Nicotine Replacement Therapy Gum Research Articles

Type-switching of short-acting nicotine replacement therapy products and its implications for treatment

IntroductionThe frequency with which people change from one medical treatment to another partly reflects satisfaction with the initial intervention. In this secondary analysis of observational data, we explore switch rates for short-acting nicotine replacement therapy (NRT) products, which differ in mode of use, rapidity of action, and adverse effect profiles. MethodsWe analyzed data from 46,882 participants in the Smoking Treatment for Ontario Patients program who received short-acting NRT (gum, lozenge, oral spray, or inhaler) at their initial visit. We used discrete-time survival analysis to model the time elapsing before a change was made to another product and included time-by-product interactions to explore differences over time and product-by-previous-quit-attempts interactions to examine the importance of potential previous exposure to NRT. We adjusted both models for a range of sociodemographic and tobacco use variables. ResultsOverall, 37.9% (95% CI = 37.5%, 38.4%) of participants switched to a different product at their first follow-up visit. Time-averaged and adjusted switch probabilities were 21.1% for gum, 23.8% for lozenge, 26.0% for inhaler, and 28.8% for oral spray. Switch rates were highest for people without past quit attempts, for women, and for people also using the nicotine patch. ConclusionsPeople frequently switch from one type of short-acting NRT to another. We did not assess reasons for switching, but they may include adverse effects, impracticality, and perceived ineffectiveness. Given the superior effectiveness of combination treatment, making multiple products available may improve outcomes by allowing some people to continue with short-acting products for longer.

Do e-cigarette sales reduce the demand for nicotine replacement therapy (NRT) products in the US? Evidence from the retail sales data

Despite mixed evidence, many smokers use e-cigarettes to quit smoking. With the substantial growth of e-cigarette sales in recent years, it is important to understand how it may affect FDA-approved nicotine replacement therapy (NRT) products in the US. This study aims to investigate the impact of e-cigarette prices and TV advertising on the demand for NRT products. Quarterly (2010 Q1–2017 Q4) retail sales and price data of e-cigarettes and NRT gum and patch, compiled from Nielsen retail store scanner database, were linked with contemporaneous quarterly television rating data for e-cigarettes and NRT products, compiled from Kantar Media, using state and county identifier. Market, year, and quarter fixed effects models were used to estimate the impact of NRT price and TV advertising, as well as e-cigarette price and TV advertising, on the demand for NRT gum and patch. NRT gum price elasticity was estimated to be −0.91. Higher patch price was found to decrease gum sales (cross-price elasticity −0.96). Higher e-cigarette prices were found to decrease NRT gum sales. Higher cigarette prices were found to increase NRT gum sales. NRT patch price elasticity was estimated to be −2.05. Higher gum price was found to increase patch sales (cross-price elasticity 0.97). E-cigarette TV advertisement was positively associated with NRT gum sales. NRT gum appeared to be complements for e-cigarettes. Recent growth in e-cigarette sales may have increased the demand for NRT gum. More studies are needed to understand the differential behavioral patterns of NRT gum users and NRT path users.

Alignment of Medical and Psychosocial Sectors for Promotion of Tobacco Cessation among Residents of Public Housing: A Feasibility Study.

The inequity in cessation resources is at the forefront of the recently enacted US smoking ban in public housing facilities. This pre-post, non-randomized pilot study assessed the feasibility of a smoking cessation program targeting smokers in Baltimore City public housing. The study implemented a four-phased, 10-week, community-based cessation program using a joint academic–housing partnership that provided on-site cessation pharmacotherapy, behavioral counseling, and psychosocial/legal services. The community-led strategy involved: (1) two-week smoking cessation training for lay health workers; (2) screening and recruitment of smokers by housing authority residential leadership; (3) four-week resident-led cessation using evidenced-based strategies along with wraparound support services; (4) formative evaluation of the intervention’s acceptability and implementation. Thirty participants were recruited of which greater than one-half attended the majority of weekly cessation events. Thirty percent were able to achieve biomarker-proven cessation, as measured by a reduction in exhaled CO levels—a percentage comparable to the reported state quitline 30-day cessation rate. Despite weekly joint community–academic led-education of nicotine replacement therapy (NRT) therapies, only two participants regularly and properly used NRT transdermal patches; <20% of participants used NRT gum correctly at their first follow-up visit. Less than one-half utilized psychosocial and legal services by our community-based organization partners. Post-intervention interviews with participants noted broad approval of the ease in accessibility of the cessation intervention, but more diversification in the timing and personalization of offerings of services would have assisted in greater adoptability and participant retention. Though a reduction in smoking behaviors was not broadly observed, we elucidated modifiable social, educational, and physical features that could enhance the likelihood of smoking cessation among public housing residents.

