This study sought to determine the relative importance of a range of Bup/Nx doses compared to Bup alone in producing subjective and reinforcing effects.Heroin-using volunteers (n = 13) were transitioned onto daily oral hydromorphone (40 mg). Laboratory sessions assessed the reinforcing and subjective effects of intravenous (IV) doses of Bup (1.51, 2.16, 6.15, and 8.64 mg) and Bup/Nx (1.51/0.44, 2.16/0.61, 6.15/1.71, and 8.64/2.44 mg). Placebo (Pbo), heroin (25 mg) and Nx (0.3 mg) were tested as neutral, positive, and negative controls, respectively.IV Bup alone was self-administered substantially less than IV heroin, though the two largest doses of Bup produced positive subjective effects, drug “Liking” (0–100 mm), which were comparable to heroin (mean difference: Heroin vs Bup 6.15 mg: −3.4 mm, Heroin vs Bup 8.64 mg: −11.3 mm). All indicators of abuse potential seen with IV Bup alone were substantially decreased with the addition of Nx. All Bup/Nx combinations produced ratings of aversive effects, “Bad”, which were comparable to, or greater than IV, Nx. On three of the four measures of aversive effects, the largest difference is seen with the 8.64 vs 8.64/2.44 condition.This study further demonstrates the ability of the Bup/Nx combination to deter IV use. Although none of the Bup/Nx combinations showed indications of abuse potential, formulations with larger absolute Nx, may be less abusable as they precipitate a greater degree of withdrawal.

INTRODUCTION:Smokers switching completely from combustible cigarettes to electronic cigarettes (e-cigarettes) are likely to reduce health risk, suggesting that e-cigarettes should be made appealing to adult smokers. However, uptake of e-cigarettes by nonsmoking teens would add risk without benefit and should be avoided. Although e-cigarette flavors may appeal to adult smokers, the concern is that flavors might attract nonsmoking teens.METHODS:Nonsmoking teens (n = 216, ages 13-17, no tobacco in past 6 months) and adult smokers (n = 432, ages 19-80, smoking 3+ years; could have used e-cigarettes) were recruited from an Internet research panel. In assessments completed online (May 22, 2014 to June 13, 2014), participants indicated their interest (0-10 scale) in e-cigarettes paired with various flavor descriptors. These were mixed (order balanced) with similar flavor offerings for ice cream and bottled water to mask the focus on e-cigarettes and validate the assessment. Mixed models contrasted interest between teens and adults and among adults by e-cigarette history.RESULTS:Nonsmoking teens' interest in e-cigarettes was very low (mean = 0.41 ± 0.14 [SE] on 0-10 scale). Adult smokers' interest (1.73 ± 0.10), while modest, was significantly higher overall (p < .0001) and for each flavor (most p values < .0001). Teen interest did not vary by flavor (p = .75), but adult interest did (p < .0001). Past-30-day adult e-cigarette users had the greatest interest in e-cigarettes, and their interest was most affected by flavor. Adults who never tried e-cigarettes had the lowest interest, yet still higher than nonsmoking teens' interest (p < .0001).CONCLUSION:The e-cigarette flavors tested appealed more to adult smokers than to nonsmoking teens, but interest in flavors was low for both groups.

ABSTRACT Aims Smokers who lapse during a cessation attempt are at particularly high risk of relapse, so interventions to help smokers recover from lapses are urgently needed. Two recent studies have suggested continuing to use nicotine patches following a lapse may be a beneficial relapse prevention strategy. However, to date no study that uses approved doses of nicotine patches under real‐world conditions has tested this hypothesis. Design and setting Clinical trial conducted across eight US study sites. Participants and measurements Using data from 509 subjects (240 active; 269 placebo) who lapsed during weeks 3–5 of treatment in a randomized, double‐blind placebo‐controlled trial of 21‐mg nicotine patches, we examined whether active nicotine patch use improved the chances of recovering abstinence (7‐day point‐prevalence) at weeks 6 and 10. Findings Active patch use (versus placebo) increased the likelihood of recovery from a lapse both at 6 weeks [8.3% versus 0.8%; relative risk (RR) = 11.0, P < 0.001] and at 10 weeks (9.6% versus 2.6%; RR = 3.7, P < 0.001). Conclusions Continuing treatment to aid smoking cessation with active patches promotes recovery from lapses. Smokers should be encouraged to persist with patch treatment if they lapse to smoking.

