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. 2023 Jun 19;6(6):CD013308.
doi: 10.1002/14651858.CD013308.pub2.

Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation

Annika Theodoulou  1 , Samantha C Chepkin  2 , Weiyu Ye  3 , Thomas R Fanshawe  1 , Chris Bullen  4 , Jamie Hartmann-Boyce  1 , Jonathan Livingstone-Banks  1 , Anisa Hajizadeh  1 , Nicola Lindson  1
Affiliations

Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation

Annika Theodoulou et al. Cochrane Database Syst Rev. .

Abstract

Background: Nicotine replacement therapy (NRT) aims to replace nicotine from cigarettes. This helps to reduce cravings and withdrawal symptoms, and ease the transition from cigarette smoking to complete abstinence. Although there is high-certainty evidence that NRT is effective for achieving long-term smoking abstinence, it is unclear whether different forms, doses, durations of treatment or timing of use impacts its effects.

Objectives: To determine the effectiveness and safety of different forms, deliveries, doses, durations and schedules of NRT, for achieving long-term smoking cessation.

Search methods: We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning NRT in the title, abstract or keywords, most recently in April 2022.

Selection criteria: We included randomised trials in people motivated to quit, comparing one type of NRT use with another. We excluded studies that did not assess cessation as an outcome, with follow-up of fewer than six months, and with additional intervention components not matched between arms. Separate reviews cover studies comparing NRT to control, or to other pharmacotherapies.

Data collection and analysis: We followed standard Cochrane methods. We measured smoking abstinence after at least six months, using the most rigorous definition available. We extracted data on cardiac adverse events (AEs), serious adverse events (SAEs) and study withdrawals due to treatment. MAIN RESULTS: We identified 68 completed studies with 43,327 participants, five of which are new to this update. Most completed studies recruited adults either from the community or from healthcare clinics. We judged 28 of the 68 studies to be at high risk of bias. Restricting the analysis only to those studies at low or unclear risk of bias did not significantly alter results for any comparisons apart from the preloading comparison, which tested the effect of using NRT prior to quit day whilst still smoking. There is high-certainty evidence that combination NRT (fast-acting form plus patch) results in higher long-term quit rates than single form (risk ratio (RR) 1.27, 95% confidence interval (CI) 1.17 to 1.37; I2 = 12%; 16 studies, 12,169 participants). Moderate-certainty evidence, limited by imprecision, indicates that 42/44 mg patches are as effective as 21/22 mg (24-hour) patches (RR 1.09, 95% CI 0.93 to 1.29; I2 = 38%; 5 studies, 1655 participants), and that 21 mg patches are more effective than 14 mg (24-hour) patches (RR 1.48, 95% CI 1.06 to 2.08; 1 study, 537 participants). Moderate-certainty evidence, again limited by imprecision, also suggests a benefit of 25 mg over 15 mg (16-hour) patches, but the lower limit of the CI encompassed no difference (RR 1.19, 95% CI 1.00 to 1.41; I2 = 0%; 3 studies, 3446 participants). Nine studies tested the effect of using NRT prior to quit day (preloading) in comparison to using it from quit day onward. There was moderate-certainty evidence, limited by risk of bias, of a favourable effect of preloading on abstinence (RR 1.25, 95% CI 1.08 to 1.44; I2 = 0%; 9 studies, 4395 participants). High-certainty evidence from eight studies suggests that using either a form of fast-acting NRT or a nicotine patch results in similar long-term quit rates (RR 0.90, 95% CI 0.77 to 1.05; I2 = 0%; 8 studies, 3319 participants). We found no clear evidence of an effect of duration of nicotine patch use (low-certainty evidence); duration of combination NRT use (low- and very low-certainty evidence); or fast-acting NRT type (very low-certainty evidence). Cardiac AEs, SAEs and withdrawals due to treatment were all measured variably and infrequently across studies, resulting in low- or very low-certainty evidence for all comparisons. Most comparisons found no clear evidence of an effect on these outcomes, and rates were low overall. More withdrawals due to treatment were reported in people using nasal spray compared to patches in one study (RR 3.47, 95% CI 1.15 to 10.46; 1 study, 922 participants; very low-certainty evidence) and in people using 42/44 mg patches in comparison to 21/22 mg patches across two studies (RR 4.99, 95% CI 1.60 to 15.50; I2 = 0%; 2 studies, 544 participants; low-certainty evidence).

Authors' conclusions: There is high-certainty evidence that using combination NRT versus single-form NRT and 4 mg versus 2 mg nicotine gum can result in an increase in the chances of successfully stopping smoking. Due to imprecision, evidence was of moderate certainty for patch dose comparisons. There is some indication that the lower-dose nicotine patches and gum may be less effective than higher-dose products. Using a fast-acting form of NRT, such as gum or lozenge, resulted in similar quit rates to nicotine patches. There is moderate-certainty evidence that using NRT before quitting may improve quit rates versus using it from quit date only; however, further research is needed to ensure the robustness of this finding. Evidence for the comparative safety and tolerability of different types of NRT use is limited. New studies should ensure that AEs, SAEs and withdrawals due to treatment are reported.

Trial registration: ClinicalTrials.gov NCT01889771 NCT00086385 NCT01807871 NCT01622998 NCT03836560 NCT00332644 NCT00861276 NCT01120704 00364156 00365508 NCT01047527 NCT01623505 NCT01122238 NCT00984724 NCT00046813 NCT04188873 NCT03000387.

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Conflict of interest statement

AT: none known.

SCC: no relevant interests; Consultant in Healthcare Public Health & Associate Medical Director for Planned Care & Prioritisation, NHS Hertfordshire and West Essex Integrated Care Board (previously at NHS East and North Hertfordshire Clinical Commissioning Group); Member of British Medical Association; Member of Faculty of Public Health; Cochrane Clinical Answers Associate Editor and authored two Cochrane Clinical Answers relating to smoking cessation.