Supporting visitor compliance with a smoke-free policy at hospital using a nicotine replacement therapy vending machine.

Issue addressedTo support visitors to comply with Central Coast Local Health District's (CCLHD) smoke‐free hospital grounds policy, a need was identified for round‐the‐clock availability of nicotine replacement therapy (NRT). Providing NRT through a vending machine was identified as a possible solution. This initiative complemented other strategies that provide staff and patients who smoke with NRT.MethodsNRT was originally provided through a snack vending machine; however, there were commercial and regulatory concerns with this method.In 2015, dedicated NRT vending machines were installed at Gosford and Wyong Hospitals, and were operated by the Health Promotion Service. The appropriate regulatory permission was gained to supply a specific brand of NRT. Sales and incident data were recorded, and ongoing smoking counts were performed both before and after installation.ResultsIn all, 247 sales of NRT gum were made through the vending machines from early 2017 to late 2019. Smoking counts show that there are very low rates of visitor smoking (<1%) in the approximately 4.5 years pre‐ and post‐installation of dedicated vending machines. There was no statistically significant change in the smoking rate of visitors since the vending machine was installed at Wyong Hospital.ConclusionsWhile NRT is generally provided to patients and staff within health settings to support compliance with smoke‐free policies, alternatives to smoking for visitors are typically overlooked. A NRT vending machine achieves this. However, because there are few purchases made, the vending machines as currently operating are unlikely to make any significant impact on smoke‐free policy compliance at these hospitals.So what?While vending machines have limited effectiveness on overall smoke‐free policy compliance, this strategy may have applicability to all sectors with smoke‐free policies, especially those operating 24 hours a day, as a means of providing an alternative to smoking for visitors.

Impact of Nicotine Replacement and Electronic Nicotine Delivery Systems on Fetal Brain Development.

Maternal tobacco smoking during pregnancy remains a major public health issue. The neurotoxic properties of nicotine are associated with fetal neurodevelopmental disorders and perinatal morbimortality. Recent research has demonstrated the effects of nicotine toxicity on genetic and epigenetic alterations. Smoking cessation strategies including nicotine replacement therapy (NRT) and electronic nicotine delivery systems (ENDS) show lack of clear evidence of effectiveness and safety in pregnant women. Limited trials using randomized controls concluded that the intermittent use formulation of NRT (gum, sprays, inhaler) in pregnant women is safe because the total dose of nicotine delivered to the fetus is less than continuous-use formulations (transdermal patch). Electronic nicotine delivery systems (ENDS) were hyped as a safer alternative during pregnancy. However, refill liquids of ENDS are suspected to be cytotoxic for the fetus. Animal studies revealed the impact of ENDS on neural stem cells, showing a similar risk of pre- and postnatal neurobiological and neurobehavioral disorders to that associated with the exposure to traditional tobacco smoking during early life. There is currently no clear evidence of impact on fetal brain development, but recent research suggests that the current guidelines should be reconsidered. The safety of NRT and ENDS is increasingly being called into question. In this review, we discuss the special features (pharmacodynamics, pharmacokinetics, and metabolism) of nicotine, NRT, and ENDS during pregnancy and postnatal environmental exposure. Further, we assess their impact on pre- and postnatal neurodevelopment.

Nicotine replacement therapy versus control for smoking cessation.

