Nicotine Replacement Therapy Products Research Articles

Fifty-two-week continuous abstinence rates of smokers being treated with varenicline versus nicotine replacement therapy

Cross-study comparisons of effect sizes suggest that varenicline is more effective than nicotine replacement therapy (NRT) in aiding smoking cessation, but evidence from direct comparisons is limited. This study compared biochemically verified 52-week sustained abstinence rates in smokers attending the same clinical service according to whether they used varenicline or NRT in their quit attempt. This was a prospective cohort study of 855 smokers attending a large smoking cessation clinic who used their choice of NRT product or varenicline in their quit attempt. All received the same behavioural support programme and chose their medication option (n = 519 varenicline; n = 336 NRT). The primary outcome measure was self-report of 52 weeks' abstinence following the target quit date confirmed by expired air carbon monoxide concentration. Baseline measures included socio-demographic variables, mental health diagnoses, measures of smoking, cigarette dependence and past use of NRT or varenicline. The 52-week abstinence rates were 42.8% versus 31.0% in those using varenicline versus NRT, respectively (P < 0.001). After adjusting for all baseline variables, the odds of remaining abstinent for 52 weeks were 2.03 (95% CI 1.46-2.82), P < 0.001 times higher in those using varenicline than those using NRT. Smokers in the same behavioural support programme who use varenicline appear to have a greater probability of achieving long-term abstinence than those using their choice of nicotine replacement therapy options, even after adjusting for potentially confounding smoker characteristics.

Clinical Strategies to Enhance the Efficacy of Nicotine Replacement Therapy for Smoking Cessation: A Review of the Literature

A number of smoking cessation pharmacotherapies have led to increases in quitting and thus to significant benefits to public health. Among existing medications, nicotine replacement therapy (NRT) has been available the longest, has the largest literature base in support, and is the only option for over-the-counter access. While the short-term efficacy of NRT is well documented in clinical trials, long-term abstinence rates associated with using NRT are modest, as most smokers will relapse. This literature review examines emerging clinical strategies to improve NRT efficacy. After an initial overview of NRT and its FDA-approved indications for use, we review randomized trials in which clinical delivery of NRT was manipulated and tested, in an attempt to enhance efficacy, through (1) duration of use (pre-quit and extended use), (2) amount of use (high-dose and combination NRT), (3) tailoring to specific smoker groups (genotype and phenotype), or (4) use of NRT for novel purposes (relapse prevention, temporary abstinence, cessation induction). Outcomes vary within and across topic area, and we highlight areas that offer stronger promise. Combination NRT likely represents the most promising strategy moving forward; other clinical strategies offer conflicting evidence but deserve further testing (pre-quit NRT or tailored treatment) or offer potential utility but are in need of further, direct tests. Some areas, though based on a limited set of studies, do not offer great promise (high-dose and extended treatment NRT). We conclude with a brief discussion of emergent NRT products (e.g., oral nicotine spray, among others), which may ultimately offer greater efficacy than current formulations. In order to further lower the prevalence of smoking, novel strategies designed to optimize NRT efficacy are needed.

Current and emerging pharmacotherapeutic options for smoking cessation.

Tobacco smoking remains the single most preventable cause of morbidity and mortality in developed countries and poses a significant threat across developing countries where tobacco use prevalence is increasing. Nicotine dependence is a chronic disease often requiring multiple attempts to quit; repeated interventions with pharmacotherapeutic aids have become more popular as part of cessation therapies. First-line medications of known efficacy in the general population include varenicline tartrate, bupropion hydrochloride, nicotine replacement therapy products, or a combination thereof. However, less is known about the use of these products in marginalized groups such as the indigenous, those with mental illnesses, youth, and pregnant or breastfeeding women. Despite the efficacy and safety of these first line pharmacotherapies, many smokers continue to relapse and alternative pharmacotherapies and cessation options are required. Thus, the aim of this review is to summarize the existing and developing pharmacotherapeutic and other options for smoking cessation, to identify gaps in current clinical practice, and to provide recommendations for future evaluations and research.

