Effect of nicotine nasal spray on smoking cessation. A randomized, placebo-controlled, double-blind study

BACKGROUND: Nicotine replacement therapies have proved to be of value in smoking cessation. However, not all smokers can use the nicotine gum or nicotine patch owing to side effects. In addition, the absorption of nicotine from these formulas is slow compared with smoking. A nicotine nasal spray delivers nicotine more rapidly. The objective of this study was to evaluate the efficacy and safety of the nicotine nasal spray for smoking cessation. METHODS: Subjects were recruited through advertisements in newspapers and among patients referred to the smoking cessation clinic at Sahlgren's Hospital, G?teborg, Sweden. Two hundred forty-eight smokers were treated in small groups with eight counseling sessions over 6 weeks. At their first group session, subjects were randomized to a group receiving nicotine spray (n = 125), 0.5 mg of nicotine per single spray, or to a placebo group (n = 123). The procedure was double blind. Success rates were measured up to 12 months. The nonsmoking status was verified by expired carbon monoxide less than 10 ppm. RESULTS: Significantly more subjects in the nicotine group were continuously abstinent for 12 months than in the placebo group (27% vs 15%; odds ratio, 2.16; 95% confidence interval, 1.15 to 4.12). Ten of the 34 abstinent subjects in the nicotine group used the spray for 1 year. Mild or moderate side effects were rather frequent for both sprays, but they were significantly more for the nicotine spray. Subjects with high scores (> 7) on Fagerstr?m's tolerance questionnaire had a significantly lower success rate with placebo than with the nicotine spray. For subjects with low scores, there was no difference. CONCLUSION: Nicotine nasal spray in combination with group treatment is an effective aid to smoking cessation.     

Depression and smoking cessation: Characteristics of depressed smokers and effects of nicotine replacement.

Previous research has linked depression to difficulties in smoking cessation. The authors followed 269 smokers who attempted to quit smoking for 3 months. Participants were given nicotine gum (2 or 4 mg) or placebo gum and brief counseling. The study found that 34% of the smokers met the criterion for current depression using the Center for Epidemiological Studies Depression Scale. Depressed smokers relapsed significantly earlier than the nondepressed. Nicotine gum was significantly more effective than placebo gum among all smokers. The benefits of nicotine gum were particularly apparent among the depressed. Only 12.5% of depressed smokers quit successfully with placebo gum for 3 months, whereas 29.5% quit with nicotine gum. Depressed smokers reported more stress, less coping resources, more physical and psychological symptoms, and more frequent smoking in the presence of negative affect than did the nondepressed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Efficacy of a smoking cessation program for hospital patients

BACKGROUND: Hospitalization may be an opportune time to change smoking behavior because it requires smokers to abstain from tobacco at the same time that illness can motivate them to quit. A hospital-based intervention may promote smoking cessation after discharge. METHODS: We tested the efficacy of a brief bedside smoking counseling program in a randomized controlled trial at Massachusetts General Hospital, Boston. The 650 adult smokers admitted to the medical and surgical services were randomly assigned to receive usual care or a hospital-based smoking intervention consisting of (1) a 15-minute bedside counseling session, (2) written self-help material, (3) a chart prompt reminding physicians to advise smoking cessation, and (4) up to 3 weekly counseling telephone calls after discharge. Smoking status was assessed 1 and 6 months after hospital discharge by self-report and validated at 6 months by measurement of saliva cotinine levels. RESULTS: One month after discharge, more intervention than control patients were not smoking (28.9% vs 18.9%; P=.003). The effect persisted after multiple logistic regression analyses adjusted for baseline group differences, length of stay, postdischarge smoking treatment, and hospital readmission (adjusted odds ratio, 2.19; 95% confidence interval, 1.34-3.57). At 6 months, the intervention and control groups did not differ in smoking cessation rate by self-report (17.3% vs 14.0%; P=.26) or biochemical validation (8.1% vs 8.7%; P=.72), although the program appeared to be effective among the 167 patients who had not previously tried to quit smoking (15.3% vs 3.7%; P=.01). CONCLUSIONS: A low-intensity, hospital-based smoking cessation program increased smoking cessation rates for 1 month after discharge but did not lead to long-term tobacco abstinence. A longer period of telephone contact after discharge might build on this initial success to produce permanent smoking cessation among hospitalized smokers.     

Concurrent brief versus intensive smoking intervention during alcohol dependence treatment.

