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Meta-Analysis
. 2018 May 31;5(5):CD000146.
doi: 10.1002/14651858.CD000146.pub5.

Nicotine replacement therapy versus control for smoking cessation

Jamie Hartmann-Boyce  1 , Samantha C Chepkin, Weiyu Ye, Chris Bullen, Tim Lancaster
Affiliations
Meta-Analysis

Nicotine replacement therapy versus control for smoking cessation

Jamie Hartmann-Boyce et al. Cochrane Database Syst Rev. .

Abstract

Background: Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence.

Objectives: To determine the effectiveness and safety of nicotine replacement therapy (NRT), including gum, transdermal patch, intranasal spray and inhaled and oral preparations, for achieving long-term smoking cessation, compared to placebo or 'no NRT' interventions.

Search methods: We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, abstract or keywords. Date of most recent search is July 2017.

Selection criteria: Randomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow-up of less than six months, except for those in pregnancy (where less than six months, these were excluded from the main analysis). We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews.

Data collection and analysis: Screening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model.

Main results: We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. A subset of six trials conducted in pregnant women found a statistically significant benefit of NRT on abstinence close to the time of delivery (RR 1.32, 95% CI 1.04 to 1.69; 2129 participants); in the four trials that followed up participants post-partum the result was no longer statistically significant (RR 1.29, 95% CI 0.90 to 1.86; 1675 participants). Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare.

Authors' conclusions: There is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, nasal spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations.

PubMed Disclaimer

Conflict of interest statement

CB was involved in a trial on pre‐cessation use of NRT (Bullen 2010)

SCC none known

JHB none known

TL none known

WY none known

Figures

1
1
Study flow diagram for most recent update
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Forest plot of comparison: 1 Any type of NRT versus placebo/no NRT control, outcome: 1.1 Smoking cessation at 6+ months follow up.
4
4
Funnel plot of comparison: 1 Any type of NRT versus placebo/no NRT control, outcome: 1.1 Smoking cessation at 6+ months follow up.
1.1
1.1. Analysis
Comparison 1 Any type of NRT versus placebo/no NRT control, Outcome 1 Smoking cessation at 6+ months follow up.
2.1
2.1. Analysis
Comparison 2 Subgroup: Definition of abstinence, Outcome 1 Nicotine gum. Smoking cessation.
2.2
2.2. Analysis
Comparison 2 Subgroup: Definition of abstinence, Outcome 2 Nicotine patch: Smoking cessation.
3.1
3.1. Analysis
Comparison 3 Subgroup: Level of behavioural support, Outcome 1 Nicotine gum. Smoking cessation.
3.2
3.2. Analysis
Comparison 3 Subgroup: Level of behavioural support, Outcome 2 Nicotine patch. Smoking cessation.
4.1
4.1. Analysis
Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 1 Community volunteer (treatment provided in medical setting).
4.2
4.2. Analysis
Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 2 Smoking clinic.
4.3
4.3. Analysis
Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 3 Primary care.
4.4
4.4. Analysis
Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 4 Hospitals.
4.5
4.5. Analysis
Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 5 Community volunteer (treatment provided in 'over‐the‐counter' setting).
4.6
4.6. Analysis
Comparison 4 Subgroup: Recruitment/treatment setting, Outcome 6 Antenatal clinic.
5.1
5.1. Analysis
Comparison 5 NRT in pregnancy, Outcome 1 Smoking cessation.
6.1
6.1. Analysis
Comparison 6 Palpitations in NRT vs placebo users, Outcome 1 Palpitations/chest pains.
See this image and copyright information in PMC

