: Miele A. , Thompson M. , Jao N.C. , Kalhan R. , Leone F. , Hogarth L. , Hitsman B. , Schnoll R. .
Source: Journal of addiction, 2018; 2018, p. 2438161.
EPub date: 2018-02-26.
PMID: 29682394
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Measures and predictors of varenicline adherence in the treatment of nicotine dependence.
Authors: Peng A.R. , Morales M. , Wileyto E.P. , Hawk L.W. , Cinciripini P. , George T.P. , Benowitz N.L. , Nollen N.L. , Lerman C. , Tyndale R.F. , et al. .
Source: Addictive behaviors, 2017 Dec; 75, p. 122-129.
EPub date: 2017-07-12.
PMID: 28728040
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The use of varenicline to treat nicotine dependence among patients with cancer.
Authors: Price S. , Hitsman B. , Veluz-Wilkins A. , Blazekovic S. , Brubaker T.R. , Leone F. , Hole A. , Wileyto E.P. , Langer C. , Kalhan R. , et al. .
Source: Psycho-oncology, 2017 Oct; 26(10), p. 1526-1534.
EPub date: 2016-05-24.
PMID: 27218657
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Treating Nicotine Dependence and Preventing Smoking Relapse in Cancer Patients.
Authors: Chang E.H.E. , Braith A. , Hitsman B. , Schnoll R.A. .
Source: Expert review of quality of life in cancer care, 2017; 2(1), p. 23-39.
EPub date: 2016-12-28.
PMID: 28808692
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Longitudinal changes in smoking abstinence symptoms and alternative reinforcers predict long-term smoking cessation outcomes.
Authors: Schnoll R.A. , Hitsman B. , Blazekovic S. , Veluz-Wilkins A. , Wileyto E.P. , Leone F.T. , Audrain-McGovern J.E. .
Source: Drug and alcohol dependence, 2016-08-01; 165, p. 245-52.
EPub date: 2016-06-25.
PMID: 27372219
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Integrating Tobacco Use Treatment Into Practice: Billing and Documentation.
Authors: Leone F.T. , Evers-Casey S. , Mulholland M.A. , Sachs D.P.L. .
Source: Chest, 2016 Feb; 149(2), p. 568-575.
EPub date: 2016-01-12.
PMID: 26426215
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Multinational Assessment of Accuracy of Equations for Predicting Risk of Kidney Failure: A Meta-analysis.
Authors: Tangri N. , Grams M.E. , Levey A.S. , Coresh J. , Appel L.J. , Astor B.C. , Chodick G. , Collins A.J. , Djurdjev O. , Elley C.R. , et al. .
Source: JAMA, 2016-01-12; 315(2), p. 164-74.
PMID: 26757465
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Rate of nicotine metabolism and smoking cessation outcomes in a community-based sample of treatment-seeking smokers.
Authors: Kaufmann A. , Hitsman B. , Goelz P.M. , Veluz-Wilkins A. , Blazekovic S. , Powers L. , Leone F.T. , Gariti P. , Tyndale R.F. , Schnoll R.A. .
Source: Addictive behaviors, 2015 Dec; 51, p. 93-9.
EPub date: 2015-07-26.
PMID: 26240944
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Long-term nicotine replacement therapy: a randomized clinical trial.
Authors: Schnoll R.A. , Goelz P.M. , Veluz-Wilkins A. , Blazekovic S. , Powers L. , Leone F.T. , Gariti P. , Wileyto E.P. , Hitsman B. .
Source: JAMA internal medicine, 2015 Apr; 175(4), p. 504-11.
PMID: 25705872
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Seventy-five genetic loci influencing the human red blood cell.
Authors: van der Harst P. , Zhang W. , Mateo Leach I. , Rendon A. , Verweij N. , Sehmi J. , Paul D.S. , Elling U. , Allayee H. , Li X. , et al. .
Source: Nature, 2012-12-20; 492(7429), p. 369-75.
EPub date: 2012-12-05.
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