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. 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. 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. 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. 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. 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. 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.

Pharmacological interventions for smoking cessation: an overview and network meta-analysis.

Pharmacological interventions for smoking cessation: an overview and network meta-analysis.

Nicotine Replacement Therapy Distribution to Light Daily Smokers Calling a Quitline

With an increasing prevalence of lighter smokers presenting for cessation assistance, outcome-based recommendations are needed to inform nicotine replacement therapy (NRT) distribution protocols by quitlines. A quasi-experimental design was utilized to compare quit rates based on samples selected from the time period before and after NRT (gum or lozenge) was offered to light daily smokers (1-9 cigarettes) contacting the New York State Smokers' Quitline. Outcome measures included self-reported 7- and 30-day abstinence rates, numbers of daily cigarettes among continuing smokers, and cost per quit analyses. Among responders to the follow-up survey, quit rates were higher for those given NRT compared with those not offered NRT at both 7 (33.0% vs. 27.2%; Relative Risk [RR] = 2.25 [95% CI: 1.15, 4.40; p < .05]) and 30 days (28.0% vs. 21.9%; RR = 2.63 [95% CI: 1.25, 5.54; p < .05]). Similar results were obtained based on intent-to-treat analyses for both 7 (13.4% vs. 11.3%; RR = 1.92 [95% CI: 1.08, 3.39; p < .05]) and 30 days (11.4% vs. 9.1%; RR = 2.29 [95% CI: 1.20, 4.40; p < .05]). Among continuing smokers, the mean number of cigarettes smoked per day increased from enrollment to follow-up in both groups, but less so in those receiving NRT. The additional cost associated with providing a 2-week free supply of nicotine replacement to smokers was $52 for gum and $74 for lozenge. This study demonstrates that light daily smokers (1-9 cigarettes) who contact a telephone quitline are interested in using NRT if offered and are able to achieve higher quit rates compared with those not offered NRT.

Nicotine replacement therapy for smoking cessation

The aim of nicotine replacement therapy (NRT) is 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. The aims of this review were: To determine the effect of NRT compared to placebo in aiding smoking cessation, and to consider whether there is a difference in effect for the different forms of NRT (chewing gum, transdermal patches, oral and nasal sprays, inhalers and tablets/lozenges) in achieving abstinence from cigarettes. To determine whether the effect is influenced by the dosage, form and timing of use of NRT; the intensity of additional advice and support offered to the smoker; or the clinical setting in which the smoker is recruited and treated. To determine whether combinations of NRT are more likely to lead to successful quitting than one type alone. To determine whether NRT is more or less likely to lead to successful quitting compared to other pharmacotherapies. 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 July 2012. Randomized trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow-up of less than six months. We extracted data in duplicate on the type of participants, the dose, duration and form of nicotine therapy, the outcome measures, method of randomization, and completeness of follow-up. 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. We identified 150 trials; 117 with over 50,000 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The risk ratio (RR) of abstinence for any form of NRT relative to control was 1.60 (95% confidence interval [CI] 1.53 to 1.68). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 55 trials) for nicotine gum; 1.64 (95% CI 1.52 to 1.78, 43 trials) for nicotine patch; 1.95 (95% CI 1.61 to 2.36, 6 trials) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials) for nicotine inhaler; and 2.02 (95% CI 1.49 to 2.73, 4 trials) for nicotine nasal spray. One trial of oral spray had an RR of 2.48 (95% CI 1.24 to 4.94). The effects were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. The effect was similar in a small group of studies that aimed to assess use of NRT obtained without a prescription. In highly dependent smokers there was a significant benefit of 4 mg gum compared with 2 mg gum, but weaker evidence of a benefit from higher doses of patch. There was evidence that combining a nicotine patch with a rapid delivery form of NRT was more effective than a single type of NRT (RR 1.34, 95% CI 1.18 to 1.51, 9 trials). The RR for NRT used for a short period prior to the quit date was 1.18 (95% CI 0.98 to 1.40, 8 trials), just missing statistical significance, though the efficacy increased when we pooled only patch trials and when we removed one trial in which confounding was likely. Five studies directly compared NRT to a non-nicotine pharmacotherapy, bupropion; there was no evidence of a difference in efficacy (RR 1.01; 95% CI 0.87 to 1.18). A combination of NRT and bupropion was more effective than bupropion alone (RR 1.24; 95% CI 1.06 to 1.45, 4 trials). Adverse effects from using NRT are related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. There is no evidence that NRT increases the risk of heart attacks. All of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler 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 70%, regardless of setting. The 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.

