Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial
Open accessAbstract
BACKGROUND: Varenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation. METHODS: In this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, The Netherlands, UK and USA, participants were randomly assigned (1:1) to receive varenicline uptitrated to 1 mg twice daily for 12 weeks or transdermal NRT (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to week 52. The primary outcome was the biochemically confirmed (exhaled carbon monoxide < or = 10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of treatment. Secondary outcomes included CAR from the last 4 weeks of treatment through weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction. RESULTS: A total of 376 and 370 participants assigned to varenicline and NRT, respectively, were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; OR 1.70, 95% CI 1.26 to 2.28, p<0.001). The week 52 CAR (NRT, weeks 8-52; varenicline, weeks 9-52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI 0.99 to 1.99, p = 0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) compared with NRT. The most frequent adverse event was nausea (varenicline, 37.2%; NRT, 9.7%). CONCLUSIONS: The outcomes of this trial established that abstinence from smoking was greater and craving, withdrawal symptoms and smoking satisfaction were less at the end of treatment with varenicline than with transdermal NRT. TRIAL REGISTRATION NUMBER: NCT00143325.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Two open-label randomized controlled trials were unable to confirm significant improvements with varenicline over NRT in continuous abstinence at 52 weeks following short-term treatment.
“Two open label, randomized controlled trial were unable to confirm significant improvements with varenicline over NRT in continuous abstinence rates at 52 weeks following short term treatment [213, 242, 243].”
From Mechanistic insights into nicotine withdrawal (2011) · cites this paper as [242]
The 52-week abstinence rate for NRT was 20.4%, higher than most previously reported rates, while varenicline maintained the usual reported rate (26.1%).
“the 52 week abstinence rate for NRT was found to be 20.4%, higher than most previously reported rates, while varenicline maintained the usual reported rate (26.1%) [242].”
From Mechanistic insights into nicotine withdrawal (2011) · cites this paper as [242]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Diagnostic and Statistical Manual of Mental Disorders
Williams, J. B. W., & First, M. B. (2013) · Oxford University Press eBooks · doi:10.1093/acrefore/9780199975839.013.104 · Cited by 109,841 · see citing works
Diagnostic and Statistical Manual of Mental Disorders
(2012) · Springer eBooks · doi:10.1007/springerreference_121117 · Cited by 20,769 · see citing works
Nicotine replacement therapy for smoking cessation
Stead, L. F., Perera, R., Bullen, C., Mant, D., Hartmann‐Boyce, J., Cahill, K., & Lancaster, T. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000146.pub4 · Cited by 2,514 · see citing works
Cigarette smoking among adults — United States, 1988
Bachman, J. G., Johnston, L. D., & O’Malley, P. M. (1992) · Patient Education and Counseling · doi:10.1016/0738-3991(92)90149-d · Cited by 1,710 · see citing works
Signs and Symptoms of Tobacco Withdrawal
Hughes, J. R. (1986) · Archives of General Psychiatry · doi:10.1001/archpsyc.1986.01800030107013 · Cited by 1,669 · see citing works
Jorenby, D. E. (2006) · JAMA · doi:10.1001/jama.296.1.56 · Cited by 1,635 · see citing works
Cigarette Smoking Among Adults--United States, 2003
(2005) · JAMA · doi:10.1001/jama.294.2.172 · Cited by 1,520 · see citing works
Shape of the relapse curve and long-term abstinence among untreated smokers
Hughes, J. R., Keely, J., & Naud, S. (2004) · Addiction · doi:10.1111/j.1360-0443.2004.00540.x · Cited by 1,414 · see citing works
Antidepressants for smoking cessation
Howes, S., Hartmann-Boyce, J., Livingstone-Banks, J., Hong, B., & Lindson, N. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000031.pub5 · Cited by 1,352 · see citing works
