Extended use of nicotine replacement therapy to maintain smoking cessation in persons with schizophrenia. Smoking cessation or reduction with nicotine replacement therapy: a placebo-controlled double blind trial with nicotine gum and inhaler. Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up. Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial. Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study. Controlled trial of three weeks nicotine replacement treatment in hospital patients also given advice and support. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. Extended treatment of older cigarette smokers. Long-term results of a smoking reduction program. Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients. Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Both smoking reduction with nicotine replacement therapy and motivational advice increase future cessation among smokers unmotivated to quit. Quitting by gradual smoking reduction using nicotine gum: a randomized controlled trial. Effectiveness of a cognitive orientation program with and without nicotine replacement therapy in stopping smoking in hospitalised patients. Nurse-conducted smoking cessation in patients with COPD using nicotine sublingual tablets and behavioral support. A comparison of smoking cessation treatments for persons with schizophrenia and other serious mental illnesses. Smoking cessation in family practice: the effects of advice and nicotine chewing gum prescription.
This study was designed to determine the feasibility and efficacy of long-term nicotine replacement therapy (NRT) in helping persons with schizophrenia remain tobacco-free. Fifty smokers with a diagnosis of schizophrenia or schizo-affective disorder and whose symptoms had been stable for at least two months were enrolled in a program providing group support and NRT (patches) in individually adjusted doses set to maintain baseline nicotine intake. All participants attended weekly group support/motivation sessions. Smoking activity was determined by measuring carbon monoxide levels in expired air. Participants who quit tobacco use completely during the first three months were entered into a single-blind phase in which they received either placebo or active nicotine patches for up to six additional months, along with biweekly group sessions. Sixty days into the open-label phase, 66% of the subjects had reduced their use of tobacco by at least 75%. After 90 days of open-label treatment, 18 subjects (36%) were tobacco-free and qualified to enter the six-month, single-blind phase, eight on placebo and nine on active patches. A significantly greater proportion of those on placebo (8 of 8) compared with those on active patches (3 of 9) relapsed prior to completion of the 6-month period. This difference is statistically significant at the p = 0.009 level. The results of this study indicate that long-term use of NRT is feasible and effective for sustained tobacco-free success and may be an important strategy for reducing health risks due to tobacco use in this special population. Even with effective smoking cessation medications, many smokers are unable to abruptly stop using tobacco. This finding has increased interest in smoking reduction as an interim step towards complete cessation.
                This multi-center, double-blind placebo-controlled study evaluated the efficacy and safety of nicotine 4 mg gum or nicotine 10 mg inhaler in helping smokers (N = 314) to reduce or quit smoking. It included smokers willing to control their smoking, and participants could set individual goals, to reduce or quit. The study was placebo-controlled, randomized in a ratio of 2:1 (Active:Placebo), and subjects could choose inhaler or gum after randomization. Outcome was short-term (from Week 6 to Month 4) and long-term (from Month 6 to Month 12) abstinence or reduction. Abstinence was defined as not a single cigarette smoked and expired CO readings of <10 ppm. Smoking reduction was defined as a reduction in number of cigarettes per day by 50% or more versus baseline, verified by a lower-than-baseline CO reading at each visit during the same periods.
                Significantly more smokers managed to quit in the Active group than in the Placebo group. Sustained abstinence rates at 4 months were 42/209 (20.1%) subjects in the Active group and 9/105 (8.6%) subjects in the Placebo group (p = 0.009). Sustained abstinence rates at 12 months were 39/209 (18.7%) and 9/105 (8.6%), respectively (p = 0.019). Smoking reduction did not differ between the groups, either at short-term or long-term. Twelve-month reduction results were 17.2% vs. 18.1%, respectively. No serious adverse events were reported.
                In conclusion, treatment with 10 mg nicotine inhaler or 4 mg nicotine chewing gum resulted in a significantly higher abstinence rate than placebo. In addition a large number of smokers managed to reduce their cigarette consumption by more than 50% compared to baseline. To test the effect of nicotine gum and placebo in smokers not motivated or not able to quit smoking with regard to smoking reduction and smoking cessation.
                This randomized study evaluated nicotine gum versus placebo for up to 1 year in 411 healthy smokers highly motivated to reduce cigarette use. Smoking reduction was defined as self-reported daily smoking less than 50% of baseline and any decrease (1 p.p.m. or more) in carbon monoxide.
                Pulmonary department, Copenhagen, Denmark.