Availability and range of tobacco products for sale in Massachusetts pharmacies

New tobacco control policies have been introduced in Massachusetts which restrict tobacco product sales in pharmacies. The purpose of this investigation was to outline the scope of pharmacy involvement in the tobacco market by assessing the availability and range of tobacco products sold in Massachusetts pharmacies. Public listings of licenced pharmacies and tobacco retailers in Massachusetts were examined to determine the proportion of pharmacies licenced to sell tobacco, and the proportion of tobacco retailers possessing a pharmacy licence. Telephone interviews were conducted with a random sample (n=70) of pharmacies possessing a tobacco licence to assess the availability and range of tobacco products for sale. The availability of nicotine replacement therapy (NRT) products was assessed as a comparison. The majority of pharmacies in Massachusetts possessed a tobacco licence (69%), and pharmacies made up 9% of licenced tobacco retailers. Among pharmacies surveyed that reported selling tobacco (90%), cigarettes were the most available tobacco product for sale (100%), followed by cigars (69%), little cigars/cigarillos (66%), moist snuff (53%), pipe tobacco (49%), roll-your-own tobacco (34%), snus (14%), dissolvable tobacco (11%) and electronic cigarettes (2%). Nearly all pharmacies selling tobacco offered the nicotine patch (100%), gum (100%) and lozenge (98%). Tobacco-free pharmacy policies would affect a majority of Massachusetts pharmacies and remove a variety of tobacco products from their store shelves. Further, nearly one in ten tobacco retailers would be eliminated by prohibiting tobacco sales in Massachusetts pharmacies statewide.

Nornicotine nitrosation in saliva and its relation to endogenous synthesis of N'-nitrosonornicotine in humans.

We recently reported that certain amounts of the carcinogen N'-nitrosonornicotine (NNN) can be formed endogenously from nicotine and/or nornicotine in some users of oral nicotine replacement therapy products. Although the acidic environment of the stomach creates the most favorable conditions for nitrosation, this reaction could also occur in the oral cavity in the presence of bacteria that catalyze nitrosation at neutral pH. To test the hypothesis that endogenous formation of NNN could occur in the oral cavity, we investigated nitrosation of nicotine and nornicotine in human saliva. To specifically identify NNN as derived from precursors added to saliva, we incubated saliva samples with [pyridine-D(4)]nicotine and [pyridine-D(4)]nornicotine, with and without the addition of nitrite, and subsequently analyzed [pyridine-D(4)]NNN by liquid chromatography-tandem mass spectrometry. Consistent with kinetic studies on nicotine and nornicotine nitrosation, incubation of saliva with [pyridine-D(4)]nornicotine alone produced detectable amounts of [pyridine-D(4)]NNN, whereas only traces of [pyridine-D(4)]NNN were found in samples incubated with [pyridine-D(4)]nicotine and sodium nitrite. Incubation of saliva samples from 10 nonsmoking volunteers with [pyridine-D(4)]nornicotine resulted in the formation of [pyridine-D(4)]NNN in 8 samples, with yields ranging from 0.003% to 0.051% of the added alkaloid. Our results demonstrate that NNN can be formed from nornicotine in human saliva without deliberate addition of any other substance. Therefore, nornicotine, as present in tobacco or in nicotine replacement products, is a carcinogen precursor.

Is pharmaceutical policy evidence-informed? A case of the deregulation process of nicotine replacement therapy products in Finland

ObjectiveThis qualitative study aims to identify the key dimensions of the political argumentation in the debate leading up to the deregulation of nicotine replacement therapy products (NRT) in Finland in 2006. The deregulation was introduced by the Amendment of larger package of changes in medical legislation prepared in 2005. MethodsAll publicly available documents of the legislative process introducing NRT deregulation and interviews of 12 Members of Finnish Parliament conducted in spring 2006 were analyzed by inductive content analysis. ResultsNRT deregulation was introduced to decision-makers as a safe intervention to increase smoking cessation and thus provide public health benefits. However, a whole variety of other features were brought into debate: NRT characteristics, principle change in prevailing medical legislation, use of evidence and the political process. Finally, the expected public health benefits of the decision were not directly informed by any evidence. ConclusionsThis study provides an example of the use of public health benefits as justification for decision-making. However, the decision can include other aspects, less brought up in its preparation stage. Our study addresses the need for policymakers to critically evaluate the evidence, its suitability in decision-making context and raise awareness of the principles of evidence-informed policy-making.

