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Neal L. Benowitz - One of the best experts on this subject based on the ideXlab platform.
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a randomized trial of Nicotine Nasal Spray in adolescent smokers
Pediatrics, 2008Co-Authors: Mark L Rubinstein, Glenna M Auerback, Neal L. Benowitz, Anna-barbara MoscickiAbstract:OBJECTIVES. Nicotine Nasal Spray has been 1 of the most successful forms of Nicotine-replacement therapy in adult populations. The Nasal Sprayer has not been studied in adolescent smokers. The objective of this pilot study was to determine the feasibility and utility of using Nicotine Nasal Spray for adolescent smokers who wanted to quit smoking. METHODS. Forty adolescent smokers who were between 15 and 18 years of age and smoked ≥5 cigarettes daily for at least 6 months were recruited from several San Francisco Bay area schools from 2005 to 2007. Using a randomized, open-label, 12-week trial, adolescent smokers were assigned to receive either weekly counseling alone (control) for 8 weeks or 8 weeks of counseling along with 6 weeks of Nicotine Nasal Spray. Self-reported smoking abstinence was verified by both expired-air carbon monoxide and salivary cotinine. RESULTS. There was no difference in cessation rates, the numbers of cigarettes smoked per day, or cotinine levels at 12 weeks. Fifty-seven percent of participants stopped using their Spray after only 1 week. The most commonly reported adverse effect was Nasal irritation and burning (34.8%) followed by complaints about the taste and smell (13%). CONCLUSIONS. The unpleasant adverse effects, poor adherence, and consequent lack of efficacy observed in our pilot study do not support the use of Nicotine Nasal Spray as an adjunct to counseling for adolescent smokers who wish to quit.
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Nicotine cotinine withdrawal and craving patterns during smoking and Nicotine Nasal Spray use results from a pilot study with african american men
Nicotine & Tobacco Research, 2007Co-Authors: Patricia L Mabry, Janet A Tooze, Richard P Moser, Erik M Augustson, Robert J Malcolm, Neal L. BenowitzAbstract:Nicotine intake via smoking is highly variable. Individualized dosing of Nicotine replacement therapy (NRT) may improve product efficacy, but a better understanding of the within-day and within-subject relationships between smoking, NRT use, Nicotine and cotinine concentrations in blood, and cravings and withdrawal symptoms is needed to inform dosing algorithms. A pilot study was undertaken to collect data on these relationships and to assess the feasibility of the methods needed for this type of research, including a sophisticated statistical modeling technique (a two-part mixed-effects model with correlated random effects that accounts for clumping at zero). Because Nicotine metabolism varies by gender and race, the sample was homogeneous with respect to these characteristics. In a within-subjects study, 27 African American adult male smokers carried a computerized cigarette dispenser for 1 week, capturing the time each cigarette was smoked. Subjects then entered an inpatient setting for 1 day of scheduled smoking (matched to data from the cigarette dispenser to create an ecologically valid schedule) and 4 days of ad libitum Nicotine Nasal Spray use, while tobacco abstinent. Eight times per day, at 2-hour intervals, blood was drawn and ratings of cigarette cravings and withdrawal symptoms were obtained. On average, subjects used less than half of the manufacturer's recommended minimum daily dose of Nicotine Nasal Spray. Large differences in Nicotine and cotinine levels were observed between individuals. When predicting Nicotine, cotinine, withdrawal, and cravings, we observed significant interactions between route of Nicotine intake and a variety of independent variables.