Update of

References

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Gourlay 1995 {published data only}
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    1. Hays JT, Croghan GA, Offord KP, Hurt RD, Schroeder DR, Wolter TD, et al. Over‐the‐counter nicotine patch therapy for smoking cessation: Results from randomized, double‐blind, placebo‐controlled and open label trials. American Journal of Public Health 1999;89:1701‐7. - PMC - PubMed
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NCT00534404 {published data only}
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Schneider 1983a {published data only}
    1. Jarvik ME, Schneider NG. Degree of addiction and effectiveness of nicotine gum therapy for smoking. American Journal of Psychiatry 1984;141:790‐1. - PubMed
    1. Schneider NG, Jarvik ME. Nicotine gum vs. placebo gum: comparisons of withdrawal symptoms and success rates. NIDA Research Monograph 1985;53:83‐101. - PubMed
    1. Schneider NG, Jarvik ME, Forsythe AB, Read LL, Elliott ML, Schweiger A. Nicotine gum in smoking cessation: a placebo‐controlled, double‐blind trial. Addictive Behaviors 1983;8:253‐61. - PubMed
Schneider 1983b {published data only}
    1. Schneider NG, Jarvik ME. Nicotine gum vs. placebo gum: comparisons of withdrawal symptoms and success rates. NIDA Research Monograph 1985;53:83‐101. - PubMed
    1. Schneider NG, Jarvik ME, Forsythe AB, Read LL, Elliott ML, Schweiger A. Nicotine gum in smoking cessation: a placebo‐controlled, double‐blind trial. Addictive Behaviors 1983;8:253‐61. - PubMed
Schneider 1995 {published data only}
    1. Schneider NG, Olmstead R, Mody FV, Doan K, Franzon M, Jarvik ME, et al. Efficacy of a nicotine nasal spray in smoking cessation: a placebo‐controlled, double‐blind trial. Addiction 1995;90:1671‐82. - PubMed
Schneider 1996 {published data only}
    1. Schneider NG, Olmstead R, Nilsson F, Mody FV, Franzon M, Doan K. Efficacy of a nicotine inhaler in smoking cessation: a double‐blind, placebo controlled trial. Addiction 1996;91:1293‐306. - PubMed
    1. Schneider NG, Olmstead R, Nilsson F, Mody FV, Franzon M, Doan K. Efficacy of a nicotine inhaler in smoking cessation: a double‐blind, placebo‐controlled trial [abstract]. Addiction 1997;92:630. - PubMed
Schnoll 2010 {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 & 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;37:565‐8. - PMC - PubMed
Segnan 1991 {published data only}
    1. Segnan N, Ponti A, Battista RN, Senore C, Rosso S, Shapiro SH, et al. A randomized trial of smoking cessation interventions in general practice in Italy. Cancer Causes and Control 1991;2:239‐46. - PubMed
    1. Senore C, Battista RN, Ponti A, Segnan N, Shapiro SH, Rosso S, et al. Comparing participants and nonparticipants in a smoking cessation trial: Selection factors associated with general practitioner recruitment activity. Journal of Clinical Epidemiology 1999;52:83‐9. - PubMed
    1. Senore C, Battista RN, Shapiro SH, Segnan N, Ponti A, Rosso S, et al. Predictors of smoking cessation following physicians' counseling. Preventive Medicine 1998;27:412‐21. - PubMed
Shiffman 2002 (2 mg) {published data only}