WY: none known.

TRF: none known.

CB: Johnson and Johnson (Consultant); Society for Research on Nicotine and Tobacco (Fiduciary Officer); published papers expressing a view on the interventions in the work as follows: Jackson S, Bullen C. (2022) UK report underscores potential of e‐cigarettes to reduce smoking harms. Lancet doi.org/10.1016/S0140-6736(22)01997-3; Public Health Medicine Specialist, University of Auckland, Smoking cessation clinic for staff and students. involved in Study 1: ASCEND Trial funded by NZ Health Research Council Study 2: ASCEND 2 Trial funded by NZ Health Research Council (ASCEND Trial, University of Auckland, PI: BULLEN (Bullen 2010); ASCEND 2 Trial, University of Auckland, PI WALKER (Walker 2011)). CB did not extract the data or conduct risk of bias assessment for these trials.

JHB: no relevant interests; has published on this topic and been interviewed by media outlets about it; Editor for Cochrane Tobacco Addiction Review Group but not involved in the editorial process for this review update.

JLB: no relevant interests; Managing Editor of the Cochrane Tobacco Addiction Group but not involved in the editorial process for this review update.

AH: none known.

NL: Cancer Research UK (Grant / Contract); National Institute for Health Research( Grant / Contract); Oxford University Hospitals NHS Foundation Trust (Employment); wrote pieces for The Conversation on the findings of Cochrane Reviews assessing the effects of treatments for smoking cessation; received funding from CRUK and the NIHR (a part of the NHS) who both have interests in people stopping smoking and run educational campaigns and in the latter case provide treatment to encourage people to stop smoking; Managing Editor of the Cochrane Tobacco Addiction and funded by the NIHR to carry out this role but not involved in the editorial process for this review update.; involved in Preloading Investigators 2018, a randomised controlled trial sponsored by the University of Birmingham in the first instance and then the University of Oxford. NL did not extract data or carry out a risk of bias assessment for this study, as advised by Cochrane.

Figures

1
1
PRISMA flow diagram for the April 2022 search update *Some studies have multiple references
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Funnel plot of comparison 4: combination versus single‐form nicotine replacement therapy, outcome: 4.1 smoking cessation
1.1
1.1. Analysis
Comparison 1: Patch dose, Outcome 1: Smoking cessation
1.2
1.2. Analysis
Comparison 1: Patch dose, Outcome 2: Fast or irregular heartbeat
1.3
1.3. Analysis
Comparison 1: Patch dose, Outcome 3: Myocardial infarction
1.4
1.4. Analysis
Comparison 1: Patch dose, Outcome 4: Overall serious adverse events
1.5
1.5. Analysis
Comparison 1: Patch dose, Outcome 5: Treatment withdrawals
2.1
2.1. Analysis
Comparison 2: Duration of patch therapy, Outcome 1: Smoking cessation
2.2
2.2. Analysis
Comparison 2: Duration of patch therapy, Outcome 2: Overall serious adverse events
2.3
2.3. Analysis
Comparison 2: Duration of patch therapy, Outcome 3: Treatment withdrawals
3.1
3.1. Analysis
Comparison 3: Effect of tapering patch dose, Outcome 1: Smoking cessation
3.2
3.2. Analysis
Comparison 3: Effect of tapering patch dose, Outcome 2: Treatment withdrawals
4.1
4.1. Analysis
Comparison 4: Combination versus single‐form NRT, Outcome 1: Smoking cessation
4.2
4.2. Analysis
Comparison 4: Combination versus single‐form NRT, Outcome 2: Any cardiac adverse event
4.3
4.3. Analysis
Comparison 4: Combination versus single‐form NRT, Outcome 3: Overall serious adverse events
4.4
4.4. Analysis
Comparison 4: Combination versus single‐form NRT, Outcome 4: Treatment withdrawals
5.1
5.1. Analysis
Comparison 5: Duration of combination therapy, Outcome 1: Smoking cessation
5.2
5.2. Analysis
Comparison 5: Duration of combination therapy, Outcome 2: Overall serious adverse events
6.1
6.1. Analysis
Comparison 6: Fast‐acting NRT versus patch, Outcome 1: Smoking cessation
6.2
6.2. Analysis
Comparison 6: Fast‐acting NRT versus patch, Outcome 2: Cardiac adverse events
6.3
6.3. Analysis
Comparison 6: Fast‐acting NRT versus patch, Outcome 3: Overall serious adverse events
6.4
6.4. Analysis
Comparison 6: Fast‐acting NRT versus patch, Outcome 4: Treatment withdrawals
7.1
7.1. Analysis
Comparison 7: Type of fast‐acting NRT, Outcome 1: Smoking cessation
8.1
8.1. Analysis
Comparison 8: 4 mg versus 2 mg gum, Outcome 1: Smoking cessation
8.2
8.2. Analysis
Comparison 8: 4 mg versus 2 mg gum, Outcome 2: Palpitations
8.3
8.3. Analysis
Comparison 8: 4 mg versus 2 mg gum, Outcome 3: Treatment withdrawals
9.1
9.1. Analysis
Comparison 9: Fixed versus ad lib dose schedule, Outcome 1: Smoking cessation
9.2
9.2. Analysis
Comparison 9: Fixed versus ad lib dose schedule, Outcome 2: Overall serious adverse events
9.3
9.3. Analysis
Comparison 9: Fixed versus ad lib dose schedule, Outcome 3: Treatment withdrawals
10.1
10.1. Analysis
Comparison 10: Preloading versus standard use, Outcome 1: Smoking cessation
10.2
10.2. Analysis
Comparison 10: Preloading versus standard use, Outcome 2: Palpitations
10.3
10.3. Analysis
Comparison 10: Preloading versus standard use, Outcome 3: Cardiac adverse events
10.4
10.4. Analysis
Comparison 10: Preloading versus standard use, Outcome 4: Cardiac serious adverse events
10.5
10.5. Analysis
Comparison 10: Preloading versus standard use, Outcome 5: Overall serious adverse events
10.6
10.6. Analysis
Comparison 10: Preloading versus standard use, Outcome 6: Treatment withdrawals
11.1
11.1. Analysis
Comparison 11: Free NRT versus purchased NRT, Outcome 1: Smoking cessation
11.2
11.2. Analysis
Comparison 11: Free NRT versus purchased NRT, Outcome 2: Cardiac adverse events
12.1
12.1. Analysis
Comparison 12: Duration of free NRT, Outcome 1: Smoking cessation
13.1
13.1. Analysis
Comparison 13: Other comparisons, Outcome 1: Smoking cessation
13.2
13.2. Analysis
Comparison 13: Other comparisons, Outcome 2: Midsternal pressure
13.3
13.3. Analysis
Comparison 13: Other comparisons, Outcome 3: Cardiac adverse events
13.4
13.4. Analysis
Comparison 13: Other comparisons, Outcome 4: Chest pain
13.5
13.5. Analysis
Comparison 13: Other comparisons, Outcome 5: Palpitations
13.6
13.6. Analysis
Comparison 13: Other comparisons, Outcome 6: Overall serious adverse events
13.7
13.7. Analysis
Comparison 13: Other comparisons, Outcome 7: Treatment withdrawals
See this image and copyright information in PMC

