Nicotine Replacement Therapy Patch Research Articles

Nicotine addiction management following surgery: a quality improvement approach in the post anesthesia care unit.

For smokers, hospital admission is accompanied by forced involuntary nicotine abstinence due to smoke-free site/grounds policies. An audit of patients admitted to our surgical wards revealed that identification of smoking status was inadequate and that nicotine addiction management (NAM) was infrequently offered. The project aimed to enhance both these metrics by initiating NAM in the post anesthesia care unit (PACU). Out of 744 patients admitted to our PACU in August 2015, 54% had their smoking status documented. The 200 patients (27%) out of the 744 were smokers and only 50% were offered NAM before discharge. PACU unit staff to determine the smoking status of every patient before discharge from the PACU (later changed to OR nursing staff) and, if a patient was identified as a smoker, to offer NRT (patch and mouth spray only) and initiate therapy prior to transfer of the patient to the ward. Data about number of patients admitted, presence of documented smoking status, number of identified smokers, and number offered/accepted nicotine replacement therapy (NRT) were collected at baseline and thereafter quarterly. Engaging video education sessions addressed the education gaps highlighted in a needs assessment. Identification of smoking status was made part of preoperative checklist and NRT was made available in post-operative recovery room. These interventions resulted in an increase in screening for tobacco use from 54% at baseline to 95% and the offer of NRT to smokers from 50 to 89%.

Nicotine Metabolism-informed Care for Smoking Cessation: A Pilot Precision RCT.

Varenicline doubles cessation over nicotine replacement therapy (NRT) patch for "normal," but not "slow," nicotine metabolizers, as assessed by the nicotine metabolite ratio (NMR). Metabolism-informed care (MIC) could improve outcomes by matching normal metabolizers with non-nicotine medication (e.g., varenicline) and slow metabolizers with NRT patch. We conducted a feasibility randomized controlled trial of MIC versus guideline based care (GBC) among 81 outpatient adult daily smokers with medical comorbidity. Participants reported perceptions of MIC, underwent blood draw for NMR, and received expert cessation counseling. For MIC participants, medication selection was informed by NMR result (normal (≥0.31) vs. slow (< 0.31)). The primary outcome was MIC feasibility, reflected by attitudes toward MIC and by match rates between NMR and medication. Secondary endpoints (cessation confidence, medication use, smoking status) were assessed over 6 months to inform future studies. Participants were median age 53 years, 46% female, 28% black, and ~90% endorsed MIC. Despite high varenicline prescription rates (~60%) in both arms, NMR-medication matching was higher in MIC (84%) versus GBC (58%) participants (p=0.02); unadjusted odds ratio (OR) 3.67, 95% confidence interval [1.33, 11.00; p-value=0.02]. Secondary endpoints were similar at 1, 3, and 6 months. MIC, an NMR-based precision approach to smoking cessation, was acceptable to 90% of smokers and improved NMR-medication match rates more than 3-fold compared to GBC, even with generally high use of varenicline. These data support the feasibility of MIC, which could maximize efficacy of smoking cessation medication while minimizing side effects and cost. Among treatment-seeking daily smokers with medical comorbidity, most viewed metabolism-informed care (MIC), guided by the nicotine metabolism ratio (NMR), favorably, and were willing to accept MIC-guided medication. Compared to GBC participants (58%), more MIC participants (84%) were prescribed NMR-matched medication (i.e., normal metabolizers received varenicline; slow metabolizers received NRT patch). MIC increased the odds of optimized matching between NMR and medication more than 3-fold over GBC. Because the number needed to treat (NNT) to help one normal metabolizer quit smoking is only 4.9 for varenicline versus 26 for patch, broad implementation of MIC will improve drug efficacy in normal metabolizers as well as minimize side effects in slow metabolizers.

The Association Between Treatment Adherence to Nicotine Patches and Smoking Cessation in Pregnancy: A Secondary Analysis of a Randomized Controlled Trial.