    1. Dresler CM, Shiffman S, Strahs KR. Safety profile of the new nicotine polacrilex lozenge (PO1 36). Society for Research on Nicotine and Tobacco 8th Annual Meeting: 2002; Savannah, Georgia, USA. 2002.
    1. Ferguson SG, Gitchell JG, Shiffman S. Continuing to wear nicotine patches after smoking lapses promotes recovery of abstinence. Addiction (Abingdon, England) 2012;107(7):1349‐53. - PubMed
    1. Shiffman S. Nicotine lozenge efficacy in light smokers. Drug & Alcohol Dependence 2005;77:311‐4. - PubMed
    1. Shiffman S. Use of more nicotine lozenges leads to better success in quitting smoking. Addiction 2007;102:809‐14. - PubMed
    1. Shiffman S, Dresler CM, Hajek P, Gilburt SJ, Targett DA, Strahs KR. Efficacy of a nicotine lozenge for smoking cessation. Archives of Internal Medicine 2002;162:1267‐76. - PubMed
Shiffman 2002 (4 mg) {published data only}
    1. Ferguson SG, Gitchell JG, Shiffman S. Continuing to wear nicotine patches after smoking lapses promotes recovery of abstinence. Addiction (Abingdon, England) 2012;107(7):1349‐53. - PubMed
    1. Shiffman S, Dresler CM, Hajek P, Gilburt SJ, Targett DA, Strahs KR. Efficacy of a nicotine lozenge for smoking cessation. Archives of Internal Medicine 2002;162:1267‐76. - PubMed
Shiffman 2009 (2 mg) {published data only}
    1. Shiffman S, Ferguson SG, Strahs KR. Quitting by gradual smoking reduction using nicotine gum: a randomized controlled trial. American Journal of Preventive Medicine 2009;36(2):96‐104. - PubMed
Shiffman 2009 (4 mg) {published data only}
    1. Shiffman S, Ferguson SG, Strahs KR. Quitting by gradual smoking reduction using nicotine gum: a randomized controlled trial. American Journal of Preventive Medicine 2009;36(2):96‐104. - PubMed
Stapleton 1995 {published data only}
    1. Russell MAH, 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 MAH, 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;90:31‐42. - PubMed
Stein 2013 {published and unpublished data}
    1. Dios MA, Anderson BJ, Caviness CM, Stein MD. Early quit days among methadone‐maintained smokers in a smoking cessation trial. Nicotine & Tobacco Research 2014;16(11):1463‐9. [CENTRAL: 1042497; CRS: 9400129000003420] - PMC - PubMed
    1. NCT00790569. Varenicline versus nicotine replacement for methadone‐maintained smokers. ClinicalTrials.gov/ct2/ (first received 13 November 2008). [CRS: 9400123000011408]
    1. Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone‐maintained smokers: A randomized clinical trial. Drug and Alcohol Dependence 2013;133(2):486‐93. [CENTRAL: 870955; CRS: 9400107000001457; EMBASE: 2013694276; PUBMED: 23953658] - PMC - PubMed
Sutherland 1992 {published data only}
    1. Stapleton JA, Sutherland G, Russell MAH. How much does relapse after one year erode effectiveness of smoking cessation treatments? Long term follow up of randomised trial of nicotine nasal spray. BMJ 1998;316(7134):830‐1. - PMC - PubMed
    1. Sutherland G, Stapleton JA, Russell MAH, Jarvis MJ, Hajek P, Belcher M, et al. Randomised controlled trial of nasal nicotine spray in smoking cessation. Lancet 1992;340:324‐9. - PubMed
Sønderskov 1997 {published data only}
    1. Sønderskov J, Olsen J, Meillier L, Overvad OK, Sabroe S. The effect of transdermal nicotine patches in smoking cessation. A randomized trial in pharmacy customers in Denmark. Ugeskrift for Laeger 1999;161:593‐7. - PubMed
