Recycling with nicotine patches in smoking cessation

The aim was to evaluate if recycling of failures from a smoking cessation study may be of value. The study comprised 126 smokers (50%) of 252 failures, from a double-blind smoking cessation trial with nicotine patch, who accepted recycling after 1 year. Subjects were allocated nicotine patches delivering 15, 20 or 25 mg of nicotine (over 16 hours) according to their base-line saliva cotinine concentrations in an open trial. The treatment period was 12 weeks followed by tapering over 6 weeks. The percentage of quitters after 3, 12, 26, and 52 weeks was 44, 20, 7 and 6%, respectively. After 26 weeks, all subjects had relapsed in the group previously treated with active nicotine patch compared with 12% abstainers in the previous placebo subjects. The sustained abstinence rate without slips after one year was 2%. Recycling does not seem to be of long-term clinical relevance in our set-up for subjects initially treated with nicotine, but of some value in subjects quitting without nicotine therapy initially.     

Factors affecting the success or failure of smoking cessation using nicotine patches]

We identified the initial diagnostic factors that influenced the success or failure of patients trying to quit smoking using nicotine patches. In a smoking cessation treatment program at a smoking clinic, each patient received about 30 minutes of counseling in the initial diagnosis, then undertook a 2-month smoking cessation program using the nicotine patch. Between March 2000 and June 2002, 45 patients consulted the clinic. We attempted to monitor 30 patients whose smoking status we were able to observe. The patient group consisted of 5 women and 25 men who ranged in age from 22 to 75 years (mean age, 49 years). A follow-up survey by telephone was carried out (median follow-up time: 184.5 days). Actuarial smoking cessation curves were calculated according to the Kaplan-Meier method, and comparisons were made with the generalized Wilcoxon test. The Cox proportional hazards model was used for multivariate analysis. At the end of the two-month period, 86.3% of the patients had not resumed smoking; at one year after the program began, 56.7% had not resumed smoking. In the univariate analysis, the significant factors in the failure to maintain cessation were: a smoking start age of under 18 years, no affective disease, and smoking the day's first cigarette within 5 minutes after waking up (p < 0.05). In the multivariate analysis, the independent predictive factors in failure were: a starting smoking age of under 18 years and no affective disease (p < 0.05). Thus, patients who started smoking at a young age or who were free of affective disease were more likely to fail in their attempt to quit smoking. Attention to these factors is necessary as part of the guidance provided for smoking cessation.     

A randomized trial of nortriptyline combined with transdermal nicotine for smoking cessation

BACKGROUND: Smoking cessation rates with current therapy are suboptimal. Tricyclic antidepressants improve cessation rates. We hypothesized that addition of nortriptyline hydrochloride to transdermal nicotine would enhance cessation rates. METHODS: We conducted a randomized, double-blind, placebo-controlled trial at a Department of Veterans Affairs medical center. Subjects were aged 18 to 65 years, smoked 10 or more cigarettes per day, and did not have current major depression. Nortriptyline hydrochloride or matched placebo was started at 25 mg 14 days before quit day, titrated to 75 mg/d as tolerated, and continued for 12 weeks after quit day. Transdermal nicotine (21 mg/d) was started on quit day and continued for 8 weeks. The behavioral intervention consisted of 12 brief, individual visits. Withdrawal symptoms were measured by means of a daily diary, and smoking cessation was defined as self-reported abstinence, expired carbon monoxide level of 9 ppm or less, and a 6-month urine cotinine level less than 50 ng/mL (284 nmol/L). RESULTS: A total of 158 patients were randomized (79 to nortriptyline and 79 to placebo). There was no significant reduction in withdrawal symptoms. The cessation rates at 6 months were 23% (18/79) and 10% (8/79), respectively (absolute difference, 13%; 95% confidence interval, 1.3%-24.5%; P = .052). Nortriptyline caused frequent side effects, including dry mouth (38%) and sedation (20%). CONCLUSIONS: Nortriptyline combined with transdermal nicotine resulted in an increased cessation rate with little effect on withdrawal symptoms. This combination may represent an option for smokers in whom standard therapy has failed.     