The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial

To determine the combined effect of very low nicotine content (VLNC) cigarettes and usual Quitline care [nicotine replacement therapy (NRT) and behavioural support] on smoking abstinence, in smokers motivated to quit. Single-blind, parallel randomized trial. New Zealand. PARTICIPANTS Smokers who called the Quitline for quitting support were randomized to either VLNC cigarettes to use whenever they had an urge to smoke for up to 6 weeks after their quit date, in combination with usual Quitline care (8 weeks of NRT patches and/or gum or lozenges, plus behavioural support) or to usual Quitline care alone. The primary outcome was 7-day point-prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, self-efficacy, alcohol use, serious adverse events and views on the use of the VLNC cigarettes at 3 and 6 weeks and 3 and 6 months. A total of 1410 participants were randomized (705 in each arm), with a 24% loss to follow-up at 6 months. Participants in the intervention group were more likely to have quit smoking at 6 months compared to the usual care group [7-day point-prevalence abstinence 33 versus 28%, relative risk (RR) = 1.18, 95% confidence interval (CI): 1.01, 1.39, P = 0.037; continuous abstinence 23 versus 15%, RR = 1.50, 95% CI: 1.20, 1.87, P = 0.0003]. The median time to relapse in the intervention group was 2 months compared to 2 weeks in the usual care group (P < 0.0001). Addition of very low nicotine content cigarettes to standard Quitline smoking cessation support may help some smokers to become abstinent.

Study protocol for a non-inferiority trial of cytisine versus nicotine replacement therapy in people motivated to stop smoking

BackgroundSmokers need effective support to maximise the chances of successful quit attempts. Current smoking cessation medications, such as nicotine replacement therapy (NRT), bupropion, nortriptyline or varenicline, have been shown to be effective in clinical trials but are underused by smokers attempting to quit due to adverse effects, contraindications, low acceptability and/or high cost. Cytisine is a low-cost, plant-based alkaloid that has been sold as a smoking cessation aid in Eastern Europe for 50 years. A systematic review of trial evidence suggests that cytisine has a positive impact on both short- and long-term abstinence rates compared to placebo. However, the quality of the evidence is poor and insufficient for licensing purposes in many Western countries. A large, well-conducted placebo-controlled trial (n = 740) of cytisine for smoking cessation has recently been published and confirms the findings of earlier studies, with 12-month continuous abstinence rates of 8.4% in the cytisine group compared to 2.4% in the placebo group (Relative risk = 3.4, 95% confidence intervals 1.7-7.1). No research has yet been undertaken to determine the effectiveness of cytisine relative to that of NRT.Methods/designA single-blind, randomised controlled, non-inferiority trial has been designed to determine whether cytisine is at least as effective as NRT in assisting smokers to remain abstinent for at least one month. Participants (n = 1,310) will be recruited through the national telephone-based Quitline service in New Zealand and randomised to receive a standard 25-day course of cytisine tablets (Tabex®) or usual care (eight weeks of NRT patch and/or gum or lozenge). Participants in both study arms will also receive a behavioural support programme comprising an average of three follow-up telephone calls delivered over an eight-week period by Quitline. The primary outcome is continuous abstinence from smoking at one month, defined as not smoking more than five cigarettes since quit date. Outcome data will also be collected at one week, two months and six months post-quit date.DiscussionCytisine appears to be effective compared with placebo, and given its (current) relative low cost may be an acceptable smoking cessation treatment for smokers, particularly those in low- and middle-income countries. Cytisine's 'natural' product status may also increase its acceptability and use among certain groups of smokers, such as indigenous people, smokers in countries where the use of natural medicines is widespread (e.g. China, India), and in those people who do not want to use NRT or anti-depressants to help them quit smoking. However it is important to ascertain the effectiveness of cytisine compared with that of existing cessation treatments.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12610000590066)

