Pre‐cessation nicotine replacement therapy: pragmatic randomized trial

Aims To determine the effectiveness of 2 weeks' pre‐cessation nicotine patches and/or gum on smoking abstinence at 6 months. Design Pragmatic randomized controlled trial. Setting New Zealand. Participants Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone. Measurements The primary outcome was self‐reported 7‐day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine‐verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events. Findings Six months after quit day 125 (22.7%) participants in the pre‐cessation group and 116 (21.0%) in the control group reported 7‐day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: ?3.2%, 6.6%). However, when pooled in a meta‐analysis with other pre‐cessation trials a moderate benefit of about a one‐quarter increase in cessation rates was evident. There was no difference in adverse events between groups. Conclusions In this, the largest pre‐cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre‐cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials.     

Does improved access and greater choice of nicotine replacement therapy affect smoking cessation success? Findings from a randomized controlled trial

Aims To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Design Single‐blind, randomized controlled trial. Setting New Zealand. Participants A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. Measurements The primary outcome was 7‐day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. Findings No differences in 6‐month quit rates (7‐day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self‐reported point prevalence, relative risk (RR) = 1.17, 95% confidence interval (CI): 1.02, 1.35, P = 0.03], had a longer time to relapse (median 70 days versus 28 days, P < 0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). Conclusions In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1‐week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period.     

A randomized controlled trial of a smoking reduction plus nicotine replacement therapy intervention for smokers not willing to quit smoking

Aims To examine the effectiveness of smoking reduction counselling plus free nicotine replacement therapy (NRT) for smokers not willing to quit. Design, setting and participants A total of 1154 Chinese adult smokers not willing to quit but who were interested in reducing smoking were allocated randomly to three arms. Intervention group A1 (n = 479) received face‐to‐face counselling on smoking reduction and adherence to NRT at baseline, 1 week and 4 weeks with 4 weeks of free NRT. Group A2 (n = 449) received the same intervention, but without the adherence intervention. Control group B (n = 226) received simple cessation advice at baseline. Measurements Self‐reported 7‐day point prevalence of tobacco abstinence and reduction of cigarette consumption (≥50%) at 6 months and continuous use of NRT for 4 weeks at 3 months. Findings Using intention‐to‐treat analysis, compared to control group B, the intervention groups (A1 + A2) had achieved higher 6‐month tobacco abstinence (17.0% versus 10.2%, P = 0.01) and reduction rates (50.9% versus 25.7%, P < 0.001). There was no significant difference in the 4‐week NRT adherence rate at 3 months, but group A1 achieved a higher abstinence rate than group A2 at 6 months (20.9% versus 12.9%; P = 0.001). Conclusions In smokers with no immediate plans to quit, smoking reduction programmes with behavioural support and nicotine replacement therapy are more effective than brief advice to quit. Current guidelines recommend advice to quit on medical grounds as the best clinical intervention in this group of smokers, but smoking reduction programmes offer an alternative and effective option.     

Motivation and patch treatment for HIV+ smokers: a randomized controlled trial

Aims To test the efficacy of two smoking cessation interventions in a HIV positive (HIV+) sample: standard care (SC) treatment plus nicotine replacement therapy (NRT) versus more intensive motivationally enhanced (ME) treatment plus NRT. Design Randomized controlled trial. Setting HIV+ smoker referrals from eight immunology clinics in the northeastern United States. Participants A total of 444 participants enrolled in the study (mean age = 42.07 years; 63.28% male; 51.80% European American; mean cigarettes/day = 18.27). Interventions SC participants received two brief sessions with a health educator. Those setting a quit date received self‐help quitting materials and NRT. ME participants received four sessions of motivational counseling and a quit‐day counseling call. All ME intervention materials were tailored to the needs of HIV+ individuals. Measurements Biochemically verified 7‐day abstinence rates at 2‐month, 4‐month and 6‐month follow‐ups. Findings Intent‐to‐treat (ITT) abstinence rates at 2‐month, 4‐month and 6‐month follow‐ups were 12%, 9% and 9%, respectively, in the ME condition, and 13%, 10% and 10%, respectively, in the SC condition, indicating no between‐group differences. Among 412 participants with treatment utilization data, 6‐month ITT abstinence rates were associated positively with low nicotine dependence (P = 0.02), high motivation to quit (P = 0.04) and Hispanic American race/ethnicity (P = 0.02). Adjusting for these variables, each additional NRT contact improved the odds of smoking abstinence by a third (odds ratio = 1.32, 95% confidence interval = 0.99–1.75). Conclusions Motivationally enhanced treatment plus NRT did not improve cessation rates over and above standard care treatment plus NRT in this HIV+ sample of smokers. Providers offering brief support and encouraging use of nicotine replacement may be able to help HIV+ patients to quit smoking.     

Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS* trial-a randomized study in smokers with medical comorbidities

Aims To assess the efficacy of nicotine replacement therapies (NRT) when the daily dose was adapted according to saliva cotinine concentrations. Design Randomized, multi‐centre, single‐blind, controlled trial. Setting Twenty‐one smoking cessation clinics in France. Participants A total of 310 smokers with medical comorbidities, motivated to quit, smoking ≥10 cigarettes/day, for whom smoking cessation was mandatory. NRT was administered for 3 months. The standard care group received nicotine patches with monthly dose decreases; buccal absorption NRT could be co‐administered at the discretion of the investigator. In the dose adaptation group, the aim was a 100 ± 5% nicotine substitution with respect to smoking state based on the determination of saliva cotinine concentrations. NRT daily doses were prescribed according to the previous week's saliva cotinine concentrations in the dose adaptation group; saliva cotinine concentrations were not provided in the standard care group. Measurements Prolonged abstinence rate (weeks 9–12, main outcome measure), point‐prevalence and continuous abstinence rate, saliva cotinine concentration, NRT daily dose, craving for cigarettes. Findings The median daily prescribed NRT dose was 30 and 31 mg/day in the first study week and 17.25 and 35.5 mg/day during weeks 9–12 in the standard care group and dose adaptation group, respectively. Saliva cotinine remained stable in the dose adaptation group and decreased in the standard care group (P < 0.01) by weeks 9–12. The cotinine substitution rate was significantly lower in the standard care group than in the dose adaptation group. Despite differences in NRT doses and cotinine substitution rates, prolonged (standard care group: 26.4%, dose adaptation group: 30.3%), continuous (standard care group: 8%, dose adaptation group: 12%) and point‐prevalence abstinence rates were similar. Conclusions In smokers with medical comorbidities and highly motivated to quit, adaptation of the nicotine replacement therapy daily dose according to saliva cotinine does not appear to be substantially superior to standard nicotine replacement therapy use.     

Impact of messages on concomitant use of nicotine replacement therapy and cigarettes: a randomized trial on the Internet

Aims To assess the impact of messages recommending the concomitant use of nicotine replacement therapy (NRT) and cigarettes on smokers’ intention to quit smoking. Design Randomized trial. Setting Internet. Participants A total of 2027 people who answered an e‐mail sent to 9074 current and former smokers recruited on a smoking cessation website. Intervention Participants were divided randomly into four groups, each of which received a unique message (in French) by e‐mail. The ‘control’ message said that nicotine replacement therapy (NRT) attenuates withdrawal symptoms in smokers who want to quit. The ‘temporary abstinence’ message added that NRT can also be used by current smokers to manage smoke‐free situations. The ‘reduction’ message indicated that NRT can be used by current smokers who do not want to quit but want to smoke fewer cigarettes. The ‘side‐effects’ message discouraged concomitant use of NRT and cigarettes. Measurements Perceived impact of these messages on motivation to quit smoking. Findings The e‐mail was answered by 2027 people (25% of 8124 valid addresses). Smokers who received the ‘reduction’ message were slightly more likely than controls to report that this message increased their motivation to quit (66% versus 60%, P = 0.02). In contrast, smokers who received the ‘side‐effects’ message were less likely than controls to report that this message increased their motivation (45% versus 60%, P < 0.001). The ‘temporary abstinence’ message had no detectable impact on motivation to quit. Conclusions Among smokers recruited via a smoking cessation website, messages encouraging concomitant use of NRT and cigarettes may have either no effect or a positive effect on motivation to quit smoking.     

Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial

Aims To determine whether 2‐week pre‐treatment with transdermal nicotine influences withdrawal symptoms or success rate of subsequent smoking cessation using nicotine patches. Design Randomized controlled trial. Setting Smoking cessation clinic. Participants Healthy smokers (n = 200, 45% female) were allocated randomly to either active nicotine‐patch (AP, 15 mg daily, n = 100) or placebo‐patch (PP, n = 100) pre‐treatment. Baseline characteristics were well balanced except for daily cigarette consumption: mean (± SD) 23.1 (8) and 26.4 (11) for AP and PP groups, respectively (P = 0.021). Intervention At the screening visit (? 2 weeks) subjects were counselled and started pre‐treatment with daily patches (AP or PP). From the quit date (week 0) onwards all subjects received active nicotine patches for 12 weeks (15 mg daily for 8 weeks, 10 and 5 mg daily for 2 weeks each) and counselling. Measurements Follow‐up visits included measurement of exhaled carbon monoxide at the quit date, 2, 6, 10 and 26 weeks. Subjects documented daily cigarette consumption and severity of withdrawal symptoms (Wisconsin scale) from ? 2 weeks to week 2. Outcome measures were withdrawal symptoms composite score and abstinence rates. Findings There was no significant difference in withdrawal symptoms, but more subjects in the AP group were smoke‐free during the 6‐month study period. Overall sustained abstinence was documented in 17% of subjects at 6 months; 22% and 12% for AP and PP, respectively (P = 0.03). Retrospective subgroup analysis showed for subjects smoking >16 cigarettes/day sustained cessation rates were 22% and 9% for AP and PP, respectively (P = 0.01). No difference in adverse event rates was observed. Conclusions Nicotine patch pre‐treatment before cessation did not reduce early withdrawal symptoms but increased sustained abstinence rates at 6 months. The nicotine pre‐treatment was equally effective in light and heavy smokers.     

A randomized controlled trial of oral selegiline plus nicotine skin patch compared with placebo plus nicotine skin patch for smoking cessation

Objectives To compare the effect of oral selegiline plus nicotine patch with placebo plus nicotine patch on smoking cessation rates. Design Randomized double‐blind placebo‐controlled trial. Setting Three community‐based clinics. Participants One hundred and nine male and female smokers aged 18–55 years, who smoked at least 15 cigarettes/day. Interventions Oral selegiline, 2.5 mg, or placebo twice/day initiated 1 week before the quit day, followed by 5 mg oral selegiline or placebo twice daily for 26 weeks, plus active nicotine skin patch to all participants for the first 8 weeks only. Measures of continuous abstinence rates up to 52 weeks, withdrawal symptoms, blood pressure and adverse events incidence. Findings Twenty‐five per cent (14 of 56) were continuously abstinent for 52 weeks in the selegiline plus nicotine group compared with 11% (6 of 53) in the placebo plus nicotine group (P = 0.08). Craving for cigarettes was lower in the selegiline plus nicotine group 4 weeks after quit day (P = 0.02). Conclusions Adding selegiline to nicotine patch was associated with a doubling of the 52‐week continuous abstinence rate, but this difference was not statistically significant. Selegiline significantly reduced craving for cigarettes and appeared to mitigate the need for nicotine replacement therapy. The results suggest that selegiline is a promising drug for future smoking cessation research.     

The effect of a minimal intervention strategy in addition to nicotine replacement therapy to support smoking cessation in cardiovascular outpatients: a randomized clinical trial.

BACKGROUND: Smoking is an important risk factor for recurrent events in cardiovascular patients. Evidence exists that nicotine replacement therapy (NRT) approximately doubles smoking cessation rates. The minimal intervention strategy (MIS) has been used successfully to assist patients to quit smoking in general practice, and was recently adapted for cardiology inpatients (C-MIS). It is hypothesized that in cardiovascular outpatients the combination of C-MIS and NRT significantly increases the number of quitters compared to NRT alone. METHODS: A randomized clinical trial in 385 smoking patients who attended the cardiovascular outpatient departments in the Academic Medical Centre, Amsterdam for the treatment of atherosclerotic disease. Patients were allocated to either NRT + C-MIS or NRT alone. Self-reported and biochemically validated abstinence rates were measured at 12 months' follow-up. RESULTS: Including patients with incomplete follow-up as smokers, abstinence was reported by 19% of the NRT + C-MIS group and 14% of the NRT group [absolute risk reduction (ARR) = 0.05; 95% confidence interval (CI) = -0.02; 0.12]. According to biochemical markers, abstinence rates were 28 and 24%, respectively (ARR = 0.04, 95% CI = -0.06; 0.14). Hence, no significant differences between groups were found. The number of cigarettes smoked a day decreased significantly at 12 months: from 21 to 15 a day in the experimental group, and from 21 to 14 in the control group (P<0.001), but did not differ between groups (P=0.32). CONCLUSIONS: The effectiveness of a minimal contact intervention was investigated in order to reach as many cardiovascular patients as possible in the setting of outpatient departments. This intervention was not found to be effective.     