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

Nicotine replacement therapy (NRT) has become a central part of the treatment of nicotine dependence. However, NRT's potential efficacy is limited to some extent by patient adherence and persistence. Here we review the relationship between NRT compliance and adherence, and overall treatment outcome. We then examine the factors that likely impact on treatment compliance and persistence, with a special focus on users' perceptions of treatment safety and efficacy as possible mediators. Potential clinical strategies for improving suboptimal medication use are also discussed.

INTRODUCTIONOver the counter, nicotine replacement therapies (NRTs) are the most widely used smoking cessation treatment. This study sheds light on the seasonality of sales of NRT.METHODSA seasonal adjustment algorithm was applied to data on the sales of NRT products for 50 metro markets in the United States to test for and characterize seasonality in NRT sales. Granger's test was applied to the data to test whether changes in NRT sales systematically predicted changes in cigarette sales 1 month later.RESULTSThe results show (a) that sales of NRT products are seasonal, (b) that the seasonality pattern is the opposite of the seasonality pattern for cigarette sales, (c) that seasonally higher NRT sales in a given month tend to be followed by seasonally lower cigarette sales in the following month, and (d) that seasonally high months for NRT sales (January to March) correspond to seasonally low months for cigarette sales.CONCLUSIONSNRT sales show a strong seasonality pattern that is the opposite of the seasonality pattern for cigarette sales. These patterns are indicative of seasonal variations in quitting behavior.

ABSTRACT Aim Using nicotine gum can reduce the amount of weight gained when quitting. Here we examine the relationship between weight gain and use of adequate amounts of gum. To mitigate the confounders associated with correlational analyses, we contrast the effects of active gum and placebo, and analyze outcomes prospectively. Design and setting Randomized double‐blind placebo‐controlled trial of nicotine gum. Participants were instructed to use nine to 15 pieces of gum/day for the first 2 months of treatment. Participants Participants ( n = 103) were randomized to either active (2 mg or 4 mg) or placebo gum. Measurements We examined the effect on weight gain of the interaction between treatment (active versus placebo) and daily gum use [≥9 pieces/day (compliant use) versus < 9 pieces/day]. Findings After 30 days of abstinence, smokers treated with active gum had not gained significantly less weight than those on placebo (1.1 kg versus 1.6 kg, P = 0.175). However, a significant compliance–treatment interaction was observed ( P = 0.005): active gum users who used ≥9 pieces/day during the first 14 days of treatment had gained less weight at follow‐up (0.6 kg versus 1.6 kg for those who used <9 pieces/day, P = 0.017), but participants randomized to the placebo group saw no such benefit from compliant use. A similar compliance–treatment interaction ( P = 0.046) was also observed when the effect of compliance was examined within active treatment (2 mg versus 4 mg). Conclusions When smokers are quitting, those who use more pieces of nicotine gum experience less weight gain in the first 30 days. This relationship is not seen for smokers on placebo gum.

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

Traditionally, smokers have been encouraged to prepare for cessation in advance of a preset quit date, with the expectation that preparation would improve their chance of success. However, a recent survey of U.K. smokers found that a substantial proportion of attempts involved no preplanning and that these spontaneous attempts were actually more likely to succeed. We set out to explore further the nature of unplanned quit attempts among U.S. smokers.Nine hundred smokers and 800 ex-smokers were recruited from a market research database for an online survey and asked about the planning involved in their most recent attempt.In all, 39.7% of subjects reported that their most recent quit attempt involved no preplanning (smokers: 29.5%; ex-smokers: 52.4%). Subjects who made an unplanned quit attempt were more likely to be non-white, have no college education, report smoking their first cigarette of the day more than 30 min after waking, and report no use of pharmacotherapy during their quit attempt. Controlling for these variables, the odds of a "spontaneous" quit attempt lasting for 6 months or longer were twice that of preplanned attempts (71.7% vs. 45.6%; adjusted odds ratio = 2.62, 95% CI = 1.99-3.45). Similar results were seen in a survival analysis.The results suggest, similar to previous research, that a substantial proportion of quit attempts are unplanned and that such attempts can be a successful route to cessation. Given the frequency of such attempts, methods of making treatment available to assist unplanned quitting should be considered.