Update of

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    1. Killen JD, Fortmann SP, Davis L, Strausberg L, Varady A. Do heavy smokers benefit from higher dose nicotine patch therapy? Experimental and Clinical Psychopharmacology 1999;7(3):226-33. - PubMed
Kornitzer 1987 {published data only}
    1. Kornitzer M, Kittel F, Dramaix M, Bourdoux P. A double blind study of 2 mg versus 4 mg nicotine-gum in an industrial setting. Journal of Psychosomatic Research 1987;31(2):171-6. - PubMed
Kornitzer 1995 {published data only}
    1. Kornitzer M, Boutsen M, Dramaix M, Thijs J, Gustavsson G. Combined use of nicotine patch and gum in smoking cessation: a placebo-controlled clinical trial. Preventive Medicine 1995;24(1):41-7. - PubMed
    1. Kornitzer M, Boutsen M, Thijs J, Gustavsson G. Efficiency and safety of combined use of nicotine patches and nicotine gum in smoking cessation: a placebo controlled double-blind trial. European Respiratory Journal 1993;6(Suppl 17):630S.
Krupski 2016 {published data only}
    1. Krupski L, Cummings MK, Hyland A, Mahoney MC, Toll BA, Carpenter MJ, et al. Cost and effectiveness of combination nicotine replacement therapy among heavy smokers contacting a quitline. Journal of Smoking Cessation 2016;11(1):50-9. [DOI: 10.1017/jsc.2014.15] - DOI
Kupecz 1996 {published data only}
    1. Kupecz D, Prochazka A. A comparison of nicotine delivery systems in a multimodality smoking cessation program. Nurse Practitioner 1996;21(2):73, 77-8, 81. - PubMed
LeBlanc 2017 {unpublished data only}
    1. LeBlanc A, Reid R, Mark A, Tulloch H, Aitken D, Mullen K, et al. STEP-ing up smoking cessation: weight-related concern of participants who want to quit smoking. Obesity Facts 2017;10:207.
    1. LeBlanc AG, Reid RD, Mark A, Tulloch H, Aitken DA, Mullen KA, et al. Does optional titrated nicotine replacement therapy aid in quitting smoking? A randomized clinical trial. Journal of Cardiopulmonary Rehabilitation and Prevention 2017;37(6):455. [DOI: 10.1097/HCR.0000000000000309] - DOI
    1. NCT01622998. Self-directed titrated transdermal nicotine patch versus standard treatment for smoking cessation (STEP). clinicaltrials.gov/ct2/show/NCT01622998 (first received 19 June 2012.
Lerman 2004 {published data only}
    1. Lerman C, Jepson C, Wileyto EP, Epstein LH, Rukstalis M, Patterson F, et al. Role of functional genetic variation in the dopamine D2 receptor (DRD2) in response to bupropion and nicotine replacement therapy for tobacco dependence: results of two randomized clinical trials. Neuropsychopharmacology 2006;31(1):231-42. - PubMed
    1. Lerman C, Kaufmann V, Rukstalis M, Patterson F, Perkins K, Audrain McGovern J, et al. Individualizing nicotine replacement therapy for the treatment of tobacco dependence: a randomized trial. Annals of Internal Medicine 2004;140(6):426-33. - PubMed
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    1. Lerman C, Wileyto EP, Patterson F, Rukstalis M, Audrain-McGovern J, Restine S, et al. The functional mu opioid receptor (OPRM1) Asn40Asp variant predicts short-term response to nicotine replacement therapy in a clinical trial. Pharmacogenomics Journal 2004;4(3):184-92. - PubMed
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Leung 2019 {published data only}
    1. Leung MK, Bai D, Yip BH, Fong MY, Lai PM, Lai P, et al. Combined nicotine patch with gum versus nicotine patch alone in smoking cessation in Hong Kong primary care clinics: a randomised controlled trial. BMC Public Health 2019;19(1):1302. [DOI: 10.1186/s12889-019-7634-z] - DOI - PMC - PubMed
    1. NCT03836560. Comparing the effectiveness of combined NRT with single NRT in primary care clinics in Hong Kong. clinicaltrials.gov/ct2/show/NCT03836560 (first received 11 February 2019).
Moolchan 2005 {published data only}
    1. Collins CC, Epstein DH, Parzynski CS, Zimmerman D, Moolchan ET, Heishman SJ. Puffing behavior during the smoking of a single cigarette in tobacco-dependent adolescents. Nicotine & Tobacco Research 2010;12(2):164-7. - PMC - PubMed
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Paoletti 1996 {published data only}
    1. Cosci F, Corlando A, Fornai E, Pistelli F, Paoletti P, Carrozzi L. Nicotine dependence, psychological distress and personality traits as possible predictors of smoking cessation. Results of a double-blind study with nicotine patch. Addictive Behaviors 2009;34(1):28-35. - PubMed
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    1. Paoletti P, Fornai E, Maggiorelli F, Puntoni R, Viegi G, Carrozzi L, et al. Importance of baseline cotinine plasma values in smoking cessation: results from a double blind study with nicotine patch. European Respiratory Journal 1996;9(4):643-51. - PubMed