Design, formulation and evaluation of nicotine chewing gum.

Background:Nicotine replacement therapy (NRT) can help smokers to quit smoking. Nicotine chewing gum has attracted the attention from pharmaceutical industries to offer it to consumers as an easily accessible NRT product. However, the bitter taste of such gums may compromise their acceptability by patients. This study was, therefore, designed to develop 2 and 4 mg nicotine chewing gums of pleasant taste, which satisfy the consumers the most.Materials and Methods:Nicotine, sugar, liquid glucose, glycerin, different sweetening and taste-masking agents, and a flavoring agent were added to the gum bases at appropriate temperature. The medicated gums were cut into pieces of suitable size and coated by acacia aqueous solution (2% w/v), sugar dusting, followed by acacia–sugar–calcium carbonate until a smooth surface was produced. The gums’ weight variation and content uniformity were determined. The release of nicotine was studied in pH 6.8 phosphate buffer using a mastication device which simulated the mastication of chewing gum in human. The Latin Square design was used for the evaluation of organoleptic characteristics of the formulations at different stages of development.Results:Most formulations released 79–83% of their nicotine content within 20 min. Nicotine-containing sugar-coated gums in which aspartame as sweetener and cherry and eucalyptus as flavoring agents were incorporated (i.e. formulations F19-SC and F20-SC, respectively) had optimal chewing hardness, adhering to teeth, and plumpness characteristics, as well as the most pleasant taste and highest acceptability to smokers.Conclusion:Taste enhancement of nicotine gums was achieved where formulations comprised aspartame as the sweetener and cherry and eucalyptus as the flavoring agents. Nicotine gums of pleasant taste may, therefore, be used as NRT to assist smokers quit smoking.

Availability of Tobacco and Alcohol Products in Los Angeles Community Pharmacies

The availability of tobacco and alcohol products in community pharmacies contradicts the pharmacists' Code of Ethics and presents challenges for a profession that is overwhelmingly not in favor of the sale of these products in its practice settings. The primary aim of this study was to estimate the proportion of pharmacies that sell tobacco products and/or alcoholic beverages and to characterize promotion of these products. The proportion of pharmacies that sell non-prescription nicotine replacement therapy (NRT) products as aids to smoking cessation also was estimated. Among 250 randomly-selected community pharmacies in Los Angeles, 32.8% sold cigarettes, and 26.0% sold alcohol products. Cigarettes were more likely to be available in traditional chain pharmacies and grocery stores than in independently-owned pharmacies (100% versus 10.8%; P<0.001), and traditional chain drug stores and grocery stores were more likely to sell alcoholic beverages than were independently-owned pharmacies (87.5% vs. 5.4%; P<0.001). Thirty-four (41.5%) of the 82 pharmacies that sold cigarettes and 47 (72.3%) of the 65 pharmacies that sold alcohol also displayed promotional materials for these products. NRT products were merchandised by 58% of pharmacies. Results of this study suggest that when given a choice, pharmacists choose not to sell tobacco or alcohol products.

Adolescents' self-reported reasons for using nicotine replacement therapy products: A population-based study

Background Available research provides evidence that adolescents use nicotine replacement therapy (NRT) products. Yet, little is known about reasons and motives behind their use. The present study examined the reasons for NRT use among 14–18-year-old Finnish adolescents. Method A national Adolescent Health and Lifestyle Survey was conducted in Finland in 2009 ( N = 4834, response rate 55%). Main measures were prevalence of NRT use, self-reported reasons for using NRT and smoking status. Results Overall, 10% had used NRT. Boys used NRT more often than girls (11.5% versus 8.7%, p < .001). The three most commonly reported reasons were ‘just try’ (56%), ‘to quit’ (33%) and ‘smoking not possible’ (24%). “Just try” was the most common reason given by non-smokers/experimental smokers whereas daily/occasional smokers used NRT mainly for quitting purposes and when smoking was impossible. Conclusions These findings suggest that when planning treatment plans for adolescent smokers, health care personnel should pay particular attention to adolescents' primary reasons and motives for using NRT before suggesting its use.