Alcohol dependent smokers (N=118) enrolled in an intensive outpatient substance abuse treatment program were randomized to a concurrent brief or intensive smoking cessation intervention. Brief treatment consisted of a 15-min counseling session with 5 min of follow-up. Intensive intervention consisted of three 1-hr counseling sessions plus 8 weeks of nicotine patch therapy. The cigarette abstinence rate, verified by breath carbon monoxide, was significantly higher for the intensive treatment group (27.5%) versus the rate for the brief treatment group (6.6%) at 1 month after the quit date but not at 6 months, when abstinence rates fell to 9.1% for the intensive treatment group and 2.1% for the brief treatment group. Smoking treatment assignment did not significantly impact alcohol outcomes. Although intensive smoking treatment was associated with higher rates of short-term tobacco abstinence, other, perhaps more intensive, smoking interventions are needed to produce lasting smoking cessation in alcohol dependent smokers. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Transdermal clonidine for smoking cessation: A double-blind randomized dose–response study.

A 4-week trial tested the effects of 4 doses (placebo, 0.1 mg/d, 0.2 mg/d, and 0.3 mg/d) of transdermal clonidine on smoking cessation and nicotine withdrawal. After a 1-week baseline, smokers (N?=?72) started the drug and tried to quit by Week 3. Significantly fewer smokers who received a placebo were abstinent at 5 days after quitting as compared with smokers who received clonidine at any dose (19% vs 57%, respectively, p?=?.007). Blood clonidine concentration interacted with nicotine dependence (p?     

The nicotine patch in smoking cessation. A randomized trial with telephone counseling

BACKGROUND: This study was conducted to determine the efficacy of the nicotine patch in smoking cessation when combined with self-help materials, three brief visits, and telephone counseling. METHODS: One hundred fifty-nine healthy volunteers who smoked at least one pack of cigarettes per day and desired to quit smoking were enrolled in a double-blind trial with 6-week treatment and 6-month follow-up periods. After review of self-help materials, subjects were randomly assigned to regimens of nicotine or placebo patches. Subjects wore two patches per day for 4 weeks (25 mg of nicotine per 24 hours), then one patch per day for 2 weeks. Return visits were at the ends of weeks 4 and 6. Telephone counseling was given during weeks 1, 2, 3, and 5. Abstinence at 6 weeks was defined as zero cigarettes smoked for the previous 28 days, verified by exhaled carbon monoxide less than 8 ppm at 4 weeks and 6 weeks. Abstinence at 3 and 6 months was defined as self-report of zero cigarettes since the previous contact, verified by carbon monoxide value at 6 months. RESULTS: Abstinence rates at 6 weeks, 3 months, and 6 months were 29.5%, 21.8%, and 20.5% in the active group, and 8.8%, 3.8%, and 2.5% in the placebo group (P < or = .001 for each comparison), respectively. Skin irritation was the main side effect, causing 1.3% to drop out. CONCLUSION: The nicotine patch is efficacious in smoking cessation over a 6-month period, when combined with only self-help materials, three brief visits, and telephone counseling.     

Smoking cessation: Social comparison level predicts success for adult smokers.

The affiliation preferences of 151 adult heavy smokers who joined smoking cessation groups were assessed at the 1st group session and were then used to predict their smoking status 6 and 12 months later. Those who preferred to be in groups with other smokers who were having relatively little trouble quitting were more likely to be successful than were those who preferred others who were having more difficulty quitting. This prospective effect was mediated by psychological distancing from the image of the typical smoker: Preference for others who were doing well was associated with a decrease in perceived similarity to the typical smoker, which, in turn, was associated with successful cessation. Implications of these findings for cessation groups and social comparison theory are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Assigned Versus Perceived Placebo Effects in Nicotine Replacement Therapy for Smoking Reduction in Swiss Smokers.

In this report, the authors explore the relationships of perceived treatment to outcome in a large, placebo-controlled trial of nicotine replacement treatment for smoking reduction. In the original study (J. F. Etter, E. Laszlo, J. P. Zellweger, C. Perrot, & T. V. Perneger, 2002), which was conducted in French-speaking Switzerland, smokers were randomly assigned to receive nicotine, matching placebo products, or no intervention. At the end of the 6-month study, participants were asked to guess whether they had received nicotine or placebo. In the present analysis, the authors examined the difference in smoking reduction between those who believed they had received nicotine and those who believed they had received placebo. Regardless of actual treatment, smokers who believed they had received nicotine had significantly better outcome than those who believed they had received placebo. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Cue-Provoked Craving and Nicotine Replacement Therapy in Smoking Cessation.