Piper 2009 {published data only}
    1. Asthana A, Johnson HM, Piper ME, Fiore MC, Baker TB, Stein JH. Effects of smoking intensity and cessation on inflammatory markers in a large cohort of active smokers. American Heart Journal 2010;160(3):458-63. - PMC - PubMed
    1. Bekiroglu K, Russell MA, Lagoa CM, Lanza ST, Piper ME. Evaluating the effect of smoking cessation treatment on a complex dynamical system. Drug & Alcohol Dependence 2017;180:215-22. [DOI: 10.1016/j.drugalcdep.2017.07.037] - DOI - PMC - PubMed
    1. Berg KM, Piper ME, Smith SS, Fiore MC, Jorenby DE. Defining and predicting short-term alcohol use changes during a smoking cessation attempt. Addictive Behaviors 2015;48:52-7. - PMC - PubMed
    1. Chen LS, Bloom AJ, Baker TB, Smith SS, Piper ME, Martinez M, et al. Pharmacotherapy effects on smoking cessation vary with nicotine metabolism gene (CYP2A6). Addiction 2014;109(1):128-37. - PMC - PubMed
    1. Cook JW, Lanza ST, Chu W, Baker TB, Piper ME. Anhedonia: its dynamic relations with craving, negative affect, and treatment during a quit smoking attempt. Nicotine & Tobacco Research 2017;19(6):703-9. [DOI: 10.1093/ntr/ntw247] - DOI - PMC - PubMed
Piper 2016 {published data only}
    1. Piper ME, Cook JW, Schlam TR, Smith SS, Bolt DM, Collins LM, et al. Toward precision smoking cessation treatment II: proximal effects of smoking cessation intervention components on putative mechanisms of action. Drug and Alcohol Dependence 2017;171:50-8. [DOI: 10.1016/j.drugalcdep.2016.11.027] - DOI - PMC - PubMed
    1. Piper ME, Fiore MC, Smith SS, Fraser D, Bolt DM, Collins LM, et al. Identifying effective intervention components for smoking cessation: a factorial screening experiment. Addiction 2016;111(1):129-41. [DOI: 10.1111/add.13162] - DOI - PMC - PubMed
    1. Piper ME, Schlam TR, Cook JW, Smith SS, Bolt DM, Loh WY, et al. Toward precision smoking cessation treatment I: moderator results from a factorial experiment. Drug and Alcohol Dependence 2017;171:59-65. [DOI: 10.1016/j.drugalcdep.2016.11.025] - DOI - PMC - PubMed
Preloading Investigators 2018 {published data only}ISRCTN33031001
    1. Aveyard P, Lindson N, Tearne S, Adams R, Ahmed K, Alekna R, et al. Nicotine preloading for smoking cessation: the Preloading RCT. Health Technology Assessment 2018;22(41). [DOI: 10.3310/hta22410] - DOI - PMC - PubMed
    1. Hajek P, Lewis S, Munafo M, Lindson N, Coleman T, Aveyard P, et al. Mediators of the effect of nicotine pre-treatment on quitting smoking. Addiction 2018;113(12):1280-9. [DOI: 10.1111/add.14401] - DOI - PubMed
    1. Lindson-Hawley N, Coleman T, Docherty G, Hajek P, Lewis S, Lycett D, et al. Nicotine patch preloading for smoking cessation (the Preloading Trial): study protocol for a randomized controlled trial. Trials 2014;15(1):1-18. [DOI: 10.1186/1745-6215-15-296] - DOI - PMC - PubMed
    1. The Preloading Investigators. Effects on abstinence of nicotine patch treatment before quitting smoking: parallel, two arm, pragmatic randomised trial. BMJ 2018;361:k2164. [DOI: 10.1136/bmj.k2164] - DOI - PMC - PubMed
Puska 1995 {published data only}
    1. Puska P, Korhonen HJ, Vartiainen E, Urjanheimo EL, Gustavsson G, Westin A. Combined use of nicotine patch and gum compared with gum alone in smoking cessation: a clinical trial in North Karelia. Tobacco Control 1995;4:231-5.
Rey 2009 {published data only}
    1. NCT00861276. Nicotine substitute prescribed at hourly intake or ad libitum for heavy smokers willing to wuit (SUNIC). clinicaltrials.gov/ct2/show/NCT00861276 (first received 13 March 2009).
    1. Rey L, Vaucher P, Secretan F, Zellweger JP, Bodenmann P. Use of nicotine substitute prescribed at hourly plus ad libitum intake or ad libitum for heavy smokers willing to quit: a randomized controlled trial. Substance Abuse Treatment, Prevention, and Policy 2009;4:12. - PMC - PubMed
Rose 1994 {published data only}
    1. Rose JE, Behm FM, Westman EC, Levin ED, Stein RM, Ripka GV. Mecamylamine combined with nicotine skin patch facilitates smoking cessation beyond nicotine patch treatment alone. Clinical Pharmacology and Therapeutics 1994;56(1):86-99. - PubMed
    1. Rose JE, Westman EC, Behm FM. Nicotine/mecamylamine combination treatment for smoking cessation. Drug Development Research 1996;38:243-56. Erratum in: Drug Development Research 1997;40:215.
Rose 1998 {published data only}
    1. Rose JE, Behm FM, Westman EC. Nicotine-mecamylamine treatment for smoking cessation: the role of pre-cessation therapy. Experimental and Clinical Psychopharmacology 1998;6(3):331-43. - PubMed