                The overall success rate for sustained smoking reduction was significantly higher at all time-points for active versus placebo gum (6.3% versus 0.5% after 24 months). Nicotine gum achieved significantly higher point prevalence cessation rates than placebo at 12 and 24 months [11.2% versus 3.9% (odds ratio = 3.1; 95% CI, 1.4-7.2 and 9.3% versus 3.4% (odds ratio = 2.9; 95% CI, 1.2-7.1), respectively]. There was a linear relationship between decrease in number of daily cigarettes and decrease in plasma cotinine, exhaled carbon monoxide and plasma thiocyanate, with significantly greater reduction in the nicotine gum group after 4 and 12 months (maximum treatment duration) but not after 24 months. The decrease in toxin intake was smaller than the decline in daily cigarette consumption, suggesting that compensatory smoking occurred.
                Nicotine gum promoted cessation in this population of smokers unwilling to quit. Among reducers, the toxin intake correlated with reduced cigarette consumption although some compensatory smoking occurred. Many smokers are not ready to quit but are interested in changing their smoking behavior, particularly if such a change is associated with a reduction in health risk. The present study evaluated the efficacy of the nicotine inhaler in reducing smoking. Exploratory studies assessed whether reduction in smoking was associated with reduction in markers of disease risk. A total of 429 healthy smokers (smoking at least 20 cigarettes/day) were randomly assigned to either nicotine-containing or placebo inhalers, which subjects were allowed to use ad libitum for up to 1 year. The nicotine inhaler was significantly superior to placebo in achieving reduction in daily cigarette consumption by at least 50% after 4 months, compared with baseline (18% vs. 8%, p = .004). Active treatment promoted smoking cessation: 8% of subjects in the nicotine group and 1% in the placebo group were abstinent at month 15. Throughout the study, smoking reduction, per se, independent of treatment group, was associated with a statistically significant decrease in exhaled carbon monoxide and serum cotinine and thiocyanate. Smoking reduction also improved established risk markers for cardiovascular disease over 4 months. The incidence of adverse events did not differ significantly between the active and placebo groups. The most common treatment-related adverse events were throat irritation and cough. In conclusion, the nicotine inhaler can help smokers who are unable or unwilling to quit to reduce daily cigarette consumption, which may be a health benefit on its own and may further promote quitting. Smoking reduction may provide a harm-reduction alternative treatment for smokers who are not ready to quit smoking. This study evaluated the efficacy of nicotine gum in helping smokers reduce or quit smoking.
                This randomized, double-blind, placebo-controlled trial involved 364 smokers who were not ready to quit but were willing to reduce their smoking intensity. Participants received either 4-mg nicotine gum (n = 184) or placebo gum (n = 180) as desired for up to 12 months. The primary outcome was sustained smoking reduction, which was defined as a decrease in daily cigarette consumption of at least 50% compared with baseline. Secondary measures included point-prevalence abstinence, intention to quit, and cardiovascular risk markers.
                At 4 months, the sustained smoking reduction rate in the nicotine gum group was twice that of the placebo group (15.8% versus 6.7%, P = .008). Point-prevalence abstinence was 6.6% for the nicotine gum group and 2.2% for the placebo group (P = .07). At 13 months, there was a significant difference in the smoking reduction rate for the nicotine (8.2%) and placebo (2.8%) groups (P = .036). At month 13, the abstinence rates were 12% and 4.5% for the nicotine and placebo groups, respectively (P = .012). Concomitant use of nicotine gum and cigarette smoking was well tolerated. Carbon monoxide levels decreased significantly (P = .01).
                Nicotine gum may be an efficacious harm-reduction alternative for smokers who are not ready to quit and may promote smoking cessation, the ultimate goal in the treatment of tobacco dependence. Smoking is a major public health issue, estimated as causing 120 000 deaths in the UK per year. Smoking cessation is an important aspect of the treatment of many diseases. Nicotine replacement therapy (NRT) has been shown to increase cessation rates among healthy volunteers and in general practice, but it is not clear whether it has an effect in hospital patients.
                Patients referred by their hospital doctor to the smoking cessation counsellor and who agreed to participate in the study were randomised to receive either NRT given as a nicotine patch daily and a nicotine inhalator on an as needed basis plus advice and support (AS+NRT), or to receive just advice and support (AS). Claims of smoking cessation were validated at 1 week, 3 months, 6 months, and 1 year by carbon monoxide (CO) breath testing.
                A total of 245 patients were randomised, 136 AS+NRT and 109 AS. There were no significant demographic differences between the two groups at baseline. At 1 year 35 (14%) had sustained cessation confirmed by a CO breath test, 20/136 (15%) AS+NRT and 15/109 (14%) AS, p=0.857. One hundred and ten patients gave up smoking for at least 1 week, 54% AS+NRT and 33% AS (p<0.001). By 6 months there was no significant difference between the two groups (22/136 (16%) AS+NRT and 15/109 (14%) AS).