Background: Smoking cessation outcomes are calculated as the probability of abstinence at follow-up among all enrolled smokers, but it is also useful to estimate the probability of success for those who experienced Success or failure at earlier time points.Objectives: The primary aims were to estimate the probability of maintaining abstinence through week 10 among subjects who were abstinent at week 2, and to assess the effect of active treatment with a nicotine patch. We also examined outcomes at week 6 and, among subjects who smoked during the first 2 weeks of treatment, the probability of reestablishing abstinence later, as well as the effect of active treatment on this outcome.Methods: We analyzed pooled data from 2 previously published, parallel, double-blind studies in which subjects were initially randomized to receive an active nicotine patch (starting at 21 mg) or a placebo patch. Subjects randomized to active treatment followed a double-blind step-down dosing regimen: 24-h/21-mg patches for the first 6 weeks of treatment, followed by 14- and 7-mg patches for successive 2-week periods. Biochemically verified abstinence (exhaled carbon monoxide <= 8 ppm) was assessed during laboratory visits.Results: Most subjects were white (94.8%) and female (61.6%), with a mean (SD) age of 43.1 (10.2) years. Subjects hid been smoking for a mean of 24.5 (10.2) years and smoked a mean of 30.6 (10.4) cigarettes per day. In both the nicotine (n = 249) and placebo (n = 253) groups, all subjects who were abstinent during the first 2 weeks had a high probability of maintaining abstinence through week 10, but subjects treated with the active patch were significantly more likely to remain abstinent (active: 79.8% [67/84], placebo: 52.6% [20/38]; relative risk [RR] = 1.52 [95% CI, 1.10-2.09]). Also, at week 6, subjects receiving active treatment had a greater chance of remaining abstinent (active: 94.3% [82/87], placebo: 78.0% [32/41]; RR = 1.21 [95% CI, 1.02-1.43]). To assess the effect of treatment on recovery from smoking lapses, we examined the probability of abstinence during week 10 among subjects who smoked during the first 2 weeks of treatment. Among them, treatment was associated with a greater probability of later success: 31.4% (50/159) of those treated with the active patch and 12.5% (26/208) of those receiving placebo were abstinent at week 10 (RR = 2.52 [95% CI, 1.64-3.85]). Similar results were observed at week 6 (49.4% [80/162] vs 21.2% [45/212]; RR = 2.33 [95% CI, 1.72-3.15]).Conclusions: More than two thirds (71.3%) of subjects who were abstinent 2 weeks into a quit attempt maintained that abstinence through the end of 10 weeks of treatment. Use of a nicotine patch was significantly associated with maintaining abstinenceand with recovering abstinence after an early lapse. (Clin Ther. 2009;31:1957-1965) (C) 2009 Excerpta Medica Inc.

