Skip to main content
Grant Details

Grant Number: 1R01CA165001-01A1 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: 2012


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. PUBLIC HEALTH RELEVANCE: About 33-50% of cancer patients who smoked before their diagnosis continue to smoke after their diagnosis and continued smoking reduces survival, quality of life, and the effectiveness of their medical treatment. To date, no study has demonstrated an efficacious approach to treating smoking among cancer patients perhaps because these treatments have not adequately addressed barriers to quitting smoking unique to this population, including a high level of nicotine dependence, a high level of psychological distress and cognitive impairment, and a protracted relapse time-line. We have found that extending treatment for nicotine dependence with the nicotine patch from the standard duration to 24-weeks increases quit rates, promotes recovery from a lapse, uniquely helps to mitigate the adverse effects of nicotine dependence and cognitive impairment on attempts to quit smoking, and increases quit rates for smokers with high levels of psychological distress. Varenicline, the most effective treatment currently available for nicotine dependence, reduces negative affect and promotes cognitive function. Thus, this clinical trial will compare standard duration (12- weeks) to extended duration (24-weeks) treatment with varenicline for nicotine dependence among cancer patients. The trial results may serve to guide the development of a treatment model for cancer patients and contribute to a growing literature demonstrating the enhanced efficacy of extended duration treatments for nicotine dependence.


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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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
Related Citations

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.
PMID: 23222517
Related Citations

Back to Top