Does improved access and greater choice of nicotine replacement therapy affect smoking cessation success? Findings from a randomized controlled trial

To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Single-blind, randomized controlled trial. New Zealand. A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR)=1.17, 95% confidence interval (CI): 1.02, 1.35, P=0.03], had a longer time to relapse (median 70 days versus 28 days, P<0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. This trial is registered with the Australasian Clinical Trials Network Number: ACTRN 12606000451505.

Abstract 4650: Nornicotine nitrosation in human saliva and its relation to endogenous formation of N′-nitrosonornicotine in oral nicotine replacement therapy users

Abstract We recently reported occasional significant increases in urinary biomarkers of the potent human carcinogen N′-nitrosonornicotine (NNN) in some users of oral nicotine replacement therapy (NRT) products, such as nicotine gum or lozenge, compared with baseline smoking levels in the same subjects. We hypothesized that this is due to endogenous synthesis of NNN through the reaction of nicotine and/or nornicotine that is metabolically formed from nicotine or originally present in NRT products, with nitrosating agents supplied by diet. While the acidic environment of the stomach creates the most favorable conditions for nitrosation, this reaction can also occur in the oral cavity in the presence of bacteria that catalyzes nitrosation at neutral pH. To test the hypothesis that endogenous formation of NNN can occur in the oral cavity of NRT users, we investigated nitrosation of nicotine and nornicotine in human saliva. To specifically identify NNN as derived from the precursors added to saliva, we used [pyridine-D4]nicotine and [pyridine-D4]nornicotine and subsequently analyzed [pyridine-D4]NNN by liquid chromatography-tandem mass spectrometry. Aliquots of pooled saliva from nonsmoking volunteers were incubated for 30 min at 37 °C with either [pyridine-D4]nicotine or [pyridine-D4]nornicotine, in the presence of various concentrations of sodium nitrite. [Pyridine-D4]NNN was not detected in the blank saliva aliquot that was added as a negative control. Incubation of saliva with 50 ng of [pyridine-D4]nornicotine alone produced 38 pg [pyridine-D4]NNN, or 0.08% yield. The aliquot incubated with 200 ng of [pyridine-D4]nornicotine and 7 mg of sodium nitrite formed 5,503 pg of [pyridine-D4]NNN (nearly 150-fold increase). Only traces of [pyridine-D4]NNN were detected in samples incubated with [pyridine-D4]nicotine. These results are in agreement with kinetic studies on nicotine and nornicotine nitrosation. To investigate the effect of natural inter-individual variations in salivary nitrite and/or oral microflora on the amount of orally synthesized NNN, saliva samples from 10 nonsmoking volunteers were incubated with deuterium-labelled nicotine and nornicotine. Formation of [pyridine-D4]NNN was observed in 6 samples treated with [pyridine-D4]nornicotine, with yields ranging from 0.001 to 0.037% of the added alkaloid. Trace amounts of [pyridine-D4]NNN were detected in some samples incubated with [pyridine-D4]nicotine. In summary, our results demonstrate that NNN can be formed in human saliva in the presence of nornicotine, supporting the hypothesis that NNN can be synthesized endogenously in oral NRT users. Removal of nornicotine from NRT products could improve the safety of these products. Additional studies are needed to evaluate the contribution of metabolically formed nornicotine to the endogenous formation of NNN in oral NRT users. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr 4650. doi:10.1158/1538-7445.AM2011-4650

Tobacco, nicotine and harm reduction

Tobacco smoking, sustained by nicotine dependence, is a chronic relapsing disorder, which in many cases results in lifelong cigarette use and consequent death of one out of two lifelong smokers from a disease caused by their smoking. Most toxicity due to cigarette smoking is related to the burning process. Models of harm reduction applied to tobacco suggest that use of non-combustible, less toxic, nicotine-containing products as a substitute for cigarette smoking would reduce the death toll arising from tobacco use. Available options include medicinal nicotine and smokeless tobacco products. The potential role of nicotine replacement therapy (NRT) products in a harm reduction strategy is currently severely restricted by strict regulations on dose, safety and potential addictiveness. As a result, NRT products are designed to provide much less nicotine, and deliver it to the brain more slowly, than cigarettes, which are widely accessible and poorly regulated. Smokeless tobacco (snus) has proved to be an acceptable reduced hazard alternative to smoking in Sweden, but supply of snus is illegal elsewhere in the European Union. To increase accessibility and reach more smokers, barriers to the use of NRT use need to be removed and more effective NRTs need urgently to be developed. Smokeless tobacco could also play an important role in harm reduction, but current European Union regulations and concerns over exploitation by tobacco companies currently preclude wider use. To improve public health there is an urgent need for an appropriate regulatory framework and regulatory authority at the European level, controlling both tobacco and nicotine products to ensure that the least harmful products are the most accessible.