    1. Rose JE, Westman EC, Behm FM. Nicotine/mecamylamine combination treatment for smoking cessation. Drug Development Research 1996;38:243-56. Erratum in: Drug Development Research 1997;40:215.
Rose 2006 {published data only}
    1. Rose JE, Behm FM, Westman EC, Kukovich P. Precessation treatment with nicotine skin patch facilitates smoking cessation. Nicotine & Tobacco Research 2006;8(1):89-101. - PubMed
Rose 2009 {published and unpublished data}
    1. Rose JE, Herskovic JE, Behm FM, Westman EC. Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment. Nicotine & Tobacco Research 2009;11(9):1067-75. - PubMed
    1. Rose JE. Nicotine preloading: the importance of a pre-cessation reduction in smoking behavior. Psychopharmacology 2011;217(3):453-4. - PubMed
Rose 2010 {published and unpublished data}
    1. Rose JE, Behm FM, Drgon T, Johnson C, Uhl GR. Personalized smoking cessation: interactions between nicotine dose, dependence and quit-success genotype score. Molecular Medicine 2010;16(7-8):247-53. - PMC - PubMed
    1. Rose JE. Nicotine preloading: the importance of a pre-cessation reduction in smoking behavior. Psychopharmacology 2011;217(3):453-4. - PubMed
    1. Uhl GR, Drgon T, Johnson C, Ramoni MF, Behm FM, Rose JE. Genome-wide association for smoking cessation success in a trial of precessation nicotine replacement. Molecular Medicine 2010;16(11-12):513-26. - PMC - PubMed
Schlam 2016 {published data only}
    1. Schlam TR, Baker TB, Smith SS, Bolt DM, McCarthy DE, Cook JW, et al. Electronically monitored nicotine gum use before and after smoking lapses: relationship with lapse and relapse. Nicotine & Tobacco Research 2020;22(11):2051-8. [DOI: 10.1093/ntr/ntaa116] - DOI - PMC - PubMed
    1. Schlam TR, Cook JW, Baker TB, Hayes-Birchler T, Bolt DM, Smith SS, et al. Can we increase smokers’ adherence to nicotine replacement therapy and does this help them quit? Psychopharmacology (Berl) 2018;235(7):2065-75. [DOI: 10.1007/s00213-018-4903-y] - DOI - PMC - PubMed
    1. Schlam TR, Fiore MC, Smith SS, Fraser D, Bolt DM, Collins LM, et al. Comparative effectiveness of intervention components for producing long‐term abstinence from smoking: a factorial screening experiment. Addiction 2016;111(1):142-55. [DOI: 10.1111/add.13153] - DOI - PMC - PubMed
Schnoll 2010a {published data only}
    1. Lerman C, Jepson C, Wileyto EP, Patterson F, Schnoll R, Mroziewicz M, et al. Genetic variation in nicotine metabolism predicts the efficacy of extended-duration transdermal nicotine therapy. Clinical Pharmacology and Therapeutics 2010;87(5):553-7. - PMC - PubMed
    1. Schnoll RA, Patterson F, Wileyto EP, Heitjan DF, Shields AE, Asch DA, et al. Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Annals of Internal Medicine 2010;152(3):144-51. - PMC - PubMed
    1. Schnoll RA, Wileyto EP, Lerman C. Extended duration therapy with transdermal nicotine may attenuate weight gain following smoking cessation. Addictive Behaviors 2012;37(4):565-8. - PMC - PubMed
Schnoll 2010b {published data only}
    1. Schnoll RA, Martinez E, Tatum KL, Glass M, Bernath A, Ferris D, et al. Increased self-efficacy to quit and perceived control over withdrawal symptoms predict smoking cessation following nicotine dependence treatment. Addictive Behaviors 2011;36(1-2):144-7. - PMC - PubMed
    1. Schnoll RA, Martinez E, Tatum KL, Glass M, Bernath A, Ferris D, et al. Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. Drug and Alcohol Dependence 2010;107(2-3):237-43. - PMC - PubMed
Schnoll 2015 {published and unpublished data}
    1. Carroll AJ, Mathew AR, Leone FT, Wileyto EP, Miele A, Schnoll RA, et al. Extended nicotine patch treatment among smokers with and without comorbid psychopathology. Nicotine & Tobacco Research 2020;22(1):24-31. [DOI: 10.1093/ntr/nty191] - DOI - PMC - PubMed
    1. Lydon-Staley DM, Schnoll RA, Hitsman B, Bassett DS. The network structure of tobacco withdrawal in a community sample of smokers treated with nicotine patch and behavioral counseling. Nicotine & Tobacco Research 2020;22(3):408-14. [DOI: 10.1093/ntr/nty250] - DOI - PMC - PubMed
    1. Schnoll RA, Goelz PM, Veluz-Wilkins A, Blazekovic S, Powers L, Leone FT, et al. Long-term nicotine replacement therapy: a randomized clinical trial. JAMA Internal Medicine 2015;175(4):504-11. [DOI: 10.1001/jamainternmed.2014.8313] - DOI - PMC - PubMed
Schuurmans 2004 {published data only}
    1. Schuurmans MM, Diacon AH, Van Biljon X, Bolliger CT. Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial. Addiction 2004;99(5):634-40. - PubMed