    1. Sønderskov J, Olsen J, Sabroe S, Meillier L, Overvad K. Nicotine patches in smoking cessation: A randomized trial among over‐ the‐counter customers in Denmark. American Journal of Epidemiology 1997;145:309‐18. - 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;28:113‐8. - 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;92:207‐17. - 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;266:3133‐8. - PubMed
Tuisku 2016 {published data only}
    1. Tuisku A, Salmela M, Nieminen P, Toljamo T. Varenicline and nicotine patch therapies in young adults motivated to quit smoking: a randomized, placebo‐controlled, prospective Studys. Basic & Clinical Pharmacology & Toxicology 2016;119(1):78‐84. - PubMed
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;318:15‐8. - PubMed
Tønnesen 1991 {published data only}
    1. Mikkelsen KL, Tønnesen P, Norregaard J. Three‐year outcome of two‐ and three‐year sustained abstainers from a smoking cessation study with nicotine patches. Journal of Smoking‐Related Disorders 1994;5:95‐100.
    1. Norregaard J, Tønnesen P, Petersen L. Predictors and reasons for relapse in smoking cessation with nicotine and placebo patches. Preventive Medicine 1993;22:261‐71. - PubMed
    1. Tønnesen P, Norregaard J, Sawe U. Two‐year outcome in a smoking cessation trial with a nicotine patch. Journal of Smoking‐Related Disorders 1992;3:241‐5.
    1. Tønnesen P, Norregaard J, Simonsen K, Sawe U. A double‐blind trial of a 16‐hour transdermal nicotine patch in smoking cessation. New England Journal of Medicine 1991;325:311‐5. - PubMed
    1. Tønnesen P, Norregaard J, Simonsen K, Sawe U. A double‐blind trial of nicotine patches in smoking cessation [En dobbeltblind undersogelse af nikotinplaster ved rygeafvaenning]. Ugeskrift for Laeger 1992;154:251‐4. - PubMed
Tønnesen 1993 {published data only}
    1. Tønnesen P, Norregaard J, Mikkelsen K, Jorgensen S, Nilsson F. A double‐blind trial of a nicotine inhaler for smoking cessation. JAMA 1993;269:1268‐71. - 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;16:717‐22. - PubMed
Tønnesen 2006 {published data only}
    1. Pbert L. Nurse‐conducted smoking cessation in patients with COPD, using nicotine sublingual tablets and behavioral support. Chest 2006;130:314‐6. - PubMed
    1. Tonnesen P, Mikkelsen K, Bremann L. Nurse‐conducted smoking cessation in patients with COPD using nicotine sublingual tablets and behavioral support. Chest 2006;130:334‐42. - PubMed
Tønnesen 2012 {published and unpublished data}
    1. Tønnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy and safety of a novel nicotine mouth spray in smoking cessation: A randomized, placebo‐controlled, double blind, multicenter study with 52‐week follow up. Poster Presented at SRNT, Feb 16‐19th, 2011, Toronto, Canada.
    1. Tønnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double blind trial. European Respiratory Journal 2012;40(3):548‐54. [DOI: 10.1183/09031936.00155811] - DOI - PMC - PubMed
Villa 1999 {published data only}
    1. Villa RS, Alvarez ABD, Hermida JRF. Effectiveness of a multicomponent program to quit smoking with and without nicotine chewing gum [Eficacia de un programa multicomponente para dejar de fumar con y sin chicle de nicotina]. Psicologia Conductual 1999;7:107‐18.