Outcomes and Cost-Effectiveness of Two Nicotine Replacement Treatment Delivery Models for a Tobacco Quitline

Many tobacco cessation quitlines provide nicotine replacement therapy (NRT) in the U.S. but consensus is lacking regarding the best shipping protocol or NRT amounts. We evaluated the impact of the Minnesota QUITPLAN® Helpline’s shift from distributing NRT using a single eight-week shipment to a two-shipment protocol. For this observational study, the eight week single-shipment cohort (n = 247) received eight weeks of NRT (patches or gum) at once, while the split-shipment cohort (n = 160) received five weeks of NRT (n = 94), followed by an additional three weeks of NRT if callers continued with counseling (n = 66). Patient satisfaction, retention, quit rates, and cost associated with the three groups were compared. A higher proportion of those receiving eight weeks of NRT, whether in one or two shipments, reported that the helpline was “very helpful” (77.2% of the single-shipment group; 81.1% of the two-shipment group) than those receiving five weeks of NRT (57.8% of the one-shipment group) (p = 0.004). Callers in the eight week two-shipment group completed significantly more calls (3.0) than callers in the five week one-shipment group (2.4) or eight week single-shipment group (1.7) (p < 0.001). Using both responder and intent-to-treat calculations, there were no significant differences in 30-day point prevalence abstinence at seven months among the three protocol groups even when controlling for demographic and tobacco use characteristics, and treatment group protocol. The mean cost per caller was greater for the single-shipment phase than the split-shipment phase ($350 vs. $326) due to the savings associated with not sending a second shipment to some participants. Assuming no difference in abstinence rates resulting from the protocol change, cost-per-quit was lowest for the five week one-shipment group ($1,155), and lower for the combined split-shipment cohort ($1,242) than for the single-shipment cohort ($1,350). Results of this evaluation indicate that while satisfaction rates increase among those receiving more counseling and NRT, quit rates do not, even when controlling for demographic and tobacco use characteristics.

Study protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice, in people who wish to stop smoking

BackgroundCurrent smoking cessation treatments focus on addressing the pharmacological dependence of smokers on nicotine. However, new strategies are needed that address both nicotine dependence and the psychological dependence on cigarettes as the source of nicotine. Evidence from a number of small smoking cessation studies suggests that the use of cigarettes with reduced nicotine content, in combination with nicotine replacement therapy (NRT), may help reduce withdrawal symptoms and increase quit rates. This paper describes the protocol for a large randomised-controlled trial to test the effect of using nicotine-free cigarettes together with NRT on long-term quit rates.Methods/designThis single-blind, randomised trial aims to recruit 1,410 participants through the national telephone-based Quitline service in New Zealand. Participants in the treatment arm will be asked to stop smoking nicotine-containing cigarettes on their chosen Quit day and smoke ad libitum nicotine-free (Quest 3) cigarettes for six weeks. At the same time people in this group will be asked to start using NRT patches, gum and/or lozenges (as recommended by Quitline) for eight weeks. Participants in the control arm will be asked to stop smoking completely on their chosen Quit day and start using NRT patches, gum and/or lozenges (as recommended by Quitline) for eight weeks. Data collection will occur at baseline, three and six weeks, and three and six months after Quit day. The primary outcome is the proportion of participants who self-report seven-day point prevalence abstinence at six months since Quit date.DiscussionSmoking prevalence in New Zealand has changed little in recent years (particularly in Māori, the indigenous people of New Zealand) and additional options for smokers who want to quit are needed. Although a variety of methods are available to help, many are expensive, have side effects, and despite their use most quit attempts still fail. This trial will test the balance of benefits and risks of a new strategy for people to overcome nicotine dependence. Since smoking is the leading cause of lost healthy life years in New Zealand, if proven effective this strategy is likely to have substantial public health benefits.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12608000410358