    1. Schuurmans MM, Diacon AH, Van Biljon X, Westin A, Landfeldt B, Bolliger CT. Effect of pre-treatment with nicotine patch on withdrawal symptoms in smokers subsequently quitting with the nicotine patch: a double-blind randomised controlled trial. In: European Respiratory Society Annual Congress, Stockholm (www.ersnetsecure.org/public/prg_congres.abstract?ww_i_presentation=6711). 2002:[no pagination].
Smith 2009 {published data only}
    1. Smith SS, McCarthy DE, Japuntich SJ, Christiansen B, Piper ME, Jorenby DE, et al. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Archives of Internal Medicine 2009;169(22):2148-55. - PMC - PubMed
Smith 2013 {published data only}
    1. Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, et al. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine & Tobacco Research 2012;15(3):718-28. [10.1093/ntr/nts186] - PMC - PubMed
Stapleton 1995 {published data only}
    1. Russell MA, Stapleton JA, Feyerabend C, Wiseman SM, Gustavsson G, Sawe U, et al. Targeting heavy smokers in general practice: randomised controlled trial of transdermal nicotine patches. BMJ 1993;306(6888):1308-12. - PMC - PubMed
    1. Stapleton JA, Russell MA, Feyerabend C, Wiseman SM, Gustavsson G, Sawe U, et al. Dose effects and predictors of outcome in a randomized trial of transdermal nicotine patches in general practice. Addiction 1995;90(1):31-42. - PubMed
TNSG 1991 {published data only}
    1. Daughton DM, Fortmann SP, Glover ED, Hatsukami DK, Heatley SA, Lichtenstein E, et al. The smoking cessation efficacy of varying doses of nicotine patch delivery systems 4 to 5 years post-quit day. Preventive Medicine 1999;28(2):113-8. - PubMed
    1. Ferguson SG, Gitchell JG, Shiffman S, Sembower MA. Prediction of abstinence at 10 weeks based on smoking status at 2 weeks during a quit attempt: secondary analysis of two parallel, 10-week, randomized, double-blind, placebo-controlled clinical trials of 21-mg nicotine patch in adult smokers. Clinical Therapeutics 2009;31(9):1957-65. - PubMed
    1. Swan GE, Jack LM, Ward MM. Subgroups of smokers with different success rates after use of transdermal nicotine. Addiction 1997;92(2):207-17. - PubMed
    1. Transdermal Nicotine Study Group. Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. JAMA 1991;266(22):3133-8. - PubMed
Tulloch 2016 {published data only}
    1. Clyde M, Pipe A, Els C, Reid R, Fu A, Clark A, et al. Nicotine metabolite ratio and smoking outcomes using nicotine replacement therapy and varenicline among smokers with and without psychiatric illness. Journal of Psychopharmacology (Oxford, England) 2018;32(9):979-85. [DOI: 10.1177/0269881118773532] - DOI - PubMed
    1. Tulloch H, Pipe A, Els C, Aitken D, Clyde M, Corran B, Reid RD. Flexible and extended dosing of nicotine replacement therapy or varenicline in comparison to fixed dose nicotine replacement therapy for smoking cessation: Rationale, methods and participant characteristics of the FLEX trial. Contemporary Clinical Trials 2014;38(2):304-13. [DOI: 10.1016/j.cct.2014.05.011] - DOI - PubMed
    1. Tulloch HE, Pipe AL, Clyde MJ, Reid RD, Els C. The quit experience and concerns of smokers with psychiatric illness. American Journal of Preventive Medicine 2016;50(6):709-18. [DOI: 10.1016/j.amepre.2015.11.006] - DOI - PubMed
    1. Tulloch HE, Pipe AL, Els C, Clyde MJ, Reid RD. Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial. BMC Medicine 2016;14:80. [DOI: 10.1186/s12916-016-0626-2] - DOI - PMC - PubMed
    1. Zhang KM, Clyde M, Pipe A, Reid R, Els C, Tulloch HE. Do women and men differ in baseline smoking characteristics and quit rates following treatment with smoking cessation medications? A secondary analysis of the FLEX study. Journal of Cardiopulmonary Rehabilitation and Prevention 2018;38(6):E21. [DOI: 10.1097/HCR.0000000000000394] - DOI
Tønnesen 1988 {published data only}
    1. Tønnesen P, Fryd V, Hansen M, Helsted J, Gunnersen AB, Forchammer H, et al. Effect of nicotine chewing gum in combination with group counseling on the cessation of smoking. New England Journal of Medicine 1988;318(1):15-8. - PubMed
Tønnesen 1996 {published data only}
    1. Tønnesen P, Mikkelsen K, Norregaard J, Jorgensen S. Recycling of hard-core smokers with nicotine nasal spray. European Respiratory Journal 1996;9(8):1619-23. - PubMed
Tønnesen 2000 {published data only}
    1. Tønnesen P, Mikkelsen KL. Smoking cessation with four nicotine replacement regimes in a lung clinic. European Respiratory Journal 2000;16(4):717-22. - PubMed
Walker 2011 {published data only}
    1. Walker N, Howe C, Bullen C, Grigg M, Glover M, McRobbie H, et al. Does improved access and greater choice of nicotine replacement therapy affect smoking cessation success? Findings from a randomized controlled trial. Addiction 2011;106(6):1176-85. - PubMed