Wallstrom 2000 {published data only}
    1. Pharmacia, Upjohn. Nicorette Nicotine Microtab Monograph. Chester: Adis International, 1998:Adis International, 1998.
    1. Wallstrom M, Nilsson F, Hirsch JM. A double‐blind placebo controlled clinical evaluation of a nicotine sublingual tablet in smoking cessation [abstract]. European Respiratory Journal 1997; Vol. 10, issue Suppl 25:440S. - PubMed
    1. Wallstrom M, Nilsson F, Hirsch JM. A randomized double‐blind placebo‐controlled clinical evaluation of a nicotine sublingual tablet in smoking cessation. Addiction 2000;95(8):1161‐71. - PubMed
Ward 2013 {published data only}
    1. Ben Taleb Z, Ward KD, Asfar T, Bahelah R, Maziak W. Predictors of adherence to pharmacological and behavioral treatment in a cessation trial among smokers in Aleppo, Syria. Drug and Alcohol Dependence 2015;153:167‐72. - PMC - PubMed
    1. Ben Taleb Z, Ward KD, Asfar T, Jaber R, Auf R, Maziak W. Predictors of nicotine withdrawal symptoms: findings from the first randomized smoking cessation trial in a low‐income country setting. International Journal of Public Health 2016;61(6):701‐8. - PubMed
    1. Ben Taleb Z, Ward KD, Asfar T, Jaber R, Bahelah R, Maziak W. Smoking cessation and changes in body mass index: Findings from the first randomized cessation trial in a low‐income country setting. Nicotine & Tobacco Research 2017;19(3):351‐6. - PubMed
    1. Ben Taleb Z, Ward KD, Asfar T, Jaber R, Bahelah R, Maziak W. Smoking cessation and changes in body mass index: findings from the first randomized cessation trial in a low‐Income country setting. Nicotine & Tobacco Research 2016;19(3):351‐56. - PubMed
    1. Lando H. Commentary on Ward et al. (2013): failure to find a treatment effect for NRT in a low‐income country ‐ implications. Addiction (Abingdon, England) 2013;108(2):404‐5. - PubMed
Wennike 2003b {published data only}
    1. Wennike P, Danielsson T, Landfeldt B, Westin A, Tønnesen P. Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo‐controlled trial of nicotine gum with 2‐year follow‐up. Addiction 2003;98(10):1395‐402. - PubMed
Westman 1993 {published data only}
    1. Westman EC, Levin ED, Rose JE. The nicotine patch in smoking cessation. A randomized trial with telephone counseling. Archives of Internal Medicine 1993;153:1917‐23. - PubMed
Wisborg 2000 {published data only}
    1. Wisborg K, Henriksen TB, Jespersen LB, Secher NJ. Nicotine patches for pregnant smokers: A randomized controlled study. Obstetrics & Gynecology 2000;96(6):967‐71. - PubMed
Wittchen 2011 {published data only}
    1. Wittchen HU, Hoch E, Klotsche J, Muehlig S. Smoking cessation in primary care ‐ a randomized controlled trial of bupropion, nicotine replacements, CBT and a minimal intervention. International Journal of Methods in Psychiatric Research 2011;20(1):28‐39. - PMC - PubMed
Zelman 1992 {published data only}
    1. Zelman DC, Brandon TH, Jorenby DE, Baker TB. Measures of affect and nicotine dependence predict differential response to smoking cessation treatments. Journal of Consulting and Clinical Psychology 1992;60:943‐52. - PubMed