The effects of fluoxetine combined with nicotine inhalers in smoking cessation--a randomized trial

Aims. Nicotine replacement therapy (NRT) is an established aid in stopping smoking, while the role of antidepressants remains uncertain. Antidepressants added to NRT might improve abstinence rates. Our aim was to determine the efficacy of nicotine inhaler and fluoxetine vs. nicotine inhaler and placebo in attempts to quit smoking. Design. A randomized, double-blind, placebo-controlled trial. Setting. A smoker's cessation clinic. Participants. One hundred volunteers smoking 10 cigarettes/day or more. Interventions. Subjects were instructed to start taking a daily dose of 10 mg of fluoxetine or placebo 16 days before stopping smoking, then 20 mg 10 days before quitting, continuing for up to at least 3 months. Subjects were instructed to use 6-12 units per day of nicotine inhalers after stopping smoking for up to 6 months. Measurements. Continuous abstinence rates recorded at various time points up to 12 months from the quit date. Findings. The sustained abstinence rate for the inhaler-fluoxetine group was 54%, 40%, 29% and 21% after 1.5, 3, 6 and 12 months, respectively, compared to 48%, 40%, 32% and 23% for the inhaler-placebo group. The differences were not significant at any time point. Abstinence up to 3 months was more likely in older smokers, those with a lower Beck Depression Inventory Score (BDI), lower Fagerstrom Test of Nicotine Dependence (FTND) score and no history of alcoholism. Fluoxetine appeared to increase abstinence rates among high BDI smokers compared to high BDI smokers assigned placebo. Serum levels of nicotine during treatment in the inhaler-fluoxetine group were lower than in the inhaler-placebo group so that fluoxetine may have reduced inhaler use through a common site of action. Conclusions. We found no evidence that fluoxetine treatment when used as an adjunct to NRT in unselected smokers is effective, but there may be an advantage to using it in depressed smokers.     

Effectiveness of a smoking cessation intervention in older adults

AIMS: To: (a) identify characteristics of older smokers considering cessation of smoking; (b) evaluate a cessation intervention plus access to nicotine replacement therapy (NRT); (c) identify predictors of those who successfully quit; and (d) evaluate the effectiveness of the intervention in those AGED >or = 75 years. DESIGN: Self-selection of: (a) a cessation of smoking programme; or (b) ongoing smoking. SETTING: Teaching hospital, Perth, Western Australia. PARTICIPANTS: A larger study recruited smokers and never smokers: from this the 215 community-dwelling smokers (>or= 5 cigarettes/day) aged >or= 68 years (171 males) were enrolled. INTERVENTION: Brief intervention with telephone support and access to NRT versus no intervention. MEASUREMENTS: (a) Profile of older adults planning to quit smoking compared with continuing smokers; (b) cessation at 6 months defined as 30-day point prevalence validated via expired carbon monoxide; and (c) factors predictive of successful cessation. FINDINGS: There were 165 intervention participants. Compared with the 50 continuing smokers, participants in the intervention were younger and had significantly less years of regular smoking, more previous quit attempts and greater nicotine dependence scores. At 6 months, the point prevalence of ex-smokers was 25% (n = 42) with 20% (n = 33) being abstinent throughout the study. No continuing smoker had ceased smoking. Among the intervention group, logistic regression showed that those who used NRT (OR 4.36), were male (OR 3.17), had higher anxiety (OR 1.67) or rejected 'more colds and coughs' as a reason for quitting (OR 2.91) were more likely to be successful quitters. Of those aged >or= 75 years (n = 77), 25% matched cessation criteria. CONCLUSIONS: Older smokers can be engaged successfully in a brief intervention plus NRT as aids to cessation of smoking. The intervention was also effective in the older subgroup of participants. Social factors may provide an additional means of motivating older smokers to quit.     

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.     