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individualizing Nicotine replacement therapy for the treatment of tobacco dependence a randomized trial
Annals of Internal Medicine, 2004Co-Authors: Caryn Lerman, Vyga Kaufmann, Margaret Rukstalis, Kenneth A Perkins, Janet Audrainmcgovern, Freda Patterson, Neal L. BenowitzAbstract:Background: Despite the well-documented efficacy and different pharmacokinetic and pharmacodynamic properties of different forms of Nicotine replacement therapy, empirical data are insufficient to guide practitioners in selecting a particular form of treatment for individual patients with tobacco dependence. Objective: To evaluate the comparative efficacy of transdermal Nicotine and Nicotine Nasal Spray and identify predictors of treatment outcome. Design: Randomized, open-label clinical trial with a 6-month follow-up period. Setting: 2 university-based smoking cessation research programs. Participants: 299 treatment-seeking smokers who were followed for 6 months after the target quit date. Intervention: Behavioral group counseling and 8 weeks of therapy with Nicotine Nasal Spray or transdermal Nicotine. Measurements: Demographic characteristics, smoking history, depression symptoms, and body mass index were measured at baseline. Smoking practices were biochemically verified at the end of treatment and at 6 months after the target quit date. Results: Abstinence rates for the transdermal Nicotine and Nicotine Nasal Spray groups were not significantly different at 6-month follow-up (15.0% vs. 12.2%, respectively; P> 0.2). Interactions in abstinence rates for subgroups of smokers were statistically significant (P < 0.05). Smokers who had low to moderate dependence levels, were not obese, and were white achieved higher abstinence rates with transdermal Nicotine, whereas smokers who were highly dependent, obese, or members of minority groups achieved higher abstinence rates with Nasal Spray. Limitations: The subgroup findings need confirmation in additional large studies before they are routinely applied. Conclusions: Ethnicity, weight, and level of Nicotine dependence may help identify smokers who have greater or lesser abstinence rates with either transdermal or Nasal Spray Nicotine.
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the functional mu opioid receptor oprm1 asn40asp variant predicts short term response to Nicotine replacement therapy in a clinical trial
Pharmacogenomics Journal, 2004Co-Authors: Caryn Lerman, Vyga Kaufmann, Margaret Rukstalis, Janet Audrainmcgovern, Freda Patterson, E P Wileyto, Stephanie Restine, Peter G Shields, David T Redden, Neal L. BenowitzAbstract:To determine whether the functional mu-opioid receptor (OPRM1) Asn40Asp variant predicts the comparative efficacy of different forms of NRT, we conducted a clinical trial of transdermal Nicotine (TN) vs Nicotine Nasal Spray (NS) in 320 smokers of European ancestry. Smokers carrying the OPRM1 Asp40 variant (n=82) were significantly more likely than those homozygous for the Asn40 variant (n=238) to be abstinent at the end of treatment, and reported less mood disturbance and weight gain. The genotype effect on treatment outcome was most pronounced among smokers receiving TN, particularly during the 21 mg dose phase. Smokers who carry the OPRM1 Asp40 variant are likely to have a favorable response to TN and may benefit from extended therapy with the 21 mg dose.
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arteriovenous differences in plasma concentration of Nicotine and catecholamines and related cardiovascular effects after smoking Nicotine Nasal Spray and intravenous Nicotine
Clinical Pharmacology & Therapeutics, 1997Co-Authors: Steven G Gourlay, Neal L. BenowitzAbstract:Background and objectives Delivery of a high concentration bolus of Nicotine through the arterial circulation is believed to be an important determinant of the addictive, behavioral, and physiologic effects of Nicotine. To better understand the pharmacologic features of Nicotine with different routes of administration, we measured arterial and venous plasma concentrations of Nicotine, cotinine, epinephrine, and norepinephrine after tobacco smoking, intravenous Nicotine infusion, and use of a Nicotine Nasal Spray. Subjects and methods Arterial and venous blood samples were drawn simultaneously from 12 male smokers. Six subjects received a single dose of 1 mg Nicotine Nasal Spray, and six subjects smoked cigarettes, one puff per minute for 10 minutes. All 12 subjects were administered Nicotine as a 30-minute infusion beginning 70 minutes after administration of the Nicotine Nasal Spray or commencement of smoking. Results The mean peak arterial plasma concentrations of Nicotine (Cmax) after smoking or administration of Nicotine Nasal Spray, or intravenous Nicotine averaged twofold those of venous plasma. For Nicotine Nasal Spray, the time to Cmax was much faster for arterial than for venous plasma (median, 5 versus 18 minutes, p < 0.01). Intravenous Nicotine produced the greatest increase in plasma epinephrine concentration, although smoking had a greater chronotropic effect. Acute tolerance to the chronotropic effects of Nicotine was suggested at pharmacodynamic analysis with venous Nicotine concentrations, whereas analysis of arterial concentrations found the opposite—a time lag between plasma concentration and effect. Conclusion Nicotine is rapidly absorbed from Nicotine Nasal Spray. The Cmax of Nicotine after smoking or administration of Nicotine Nasal Spray, or intravenous Nicotine is substantially higher in arterial than venous plasma. Acute tolerance to the chronotropic effects of Nicotine is not apparent if arterial plasma concentrations are measured. Clinical Pharmacology & Therapeutics (1997) 62, 453–463; doi:
Edward F Domino - One of the best experts on this subject based on the ideXlab platform.