Background: It has been reported that the efficacy of acute forms of nicotine replacement therapy, such as nicotine gum and lozenges, improves when sufficient quantities of medication are used.Objective: This analysis examined whether adherence with daily nicotine patch wear was associated with improved rates of smoking abstinence.Methods: This was a secondary analysis of data from a double-blind study in which subjects were randomized to receive either an active nicotine patch or a placebo patch under simulated over-the-counter conditions. Subjects were asked to complete a daily diary on their patch use and smoking. Logistic regression, controlling for smoking in the first 3 weeks of treatment, was used to evaluate the likelihood of abstinence at 6 weeks as a function of treatment assignment (active vs placebo) and adherence (le, patch wear for >= 20 of the first 21 days of treatment). The relationship between reported adverse events and adherence was also examined.Results: This analysis Involved data from 371 subjects, 204 using the active patch and 167 using the placebo patch. The study population was mainly white (87.3%), had a mean age of 42.8 years, a mean weight of 77.3 kg, had been smoking for a mean of 24.4 years, and smoked a mean of 25.2 cigarettes per day. Two hundred fifty-three subjects were classified as adherent. Rates of adherence did not differ significantly between the active and placebo groups (139 [68.1%] and 114 [68.3%], respectively). The likelihood of experiencing an adverse event did not differ significantly between adherent and nonadherent subjects in either group. Among active patch users, 61.5% of nonadherent subjects experienced an adverse event, compared with 59.7% of adherent subjects; among placebo patch users, the corresponding proportions were 41.5% and 43.9%. Among active patch users, the odds of abstinence at 6 weeks were more than 3 times greater for adherent versus nonadherent subjects (53.2% vs 21.5%, respectively; adjusted odds ratio [OR] = 3.25; 95% CI, 1.30-8.09; P = 0.011); no benefit of adherence over nonadherence was seen among users of the placebo patch (16.7% vs 15.1%; adjusted OR = 0.60; 95% CI, 0.16-2.31). The interaction between treatment group and adherence was statistically significant (P = 0.022).Conclusion: Under conditions simulating over-the-counter use, adherence to daily nicotine patch wear within the first 3 weeks of treatment was associated with an improved likelihood of achieving smoking abstinence at 6 weeks. (Clin Ther. 2008;30:1852-1858) (C) 2008 Excerpta Medica Inc.

AIMNicotine replacement therapy (NRT) is effective for smoking cessation, but most smokers try to quit without using it. We examined the impact of misperceptions of NRT safety and efficacy on its use.DESIGN AND PARTICIPANTSA total of 3203 current and former US smokers completed a national mail-out survey of issues and attitudes related to smoking cessation.FINDINGSTwo-thirds (66%) of respondents either agreed that 'Stop-smoking products with nicotine are just as harmful as cigarettes' or were unsure whether the statement was true. These respondents were less likely to have used NRT in the past [30% versus 49%; odds ratio (OR) = 0.45, 95% confidence interval (CI): 0.39-0.53] and less likely to consider using NRT during future quit attempts (40% versus 53%; OR = 0.60, 95% CI = 0.51-0.71). Additionally, of the respondents who had used nicotine gum in the past 12 months (n = 407), those who had concerns about the safety of NRT reported using fewer pieces of gum per day during treatment (six versus eight pieces/day; P < 0.05), and were less likely to report that they used the gum for greater than 4 weeks (28.5% versus 46.8%; OR = 0.45, 95% CI: 0.27-0.76). A large proportion of the respondents also stated that they did not believe NRT to be efficacious.CONCLUSIONSThe findings suggest that many smokers are misinformed about the health risks of NRT and that these misperceptions impede not only the adoption of NRT but also compliance during treatment. Misperception of NRT safety is one barrier to effective use of NRT and probably reduces success in quitting.

Background: Health promotion efforts encourage smokers to quit and to use effective cessation treatments. Randomized controlled trials demonstrate that medications and behavioral treatments improve cessation rates, but retrospective surveys have been inconsistent. This study assessed frequency of quit attempts, use of treatments for cessation, and abstinence rates among treatment users and non-users.Methods: Data were analyzed from the 2003 Tobacco Use Special Cessation Supplement to the Current Population Survey. Participants included. 29,537 U.S. smokers aged >= 18 years who smoked daily 12 months before the survey. Outcome measures included past-year quit attempts; use of behavioral, pharmacologic, and alternative treatments; receipt of social support; and abstinence for >= 4 weeks at time of survey.Results: Approximately 43.5% of smokers reported a quit attempt in the preceding year: 64.2% of attempters used no cessation treatments; 8.8% used behavioral treatment; 32.2% used medication; and 14.1% used more than one treatment. Social support was reported to have been received by 24.1%. More nicotine-dependent smokers were more likely to use medications (OR=3.58; 95% CI=3.04-4.20). At the time of the survey, 19.3% of attempters were abstinent >= 4 weeks. Smokers who sought treatment were less likely to be abstinent (OR=0.75; 95% CI=0.67-0.84), and those who sought multiple treatments were even less likely to be abstinent.Conclusions: Many U.S. smokers make quit attempts, but most do not use behavioral or pharmacologic treatments. More nicotine-dependent smokers were more likely to seek treatment. Smokers who sought treatment were less likely to report abstinence, probably due to biased self-selection and recall. Retrospective survey data are not well-suited to assess the effectiveness of treatment.