Bupropion for smoking cessation: a randomized trial

BACKGROUND: Bupropion hydrochloride is recommended for smoking cessation; however, there have been relatively few clinical trials examining its efficacy. METHODS: A total of 244 current smokers were enrolled in an outpatient randomized blinded smoking cessation trial conducted at the San Francisco Veterans Affairs Medical Center, San Francisco, Calif. Of the 244 participants, 121 received a 7-week course of bupropion and 123 received placebo. All participants received 2 months of transdermal nicotine replacement therapy and 3 months of cognitive-behavioral counseling. We determined on-medication treatment, end-of-medication treatment, 3-month, 6-month, and 1-year quit rates. RESULTS: During treatment with bupropion vs placebo, there was a trend toward increased quit rates among participants randomized to bupropion; the self-reported end-of-medication treatment quit rates were 64% for the bupropion group vs 57% for the placebo group (P =.23). The trend favoring bupropion persisted at 3 months of follow-up (P =.12) but was not apparent at 6 months and 1 year of follow-up (both P>.78). The 12-month quit rates, validated by either saliva cotinine or spousal proxy, were 22% in the bupropion group and 28% in the placebo group (P =.31). Based on biochemical validation, 19% of the bupropion group vs 24% of the placebo group had quit smoking by 1 year (P =.36). CONCLUSIONS: In this randomized blinded trial of mostly veteran participants, the addition of a brief 7-week bupropion trial to treatment with nicotine replacement therapy and counseling did not significantly increase smoking cessation rates.     

Bupropion for smoking cessation : predictors of successful outcome

OBJECTIVES: To identify predictors of smoking abstinence at the end of medication use that could assist in the optimal use of a sustained-release (SR) form of bupropion for treating cigarette smokers. DESIGN: A double-blind, placebo-controlled, dose-response trial. SETTING: Multicenter (three sites) study conducted in the United States. PARTICIPANTS: Six hundred fifteen healthy men and women (> or = 18 years of age) who were smoking > or = 15 cigarettes per day and who were motivated to stop smoking. INTERVENTION: Random assignment of patients to placebo or SR bupropion treatment, 100, 150, or 300 mg/d, for 7 weeks (total duration of study was 52 weeks: 7 weeks of treatment and 45 weeks of follow-up). Measurements and results: Logistic regression was used to identify predictors of abstinence at the end of the medication phase. Univariate predictors included the following: bupropion dose (p < 0.001); older age (p = 0.024); lower number of cigarettes smoked per day (cpd) (p < 0.001); lower Fagerstr?m Tolerance Questionnaire score (p = 0.011); longest time previously abstinent that was < 24 h or > 4 weeks (p < 0.001); absence of other smokers in the household (p = 0.021); greater number of previous stop attempts (p = 0.019); and study site (p = 0.004). Multivariate predictors of abstinence at the end of the medication phase were the following: higher bupropion dose (p < 0.001); lower number of cpd (p < 0.001); longest time previously abstinent from smoking (p = 0.002); male gender (p = 0.014); and study site (p = 0.021). CONCLUSION: Bupropion SR therapy was effective in treating cigarette smokers independently of all other characteristics studied. Lower smoking rate, brief periods (ie, < 24 h) or long periods (ie, > 4 weeks) of abstinence with previous attempts to stop smoking, and male gender were predictive of better outcomes, independent of the dose of bupropion that was used.     

The use of transdermal nicotine in smoking cessation

The transdermal administration of nicotine by means of a transdermal nicotine system (TNS) affords a novel way of nicotine replacement to alleviate smoking cessation. The plasma levels of nicotine maintained with the TNS are in the range of the footpoint concentrations observed in smokers. The efficacy of the TNS was investigated in two placebo-controlled double-blind smoking cessation programs with minimal contact and minimal psychological support. A total of 311 smokers were treated for 3 months or 9 weeks. The abstinence rates at the end of the treatment and weaning periods were almost doubled in the TNS groups (36% and 39%) as compared to the placebo groups (23% and 20%) with a significant difference for both studies (p<0.05). These data suggest that the TNS can also improve the smoking cessation rates under the conditions of general medical advice, making it suitable for use outside of specialized smoking cessation centers.     

Efficacy of a nicotine lozenge for smoking cessation

BACKGROUND: Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation. METHODS: Double-blind, placebo-controlled, randomized clinical trial with parallel arms testing 2- and 4-mg nicotine lozenges. Smokers (n = 1818) were assigned to a lozenge dose on the basis of nicotine dependence, assessed by time to the first cigarette of the day. Low-dependence smokers were randomized to receive the 2-mg nicotine (n = 459) or placebo (n = 458) lozenge; high-dependence smokers, the 4-mg nicotine (n = 450) or placebo (n = 451) lozenge. We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal symptoms. RESULTS: Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds ratio [OR], 2.10; 95% confidence interval [CI], 1.59-2.79; P<.001) and the 4-mg (48.7% vs. 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges, compared with placebo. Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects. Use of the active lozenge also resulted in reduced craving and withdrawal. Most adverse events were moderate and resembled those seen with nicotine gum. CONCLUSION: The nicotine lozenge is a safe and effective new treatment for smoking cessation in low- and high-dependence smokers.     