Cue exposure paradigms have been used to examine reactivity to smoking cues. However, it is not known whether cue-provoked craving is associated with smoking cessation outcomes or whether cue reactivity can be attenuated by nicotine replacement therapy (NRT) in clinical samples. Cue-provoked craving ratings and reaction time responses were measured on the 1st day of abstinence among 158 smokers who had been randomized to high-dose nicotine (35 mg) or placebo patch. The nicotine patch reduced overall levels of craving but did not attenuate cue-provoked craving increases or reaction time responses. Cue-provoked craving predicted relapse among participants on the nicotine patch but not among those on placebo. In summary, NRT users could benefit from treatment that attenuates cue-provoked craving. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Long-term effectiveness of two Dutch work site smoking cessation programs

This article reports on one of the few experimental studies in Europe to examine work site smoking cessation. The study examined whether a comprehensive intervention (self-help manuals, group courses, a mass media campaign, smoking policies, and a second-year program) is more effective than a minimal intervention (self-help manuals only). Eight work sites participated in the study. The effect of treatment on smoking cessation depended on nicotine dependency levels: Heavy smokers had more success with the comprehensive smoking cessation intervention than with the minimal intervention (with respect to both 14-month quit rate and 6-month prolonged abstinence). For heavy smokers, exposure to mass media exhibitions or to group courses had a beneficial effect on prolonged abstinence. Comprehensive programs may be most appropriate in Dutch work sites with large proportions of heavily addicted smokers.     

Effectiveness of the 4-mg dose of nicotine polacrilex for the initial treatment of high-dependent smokers

PURPOSE: To determine the effectiveness of the 4-mg and 2-mg dosages of nicotine polacrilex vs placebo through the first 6 weeks of treatment (during which 75% of relapse occurs when there is no treatment) in assisting high-dependent smokers to stop smoking when instructed to use a fixed number (12 pieces) of medication daily. SUBJECTS AND METHODS: Ninety high-dependent (Fagerstr?m Tolerance Questionnaire score > or = 7 plus baseline carbon monoxide level > 15 ppm) healthy male and female smokers, highly motivated to quit smoking, were enrolled in a 6-week, randomized, double-blind, placebo-controlled trial in which they were instructed to use 12 pieces per day of their assigned dosage formulation: 4 mg, 2 mg, or 0.5 mg (placebo) of nicotine polacrilex. The behavioral intervention did not depend on providing any special psychological training, skills, or services but rather employed a standard medical practice model that could easily be implemented by any primary care physician. RESULTS: Sustained abstinence from weeks 2 through 6, determined at each visit by absolutely no cigarette use plus a carbon monoxide level of 8 ppm or lower was 59% (4-mg group), 30% (2-mg group), and 39% (placebo group) (P < .02). For the 55 of the 90 smokers who met the originally planned definition of high dependence (Fagerstr?m Tolerance Questionnaire score > or = 7 plus baseline smoking serum cotinine level > 250 ng/mL plus baseline carbon monoxide level > 15 ppm), results were 63% (4-mg group), 25% (2-mg group), and 25% (placebo group) (P < .02). In addition, the 4-mg dose produced statistically significantly higher abstinence rates in compliant subjects (P < .02) and also in subjects with high baseline serum continine levels who were compliant (P < .01) than did either the 2-mg dose or placebo. CONCLUSIONS: It appears that the 4-mg dose of nicotine polacrilex is the drug and dose of choice for the initial phase of tobacco dependence treatment in high-dependent smokers; the 2-mg dose of nicotine polacrilex is not better than placebo during the first 6 weeks of treatment for high-dependent cigarette smokers, and thus should not be used for these patients during the initial treatment phase.     

Mood influences on acute smoking responses are independent of nicotine intake and dose expectancy.

Acute responses to smoking are influenced by nicotine and by nonpharmacological factors such as nicotine dose expectancy and sensory effects of smoke inhalation. Because negative mood increases smoking reinforcement, the authors examined whether these effects may be altered by mood context. Smokers (n=200) participated in 2 sessions, negative or positive mood induction, and were randomized to 1 of 5 groups. Four groups comprised the 2×2 balanced placebo design, varying actual (0.6 mg vs. 0.05 mg yield) and expected nicotine dose (expected nicotine vs. denicotinized [denic]) of cigarettes. A fifth group was a no-smoking control. Smoking, versus not smoking, attenuated negative affect, as well as withdrawal and craving. Negative mood increased smoking reinforcement. However, neither actual nor expected nicotine dose had much influence on these responses; even those smokers receiving and expecting a denic cigarette reported attenuated negative affect. A follow-up comparison suggested that the sensory effects of smoke inhalation, but not the simple motor effects of smoking behavior, were responsible. Thus, sensory effects of smoke inhalation had a greater influence on relieving negative affect than actual or expected nicotine intake. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effect of night smoking, sleep disturbance, and their co-occurrence on smoking outcomes.