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Nicotine effects on regional cerebral blood flow in awake, resting tobacco smokers. Synapse 38: 313–321
2000Co-Authors: Edward F Domino, Robert A Koeppe, Satoshi Minoshima, Sally Guthrie, Linda Ohl, Jon Kar ZubietaAbstract:15 water ABSTRACT The hypothesis for this research was that regional cerebral blood flow (rCBF) would increase following Nasal Nicotine administration to overnight abstinent tobacco smokers in relationship to the known brain distribution of nicotinic cholinergic receptors (nAChRs). Nine male and nine female healthy adult smokers were studied. They abstained overnight from tobacco products for 10 or more hours prior to study the next morning. Nicotine Nasal Spray was given in doses of 1–2.5 mg total with half in each nostril while the subject was awake and resting in a supine position. Oleoresin of pepper solution in a similar volume was used as an active placebo to control for the irritating effects of Nicotine. Both substances were given single blind to the subjects. Positron emission tomography (PET) with H2 15O was used to measure rCBF. The data from each subject volunteer were normalized to global activity to better assess regional brain changes. Both Nasal Nicotine and pepper Spray produced similar increases in CBF in somesthetic area II, consistent with the irritant effects of both substances. The mea
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arterial venous plasma Nicotine concentrations following Nicotine Nasal Spray
European Journal of Clinical Pharmacology, 1999Co-Authors: Sally K Guthrie, Jon Kar Zubieta, L E Ohl, Robert A Koeppe, Satoshi Minoshima, Edward F DominoAbstract:Background and objectives: Arterial (A) and venous (V) plasma Nicotine and cotinine concentrations were measured after Nasal Nicotine Spray in tobacco smokers of both genders. The hypothesis for this research was that a greater A/V difference in plasma Nicotine would be present in males than females because males have greater skeletal muscle mass to bind Nicotine.
Tim Lancaster - One of the best experts on this subject based on the ideXlab platform.
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Nicotine replacement therapy versus control for smoking cessation
Cochrane Database of Systematic Reviews, 2018Co-Authors: Jamie Hartmannboyce, Samantha C. Chepkin, Chris Bullen, Tim LancasterAbstract:© 2018 The Cochrane Collaboration. Background: Nicotine replacement therapy (NRT) aims to temporarily replace much of the Nicotine from cigarettes to reduce motivation to smoke and Nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. Objectives: To determine the effectiveness and safety of Nicotine replacement therapy (NRT), including gum, transdermal patch, intraNasal Spray and inhaled and oral preparations, for achieving long-term smoking cessation, compared to placebo or 'no NRT' interventions. Search methods: We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of Nicotine replacement therapy in the title, abstract or keywords. Date of most recent search is July 2017. Selection criteria: Randomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow-up of less than six months, except for those in pregnancy (where less than six months, these were excluded from the main analysis). We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews. Data collection and analysis: Screening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model. Main results: We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for Nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for Nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for Nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for Nicotine Nasal Spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. A subset of six trials conducted in pregnant women found a statistically significant benefit of NRT on abstinence close to the time of delivery (RR 1.32, 95% CI 1.04 to 1.69; 2129 participants); in the four trials that followed up participants post-partum the result was no longer statistically significant (RR 1.29, 95% CI 0.90 to 1.86; 1675 participants). Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare. Authors' conclusions: There is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, Nasal Spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations.