Providing accurate safety information may increase a smoker's willingness to use nicotine replacement therapy as part of a quit attempt

Aim Previous studies have reported that smokers who are misinformed about the safety of Nicotine Replacement Therapy (NRT) are less likely to report using it. In this study, we examined whether providing information that counters these concerns might impact on intentions to use NRT. Participants 900 smokers recruited from a market research database. Design and setting Participants completed an online survey that asked about their views about NRT. Smokers with safety and efficacy concerns were queried to determine whether accurate information might increase their interest in using NRT. Findings Misperceptions of NRT safety were common: 93% of smokers did not know that smoking while wearing the nicotine patch does not cause heart attacks; 76% that nicotine gum/lozenge are not as addictive as cigarettes; and 69% that NRT products are not as dangerous as cigarettes. Over half of the smokers with misperceptions reported that they would be more likely to use NRT to help them quit smoking if they were exposed to information correcting their concerns (53%, 58% and 66%, respectively, for each of the misperceptions). Conclusions These data suggest that while a sizeable proportion of smokers are still misinformed about the safety of NRT, misinformed smokers would increase consideration of NRT if these misperceptions are addressed by corrective information.

FDA Considering Data on Long-term Use of Nicotine Replacement Therapy Products

FDA Considering Data on Long-term Use of Nicotine Replacement Therapy Products

Perceived Safety of Nicotine and the Use of Nicotine Replacement Products Among Current Smokers in Great Britain: Results From Two National Surveys

AbstractThe hypotheses that smokers hold misconceptions around nicotine replacement therapy (NRT) safety, and that these concerns limit the use of NRT, was tested with two large face-to-face surveys of current smokers in Great Britain in 2004 (N= 605) and 2006 (N= 1,434). In both studies, participants were questioned regarding the safety of nicotine and NRT products, their past experience with NRT and anticipated future use. Across both surveys, approximately two thirds of smokers believed that, or were unsure whether, NRT was as harmful as cigarette smoking. Combining information across surveys, smokers with safety misconceptions reported being less likely to want to quit in the future (63% vs. 73%;p&lt; .001), and, among those who were interested in quitting, were less likely to report an intention to use NRT during their next quit attempt. The majority of smokers were misinformed about the safety of NRT products, and smokers with safety misconceptions were less likely to report that they plan to use NRT during future quit attempts, suggesting that safety concerns are a barrier to NRT utilisation.

A Targeted Review of Smoking Cessation Aids and Their Pharmacology for the Pharmacy Technician

Objective: To review the pharmacologic treatment options available for smoking cessation. Data Synthesis: Nicotine replacement therapy (NRT) has a less rapid onset than that of nicotine received from smoking; therefore, it does not cause the same pleasurable response but helps to decrease the cravings. NRT is available over the counter as a gum, lozenge, and patch. NRT is also available by prescription as a nasal spray and inhaler. Information is also provided on the dosing and adverse effect profiles of 2 non-NRT prescription products used for smoking cessation including bupropion SR and varenicline. Conclusions: It is important for pharmacy technicians to be aware of the NRT and non-NRT products available both over the counter and by prescription so that they can better work with the pharmacist to aid patients in the smoking cessation process. Current guidelines do not specify any of the medications as first line. Patients should be educated on all of the options available so that they can decide which option they think will help them succeed.

Community pharmacists' involvement in smoking cessation: familiarity and implementation of the National smoking cessation guideline in Finland.