Outcome criteria in smoking cessation trials: proposal for a common standard
West, R., Hajek, P., Stead, L., & Stapleton, J. (2005) · Addiction · doi:10.1111/j.1360-0443.2004.00995.x · Cited by 1,285 · see citing works
Spall, H. G. C. V., Toren, A., Kiss, A., & Fowler, R. (2007) · JAMA · doi:10.1001/jama.297.11.1233 · Cited by 1,054 · see citing works
Nicotine replacement therapy for smoking cessation
Silagy, C., Lancaster, T., Stead, L., Mant, D., & Fowler, G. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000146.pub2 · Cited by 972 · see citing works
Varenicline: An α4β2 Nicotinic Receptor Partial Agonist for Smoking Cessation
Coe, J. W., Brooks, P. R., Vetelino, M. G., Wirtz, M. C., Arnold, E. P., Huang, J., Sands, S. B., Davis, T. I., Lebel, L. A., Fox, C. B., et al. (2005) · Journal of Medicinal Chemistry · doi:10.1021/jm050069n · Cited by 930 · see citing works
Nicotine receptor partial agonists for smoking cessation
Hey, K., Lancaster, T., & Bala, M. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103 · Cited by 864 · see citing works
Fiore, M. (2000) · Respiratory care · doi:10.1177/002013240004501006 · Cited by 773 · see citing works
Nicotine receptor partial agonists for smoking cessation
Cahill, K., Stead, L., & Lancaster, T. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub2 · Cited by 747 · see citing works
Antidepressants for smoking cessation
Hughes, J., Stead, L., & Lancaster, T. (2003) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000031 · Cited by 683 · see citing works
Antidepressants for smoking cessation
Hughes, J. R., Stead, L. F., & Lancaster, T. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000031.pub3 · Cited by 567 · see citing works
Rollema, H., Chambers, L. K., Coe, J. W., Glowa, J., Hurst, R. S., Lebel, L. A., Lu, Y., Mansbach, R. S., Mather, R. J., Rovetti, C. C., et al. (2007) · Neuropharmacology · doi:10.1016/j.neuropharm.2006.10.016 · Cited by 533 · see citing works
Self-citationEffectiveness of smoking cessation therapies: a systematic review and meta-analysis
Wu, P., Wilson, K., Dimoulas, P., & Mills, E. J. (2006) · BMC Public Health · doi:10.1186/1471-2458-6-300 · Cited by 484 · see citing works
Tønnesen, P., Carrozzi, L., Fagerström, K. O., Gratziou, C., Jimenez-Ruiz, C. A., Nardini, S. G., Viegi, G., Lazzaro, C. R., Campell, I. A., Dagli, E., et al. (2007) · European Respiratory Journal · doi:10.1183/09031936.00060806 · Cited by 248 · see citing works
Stapleton, J., Watson, L. A., Spirling, L. I., Smith, R. C., Milbrandt, A., Ratcliffe, M., & Sutherland, G. (2007) · Addiction · doi:10.1111/j.1360-0443.2007.02083.x · Cited by 206 · see citing works
Nicotine receptor partial agonists for smoking cessation (Review)
Cahill, K., Lf, S., & Lancaster, T. (2007) · Cited by 205 · see citing works
Nakamura, M., Oshima, A., Fujimoto, Y., Maruyama, N., Ishibashi, T., & Reeves, K. R. (2007) · Clinical Therapeutics · doi:10.1016/j.clinthera.2007.06.012 · Cited by 185 · see citing works
Self-citationA double-blind study evaluating the long-term safety of varenicline for smoking cessation
Williams, K. E., Reeves, K. R., Billing, C. B., Pennington, A. M., & Gong, J. (2007) · Current Medical Research and Opinion · doi:10.1185/030079907x182185 · Cited by 184 · see citing works
Nicotine-mecamylamine treatment for smoking cessation: The role of pre-cessation therapy.
Rose, J. E., Behm, F. M., & Westman, E. C. (1998) · Experimental and Clinical Psychopharmacology · doi:10.1037//1064-1297.6.3.331 · Cited by 159 · see citing works
Cigarette Smoking Among Adults—United States, 1999
(2001) · JAMA · doi:10.1001/jama.286.22.2802-jwr1212-2-1 · Cited by 152 · see citing works
Nicotine–mecamylamine treatment for smoking cessation: The role of pre-cessation therapy.
Rose, J. E., Behm, F. M., & Westman, E. C. (1998) · Experimental and Clinical Psychopharmacology · doi:10.1037/1064-1297.6.3.331 · Cited by 146 · see citing works
Tsai, S.-T., Cho, H., Cheng, H., Kim, C.-H., Hsueh, K.-C., Billing, C. B., & Williams, K. E. (2007) · Clinical Therapeutics · doi:10.1016/j.clinthera.2007.06.011 · Cited by 134 · see citing works
Self-citationVarenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis.