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Nicotine replacement therapy versus control for smoking cessation
Cochrane Database of Systematic Reviews, 2018Co-Authors: Jamie Hartmann-boyce, Samantha C. Chepkin, Weiyu Ye, Chris Bullen, Tim LancasterAbstract:BACKGROUND: Nicotine replacement therapy (NRT) aims to temporarily replace much of the Nicotine from cigarettes to reduce motivation to smoke and Nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. OBJECTIVES: To determine the effectiveness and safety of Nicotine replacement therapy (NRT), including gum, transdermal patch, intraNasal Spray and inhaled and oral preparations, for achieving long-term smoking cessation, compared to placebo or 'no NRT' interventions. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of Nicotine replacement therapy in the title, abstract or keywords. Date of most recent search is July 2017. SELECTION CRITERIA: Randomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow-up of less than six months, except for those in pregnancy (where less than six months, these were excluded from the main analysis). We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews. DATA COLLECTION AND ANALYSIS: Screening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model. MAIN RESULTS: We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for Nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for Nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for Nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for Nicotine Nasal Spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. A subset of six trials conducted in pregnant women found a statistically significant benefit of NRT on abstinence close to the time of delivery (RR 1.32, 95% CI 1.04 to 1.69; 2129 participants); in the four trials that followed up participants post-partum the result was no longer statistically significant (RR 1.29, 95% CI 0.90 to 1.86; 1675 participants). Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare. AUTHORS' CONCLUSIONS: There is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, Nasal Spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations.
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Nicotine replacement therapy for smoking cessation
Cochrane Database of Systematic Reviews, 2012Co-Authors: Lindsay F Stead, Chris Bullen, Rafael Perera, David Mant, Jamie Hartmannboyce, Kate Cahill, Tim LancasterAbstract:BACKGROUND: The aim of Nicotine replacement therapy (NRT) is temporarily to replace much of the Nicotine from cigarettes to reduce motivation to smoke and Nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. OBJECTIVES: 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, Nasal Spray, 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. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group trials register for papers with 'Nicotine' or 'NRT' in the title, abstract or keywords. Date of most recent search July 2007. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: We identified 132 trials; 111 with over 40,000 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The RR of abstinence for any form of NRT relative to control was 1.58 (95% confidence interval [CI] : 1.50 to 1.66). The pooled RR for each type were 1.43 (95% CI: 1.33 to 1.53, 53 trials) for Nicotine gum; 1.66 (95% CI: 1.53 to 1.81, 41 trials) for Nicotine patch; 1.90 (95% CI: 1.36 to 2.67, 4 trials) for Nicotine inhaler; 2.00 (95% CI: 1.63 to 2.45, 6 trials) for oral tablets/lozenges; and 2.02 (95% CI: 1.49 to 3.73, 4 trials) for Nicotine Nasal Spray. 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. Only one study directly compared NRT to another pharmacotherapy. In this study quit rates with Nicotine patch were lower than with the antidepressant bupropion. AUTHORS' CONCLUSIONS: 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 50-70%, 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.
Richard D Hurt - One of the best experts on this subject based on the ideXlab platform.
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comparison of Nicotine patch alone versus Nicotine Nasal Spray alone versus a combination for treating smokers a minimal intervention randomized multicenter trial in a nonspecialized setting
Nicotine & Tobacco Research, 2003Co-Authors: Gary A Croghan, Ivana T Croghan, Richard D Hurt, Jeff A Sloan, Paul J Novotny, Wanda L Dekrey, James A Mailliard, Larry P Ebbert, Debra Swan, Daniel J WalshAbstract:This multicenter, randomized, open-label clinical trial was conducted to determine whether the combined use of Nicotine patch therapy and a Nicotine Nasal Spray would improve smoking abstinence rates compared to either treatment alone, without behavioral counseling. Data were collected at 15 regional cancer control oncology centers within the North Central Cancer Treatment Group. Of the 1384 smokers randomized to the study, 20% were abstinent from smoking at 6 weeks and 8% were abstinent at 6 months. At 6 weeks, the 7-day point prevalence smoking abstinence rate for the patch alone (21.1%) was superior to the Spray (13.6%) but was significantly lower than the rate for combination therapy (27.1%). At 6 months, the 7-day point prevalence abstinence rates were not significantly different among the three groups. Combination Nicotine Nasal Spray and Nicotine patches were delivered safely in a nonspecialized outpatient clinical setting and enhanced short-term smoking abstinence rates, but these rates were not sustained at 6 months.