Introduction:In nonpregnant “quitters,” adherence to nicotine replacement therapy (NRT) increases smoking cessation. We investigated relationships between adherence to placebo or NRT patches and cessation in pregnancy, including an assessment of reverse causation and whether any adherence: cessation relationship is moderated when using nicotine or placebo patches.Methods:Using data from 1050 pregnant trial participants, regression models investigated associations between maternal characteristics, adherence and smoking cessation.Results:Adherence during the first month was associated with lower baseline cotinine concentrations (β −0.08, 95% confidence interval [CI] −0.15 to −0.01) and randomization to NRT (β 2.59, 95% CI 1.50 to 3.68). Adherence during both treatment months was associated with being randomized to NRT (β 0.51, 95% CI 0.29 to 0.72) and inversely associated with higher nicotine dependence. Adherence with either NRT or placebo was associated with cessation at 1 month (odds ratio [OR] 1.11, 95% CI 1.08 to 1.13) and delivery (OR 1.06, 95% CI 1.03 to 1.09), but no such association was observed in the subgroup where reverse causation was not possible. Amongst all women, greater adherence to nicotine patches was associated with increased cessation (OR 2.47, 95% CI 1.32 to 4.63) but greater adherence to placebo was not (OR 0.98, 95% CI: 0.44 to 2.18).Conclusion:Women who were more adherent to NRT were more likely to achieve abstinence; more nicotine dependent women probably showed lower adherence to NRT because they relapsed to smoking more quickly. The interaction between nicotine-containing patches and adherence for cessation suggests that the association between adherence with nicotine patches and cessation may be partly causal.Implications:This study used placebo randomized controlled trial data to investigate both associations between women’s characteristics and adherence to NRT patch treatment, and the relationship between adherence to NRT patch treatment and odds of cessation in pregnant quitters. Greater adherence was seen with NRT patches, and greater adherence with NRT patches increased the odds of smoking cessation. A likely explanation for findings is that NRT patches, if used sufficiently, may be effective for at least some pregnant women who try to stop smoking. Trials testing interventions which encourage women’s adherence to higher dose NRT are indicated.

Outcomes of a One-Time Telephone Intervention for Smoking Cessation in Adults.

Tobacco use is the single greatest cause of disease and premature death in America today. To address this major public health concern, states are required to provide smoking cessation services. The purpose of this article is to examine the effectiveness of a one-time telephone adult smoking cessation program designed by a certified addictions registered nurse-advanced practice and conducted over an 11-month period by the State of Nevada. Specifically, the program included a telephone-based counseling session and distribution of a 2-week supply of nicotine replacement therapy patches. The sample population consisted of 1471 Nevada residents, men and women, aged 18 years and over who called the Quitline for smoking cessation help. All participants in the program provided consent for a follow-up call to report on their quit rates and satisfaction with the intervention at 7 months postintervention. Although everyone who participated in the interventions was called, only 373 (25.4%) were actually reached via telephone contact. Of this group, quit rates showed that 34.6% reported continuous abstinence at 7 months, whereas 35.1% were abstinent at the 7-day point prevalence and 31.9% were abstinent at the 30-day point prevalence. Patient satisfaction with the program revealed that 87.6% (n = 373) of the participants reported being very or mostly satisfied. This program evaluation study shows that short-duration telephone counseling plus nicotine replacement therapy was associated with helping at least one third of the participants to quit using tobacco for all of the prevalence points-7 and 30 days and at 7 months postintervention.

Constituents of smoke from cigarettes made from diverted nicotine replacement therapy patches.

Anecdotes of nicotine replacement therapy patch misuse associated with the introduction of smoke-free prisons have been reported by media internationally, including Canada in 2006, New Zealand in 2011 and Australia in 2014. This study identifies chemical compounds released through diverted nicotine replacement therapy patches when they are smoked. Two samples were produced: (i) shredded 21 mg nicotine replacement therapy patches rolled with tea leaves into a cigarette; and (ii) patches boiled in water and tea leaves, and then dried tea leaves rolled into a cigarette. The smoke was tested for nicotine, caffeine and toxins. High-performance liquid chromatography, mass spectrometry and spectrophotometry were used to detect the presence and quantity of nicotine and caffeine. A specialised laboratory was contracted to test the presence of toxins. Nicotine was liberated when the two samples were burnt but not if the nicotine replacement therapy patches were boiled in water alone. High concentrations of formaldehyde, acetaldehyde, acrolein, toluene, xylene and heavy metals were also released. Nicotine is released when diverted nicotine replacement therapy patches are smoked, as are caffeine and harmful toxins. These toxins have the potential to cause short- and long-term health damage.

The Nicotine Metabolite Ratio in Pregnancy Measured by trans-3'-Hydroxycotinine to Cotinine Ratio: Characteristics and Relationship With Smoking Cessation.