Nides, M. A., Glover, E. D., Reus, V. I., et al. (2009) · PubMed · doi:10.5555/ajhb.2008.32.6.664 · Cited by 110 · see citing works
THIERS, B. H. (2008) · Yearbook of Dermatology and Dermatologic Surgery · doi:10.1016/s0093-3619(08)70887-6 · Cited by 109 · see citing works
Impact of UK policy initiatives on use of medicines to aid smoking cessation
West, R., DiMarino, M. E., Gitchell, J., & McNeill, A. (2005) · Tobacco Control · doi:10.1136/tc.2004.008649 · Cited by 92 · see citing works
Use of FDA-approved pharmacologic treatments for tobacco dependence--United States, 1984-1998.
Burton, S. L., Gitchell, J. G., & Shiffman, S. S. (2000) · PubMed · Cited by 88 · see citing works
Stopping smoking can cause constipation
Hájek, P., Gillison, F., & McRobbie, H. J. (2003) · Addiction · doi:10.1046/j.1360-0443.2003.00497.x · Cited by 80 · see citing works
Revealing the multidimensional framework of the Minnesota nicotine withdrawal scale
Cappelleri, J. C., Bushmakin, A. G., Baker, C. L., Merikle, E. P., Olufade, A. O., & Gilbert, D. G. (2005) · Current Medical Research and Opinion · doi:10.1185/030079905x43712 · Cited by 75 · see citing works
Individual differences in smoking reward from de-nicotinized cigarettes
Brauer, L. H. (2001) · Nicotine & Tobacco Research · doi:10.1080/14622200123249 · Cited by 74 · see citing works
Coe, J. W., Brooks, P. R., Wirtz, M. C., Bashore, C. G., Bianco, K. E., Vetelino, M. G., Arnold, E. P., Lebel, L. A., Fox, C. B., Tingley, F. D., et al. (2005) · Bioorganic & Medicinal Chemistry Letters · doi:10.1016/j.bmcl.2005.08.035 · Cited by 73 · see citing works
Nicotine Replacement Therapy for Smoking Cessation
Takagi, K., Kato, N., Sasamoto, S., & Hata, Y. (2005) · Nihon Kikan Shokudoka Gakkai Kaiho · doi:10.2468/jbes.56.424 · Cited by 33 · see citing works
Hasford, J., Fagerström, K. O., & Haustein, K.-O. (2003) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-003-0629-8 · Cited by 24 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Nicotine receptor partial agonists for smoking cessation
Cahill, K., Stead, L., & Lancaster, T. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub2 · Cited by 747 · see citing works
Weight gain in smokers after quitting cigarettes: meta-analysis
Aubin, H.-J., Farley, A., Lycett, D., Lahmek, P., & Aveyard, P. (2012) · BMJ · doi:10.1136/bmj.e4439 · Cited by 510 · see citing works
Self-citationNicotine receptor partial agonists for smoking cessation
Cahill, K., Lindson-Hawley, N., Thomas, K. H., Fanshawe, T. R., & Lancaster, T. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub7 · Cited by 433 · see citing works
Singh, S., Loke, Y. K., Spangler, J. G., & Furberg, C. D. (2011) · Canadian Medical Association Journal · doi:10.1503/cmaj.110218 · Cited by 286 · see citing works
Diretrizes para cessação do tabagismo - 2008
Reichert, J., Araújo, A. J. D., Gonçalves, C. M. C., Godoy, I., Chatkin, J. M., Sales, M. D. P. U., & Santos, S. R. R. D. A. (2008) · Jornal Brasileiro de Pneumologia · doi:10.1590/s1806-37132008001000014 · Cited by 166 · see citing works
Mills, E. J., Wu, P., Lockhart, I., Wilson, K., & Ebbert, J. O. (2010) · Tobacco Induced Diseases · doi:10.1186/1617-9625-8-8 · Cited by 166 · see citing works
Suicidal Behavior and Depression in Smoking Cessation Treatments
Moore, T. J., Furberg, C. D., Glenmullen, J., Maltsberger, J. T., & Singh, S. (2011) · PLoS ONE · doi:10.1371/journal.pone.0027016 · Cited by 150 · see citing works
Tonstad, S., Davies, S., Flammer, M., Russ, C., & Hughes, J. (2010) · Drug Safety · doi:10.2165/11319180-000000000-00000 · Cited by 142 · see citing works
Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice
Aubin, H., Luquiens, A., & Berlin, I. (2014) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12116 · Cited by 138 · see citing works
Self-citationO’Connor, E. C., Parker, D., Rollema, H., & Mead, A. N. (2010) · Psychopharmacology · doi:10.1007/s00213-009-1739-5 · Cited by 118 · see citing works
Adverse effects and tolerability of medications for the treatment of tobacco use and dependence
Hays, J. T., & Ebbert, J. O. (2010) · Drugs · doi:10.2165/11538190-000000000-00000 · Cited by 74 · see citing works
Mechanistic insights into nicotine withdrawal
Paolini, M., & De Biasi, M. (2011) · Biochemical Pharmacology · doi:10.1016/j.bcp.2011.07.075 · Cited by 66 · see citing works
Combination Pharmacotherapy for Stopping Smoking: What Advantages Does it Offer?