References to studies excluded from this review

Adelman 2009 {published data only}
    1. Adelman WP. Nicotine nasal spray neither effective nor well‐tolerated by adolescent smokers. Journal of Pediatrics 2009;154(3):462‐3. - PubMed
Allen 2005 {published data only}
    1. Allen SS, Hatsukami D, Brintnell DM, Bade T. Effect of nicotine replacement therapy on post‐cessation weight gain and nutrient intake: A randomized controlled trial of postmenopausal female smokers. Addictive Behaviors 2005;30:1273‐80. - PubMed
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Allen 2011 {published data only}
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Aubin 2006 {published data only}
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Berlin 2011 {published data only}
    1. Berlin I, Jacob N, Coudert M, Perriot J, Schultz L, Rodon N. Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS* trial‐a randomized study in smokers with medical comorbidities. Addiction 2011;106(4):833‐43. - PubMed
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Bock 2010 {published data only}
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Bolliger 2000a {published data only}
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Bolliger 2007 {published data only}
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Brantmark 1973a {published data only}
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Caldwell 2016 {published data only}
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Carpenter 2003 {published data only}
    1. Carpenter MJ, Hughes JR, Keely JP. Effect of smoking reduction on later cessation: a pilot experimental study. Nicotine & Tobacco Research 2003;5(2):155‐62. - 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
Chan 2011 {published data only}
    1. Chan SS, Leung DY, Abdullah AS, Wong VT, Hedley AJ, Lam TH. A randomized controlled trial of a smoking reduction plus nicotine replacement therapy intervention for smokers not willing to quit smoking. Addiction 2011;106(6):1155‐63. - PubMed
Chou 2004 {published data only}
    1. Chou KR, Chen R, Lee JF, Ku CH, Lu RB. The effectiveness of nicotine‐patch therapy for smoking cessation in patients with schizophrenia. International Journal of Nursing Studies 2004;41:321‐30. - PubMed
Christen 1984 {published data only}
    1. Christen AG, Drook C, McDonald JL, Stookey G, Olson B. Efficacy of nicotine chewing gum in facilitating smoking cessation. Journal of the American Dental Association 1984;108:594‐7. - PubMed
Cohen 1989a {published data only}
    1. Cohen SJ, Stookey GK, Katz BP, Drook CA, Christen AG. Helping smokers quit: a randomized controlled trial with private practice dentists. Journal of the American Dental Association 1989;118:41‐5. - PubMed
Cohen 1989b {published data only}
    1. Cohen SJ, Stookey GK, Katz BP, Drook CA, Smith DM. Encouraging primary care physicians to help smokers quit. A randomised, controlled trial. Annals of Internal Medicine 1989;110:648‐52. - PubMed
Croghan 2007 {published data only}
    1. Clark MM, Hurt RD, Croghan I, Patten CA, Novotny P, Sloan JA, et al. The prevalence of weight concerns in a smoking abstinence clinical trial (POS2‐84). Society for Research on Nicotine and Tobacco 12th Annual Meeting; 2006 February 15‐18, Orlando, Florida, USA. 2006.
    1. Croghan IT, Hurt RD, Croghan GA, Sloan JA. Comparing nicotine inhaler, bupropion and nicotine inhaler plus bupropion in treating tobacco dependence [abstract]. Nicotine & Tobacco Research 2005;7(4):680‐1.
    1. Croghan IT, Hurt RD, Dakhil SR, Croghan GA, Sloan JA, Novotny PJ, et al. Randomized comparison of a nicotine inhaler and bupropion for smoking cessation and relapse prevention. Mayo Clinic Proceedings 2007;82:186‐95. - PubMed
    1. Croghan IT, Hurt RD, Ebbert JO, Croghan GA, Polk J, Stella PJ, et al. Racial differences in smoking abstinence rates in a multicenter, randomized, open‐label trial in the United States. Journal of Public Health 2010;18:59‐68. - PMC - PubMed
Cummings 2011 {published data only}
    1. Cummings KM, Hyland A, Carlin‐Menter S, Mahoney MC, Willett J, Juster HR. Costs of giving out free nicotine patches through a telephone quit line. Journal of Public Health Management & Practice 2011;17(3):E16‐23. - 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;49:127‐8. - PMC - PubMed
Donny 2009 {published data only}
    1. Donny EC, Jones M. Prolonged exposure to denicotinized cigarettes with or without transdermal nicotine. Drug & Alcohol Dependence 2009;104(1‐2):23‐33. - PMC - PubMed
Ebbert 2009 {published data only}
    1. Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A randomized clinical trial of nicotine lozenge for smokeless tobacco use. Nicotine & Tobacco Research 2009;11(12):1415‐23. - PMC - PubMed
Ebbert 2010 {published data only}