Nicotine replacement therapy (NRT) helps nonpregnant smokers quit, but there is no evidence that standard dose NRT is effective in pregnancy. As nicotine metabolism increases in pregnancy, this could reduce NRT efficacy. Using the ratio of trans-3'-hydroxycotinine to cotinine, the nicotine metabolite ratio (NMR), we investigated relationships between the rate of nicotine metabolism, maternal characteristics and smoking cessation in pregnant women recruited to a randomized controlled trial of NRT. Data from 1,050 pregnant smokers in the Smoking, Nicotine and Pregnancy trial who were of 12-24 weeks gestation had exhaled carbon monoxide readings of ≥8 ppm at recruitment and who were randomized to NRT or placebo patches were used. Linear and logistic regression investigated associations between maternal characteristics and NMR and also between NMR and subsequent validated cessation from smoking. Six hundred and sixty-two women (63%) provided blood samples for NMR estimation. Higher NMR was associated with increased cigarette consumption prior to pregnancy. At 1 month (odds ratio [OR] = 0.87; 95% CI = 0.76-0.99; p = .043) and delivery (OR = 0.79; 95% CI = 0.66-0.95; p = .010), there was a significant negative association between a 0.1 unit increase in NMR and odds of achieving cessation after adjusting for possible confounders. There was no evidence for an interaction between a 0.1 unit increase in NMR and treatment assignment on the odds of cessation at 1 month post-quit date (p = .556). Pregnant women who metabolize nicotine more rapidly are less likely to achieve cessation when they try to quit smoking. There is no evidence that NRT is more effective in women who metabolize nicotine more slowly.

Importance of national context in the translation of personalised treatments for smoking cessation

Caryn Lerman and colleagues1 present the results of a placebo-controlled randomised trial of two smoking cessation treatments, nicotine replacement therapy patch and varenicline, in a sample of adult, daily smokers. Participants were stratified within each treatment group according to a biomarker of nicotine metabolism, the nicotine metabolite ratio (NMR; 3-hydroxycotinine:cotinine). The NMR reflects the rates of nicotine and cotinine metabolism, which are affected primarily by the activity of the CYP2A6 enzyme, which is itself affected by genetic and environmental factors.

Cost-Effectiveness of Nicotine Patches for Smoking Cessation in Pregnancy: A Placebo Randomized Controlled Trial (SNAP).

Smoking during pregnancy is the most important, preventable cause of adverse pregnancy outcomes including miscarriage, premature birth, and low birth weight with huge financial costs to the National Health Service. However, there are very few published economic evaluations of smoking cessation interventions in pregnancy and previous studies are predominantly U.S.-based and do not present incremental cost-effectiveness ratios (ICER). A number of studies have demonstrated cost-effectiveness of nicotine replacement therapy (NRT) in the general population, but this has yet to be tested among pregnant smokers. A cost-effectiveness analysis was undertaken alongside the smoking, nicotine, and pregnancy trial to compare NRT patches plus behavioral support to behavioral support alone, for pregnant women who smoked. At delivery, biochemically verified quit rates were slightly higher at 9.4% in the NRT group compared to 7.6% in the control group (odds ratio = 1.26, 95% CI = 0.82-1.96), at an increased cost of around £90 per participant. Higher costs in the NRT group were mainly attributable to the cost of NRT patches (mean = £46.07). The incremental cost-effectiveness ratio associated with NRT was £4,926 per quitter and a sensitivity analysis including only singleton births yielded an ICER of £4,156 per quitter. However, wide confidence intervals indicated a high level of uncertainty. Without a specific willingness to pay threshold, and due to high levels of statistical uncertainty, it is hard to determine the cost-effectiveness of NRT in this population. Furthermore, future research should address compliance issues, as these may dilute any potential effects of NRT, thus reducing the cost-effectiveness.

Comparison of cotinine levels in pregnant women while smoking and when using nicotine replacement therapy.

Background:Nicotine replacement therapy (NRT) helps smokers quit smoking, but trials indicate that there is no evidence that it is effective during pregnancy. As metabolism increases during pregnancy, NRT may deliver insufficient nicotine to alleviate withdrawal symptoms. There is mixed evidence as to what levels of cotinine are reached from nicotine exposure during pregnancy while using NRT compared with smoking.Methods:We analyzed data on 33 pregnant participants from the NRT arm of a randomized control trial who had stopped smoking and were still using 15mg/16hr nicotine patches 1 month after quitting. Salivary cotinine levels when smoking at baseline were compared with levels on NRT at 1 month using the Wilcoxon test.Results:Cotinine levels were a median of 98.5ng/ml while smoking and 62.8ng/ml while using NRT and remaining abstinent (p = .045). Participants with the highest cotinine measurements when smoking also tended to have the steepest reduction in cotinine levels while using NRT. This was most noticeable among participants with baseline cotinine levels more than 150ng/ml (n = 9) who had a greater reduction in median cotinine levels (median difference −134.8ng /ml [95% CI = −144.5 to −125.9]) than those with a baseline cotinine level under 150ng/ml (n = 24; median difference −27.9ng/ml [95% CI = −49.35 to −1.75]).Conclusions:In a pragmatic trial that replicated clinical practice, cotinine levels generated using NRT during pregnancy were lower than levels achieved from smoking. Although the sample size of this study was small, our findings are significant and are consistent with the hypothesis that NRT patches deliver an inadequate dose of nicotine to aid smoking cessation during pregnancy.