BackgroundGuidelines on smoking cessation (SC) emphasize healthcare cooperation and community pharmacists' involvement. This study explored the familiarity and implementation of the National SC Guideline in Finnish community pharmacies, factors relating to Guideline familiarity, implementation and provision of SC services.MethodsA nationwide mail survey was sent to a systematic, sample of community pharmacy owners and staff pharmacists (total n = 2291). Response rate was 54% (n = 1190). Factors related to the SC Guideline familiarity were assessed by bivariate and multivariate analysis.ResultsAlmost half (47%) of the respondents (n = 1190) were familiar with the SC Guideline and familiarity enhanced Guideline implementation. The familiarity was associated with the respondents' perceptions of their personal SC skills and knowledge (OR 3.8); of customers' value of counseling on nicotine replacement therapy (NRT) (OR 3.3); and regular use of a pocket card supporting SC counseling (OR 3.0). Pharmacists' workplaces' characteristics, such as size and geographical location were not associated with familiarity. In addition to recommending NRT, the pharmacists familiar with the Guideline used more frequently other Guideline-based SC methods, such as recommended non-pharmacological SC aids, compared to unfamiliar respondents.ConclusionsSC Guideline familiarity and implementation is crucial for community pharmacists' involvement in SC actions in addition to selling NRT products. Pharmacists can constitute a potential public health resource in SC easily accessible throughout the country.

Are Australian smokers interested in using low-nitrosamine smokeless tobacco for harm reduction?

AimsTo determine (1) whether Australian smokers are aware of low-nitrosamine smokeless tobacco (LNSLT) products and (2) whether they would be interested in using LNSLT either as a long-term substitute for...

Use and acquisition of nicotine replacement therapy products among underaged adolescents after deregulation of the sales

Limited information is available on the use and acquisition of nicotine replacement therapy (NRT) products in minors after deregulation of the sales. In Finland, deregulation releasing the NRT products for general sale took place in 2006. The sale is prohibited to those under the age of 18 years. We examine underaged adolescents' use, acquisition, and awareness of NRT products after the deregulation. Nationwide mailed survey of 12- to 18-year olds (N = 5,840, response rate 61%) was conducted in 2007. The main outcomes were ever use of NRT, acquisition of NRT products in different locations (retail outlet, family member, friend, health care personnel, and pharmacy), and awareness of NRT. Eighteen-year olds were analyzed as a comparison group as they were at legal age to buy the products. Among 14-year olds, 2% of boys and 2% of girls had used NRT. The corresponding figures for 16-year olds were 7% and 5%, respectively, and for 18-year olds 10% and 8%, respectively. Few 12-year olds had used NRT. Over a quarter of 12-year-old girls and 15% of boys did not know what NRT products were. Awareness increased with age. Of 12- to 16-year-old NRT users, 79% were daily smokers, 10% had smoked >50 but not daily, 10% had smoked <50, and 2% were never-smokers. The underaged NRT users acquired the products mainly not only from friends (42%) but also from retail outlets (13%). One year after deregulation, NRT use among minors is uncommon. Also misuse seems rare. NRT products are sold to minors from retail outlets despite sales ban. However, the underaged NRT users acquired the products mainly from friends.

Maternal use of nicotine replacement therapy during pregnancy and offspring birthweight: a study within the Danish National Birth Cohort

Smoking is a well-established risk factor for fetal growth restriction and other adverse pregnancy outcomes, and nicotine may be one of the chemical compounds that drive these associations. Nicotine replacement therapy (NRT) is a smoking cessation aid, which can facilitate smoking cessation. It is, however, unknown whether NRT used during pregnancy impairs fetal growth. The aim of this study was to estimate the association between the use of NRT during pregnancy and offspring birthweight. The study population consisted of 72 761 women enrolled in the Danish National Birth Cohort between 1996 and 2002. Information on NRT and potential confounders was obtained from two computer-assisted telephone interviews conducted in the second and third trimesters, respectively. Multiple linear regression in a multilevel model was used to estimate the association between NRT use and birthweight adjusted for gestational age and potential confounders. The adjusted analyses showed no significant association between the duration of NRT use and birthweight (b = 0.25 g per week of NRT use [95% CI -2.31, 2.81]) and neither was the type of NRT product (patch, gum, inhaler) associated with reduced birthweight. However, simultaneous use of more than one NRT product was associated with reduced birthweight (b = -10.73 g per week of NRT use [95% CI -26.51, 5.05]), although the association was not statistically significant. The results of this study suggest that maternal use of NRT in pregnancy does not seriously affect birthweight, but there could be a negative effect on birthweight associated with simultaneous use of more than one type of NRT product.