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temporal effects of Nicotine Nasal Spray and gum on Nicotine withdrawal symptoms
Psychopharmacology, 1998Co-Authors: Richard D Hurt, Lowell C Dale, Ivana T Croghan, Gary A Croghan, Kenneth P Offord, Leigh C Gomezdahl, Troy D Wolter, Thomas P MoyerAbstract:Nicotine Nasal Spray and Nicotine gum have been found to be effective in relieving Nicotine withdrawal symptoms. In this randomized single-blind study, 91 cigarette smokers were randomly assigned to a single 1 mg dose of active Nicotine Nasal Spray (n = 29), active 4 mg Nicotine gum (n = 31), saline placebo Nasal Spray (n = 16) or placebo gum (n = 15). Following overnight abstinence, subjects repeatedly completed visual analog scales for assessing Nicotine withdrawal symptoms over 30 min preceding (time -30 min to time 0) and 120 min following a single dose of study medication. This sequence was performed 3 times during the day. Nicotine withdrawal symptoms were assessed on a 41-point visual analog scale (1 = no withdrawal, 41 = extreme withdrawal). At the initial session only, blood samples for serum Nicotine levels were taken at baseline, then at 5, 10, 30 and 120 min following study drug administration. The mean (± SD) age of the subjects was 38.6 (±10.1) years, 48% were females, smoking rate was 24.5 (±7.8) cigarettes per day, and years of smoking was 19.9 (±10.0). A single 1 mg dose of Nicotine Nasal Spray provided more immediate relief for craving for a cigarette compared to a single 4 mg dose of Nicotine gum. Serum venous Nicotine levels for the active Nicotine Nasal Spray and Nicotine gum were comparable at 5 and 10 min while the levels were higher for Nicotine gum at 30 and 120 min. Changes in withdrawal symptoms were not found to be related to serum venous Nicotine levels. Our findings provide a rationale for the as needed use of Nicotine Nasal Spray to control withdrawal symptoms, possibly in combination with other medications with longer acting effects.
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Nicotine Nasal Spray for Smoking Cessation: Pattern of Use, Side Effects, Relief of Withdrawal Symptoms, and Cotinine Levels
Mayo Clinic proceedings, 1998Co-Authors: Richard D Hurt, Lowell C Dale, Ivana T Croghan, Leigh C. Gomez-dahl, Gary A Croghan, Kenneth P OffordAbstract:• Objective To determine the extent of side effects during the initial use of Nicotine Nasal Spray for smoking cessation. • Design We performed a one-sample, noncomparative, open-label evaluation of the pattern of use, side effects, relief of withdrawal symptoms, and cotinine levels with Nicotine Nasal Spray. • Material and Methods Adult smokers were recruited to use the Nicotine Nasal Spray for smoking cessation at a dosage of 1 to 2 mg/h. Subjects completed daily diaries, which included an assessment of Nicotine withdrawal symptoms, previously reported irritant effects of the Nicotine Nasal Spray, and symptoms of Nicotine toxicity. A plasma cotinine level was measured at baseline and at day 7 for calculation of percentage replacement. • Results The mean age of the 50 study subjects was 43.7 years, 46% were women, and the mean baseline smoking rate was 28.5 cigarettes per day. We found an increase in five symptoms (runny nose, Nasal irritation, throat irritation, watering eyes, and sneezing) that had been essentially absent before initiation of use of the Nicotine Nasal Spray. All but throat irritation decreased significantly during days 0 through 7 of the study. The mean daily frequency of Nicotine Nasal Spray use for the first week was 15.0 doses. Use of the Nasal Spray decreased significantly (P • Conclusion Although Nicotine Nasal Spray causes substantial irritant side effects during the first few days of use, these adverse effects decrease significantly within the first week. Despite these side effects, subjects continued to use the Nicotine Nasal Spray and experienced a high rate of initial abstinence from smoking.
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plasma nitric oxide before and after smoking cessation with Nicotine Nasal Spray
The Journal of Clinical Pharmacology, 1998Co-Authors: Virginia M Miller, Ivana T Croghan, Kenneth P Offord, Debra A Lewis, Kevin S Rud, Richard D HurtAbstract:Nicotine may affect cardiovascular function through release of neurotransmitters from autonomic nerves or release of vasoactive substances from the vascular endothelium. Nitric oxide is a neurotransmitter and endothelium-derived factor that reduces tone of vascular smooth muscle. Experiments were designed to determine whether or not use of Nicotine Nasal Spray for smoking cessation affects plasma levels of nitric oxide. Forty smokers self-administered Nicotine by Nasal Spray (one 0.5 mg Spray to each nostril). Blood samples were taken before the use of the Nasal Spray and at treatment day 7 for the measurement of cotinine by high pressure liquid chromatography and nitric oxide (NOx) by chemiluminescence. Age-comparable controls were never-smokers nonNicotine users recruited from laboratory personnel. Mean plasma concentrations of NOx from smokers before treatment were significantly greater compared with nonsmokers (23 +/- 10, n = 40 and 15 +/- 6, n = 13 nmoles/mL [mean +/- SD], respectively, P 0.05) but was positively and linearly correlated with plasma cotinine (r2 = 0.13, P < 0.02). In 32 self-reported abstinent smokers (confirmed by expired carbon monoxide < 9 ppm) using Nicotine Nasal Spray, cotinine decreased by 64% from pretreatment levels of 284 +/- 103 to posttreatment levels of 90 +/- 58 ng/mL. Plasma NOx was unchanged and went from 23.0 +/- 10.1 at pretreatment to 21 +/- 12 nmoles/mL with Nicotine treatment. These results suggest that Nicotine-use, independent of cigarette smoking, affects plasma NOx.