                In hospital patients NRT, given as regular daily patches plus an inhalator to be used as needed, did not add to the smoking cessation rate achieved at 1 year by regular advice and support, despite significantly increasing the cessation rate at 1 week. The objective of this study was to examine whether there is a benefit of adding bupropion SR to high-dose combination nicotine replacement therapy (NRT) and weekly group cognitive behavioral therapy (CBT) for smoking reduction or cessation in schizophrenia. Fifty-one adult smokers with schizophrenia were randomly assigned to a 12-week trial of bupropion SR 300 mg/d or placebo added to transdermal nicotine patch, nicotine polacrilex gum, and CBT. The treatment goal was smoking cessation. The primary outcome measure was biochemically confirmed 7-day point-prevalence of 50% to 100% smoking reduction at week 12. Secondary outcomes were biochemically confirmed tobacco abstinence and change from baseline in expired air carbon monoxide (CO) and psychiatric symptoms. Subjects on bupropion + NRT had a greater rate of 50% to 100% smoking reduction at weeks 12 (60% vs. 31%; P = 0.036) and 24, a lower expired air CO in the treatment and follow-up periods, (F = 13.8; P < 0.001) and a greater continuous abstinence rate at week 8, before NRT taper, (52% vs. 19%; P = 0.014). However, relapse rates in subjects on bupropion + dual NRT were 31% during NRT taper (weeks 8-12) and 77% at the 12-month follow-up. Abstinence rates did not differ by treatment group at weeks 12 (36% vs. 19%), 24 (20% vs. 8%), or 52 (12% vs. 8%). Because abstinence rates were high during treatment with combination pharmacotherapy and relapse rates were very high during taper and after discontinuation of treatment, study of longer term treatment with combination pharmacotherapy and CBT for sustained abstinence is warranted in those who attain initial abstinence with this intervention. Tobacco dependence treatments achieve abstinence rates of 25-30% at 1 year. Low rates may reflect failure to conceptualize tobacco dependence as a chronic disorder. The aims of the present study were to determine the efficacy of extended cognitive behavioral and pharmacological interventions in smokers > or = 50 years of age, and to determine if gender differences in efficacy existed.
                Open randomized clinical trial.
                A free-standing, smoking treatment research clinic.
                A total of 402 smokers of > or = 10 cigarettes per day, all 50 years of age or older.
                Participants completed a 12-week treatment that included group counseling, nicotine replacement therapy (NRT) and bupropion. Participants, independent of smoking status, were then assigned randomly to follow-up conditions: (i) standard treatment (ST; no further treatment); (ii) extended NRT (E-NRT; 40 weeks of nicotine gum availability); (iii) extended cognitive behavioral therapy (E-CBT; 11 cognitive behavioral sessions over a 40-week period); or (iv) E-CBT plus E-NRT (E-combined; 11 cognitive behavioral sessions plus 40 weeks nicotine gum availability).
                Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at weeks 24, 52, 64 and 104.
                The most clinically important findings were significant main effects for treatment condition, time and the treatment x time interaction. The E-CBT condition produced high cigarette abstinence rates that were maintained throughout the 2-year study period [(week 24 (58%), 52 (55%), 64 (55%) and 104 (55%)], and was significantly more effective than E-NRT and ST across that period. No other treatment condition was significantly different to ST. No effects for gender were found.
                Extended cognitive behavioral treatments can produce high and stable cigarette abstinence rates for both men and women. NRT does not add to the efficacy of extended CBT, and may hamper its efficacy. Research is needed to determine if these results can be replicated in a sample with a greater range of ages, and improved upon with the addition of medications other than NRT. There have been few comprehensive evaluations of smoking reduction, especially in health care delivery systems, and little is known about its cost, maintenance of reduced smoking, or robustness across patient subgroups.
                A generally representative sample of 320 adult smokers from an HMO scheduled for outpatient surgery or a diagnostic procedure was randomized to enhanced usual care or a theory-based smoking reduction intervention that combined telephone counseling and tailored newsletters. Outcomes included cigarettes smoked, carbon monoxide levels, and costs.
                Both intervention and control conditions continued to improve from 3- to 12-month assessments. Between-condition differences using intent-to-treat analyses on both self-report and carbon monoxide measures were nonsignificant by the 12-month follow-up (25% vs. 19% achieved 50% or greater reductions in cigarettes smoked). The intervention was implemented consistently despite logistical constraints and was generally robust across patient characteristics (eg, education, ethnicity, health literacy, dependence).