Nicotine replacement therapies (NRT) have been available without a prescription in the United States since 1996. Given that nicotine, at least as it is delivered through tobacco products, is addictive, we examined whether NRT was being used by individuals who have never smoked cigarettes. Adults (n=18,986) and adolescents (n=9187) who participated in the in-home survey and physical examination components of the 1999-2006 National Health and Nutrition Examination Surveys were assessed for cigarette smoking status, other tobacco use or exposure, and use of NRT. Among the 8415 adults (ages 20 and older) who reported never having smoked 100 cigarettes and who provided a blood sample during their physical exam, 3 (0.08%; 95% CI=0.02-0.28%) reported using NRT within the 5 days prior to being examined. Among the 5510 adolescents (aged 12-19 years) who reported never smoking and who provided a blood sample, 5 (0.12%; 95% CI=0.04%-0.36%) reported using NRT. Analyses of cotinine (a metabolite of nicotine) from their blood samples, along with analysis of their other survey responses regarding additional nicotine exposures suggest that it is unlikely that any of the adults were never smokers using NRT and perhaps 2 adolescents may have been never smokers who used NRT. Based on these assessments, the re-estimated prevalence of NRT use by never smokers would be 0% among adults and 0.05% (95% CI=0.01-0.27%) among adolescents.

BACKGROUND:Behavioral and pharmacological treatments have been shown to improve smoking cessation rates, but treatments are under-utilized. AIMS:To examine the demographic and smoking history characteristics associated with adoption of treatment for cessation. DESIGN:Analysis of the 2003 tobacco use special cessation supplement to the current population survey. PARTICIPANTS:Representative sample of 12,027 U.S. daily smokers ages 18 and older who made a quit attempt in the past year. MEASUREMENTS:Use of behavioral, pharmacological or alternative treatments for cessation; demographic variables (age, gender, ethnicity, education and income) and measures of nicotine dependence. RESULTS:Females, Whites, older, more educated and wealthier smokers were more likely to adopt treatment in a quit attempt, as were more nicotine dependent smokers. Females were more likely than males to use behavioral treatments. Females and more educated smokers were more likely to combine behavioral and pharmacological treatment. Among those who used only one treatment, males, older and more nicotine dependent smokers were more likely to adopt pharmacological treatments. CONCLUSIONS:The majority of smokers make quit attempts without the benefit of proven behavioral or pharmacological treatments. Efforts are needed to increase use of smoking cessation treatments among all smokers, particularly combination treatment.

In recent years the public health community has considered the risks and benefits of encouraging smokers to reduce their smoking, perhaps with the aid of nicotine replacement therapy (NRT). Little is known, however, about whether smokers themselves are interested in smoking reduction; whether they see reduction as an endpoint, or primarily as a route to cessation; or whether they are receptive to the notion of using NRT to achieve reduction. We conducted a population-based national telephone survey of 1,000 current daily cigarette smokers (499 male, 501 female). Most smokers (57%) reported previously trying to reduce their smoking, and many (26%) said that they plan to reduce within the next year. Almost half of those planning to quit in the next 12 months (44%) preferred to quit via gradual cessation and most (68%) indicated that they would consider using a reduction product or medication. Respondents reported that they would prefer a product with a cessation endpoint rather than a reduction endpoint (63% vs. 21%). Interest in reduction was highest among smokers who were less interested in quitting and among heavier smokers. We conclude that many smokers are interested in gradually reducing prior to quitting and that promoting reduction is unlikely to undermine motivation to quit smoking.