Ake Westin - One of the best experts on this subject based on the ideXlab platform.
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Effect of smoking reduction and cessation on cardiovascular risk factors. Nicotine Tob Res 3:249–55
2001Co-Authors: Ake Westin, Agneta Hjalmarson, Department Of Medicine, Göteborg Elisabeth Kruse, Pharmacia Consumer Healthcare, Elisabeth KruseAbstract:This open study examined the effect of smoking reduction and smoking cessation on established cardiovascular risk factors. Fifty-eight healthy adult smokers (smoking 15 cigarettes/day for at least 3 years) were provided with Nicotine Nasal Spray (to be used ad libitum) and asked to stop smoking. The primary goal during the first 8 weeks, however, was to reduce their daily smoking by at least 50%. Subjects were then followed for another 8 weeks; at this point, 33 participants had successfully stopped smoking. Cardiovascular risk factors including fibrinogen, hemoglobin, hematocrit, triglycerides, and cholesterol were measured at baseline and at 9 and 17 weeks. After 8 weeks of smoking reduction, the mean number of cigarettes smoked per day had decreased from 21.5 ± 0.6 (baseline) to 10.8 ± 0.6 (p<0.001). This was accompanied by significant improvements in fibrinogen (from 2.9 ± 0.1 g/l at baseline to 2.6 ± 0.1 g/l, p = 0.011), white blood cells (from 7.0 ± 0.4 to 6.2 ± 0.3 3 109/l, p = 0.005) and the high-density/low-density lipoprotein (HDL/LDL) ratio (0.33 ± 0.03 to 0.37 ± 0.03, p<0.005). Following 8 weeks of abstinence from smoking, the mean white blood cell count was further reduced (to 6.1 ± 0.3 3 109/l, p = 0.026 vs. baseline) and there were also significant improvements in HDL (from 1.16 ± 0.06 mmol/l at baseline to 1.32 ± 0.06, p<0.001) and LDL (from 3.78 ± 0.16 mmol/l at baseline to 3.52 ± 0.17, p = 0.015). In conclusion, 8 weeks of smoking reduction resulted in clinically significant improvements in established cardiovascular risk factors. These improvements were even greater after an additional period of abstinence from smoking
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Nicotine Nasal Spray with Nicotine patch for smoking cessation randomised trial with six year follow up
BMJ, 1999Co-Authors: Thorsteinn Blondal, Ingileif Olafsdottir, Gunnar Gustavsson, Larus J Gudmundsson, Ake WestinAbstract:# Nicotine Nasal Spray with Nicotine patch for smoking cessation: randomised trial with six year follow up {#article-title-2} Objective : To evaluate the efficacy of using a Nicotine patch for 5 months with a Nicotine Nasal Spray for 1 year. Design : Placebo controlled, double blind trial. Setting : Reykjavik health centre. Subjects : 237 smokers aged 22-66 years living in or around Reykjavik. Interventions : Nicotine patch for 5 months with Nicotine Nasal Spray for 1 year (n=118) or Nicotine patch with placebo Spray (n=119). Treatment with patches included 15 mg of Nicotine for 3 months, 10 mg for the fourth month, and 5 mg for the fifth month, whereas Nicotine in the Nasal Spray was available for up to 1 year. Both groups received supportive treatment. Main outcome measure : Sustained abstinence from smoking. Results : The log rank test for 6 years (χ2=8.5, P=0.004) shows a significant association between abstinence from smoking and type of treatment. Sustained abstinence rates for the patch and Nasal Spray group and patch only group were 51% v 35% after 6 weeks (P=0.011 (χ 2), 95% confidence interval 1.17% to 3.32%), 37% v 25% after 3 months (P=0.045, 1.01% to 3.08%), 31% v 16% after 6 months (P=0.005, 1.27% to 4.50%), 27% v 11% after 12 months (P=0.001, 1.50% to 6.14%), and 16% v 9% after 6 years (P=0.077, 0.93% to 4.72%). Conclusions : Short and long term abstinence rates show that the combination of using a Nicotine patch for 5 months with a Nicotine Nasal Spray for 1 year is a more effective method of stopping smoking than using a patch only. The low percentage of participants using the Nasal Spray at 1 year, and the few relapses during the second year, suggest that it is not cost effective to use a Nasal Spray for longer than 7 months after stopping a patch. # Commentary: Progress on Nicotine replacement therapy for smokers {#article-title-20}