                In the absence of nicotine replacement therapy, the long-term effects of this smoking reduction intervention seem modest and nonsignificant. Future research is indicated to enhance intervention effects and conduct more comprehensive economic analyses of program variations. Guidelines recommend that smoking cessation interventions are offered in all clinical settings to all smokers willing to make a quit attempt. Since the effectiveness of routine provision of behavioural counselling and nicotine replacement therapy (NRT) to smokers admitted to hospital has not been established, a randomised controlled trial of these interventions given together compared with counselling alone or minimal intervention was performed in hospital inpatients.
                Medical and surgical inpatients who were current smokers at the time of admission were randomised to receive either usual care (no additional advice at admission), counselling alone (20 minute intervention with written materials), or NRT plus counselling (counselling intervention with a 6 week course of NRT). Continuous and point prevalence abstinence from smoking (validated by exhaled carbon monoxide <10 ppm) was measured at discharge from hospital and at 3 and 12 months, and self-reported reduction in cigarette consumption in smokers was assessed at 3 and 12 months.
                274 inpatient smokers were enrolled. Abstinence was higher in the NRT plus counselling group (n=91) than in the counselling alone (n=91) or usual care (n=92) groups. The difference between the groups was significant for validated point prevalence abstinence at discharge (55%, 43%, 37% respectively, p=0.045) and at 12 months (17%, 6%, 8%, p=0.03). The respective differences in continuous validated abstinence at 12 months were 11%, 4%, 8% (p=0.25). There was no significant difference between counselling alone and usual care, or in reduction in cigarette consumption between the treatment groups.
                NRT given with brief counselling to hospital inpatients is an effective routine smoking cessation intervention. To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention.
                Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway.
                Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older.
                The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT).
                Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation.
                Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group.
                As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change. Smokers not currently interested in quitting (N = 616) were randomized to receive telephone-based (a) reduction counseling plus nicotine replacement therapy (NRT) plus brief advice to quit, (b) motivational advice plus brief advice, or (c) no treatment. More smokers in the reduction (43%) and motivational (51%) conditions made a 24-hr quit attempt over 6 months than smokers in the no-treatment condition (16%; p < or = .01), but the 2 active conditions did not differ (p > or = .05). Similarly, 18%, 23%, and 4% of each condition were abstinent (7-day point prevalence) at 6 months (p < or = .01). Results indicate smoking reduction using NRT does not undermine cessation but rather increases the likelihood of quitting to a degree similar to motivational advice.
                (c) 2004 APA, all rights reserved Many smokers express a desire to quit smoking by gradually reducing the number of cigarettes they smoke until they stop completely. This study tested the efficacy of nicotine gum in facilitating cessation through gradual reduction.
                This was a multi-center, placebo-controlled, double-blind RCT of 2- and 4-mg nicotine gum versus placebo.
                3297 smokers who were interested in quitting gradually.
                Subjects were instructed to gradually reduce their smoking while increasing their gum use over the course of up to 8 weeks. Once they had achieved initial abstinence (no smoking for 24 hours), gum was to be used in accordance with the current FDA-approved directions for cessation. The study was conducted under over-the-counter conditions, with no counseling provided. Continuous abstinence was assessed after 28 days and 6 months. Secondary measures of smoking reduction were also assessed. Analyses were conducted in 1999-2000 and 2007-2008.
                Smokers on active gum were significantly more likely to achieve initial cessation (2 mg: OR=1.42; 4 mg: OR=1.90); 28-day continuous abstinence (2 mg: OR=2.01; 4 mg: OR=4.66); and continuous abstinence at 6 months (2 mg: OR=1.80; 4 mg: OR=5.96). During the reduction phase, active gum aided smoking reduction, and participants who reduced their smoking were more likely to achieve abstinence.
                These findings demonstrate that smokers who wish to quit smoking by gradual reduction can increase their success by using nicotine gum to facilitate reduction and cessation. We analysed the effectiveness of a high intensity behavioural-cognitive intervention compared to minimal intervention started during a hospital stay, to see if the combination of nicotine replacement therapy (NRT) can increase the quitting rate at 12 months of follow up.
                A total of 2560 active smokers were studied during their hospital stay. Of these, 717 smokers refused to enter the study and after a minimal intervention they were asked if we could telephone them after one year to ask if they still smoked. The remaining 1843 smokers who received high intensity cognitive therapy were randomised to receive or not receive NRT. The follow up after discharge was carried out by outpatient visits or with telephone sessions.