Ebbert, J. O., Hays, J. T., & Hurt, R. D. (2010) · Drugs · doi:10.2165/11536100-000000000-00000 · Cited by 53 · see citing works
Tsukahara, H., Noda, K., & Saku, K. (2010) · Circulation Journal · doi:10.1253/circj.cj-09-0803 · Cited by 50 · see citing works
Nicotine receptor partial agonists for smoking cessation
Cahill, K., Stead, L. F., & Lancaster, T. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub4 · Cited by 46 · see citing works
Combination Therapies for Smoking Cessation
Windle, S. B., Filion, K. B., Mancini, J. G., Adye-White, L., Joseph, L., Gore, G. C., Habib, B., Grad, R., Pilote, L., & Eisenberg, M. J. (2016) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2016.07.011 · Cited by 46 · see citing works
Pharmacotherapy for smoking cessation: present and future
Aubin, H.-J., Karila, L., & Reynaud, M. (2011) · Current Pharmaceutical Design · doi:10.2174/138161211796150837 · Cited by 39 · see citing works
Self-citationKralikova, E., Kmetova, A., Stepankova, L., Zvolska, K., Davis, R., & West, R. (2013) · Addiction · doi:10.1111/add.12219 · Cited by 41 · see citing works
Neuropsychiatric Adverse Events of Varenicline: A Systematic Review of Published Reports
Ahmed, A. I. A., Ali, A. N. A., Kramers, C., Härmark, L. V. D., Burger, D. M., & Verhoeven, W. M. A. (2013) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e31827c0117 · Cited by 34 · see citing works
- Authors
- Aubin, H.-J., Bobak, A., Britton, J. R., Oncken, C., Billing, C. B., Gong, J., Williams, K. E., & Reeves, K. R.
- Affiliations
- Assistance Publique – Hôpitaux de Paris (FR)
- University of Nottingham (GB)
- UConn Health (US)
- Pfizer (United States) (US)
- Corresponding author
- Aubin, H-J
- Venue
- Thorax
- Publisher
- BMJ
- Published
- 2008-08-01
- Volume
- 63
- Issue
- 8
- Pages
- 717-724
- ISSN
- 0040-6376 (ISSN-L)
- PMC
- PMC2569194
- OpenAlex
- W2129372385
- Cited by
- 344
- References
- 40
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 11 · 2023: 10 · 2022: 11 · 2021: 13 · 2020: 8 · 2019: 10 · 2018: 12 · 2017: 18 · 2016: 18 · 2015: 22 · 2014: 20 · 2013: 31 · 2012: 36
- FWCI
- 26.26
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Thorax (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Pfizer
- GlaxoSmithKline
- Sanofi
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
- Keywords
- varenicline, nicotine patch, smoking cessation, nicotine replacement therapy, continuous abstinence rate, nicotine craving, withdrawal symptoms, smoking satisfaction, nicotine dependence, adverse events, nausea, exhaled carbon monoxide, long-term follow-up, relapse after treatment discontinuation
- MeSH terms
- Varenicline, Smoking Prevention, Administration, Cutaneous, Adolescent, Adult, Aged, Benzazepines, Female, Humans, Male, Middle Aged, Nicotine, Patient Compliance, Quinoxalines, Reinforcement, Psychology, Substance Withdrawal Syndrome, Smoking Cessation, Treatment Outcome, Nicotinic Agonists
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