The efficacy of a comprehensive smoking cessation class, combined with nicotine patch and gum replacement therapy]

A six-month comprehensive smoking cessation class was conducted in our hospital, and the results were evaluated after one year. To increase the rate of smoking cessation, a smoking cessation support team composed of a medical doctor, a pharmacist, nurses, a registered dietitian, and a physical therapist was formed. The team provided specialized lectures and comprehensive group counseling programs every two weeks for the first two months and every month for the next four months. Each participant's expired carbon monoxide concentration and body weight were measured at every attendance. The participant continued with beneficial behavioral treatment for smoking cessation for six months, with nicotine replacement therapy (NRT) for the first eight weeks. The protocol of our NRT consisted of both the routine use of nicotine patches (Nicotinell TTS) and the rescue use of nicotine gum (Nicorette). We first ascertained each participant's degree of nicotine dependence, using the Fagerstr?m Tolerance Questionnaire score, and daily nicotine intake was estimated by a detailed questionnaire. We then divided the participants into two NRT groups according to their nicotine dependence. The higher nicotine dependence group consisted of those whose Fagerstr?m Tolerance Questionnaire score was more than 5 points or whose estimated nicotine intake was more than 10 mg/day. This group they used Nicotinell TTS 30 (TTS 30) for the first four weeks, TTS 20 for the next two weeks, and TTS 10 for the last two. In the lower dependence group. TTS 20 and TTS 10 were each given for four weeks. Nicotine gum use was restricted to 4 pieces a day for the first week and reduced by one per day each subsequent week. As a result, there was an 81.3% smoking cessation rate after eight weeks, 70.3% after six months, and 58.2% after one year. In conclusion, two courses of routine nicotine patch use, with the addition of restricted rescue use of nicotine gum, can produce better longterm abstinence results than previously reported NRTs, suggesting that this may be one of the best ways to cease smoking. We also emphasize that intensive group counseling programs and lectures supported by doctors and medical teams, as well as a continuing behavioral treatment component, may be indispensable for enhancing longterm sustained abstinence rates.     

Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study.

AIMS: To investigate the safety and efficacy of bupropion sustained release (bupropion SR) in promoting abstinence from smoking in subjects with cardiovascular disease (CVD). METHODS: Six hundred twenty-nine subjects with CVD who smoked >/=10 cigarettes/day were randomised in a double-blind, multicentre study to receive bupropion SR (150 mg twice daily) or placebo for 7 weeks, with a follow-up of 52 weeks. Primary efficacy endpoint: continuous abstinence from smoking from weeks 4 to 7. Secondary endpoints: continuous abstinence (weeks 4-12, 4-26 and 4-52) and weekly point prevalence abstinence. All participants received brief motivational support. Safety was evaluated throughout the study. RESULTS: Continuous smoking abstinence rates from weeks 4 to 7 were significantly higher in subjects receiving bupropion SR compared with placebo (43 vs. 19%, odds ratio [OR]=3.27, 95% confidence interval [CI] 2.24-4.84; P<0.001). Continuous abstinence rates from weeks 4 to 26 and 4 to 52 continued to be more than double for bupropion SR compared with placebo (27 vs. 11%; 22 vs. 9%, P<0.001). Weekly point prevalence abstinence was significantly higher for participants who received bupropion SR compared with placebo at weeks 3, 7, 26 and 52 (P<0.001). In both groups, there were no clinically significant changes in blood pressure and heart rate throughout the treatment phase. Overall, 6% of the participants (n=36) discontinued study medication due to an adverse event (bupropion SR, n=17; placebo, n=19). CONCLUSIONS: After 7 weeks of bupropion SR treatment, more than twice as many smokers with CVD had quit smoking at 1 year compared with placebo. The safety profile of bupropion SR was similar to that previously observed in general smoking populations.     