References to studies excluded from this review

ACTRN12612001210864 {unpublished data only}
    1. ACTRN12612001210864. Can using nicotine as a long-term substitute enhance smoking cessation over using it only as a cessation aid? [An open-label randomised pragmatic policy trial examining effectiveness of short-term use of Nicotine Replacement Therapy (NRT) vs short- or long-term use of NRT vs short- or long-term use of NRT or electronic nicotine delivery systems for smoking cessation in cigarette smokers]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001210864 (first received 15 November 2012).
Aubin 2006 {published data only}
    1. Aubin HJ, Luthringer R, Demazieres A, Dupont C, Lagrue G. Comparison of the effects of a 24-hour nicotine patch and a 16-hour nicotine patch on smoking urges and sleep. Nicotine & Tobacco Research 2006;8(2):193-201. - PubMed
Baker 2021 {published data only}
    1. Baker TB, Piper ME, Smith SS, Bolt DM, Stein JH, Fiore MC. Effects of combined varenicline with nicotine patch and of extended treatment duration on smoking cessation: a randomized clinical trial. JAMA 2021;326(15):1485-93. [DOI: 10.1001/jama.2021.15333] - DOI - PMC - PubMed
    1. NCT03176784. UW Quitting Using Intensive Treatment Study. clinicaltrials.gov/ct2/show/NCT03176784 (first received 11 November 2017).
Berlin 2012 {published data only}
    1. Berlin I, Hunneyball IM, Greiling D, Jones SP, Fuder H, Stahl HD. A selective reversible monoamine oxidase B inhibitor in smoking cessation: effects on its own and in association with transdermal nicotine patch. Psychopharmacology 2012;223(1):89-98. - PubMed
Carpenter 2011 {published data only}
    1. Carpenter MJ, Alberg AJ, Gray KM, Saladin ME. Motivating the unmotivated for health behavior change: a randomized trial of cessation induction for smokers. Clinical Trials 2010;7(2):157-66. - PMC - PubMed
    1. Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Archives of Internal Medicine 2011;171(21):1901-7. - PMC - PubMed
Chan 2010 {published data only}
    1. Chan SS, Leung DY, Abdullah AS, Lo SS, Yip AW, Kok WM, et al. Smoking-cessation and adherence intervention among Chinese patients with erectile dysfunction. American Journal of Preventive Medicine 2010;39(3):251-8. - PubMed
Cook 2016 {published data only}
    1. Cook JW, Collins LM, Fiore MC, Smith SS, Fraser D, Bolt DM, et al. Comparative effectiveness of motivation phase intervention components for use with smokers unwilling to quit: a factorial screening experiment. Addiction 2016;111(1):117-28. [DOI: 10.1111/add.13161] - DOI - PMC - PubMed
    1. Engle JL, Mermelstein R, Baker TB, Smith SS, Schlam TR, Piper ME, et al. Effects of motivation phase intervention components on quit attempts in smokers unwilling to quit: a factorial experiment. Drug and Alcohol Dependence 2019;197:179-57. [DOI: 10.1016/j.drugalcdep.2019.01.011] - DOI - PMC - PubMed
Cook 2021 {published data only}
    1. Cook JW, Baker TB, Fiore MC, Collins LM, Piper ME, Schlam TR, et al. Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experiment. Addiction 2021;116(11):3167-79. [DOI: 10.1111/add.15528] - DOI - PMC - PubMed
Dey 1999 {published data only}
    1. Dey P, Foy R, Woodman M, Fullard B, Gibbs A. Should smoking cessation cost a packet? A pilot randomized controlled trial of the cost-effectiveness of distributing nicotine therapy free of charge. British Journal of General Practice 1999;49(439):127-8. - PMC - PubMed
Etter 2009 {published data only}
    1. Etter JF, Huguelet P, Perneger TV, Cornuz J. Nicotine gum treatment before smoking cessation: a randomized trial. Archives of Internal Medicine 2009;169(11):1028-34. - PubMed
Fagerström 1993 {published data only}
    1. Fagerström KO, Schneider NG, Lunell E. Effectiveness of nicotine patch and nicotine gum as individual versus combined treatments for tobacco withdrawal symptoms. Psychopharmacology (Berl) 1993;111(3):271-7. - PubMed
Fagerström 1997 {published data only}
    1. Fagerström KO, Tejding R, Westin A, Lunell E. Aiding reduction of smoking with nicotine replacement medications: hope for the recalcitrant smoker? Tobacco Control 1997;6(4):311-6. - PMC - PubMed
Fagerström 2000 {published data only}
    1. Fagerström KO, Hughes JR, Rasmussen T, Callas PW. Randomised trial investigating effect of a novel nicotine delivery device (Eclipse) and a nicotine oral inhaler on smoking behaviour, nicotine and carbon monoxide exposure, and motivation to quit. Tobacco Control 2000;9(3):327-33. - PMC - PubMed
Ferguson 2015 {published data only}
    1. Ferguson SG, Walters JA, Lu W, Wells GP, Schuz N. Examination of the mechanism of action of two pre-quit pharmacotherapies for smoking cessation. BMC Public Health 2015;15(1):1268-73. - PMC - PubMed
Hajek 1999 {published data only}
    1. Hajek P, West R, Foulds J, Nilsson F, Burrows S, Meadow A. Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler. Archives of Internal Medicine 1999;159(17):2033-8. - PubMed
    1. West R, Hajek P, Foulds J, Nilsson F, May S, Meadows A. A comparison of the abuse liability and dependence potential of nicotine patch, gum, spray and inhaler. Psychopharmacology (Berl) 2000;149(3):198-202. - PubMed
Haustein 2003 {published data only}
    1. Haustein KO, Batra A, Landfeldt B, Westin A. The effect of short-term or long-term reduction on smoking cessation; results from a placebo controlled smoking reduction study with the nicotine gum. Nicotine & Tobacco Research 2003;5:278.
    1. Pfizer. Summary of Clinical Efficacy. Application for licensing of Nicorette Inhalator/Gum for smoking reduction leading to cessation. Company data NICORE-1013-273-SU.
Hollands 2013 {published data only}
    1. Hollands GJ, Sutton S, McDermott MS, Marteau TM, Aveyard P. Adherence to and consumption of nicotine replacement therapy and the relationship with abstinence within a smoking cessation trial in primary care. Nicotine & Tobacco Research 2013;15(9):1537-44. - PMC - PubMed
Hughes 1989 {published data only}
    1. Hughes JR, Gulliver SB, Amori G, Mireault GC, Fenwick JF. Effect of instructions and nicotine on smoking cessation, withdrawal symptoms and self-administration of nicotine gum. Psychopharmacology (Berl) 1989;99(4):486-91. - PubMed
Hughes 2010 {published data only}
    1. Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug & Alcohol Dependence 2010;111(1-2):105-13. [NCT00297492] - PMC - PubMed