    1. Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. A pilot study of mailed nicotine lozenges with assisted self‐help for the treatment of smokeless tobacco users. Addictive Behaviors 2010;35(5):522‐5. - PMC - PubMed
Elan Pharm 88‐02 {published data only}
    1. Elan Pharmaceutical Research Corp. NDA 19‐983 for Approval of PROSTEP. Study 88‐02 1992.
Elan Pharm 90‐03 {published data only}
    1. Elan Pharmaceutical Research Corp. NDA 19‐983 for Approval of PROSTEP. Study 90‐03 1992.
Etter 2004 {published data only}
    1. Dar R, Stronguin F, Etter JF. Assigned versus perceived placebo effects in nicotine replacement therapy for smoking reduction in Swiss smokers. Journal of Consulting & Clinical Psychology 2005;73:350‐3. - PubMed
    1. Etter JF, Laszlo E, Perneger TV. Postintervention effect of nicotine replacement therapy on smoking reduction in smokers who are unwilling to quit: Randomized trial. Journal of Clinical Psychopharmacology 2004;24(2):174‐9. - PubMed
    1. Etter JF, Laszlo E, Zellweger JP, Perrot C, Perneger TV. Nicotine replacement to reduce cigarette consumption in smokers who are unwilling to quit: a randomized trial. Journal of Clinical Psychopharmacology 2002;22:487‐95. - 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;111:271‐7. - 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;6:311‐6. - 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;9:327‐33. - PMC - PubMed
Ferguson 2012 {published data only}
    1. Coleman T, McEwen A, Bauld L, Ferguson J, Lorgelly P, Lewis S. Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial. Trials 2009;10(26). - PMC - PubMed
    1. Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, et al. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ March 2012;344:e1696. [DOI: 10.1136/bmj.e1696] - DOI - PMC - PubMed
Finland unpublished {unpublished data only}
    1. Anon. Combination NRT; Improving efficacy in smoking cessation. McNeil Consumer Healthcare booklet, 2007. Short term outcomes reported on p17.
Foulds 1993 {published data only}
    1. Foulds J, Stapleton J, Hayward M, Russell MA, Feyerabend C, Fleming T, et al. Transdermal nicotine patches with low‐intensity support to aid smoking cessation in outpatients in a general hospital. A placebo‐controlled trial. Archives of Family Medicine 1993;2:417‐23. - PubMed
Garvey 2006 {unpublished data only}
    1. Garvey AJ, Hoskinson RA, Wadler BM, Kinnunen T, Sachs DPL. Individualising nicotine patch dose to match smokers' usual nicotine intake levels (PA9‐4). Society for Research on Nicotine and Tobacco 12th Annual Meeting; 2006 February 15‐18; Orlando, Florida, USA. 2006:32.
    1. Mustonen TK, Spencer SM, Hoskinson RA, Sachs DPL, Garvey AJ. The influence of gender, race, and menthol content on tobacco exposure measures. Nicotine & Tobacco Research 2005;7:581‐90. - PubMed
Glover 1992 {published data only}
    1. Glover ED, Glover PN, Sullivan CR, Sullivan P, Nilsson F, Sawe U. Nicotine inhaler versus placebo in smoking cessation [abstract 237]. 8th World Conference on Tobacco or Health; 1992; Buenos Aires, Argentina. 1992.
Gross 1989 {published data only}
    1. Gross J, Stitzer ML, Maldonado J. Nicotine replacement: effects on postcessation weight gain. Journal of Consulting and Clinical Psychology 1989;57:87‐92. - PubMed
Guo 2006 {published data only}
    1. Guo S, Sun H, Niu G, Gao J, Yang X, Zhou D. The smoking cessation efficacy of nicotine sublingual tablet: A double‐blind, placebo controlled trial. Chinese Journal of Psychiatry 2006;39(2):102‐5.
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;159:2033‐8. - 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;149:198‐202. - PubMed
Hanson 2003 {published data only}
    1. Dickmann PJ, Mooney ME, Allen SS, Hanson K, Hatsukami DK. Nicotine withdrawal and craving in adolescents: effects of sex and hormonal contraceptive use. Addictive Behaviors 2009;34(6‐7):620‐3. - PMC - PubMed
    1. Hanson K, Allen S, Jensen S, Hatsukami D. Treatment of adolescent smokers with the nicotine patch. Nicotine & Tobacco Research 2003;5(4):515‐26. - 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.
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Hoch 2006 {published data only}
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References to ongoing studies

NCT01010477 {unpublished data only}
    1. NCT01010477. Trial of nicotine nasal spray as an aid for smoking cessation in schizophrenia. ClinicalTrials.gov/show/NCT01010477 2009.
NCT01484340 {published data only}
    1. NCT01484340. A smoking cessation trial in HIV‐infected patients in South Africa. ClinicalTrials.gov/show/NCT01484340 (first received 2 December 2011).
NCT02918500 {published data only}
    1. NCT02918500. Effect of pre‐op NRT on peri‐operative complications and long‐term abstinence: a pilot trial in patients undergoing CABG surgery. ClinicalTrials.gov/show/NCT02918500 (first received 29 September 2016).

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