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a double blind randomized trial of Nicotine Nasal Spray as an aid in smoking cessation
European Respiratory Journal, 1997Co-Authors: Thorsteinn Blondal, Mikael Franzon, Ake WestinAbstract:The objective of the study was to evaluate the therapeutic efficacy of Nicotine Nasal solution (NNS) for smoking cessation from the stopping day up to 3 months. We also followed the participants for 2 yrs after ceasing smoking to assess what happens after stopping using NNS. In a placebo-controlled, double-blind, 2 yr prospective study, 157 smokers were given either NNS, one dose containing 1 mg of Nicotine per 100 microL (n=79), or placebo (n=78). Treatment was continued for up to 1 yr. One day after quitting smoking, the average number of daily doses was 11 in the group assigned NNS and 14 in the group assigned the placebo, and after 6 weeks, 14 and 6 doses, respectively, among abstinent participants still using Spray. After 3 months, 65% of the abstainers in the Nicotine group were still using the NNS. The abstinence rates were 51, 39 and 29% after 6 weeks, 3 and 6 months, respectively, as compared to 24, 19 and 18% in the placebo group (p=0.0003; p=0.003; p=0.050). The proportion abstinent at the 1 yr (25 vs 17%) and 2 yr follow-ups (19 vs 14%) was higher among those assigned to the Nicotine than to the placebo group, but not significantly so for the numbers used in the study. In conclusion, the use of Nicotine Nasal Spray significantly increased the abstinence rate during the first 6 months following the quitting day.
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effect of Nicotine Nasal Spray on smoking cessation a randomized placebo controlled double blind study
JAMA Internal Medicine, 1994Co-Authors: Agneta Hjalmarson, Ake Westin, Mikael Franzon, Olov WiklundAbstract:Background: Nicotine replacement therapies have proved to be of value in smoking cessation. However, not all smokers can use the Nicotine gum or Nicotine patch owing to side effects. In addition, the absorption of Nicotine from these formulas is slow compared with smoking. A Nicotine Nasal Spray delivers Nicotine more rapidly. The objective of this study was to evaluate the efficacy and safety of the Nicotine Nasal Spray for smoking cessation. Methods: Subjects were recruited through advertisements in newspapers and among patients referred to the smoking cessation clinic at Sahlgren's Hospital, Goteborg, Sweden. Two hundred forty-eight smokers were treated in small groups with eight counseling sessions over 6 weeks. At their first group session, subjects were randomized to a group receiving Nicotine Spray (n=125), 0.5 mg of Nicotine per single Spray, or to a placebo group (n=123). The procedure was double blind. Success rates were measured up to 12 months. The nonsmoking status was verified by expired carbon monoxide less than 10 ppm. Results: Significantly more subjects in the Nicotine group were continuously abstinent for 12 months than in the placebo group (27% vs 15%; odds ratio, 2.16; 95% confidence interval, 1.15 to 4.12). Ten of the 34 abstinent subjects in the Nicotine group used the Spray for 1 year. Mild or moderate side effects were rather frequent for both Sprays, but they were significantly more for the Nicotine Spray. Subjects with high scores (> 7 ) on Fagerstrom's tolerance questionnaire had a significantly lower success rate with placebo than with the Nicotine Spray. For subjects with low scores, there was no difference. Conclusion: Nicotine Nasal Spray in combination with group treatment is an effective aid to smoking cessation. (Arch Intern Med. 1994;154:2567-2572)