                At one year of follow up, 7% of those who declined to enter the study had stopped smoking compared to 27% of those who entered the study (p<0.001). There were significant differences between the group that only had behavioural therapy (21% stopped) compared to the group that also had NRT (33% stopped; p=0.002). In this latter group there were significant differences (p=0.03) between those who had follow up in clinics (39% stopped) compared to those who were followed up telephone sessions (30%). In the multivariate analysis, the predictors of quitting at 12 months were: to have used NRT (OR 12.2; 95% CI, 5.2-32; p=0.002) and a higher score in the Richmond Test (OR 10.1; 95% CI, 3.9-24.2; p=0.01).
                A cognitive type intervention started on smokers when admitted to hospital increases quitting rates at 12 months, compared to a minimal intervention, and these rates increase even more significantly if NRT is added.
                Copyright © 2010 SEPAR. Published by Elsevier Espana. All rights reserved. Few studies have examined the effect of nicotine replacement therapy (NRT) in COPD patients.
                To evaluate the efficacy of nicotine sublingual tablets and two levels of support for smoking cessation in COPD patients.
                Double-blind, multicenter, placebo-controlled smoking cessation trial.
                Pulmonary outpatient clinics.
                Three hundred seventy COPD patients who smoked a mean of 19.6 cigarettes per day (mean, 42.7 pack-years; mean FEV(1), 56% of predicted).
                Nicotine sublingual tablet or placebo for 12 weeks combined with either low support (four visits plus six telephone calls) or high support (seven visits plus five telephone calls) provided by nurses.
                Carbon monoxide-verified abstinence rates and St. George Respiratory Questionnaire (SGRQ) assessed at 6 months and 12 months.
                Two hundred eighty-eight of 370 patients were evaluable for the final study end points. Smoking cessation rates were statistically significantly superior with sublingual nicotine vs placebo for all measures of abstinence: 6-month point prevalence, 23% vs 10%; 12-month point prevalence, 17% vs 10%. There was no significant difference in effect between low vs high behavioral support. The SGRQ score improved significantly in abstainers vs nonabstainers; the changes in mean scores were -10.9 vs - 2.9 for total score, and - 28.6 vs - 2.3 for symptom score, respectively.
                This trial demonstrated the long-term efficacy of NRT for cessation for the general population of COPD smokers, regardless of daily cigarette consumption. Cessation success rates were in the same range as in healthy smokers, and abstinence improved SGRQ scores. NRT should be used to aid cessation in all smokers with COPD, regardless of disease severity and number of cigarettes smoked. Adults with any DSM-IV diagnosed mental illness smoke nearly half of the cigarettes consumed in the U.S. (Lasser et al. 2000). This study compared two smoking cessation interventions for persons with schizophrenia or other serious mental illness because national data suggests that: (1) they smoke at two to three times the rate of the general population; (2) cessation interventions for this population are understudied; (3) most cessation studies exclude persons with serious mental illness; and (4) cessation results in public health care savings and disposable income savings for clients. This study included a large number of persons with serious mental illness (N=181) who were randomly assigned to one of three groups: contingent reinforcement (CR), CR plus nicotine patch (21 mg, CR+NRT) for 16 weeks, and a minimal intervention, self-quit control group. These participants were followed for 36 weeks. CR was accomplished with escalating financial compensation for achieving and maintaining abstinence as verified by expired carbon monoxide (CO). Quit rates, as measured by expired CO, were higher and discordant with saliva cotinine quit rates. Cotinine showed lower quit rates and small differences between intervention and control participants at weeks 20 and 36. There was, however, evidence of reduced smoking and importantly, no evidence of psychiatric exacerbation. The efficacy of physician anti-smoking intervention with 289 patients in a family practice setting was assessed. The design included two treatment conditions, physician advice and physician advice plus the offer of nicotine chewing gum (NCG) prescription. A no-advice group permitted assessment of the effects of repeated testing. The NCG group had higher rates of abstinence at all follow-up points, but the difference approached statistical significance at 3 months only (p less than .10). Comparison of those who actually used NCG to all other groups revealed significantly more users were abstinent at 1- and 3-month follow-up. A similar pattern occurred for proportion attempting cessation and smoking reduction. A dose-response relationship of gum use to outcome was identified. Long-term users (greater than 20 days) had 86% abstinence at 3 months versus 18% for short-term users. Thus, NCG does appear to have a role in family practice for promoting short-term cessation.
There is insufficient evidence about long-term benefit to support the use of interventions intended to help smokers reduce but not quit smoked tobacco use. Some people who do not wish to quit can be helped to cut down the number of cigarettes smoked and reduce their CO levels by using nicotine gum or nicotine inhaler. Because the long-term health benefit of a reduction in smoking rate is unclear, but is likely to be small, this application of NRT is more appropriately used as a precursor to quitting.