A randomized, controlled trial to assess the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers

AIMS: To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine, compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine). DESIGN: Multi-center (n = 4), double-blind, randomized, parallel group, repeat-dose study. SETTING: Clinical laboratory. PARTICIPANTS: A total of 540 subjects were enrolled into the study-135 from each of four sites; 180 patients in each of three treatment arms. INTERVENTION: Treatment was administered for the first 6 weeks of the 8-week study. Patients were instructed to continue smoking for the first 2 weeks of treatment. MEASUREMENTS: The primary efficacy parameter was 4-week continuous abstinence after the quit date, confirmed with an expired carbon monoxide of < 10 parts per million. FINDINGS: Analysis of the 4-week continuous abstinence for the intent-to-treat population showed overall rates of 29% (nicotine + 6 mg mecamylamine), 29% (nicotine + 3 mg mecamylamine) and 23% (nicotine only) using the slip definition which allows smoking in the first 2 weeks after the quit date. Statistical analyses revealed no significant treatment differences. Analyses using the strict definition (no smoking after the quit date) yielded similar non-significant group differences (29%, 27%, 26%). CONCLUSION: If adding mecamylamine to nicotine replacement therapy (NRT) improves the chances of success at stopping smoking, the results of this study suggest that the effect is very small.     

Reduced nicotine content cigarettes: effects on toxicant exposure,dependence and cessation

Aims To examine the effects of reduced nicotine cigarettes on smoking behavior, toxicant exposure, dependence and abstinence. Design Randomized, parallel arm, semi‐blinded study. Setting University of Minnesota Tobacco Use Research Center. Interventions Six weeks of: (i) 0.05 mg nicotine yield cigarettes; (ii) 0.3 mg nicotine yield cigarettes; or (iii) 4 mg nicotine lozenge; 6 weeks of follow‐up. Measurements Compensatory smoking behavior, biomarkers of exposure, tobacco dependence, tobacco withdrawal and abstinence rate. Findings Unlike the 0.3 mg cigarettes, 0.05 mg cigarettes were not associated with compensatory smoking behaviors. Furthermore, the 0.05 mg cigarettes and nicotine lozenge were associated with reduced carcinogen exposure, nicotine dependence and product withdrawal scores. The 0.05 mg cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. The 0.05 mg cigarette led to a significantly higher rate of cessation than the 0.3 mg cigarette and a similar rate as nicotine lozenge. Conclusion The 0.05 mg nicotine yield cigarettes may be a tobacco product that can facilitate cessation; however, future research is clearly needed to support these preliminary findings.     

Nicotine replacement therapy

AIM: To determine the association between daily smoking and use of nicotine replacement therapy (NRT), and to determine predictors of greater NRT use among methadone-maintained smokers. INTERVENTION: Assignment to free nicotine patch (8 to 12 weeks) plus either (1) a baseline-tailored brief motivational intervention, a quit date behavioral skills counseling session, and a relapse prevention follow-up session (max), or (2) brief advice using NCI's 4 A's model (min). SETTING: Five methadone maintenance treatment centers. PARTICIPANTS: Of the 383 methadone-maintained smokers enrolled, 309 (80.6%) set a specific quit date (received NRT) and were located for assessments. Participants were 51.8% male, 78.6% Caucasian, and smoked 26.6 (SD=12.2) cigarettes/day. OUTCOME: Use of NRT and smoking behaviors during the 180-day follow-up period assessed by the Timeline follow-back method. FINDINGS: On the day following their quit day, 86.4% of participants used NRT. The percentage of participants using NRT was 52.3%, 27.1%, and 10.4% on day 30, day 60, and day 90, respectively. Participants used NRT on 44.1% of the days through the 90 days of the treatment protocol. The estimated odds of smoking abstinence was 7.1 (P<.001) times higher on days when NRT was used than on days when NRT was not used, and cigarettes/day was also significantly lower on NRT days (14.93 vs 4.65; P<.001). CONCLUSION: Nicotine replacement therapy use was inconsistent following an initial quit attempt among methadone-maintained smokers. On days when NRT was used, individuals were likely to smoke at reduced levels or not at all.     

Perceived safety and efficacy of nicotine replacement therapies among US smokers and ex-smokers: relationship with use and compliance

AIM: Nicotine 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 PARTICIPANTS: A total of 3203 current and former US smokers completed a national mail-out survey of issues and attitudes related to smoking cessation. FINDINGS: Two-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. CONCLUSIONS: The 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.     

A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain

Aims Because smoking cessation rates might be improved by combining drugs and by reducing post‐cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the nicotine patch to rimonabant, a cannabanoid type‐1 receptor antagonist that reduces body weight. Design Randomized double‐blind placebo‐controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open‐label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a nicotine patch (n = 369) or placebo patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2‐week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4‐week continuous abstinence at end‐of‐treatment (weeks 6–9; primary end‐point); 7‐day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end‐of‐treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight‐concerned smokers. Serious adverse event rates did not differ between groups. Depression‐ and anxiety‐related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a nicotine patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post‐cessation weight gain in either group, even among weight‐concerned smokers, during drug treatment.     