Nasal nicotine spray in smoking cessation. Results of a multicenter study

We have carried out an open multicenter follow-up study of the efficacy of a smoking cessation therapy that combined psychological support with use of a nicotine nasal spray. Fifty-seven subjects (37 men, 20 women) with a mean age of 40.3 +/- 15.7 yr and smoking 37.4 +/- 4.7 cigarettes per day were enrolled. The mean Fagerstr?m test score was 8.9 +/- 1.1. Patients received minimal psychological support and were prescribed a nicotine nasal spray at the recommended dose of 1 to mg/h for use while awake for a period of three months, with gradual reduction of dose. Subjects were seen on six occasions (on the first day of consultation; 1, 2 and 6 weeks after quitting; 3 and 6 months after quitting). After three months of follow-up, 22 patients (39%) were abstinent; six months after first trying to quit, only 20 of the 57 enrolled had succeeded (35%). Although most subjects (over 90% in the first 15 days, and over 50% at three months) used the treatment, only a small percentage (3%) followed the appropriate doses in the first 15 days and 31% reported doing so at the three-month check-up. The mean score reflecting withdrawal syndrome tripled over baseline level during the first six weeks of follow-up. Over three quarters of the subjects suffered side effects caused by the spray, the most common being nasal irritation, rhinorrhea and tearing. Five patients (87%) lef the study because of intolerance to medication. In conclusion, our study found a rate of success of 35% after six months of follow-up. Use of the prescribed medication was inadequate; withdrawal syndrome was more intense and the prevalence of side effects increased during the early treatment period.     

112例中重度尼古丁依赖吸烟者临床戒断方法分析

目的 分析中重度尼古丁依赖吸烟者不同戒烟方法的临床戒断效果.方法 回顾性分析112例在中日友好医院戒烟门诊就诊的中重度尼古丁依赖吸烟者的戒断方法和不同时期的戒断率.结果 尼古丁替代治疗(nicotine replacement theraphy,NRT)62例,盐酸安非他酮缓释剂治疗11例,盐酸安非他酮缓释剂联合NRT 39例,3个月的戒断率分别为34.7%、34.2%、58.0%,6个月戒断率分别为28.5%、25.2%、43.3%.联合治疗组戒断症状及体质量增加小于单独治疗组(P值均＜0.05).结论 缓释盐酸安非他酮联合NRT戒烟方式更有效,且戒断相关症状少,体质量增加少,复吸率低,单纯使用NRT药物相关不良反应少.对重度尼古丁依赖吸烟者或合并慢性疾病的患者,以及女性或合并抑郁患者,建议联合治疗.此外戒烟过程中行为心理分析及治疗十分重要.     

Nurse-conducted smoking cessation in patients with COPD, using nicotine sublingual tablets and behavioral support

CONTEXT: Few studies have examined the effect of nicotine replacement therapy (NRT) in COPD patients. STUDY OBJECTIVE: To evaluate the efficacy of nicotine sublingual tablets and two levels of support for smoking cessation in COPD patients. DESIGN: Double-blind, multicenter, placebo-controlled smoking cessation trial. SETTING: Pulmonary outpatient clinics. PATIENTS: 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). INTERVENTIONS: 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. MEASUREMENTS: Carbon monoxide-verified abstinence rates and St. George Respiratory Questionnaire (SGRQ) assessed at 6 months and 12 months. RESULTS: 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. CONCLUSIONS: 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.     

Outcomes and predictive factors for successful smoking cessation therapy in COPD patients with nicotine dependence

BackgroundThe data on smoking cessation treatment outcomes for smokers with chronic obstructive pulmonary disease (COPD) are limited. The present study assessed the effectiveness of smoking cessation interventions at our clinic.MethodsData from a prospective registry of a 3-month smoking cessation program were evaluated. The primary outcome, smoking cessation, was defined as the complete abstinence from smoking between the 8-week and 12-week clinic visits. Pulmonary function and health-related quality of life using St. George's Respiratory Questionnaire (SGRQ) were assessed at baseline and at the end of the program.ResultsOut of the 155 COPD patients with nicotine dependence (female/male = 39/116; mean age, 67.2 ± 9.8 years; mean forced expiratory volume in 1 s (FEV1), 59.7 ± 21.1% predicted), 107 participants completed the program. Among the completers, 74 achieved smoking cessation. In the multivariate analysis, mental disorders (odds ratio [OR] 3.678, 95% confidence interval [CI]: 1.182, 11.445), higher exhaled carbon monoxide (CO) level (OR 1.080, 95% CI: 1.013, 1.151) and lower FEV1/forced vital capacity (FVC) (OR 0.958, 95% CI: 0.923, 0.995) were negatively associated with successful smoking termination. Significant changes in pulmonary function were found in quitters but not in continuous smokers (increases in FEV1 by 0.09 L/s [95% CI: 0.03, 0.15] and peak expiratory flow by 0.23 L/s [95% CI: 0.01, 0.44]). SGRQ total scores improved significantly in both quitters (−5.4 [95% CI: −8.4, −2.5]) and continuous smokers (−7.0 [95% CI: −11.6, −2.5]).ConclusionIn the program completers, the exhaled CO levels, FEV1/FVC ratio, and presence of mental disorders were significantly associated with program success or failure in COPD patients with nicotine dependence.     

Continuing to wear nicotine patches after smoking lapses promotes recovery of abstinence

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.