Gender, smoking status, and risk behavior attitudes explain adolescents' patterns of nicotine replacement therapy use

Treatment studies provide minimal support for nicotine replacement therapy (NRT) with youth; however, survey studies suggest that adolescents use NRT, and may engage in inappropriate use. The current study sought to examine patterns of NRT use and risk factors for use to further aid smoking cessation efforts including prevention of potential misuse. In-school surveys assessing socio-demographic and behavioral factors associated with NRT use, gum or patch, were completed by 4078, predominantly African American, high school students. Approximately 5% of students reported former or current use of NRT products: 42% gum, 29% patch, and 29% both gum and patch. Among smokers, 5.4% reported use of both NRT gum and patch, with exclusive use of gum twice as likely as exclusive use of the patch. Those with high-risk-taking attitudes were more likely than low-risk takers (3% vs. 1%) to report use of both products, with exclusive gum use more prevalent than patch use. A cumulative logit model revealed males, risk takers, and/or smokers were at greatest odds for NRT use. Among this adolescent sample, NRT gum was used more often than the patch. Adolescent males, risk takers, and/or smokers appear more likely to use NRT (gum and/or patch) compared to their counterparts, despite limited empirical support for effective use of these products as cessation aids among adolescents. Smoking cessation and prevention programs may emphasize appropriate NRT use, specifically within these populations.

Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis

Objective To determine the effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking.Design Systematic review of randomised controlled trials.Data sources Cochrane Library, Medline, Embase, CINAHL, PsychINFO, Science...

Increased reach and effectiveness of a statewide tobacco quitline after the addition of access to free nicotine replacement therapy

Background: Tobacco users receiving behavioural and pharmacological assistance are more likely to quit. Although telephone quitlines provide population access to counselling, few offer pharmacotherapy. Objective: To assess change in cessation...

Inappropriate use of nicotine replacement therapy (NRT) related to age at first use &amp; risk behavior attitudes in U.S. Air Force recruits

The public health impact of NRT (patches, gum, nasal spray, lozenges, and inhaler) balances the benefits of cessation and attempts to quit vs. unsuccessful cessation and the potential for inappropriate use. As part of a tobacco use cessation/ prevention intervention, all new Air Force recruits who entered Basic Military Training (n = 36,013) were surveyed between October, 1999 to October, 2000; Items included smoking habits, NRT use, psychosocial factors, and demographics. About 5% of recruits indicated previously using NRT. Of these, 78% indicated appropriate use (i.e., status as former or current smoker and endorsed use “to try to quit smoking”) while 22% indicated inappropriate use (i.e., status as former or current smoker and endorsed NRT use “when I couldn't smoke” or were never or experimental smokers that claimed use “but am not a smoker”). Inappropriate NRT use was more likely in males, those with high school education or less, and those using NRT at a younger age. Inappropriate NRT use was more frequent at higher vs. lower levels of risk behavior attitudes such as rebelliousness, unhealthy behaviors, and dangerous legal and illegal behaviors. Independent associations were verified between inappropriate NRT use and younger age at first NRT use [OR = 1.25, 95% CI (1.18–1.32)], rebelliousness [OR = 0.54, 95% CI (0.41–071)], and enjoyment of risky health behaviors (e.g., overeating, inactivity, driving fast) [OR = 0.42, 95% CI (0.28–0.62)]. Similar to smoking patterns, more frequent NRT misuse was related to higher risk-taking attitudes and younger age at first use. Implications for interpreting NRT benefits and promoting appropriate use of NRT will be discussed.

Nicotine replacement therapy for smoking cessation.