Smoking cessation among inner-city African Americans unsing the nicotine transdermal patch

OBJECTIVE: To determine the efficacy of the transdermal nicotine patch for smoking cessation in inner-city African Americans. DESIGN: Double-blind, placebo-controlled, randomized trial. SETTING: Outpatient in an inner-city hospital. PATIENTS AND PARTICIPANTS: A computer-generated random numbers table with a block size set at 20 was used to randomize 410 patients to one of two study arms. INTERVENTIONS: The transdermal nicotine patch for 10 weeks as an adjunct to brief counseling. MEASUREMENTS AND MAIN RESULTS: Of the 410 patients randomized, mean age was 48 years, 65% were female, 41% had less than a high school education, 51% had an annual household income of less than $8,000, and the average number of cigarettes smoked per day was 20. Quit rates at 10 weeks were 21.5% (44/205) with the nicotine patch, and 13.7% (28/205) with the placebo patch (p=.03). At 6 months, quit rates were 17.1% (35/205) with the nicotine patch, and 11.7% (24/205) with the placebo patch (p=.08). After adjusting for baseline differences in age and educational attainment, differences remained significant at 10 weeks (p=.04), but were not significant at 6 months (p=.14). Compliance rates for return visits were 83%, 78%, 55%, and 52%, at 1, 2, 6, and 10 weeks, respectively. CONCLUSIONS: The nicotine patch significantly improves short-term quit rates in inner-city African Americans who are interested in trying to quit smoking. Efforts should be made to reach underserved populations through smoking cessation programs, and to assist in maintaining abstinence. Presented in part at the annual meeting of the Society of General Internal Medicine, San Giego, Calif., May 6, 1995. Supported by an American Cancer Society Career Development Award to Dr. Ahluwalia, an unrestricted grant from Marion Merrell Dow, Inc., and the Emory Medical Care Foundation.     

Relationship between menthol cigarettes and smoking cessation among African American light smokers

AIMS: To determine whether African American light smokers who smoked menthol cigarettes had lower cessation when treated with nicotine replacement therapy and counseling. DESIGN: Data were derived from a clinical trial that assessed the efficacy of 2 mg nicotine gum (versus placebo) and counseling (motivational interviewing counseling versus Health Education) for smoking cessation among African American light smokers (smoked < or = 10 cigarettes per day). PARTICIPANTS: The sample consisted of 755 African American light smokers. MEASUREMENTS: The primary outcome variable was verified 7-day point-prevalence smoking cessation at 26 weeks follow-up. Verification was by salivary cotinine. FINDINGS: Compared to non-menthol smokers, menthol smokers were younger and less confident to quit smoking (P = 0.023). At 26 weeks post-randomization, 7-day verified abstinence rate was significantly lower for menthol smokers (11.2% versus 18.8% for non-menthol, P = 0.015). CONCLUSIONS: Among African American light smokers, use of menthol cigarettes is associated with lower smoking cessation rates. Because the majority of African American smokers use menthol cigarettes, a better understanding of the mechanism for this lower quit rate is needed.     

Harm reduction--a treatment approach for resistant smokers with tobacco-related symptoms

Smokers with chronic obstructive pulmonary disease (COPD) appear to represent a hard-core group, and this presents a dilemma for chest physicians. A reduction in cigarette smoking benefits health, and nicotine replacement therapy (NRT) can aid smoking reduction. Hence we studied the efficacy of nicotine gum in helping hard-core smokers with severe COPD to quit. Seventeen smokers with severe COPD (FEV(1) 38-47% of predicted normal) who smoked >30 cigarettes/day but were unable to quit were encouraged to reduce their smoking as much as possible by using 4-mg nicotine gum. Five gradually reduced their daily tobacco consumption and, 18 months after starting NRT, were smoking an average of 6 cigarettes/day while still using nicotine gum. Compared to baseline, their respiratory symptoms had improved, and both FEV(1) and FVC had increased. There was no improvement in pulmonary function in the group of smokers who did not reduce their cigarette consumption. No adverse events relating to nicotine occurred among the patients who used NRT to reduce their smoking. We propose that this reduction approach should be considered for patients with respiratory disease who are unable or unwilling to stop smoking.