Jibrail 2010 {published data only}
    1. Jibrail JJ, Cortas NK, Sarieddine DS, Kanj NA, Zaatari GS, Daher RT. Impact of nicotine metabolite monitoring on the efficacy of smoke cessation and usefulness of sequential CRP measurements. American Journal of Respiratory Critical Care Medicine 2010;181:A2652.
Kozak 1995 {published data only}
    1. Kozak J, Fagerström KO, Sawe U. High-dose treatment with the nicotine patch. International Journal of Smoking Cessation 1995;4(2):26-8.
Kras 2010 {published data only}
    1. Kras M, Stough C, Scholey A, Kure C, Camfield D. Hypericum perforatum, nicotine patches and combination hypericum perforatum/nicotine patches for smoking cessation. European Neuropsychopharmacology 2010;20:S608-9.
Landfeldt 1998 {unpublished data only}
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Leischow 1999 {published data only}
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Leischow 2004 {published data only}
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McNeil 2007 {unpublished data only}
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McRobbie 2010 {published data only}
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Minneker 1989 {published data only}
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NCT00985985 {unpublished data only}
    1. NCT00985985. A multi-center, randomized, double-blind, parallel, placebo-controlled clinical study to evaluate efficacy and safety of nicotine mint lozenge (2mg and 4mg) in smoking cessation. www.gsk-clinicalstudyregister.com/study/CHN-Nicotine%20Mint%20Lozenge-00... (first received 16 July 2009).
    1. NCT00985985. Efficacy and safety study of nicotine mint lozenge (2mg and 4mg) in smoking cessation. clinicaltrials.gov/ct2/show/NCT00985985 (first received 29 September 2009).
    1. Xiao D, Kotler M, Kang J, Wang C. A multicenter, randomized, double-blind, parallel, placebo-controlled clinical study to evaluate the efficacy and safety of a nicotine mint lozenge (2 and 4 mg) in smoking cessation. Journal of Addiction Medicine 2020;14(1):69-77. [DOI: 10.1097/ADM.0000000000000547] - DOI - PMC - PubMed
NCT01592695 {unpublished data only}
    1. NCT01592695. Tailored tobacco cessation program for rural vVeterans with comorbid depression, alcoholism or obesity. clinicaltrials.gov/show/NCT01592695 (first received 11 April 2012).
NCT01892813 {unpublished data only}
    1. NCT01892813. Dissemination of a tailored tobacco quitline for rural veteran smokers. clinicaltrials.gov/ct2/show/NCT01892813 (first received 1 July 2013).
NCT02147132 {unpublished data only}
    1. NCT02147132. Pilot study of nicotine nasal spray and varenicline on smoking in methadone-maintained patients. clinicaltrials.gov/ct2/show/NCT02147132 (first received 19 May 2014).
NCT02271919 {unpublished data only}
    1. NCT02271919. Varenicline and combined nicotine replacement therapy (NRT) for smoking cessation. clinicaltrials.gov/ct2/show/NCT02271919 (first received 17 October 2014).
NCT04946825 {unpublished data only}
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Oncken 2009 {published data only}
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Pomerleau 2003 {published data only}
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Shiffman 2000a {published data only}
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Shiffman 2000b {published data only}
    1. Shiffman S, Elash CA, Paton SM, Gwaltney CJ, Paty JA, Clark DB, et al. Comparative efficacy of 24-hour and 16-hour transdermal nicotine patches for relief of morning craving. Addiction 2000;95(8):1185-95. - PubMed
Shiffman 2002 {published data only}
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Sutherland 1999 {published data only}
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Tundulawessa 2010 {published data only}
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Vikhireva 2003 {published data only}
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    1. Vikhireva O, Shalnova S, Deev A. Nicotine replacement therapy in Russia: old wine in new skins? Randomized parallel study of nicotine gum/inhaler in smoking cessation/reduction. In: Society for Research on Nicotine and Tobacco. Fifth European Conference. 2003 November 20-22, Padua, Italy. 2003.
Vinci 2021 {published data only (unpublished sought but not used)}
    1. Vinci C, Lam C, Schlechter CR, Shono Y, Vidrine JI, Wetter DW. Increasing treatment enrollment among smokers who are not motivated to quit: a randomized clinical trial. Translational Behavioral Medicine 2022;12(1):ibab114. [DOI: 10.1093/tbm/ibab114] - DOI - PMC - PubMed
Williams 2007 {published and unpublished data}
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Wright 2018 {published data only}
    1. Marteau TM, Munafò MR, Aveyard P, Hill C, Whitwell S, Willis TA, et al. Trial protocol: using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence. BMC Public Health 2010;10:680. [DOI: 10.1186/1471-2458-10-680] - DOI - PMC - PubMed
    1. Wright AJ, Sutton S, Armstrong D, Aveyard P, Kinmonth AL, Marteau TM. Factors influencing the impact of pharmacogenomic prescribing on adherence to nicotine replacement therapy: a qualitative study of participants from a randomized controlled trial. Translational Behavioral Medicine 2018;8(1):18-28. [DOI: 10.1093/tbm/ibx008] - DOI - PubMed

References to ongoing studies

NCT03538938 {unpublished data only}
    1. NCT03538938. Improving Quitline Support Study (IQS). clinicaltrials.gov/show/NCT03538938 (first received 29 May 2018).
NCT03611881 {unpublished data only}
    1. NCT03611881. Assessing the integration of tobacco cessation treatment into lung cancer screening. clinicaltrials.gov/ct2/show/NCT03611881 (first received 2 August 2018).
NCT04188873 {unpublished data only}
    1. NCT04188873. Cessation Screening Project. clinicaltrials.gov/ct2/show/NCT04188873 (first received 6 December 2019).
Zawertailo 2020 {published data only (unpublished sought but not used)}
    1. Zawertailo L, Hendershot CS, Tyndale RF, Le Foll B, Samokhvalov AV, Thorpe KE, et al. Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial. Trials 2020;21(1):592. [DOI: 10.1186/s13063-020-04532-7] - DOI - PMC - PubMed

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References to other published versions of this review

Lindson 2019
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