The aim of nicotine replacement therapy (NRT) is to replace nicotine from cigarettes. This reduces withdrawal symptoms associated with smoking cessation thus helping resist the urge to smoke cigarettes. The aims of this review were:to determine the effectiveness of the different forms of NRT (chewing gum, transdermal patches, nasal spray, inhalers and tablets) in achieving abstinence from cigarettes, or a sustained reduction in amount smoked; to determine whether the effect is influenced by the clinical setting in which the smoker is recruited and treated, the dosage and form of the NRT used, or the intensity of additional advice and support offered to the smoker; to determine whether combinations of NRT are more effective than one type alone; to determine its effectiveness compared to other pharmacotherapies. We searched the Cochrane Tobacco Addiction Group trials register in March 2004. Randomized trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow up of less than six months. We extracted data in duplicate on the type of participants, the dose, duration and form of nicotine therapy, the outcome measures, method of randomization, and completeness of follow up. 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. For each study we calculated summary odds ratios. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed effect model. We identified 123 trials; 103 contributing to the primary comparison between NRT and a placebo or non-NRT control group. The odds ratio (OR) for abstinence with NRT compared to control was 1.77 (95% confidence intervals (CI): 1.66 to 1.88). The ORs for the different forms of NRT were 1.66 (95% CI: 1.52 to 1.81) for gum, 1.81 (95% CI: 1.63 to 2.02) for patches, 2.35 (95% CI: 1.63 to 3.38) for nasal spray, 2.14 (95% CI: 1.44 to 3.18) for inhaled nicotine and 2.05 (95% CI: 1.62 to 2.59) for nicotine sublingual tablet/lozenge. These odds were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. In highly dependent smokers there was a significant benefit of 4 mg gum compared with 2 mg gum (OR 2.20, 95% CI: 1.85 to 3.25). There was weak evidence that combinations of forms of NRT are more effective. Higher doses of nicotine patch may produce small increases in quit rates. Only one study directly compared NRT to another pharmacotherapy. In this study quit rates with bupropion were higher than with nicotine patch or placebo. All of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) are effective as part of a strategy to promote smoking cessation. They increase the odds of quitting approximately 1.5 to 2 fold regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the smoker. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT.

Comparison of the effects of combined nicotine replacement therapy vs. cigarette smoking in males

This open study assessed the effects of nicotine replacement therapy (NRT) on the normalizing of exhaled carbon monoxide (CO), transcutaneous partial oxygen tension (tcpO 2 ), plasma cotinine and thiocyanate levels, and cardiovascular risk markers in abstinent subjects compared with untreated smokers after 4, 8, 12, and 26 weeks. The trial enrolled 197 subjects in two parallel groups: 164 subjects who received NRT (patch plus gum) for 12 weeks and 33 untreated smokers (controls). At 26 weeks, 123/164 participants in the treatment group had completed the study; 51/123 (41.5%) sustained abstinence from smoking, whereas 72/123 (58.5%) had relapsed. Changes in cotinine (abstainers: 291.6 ng/ml at baseline vs. 27.3 ng/ml at week 26; p<.0001) and thiocyanate levels (abstainers: 10.4 ng/ml at baseline vs. 6.2 ng/ml at week 26; p<.0001) and expired CO (abstainers: 30.4 ppm at baseline vs. 4.2 ppm at week 26; p<.0001) accurately reflected the changes in smoking and/or NRT use in both abstainers and relapsers. After they stopping smoking, tcpO2 significantly improved in abstainers (34.9 mmHg at baseline vs. 50.4 mmHg at week 26; p<0.0001). Inverse correlations between the number of daily cigarettes and plasma cotinine, thiocyanate, and exhaled CO levels were observed in both relapsers and smokers. A clinically significant increase in HDL cholesterol (39.0 vs. 44.7 mg/dl; p<.0001) occurred in the abstainers between baseline and study end. Use of combination NRT to achieve abstinence resulted in marked improvements in biochemical parameters in abstainers and partial improvements in relapsers. The safety of combination NRT was confirmed by the absence of overdose-related adverse events.

A meta-analysis of the efficacy of over-the-counter nicotine replacement

Objective: To determine whether over-the-counter (OTC) nicotine replacement therapy (NRT) is pharmacologically efficacious, whether it produces abstinence rates similar to those in prescription settings, and to estimate the long term...