Association between nicotine replacement therapy use in pregnancy and smoking cessation

BackgroundThere is an urgent need to find better ways of helping pregnant smokers to stop. Randomized controlled trials (RCTs) have not detected an effect of nicotine replacement therapy (NRT) for smoking cessation in pregnancy. This may be because of inadequate dosing because of faster nicotine metabolism in this group. In England, many pregnant smokers use single form and combination NRT (patch plus a faster acting form). This correlational study examined whether the latter is associated with higher quit rates. MethodsRoutinely collected data from 3880 pregnant smokers attempting to stop in one of 44 Stop Smoking Services in England. The outcome measure was 4-week quit rates, verified by expired-air carbon monoxide level<10ppm. Outcome was compared between those not using medication versus using single form NRT (patch or one of the faster acting forms), or combination NRT. Potential confounders were intervention setting (specialist clinic, home visit, primary care, other), intervention type (one-to-one, group, drop-in, other), months pregnant, age, ethnicity and occupational group in multi-level logistic regressions. ResultsAfter adjustment, combination NRT was associated with higher odds of quitting compared with no medication (OR=1.93, 95% CI=1.13–3.29, p=0.016), whereas single NRT showed no benefit (OR=1.06, 95% CI=0.60–1.86, p=0.84). ConclusionsUse of a combination of nicotine patch and a faster acting form may confer a benefit in terms of promoting smoking cessation during pregnancy. While this conclusion is based on correlational data, it lends support to continuing this treatment option pending confirmation by an RCT.

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

Neuropsychiatric events in varenicline and nicotine replacement patch users in the Military Health System

To determine the rate ratio of neuropsychiatric hospitalizations in new users of varenicline compared to new users of nicotine replacement therapy (NRT) patch in the Military Health System (MHS). Varenicline (n = 19,933) and NRT patch (n = 15,867) users who initiated therapy from 1 August 2006 to 31 August 2007 within the MHS were included in this retrospective cohort study. After matching according to propensity scores, 10,814 users remained in each cohort. The study population included those with and without a history of neuropsychiatric disease. Patients were followed for neuropsychiatric hospitalizations defined by primary neuropsychiatric discharge diagnosis using ICD-9 codes from in-patient administrative claims. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated after propensity score matching on exposure for socio-demographic factors, health-care utilization, comorbidities, medication history and neuropsychiatric history. There was no increase in the rate of neuropsychiatric hospitalizations in patients treated with varenicline compared to NRT patch when followed for 30 days (propensity-score matched HR = 1.14, 95% CI: 0.56-2.34). Results were similar after 60 days of follow-up. There does not appear to be an increase in neuropsychiatric hospitalizations with varenicline compared with nicotine replacement therapy patch over 30 or 60 days after drug initiation.

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

Coleman, Tim*; Cooper, Sue*; Thornton, James G.†; Grainge, Matthew J.‡; Watts, Kim§; Britton, John‡; Lewis, Sarah‡ and For the Smoking Nicotine and Pregnancy (SNAP) Trial Team Author Information

Comparisons of high-dose and combination nicotine replacement therapy, varenicline, and bupropion for smoking cessation: A systematic review and multiple treatment meta-analysis

Aim. This review compared the effect of high-dose nicotine replacement therapy (NRT) and combinations of NRT for increasing smoking abstinence rates compared to standard-dose NRT patch, varenicline, and bupropion on smoking abstinence.Methods. Ten electronic databases were searched (up to January 2012) for randomized controlled trials (RCT) of standard-dose (≤ 22 mg) or high-dose nicotine patch therapy (> 22 mg), combination NRT (e.g. nicotine patch + nicotine inhaler), bupropion, and varenicline. Analysis consisted of random-effects pairwise meta-analysis and a Bayesian multiple treatment comparison (MTC).Results. We identified 146 RCTs (65 standard-doses of the nicotine patch (≤ 22 mg); 6 high-dose NRT patch (> 22 mg); 5 high versus standard-dose NRT patch; 5 combination NRT versus inert controls; 6 combination versus single NRT patch; 48 bupropion; and 11 varenicline). The MTC found that all therapies offered treatment benefits at most time points over controls. Combination NRT and higher-dose NRT did not demonstrate consistent effects over other interventions. With the exception of varenicline, the benefits of treatments over standard-dose NRT were not retained in the long term.Conclusions. All pharmacologic treatments were significantly more effective than inert controls. Varenicline was the only treatment demonstrating effects over other options. These results should be considered in the development of clinical practice guidelines.

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. The authors investigated the efficacy and safety of nicotine patches during pregnancy.

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.

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

BackgroundNicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy.MethodsWe recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes.ResultsOf 1050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups.ConclusionsAdding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN07249128.)

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

A Randomized Trial of Nicotine-Replacement Therapy Patches in Pregnancy

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)