Recent evidence suggests that smoking during the night is an indicator of nicotine dependence and predicts smoking cessation failure. Night smokers are likely to experience disturbance to their sleep cycle when they wake to smoke, but we are not aware of the prevalence of night smokers' self-reported sleep disturbance. Because sleep disturbance also predicts smoking cessation failure, we examined how the pre-cessation risk factors of night smoking and sleep disturbance, and their co-occurrence, predict smoking cessation failure in a 6-week double-blind randomized controlled trial examining whether naltrexone augments the efficacy of the nicotine patch (O'Malley et al., 2006). Smokers (N = 385) completed the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989) and a single item of waking at night to smoke pre-cessation. Smoking status was determined at weeks 1, 6, 24, and 48 weeks after quitting. The two main findings were: (a) night smokers reported significantly greater sleep disturbance than nonnight smokers; and (b) smokers with co-occurring night smoking and sleep disturbance experienced significantly greater risk for smoking than smokers with neither risk factor. Results suggest that individuals who both wake during the night to smoke and report clinically-significant sleep disturbance represent a high-risk group of smokers. Future smoking cessation treatment might incorporate strategies related to managing these smokers' sleep habits and physiological dependence on nicotine in order to bolster their cessation outcomes. (PsycINFO Database Record (c) 2011 APA, all rights reserved)     

Do adolescent smokers experience withdrawal effects when deprived of nicotine?

This is the first controlled prospective study of the effects of nicotine deprivation in adolescent smokers. Heart rate and subjective withdrawal symptoms were measured over and 8-hr period while participants smoked normally. Seven days later, participants were randomized to wear a 15-mg (16-hr) nicotine patch or placebo patch for 8 hr, and they refrained from smoking during the session. Those wearing the placebo experienced a decrease in heart rate across sessions and an increase in subjective measures of nicotine withdrawal. Those wearing the active patch also reported significant increases for some subjective symptoms. Expectancy effects were also observed. The findings indicate that adolescent smokers experience subjective and objective changes when deprived of nicotine. As in previous research with adults, expectancies concerning the effects of nicotine replacement also influenced perceptions of withdrawal. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Nicotine gum and self-help behavioral treatment for smoking relapse prevention: Results from a trial using population-based recruitment.

Smokers aged 18–65 yrs (N?=?1,044) who were able to quit for 24 hr were randomized using a 2?×?2 factorial design to compare nicotine gum to no gum use and self-help materials to no use of materials. All participants were offered a $100 incentive to quit and stay quit for 6 months. Six month abstinence was 27% in the gum groups, compared with 19% in the no-gum group (p?=?.002). Compared with the no-gum group, relapse occurred at a significantly lower rate in the gum group for the entire 12 months of follow-up There was no significant main effect for the self-help materials, no interaction between gum and materials, and no evidence that the effectiveness of gum differed between the sexes or between heavy and light smokers. Nicotine gum is an effective adjunct to minimal-contact smoking cessation materials plus monetary incentive in a population-based sample of smokers. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Strike while the iron is hot: Can stepped-care treatments resurrect relapsing smokers?

The efficacies of 2 group counseling step-up treatments for smoking cessation, cognitive-behavioral/skill training therapy (CBT) and motivational interviewing/supportive (MIS) therapy, were compared with brief intervention (BI) treatment in a sample of 677 smokers. Differential efficacy of the 2 step-up treatments was also tested in smokers at low and high risk for relapse (no smoking vs. any smoking during the first postquit week, respectively). All participants received 8 weeks of nicotine patch therapy. BI consisted of 3 brief individual cessation counseling sessions; CBT and MIS participants received BI treatment and 6 group counseling sessions. Neither CBT nor MIS treatment improved long-term abstinence rates relative to BI. Limited support was found for the hypothesis that high-risk smokers would benefit more from MIS than CBT. Other hypotheses were not supported. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effects of Transdermal Nicotine During Imaginal Exposure to Anxiety and Smoking Cues in College Smokers.

In a 2 (patch) × 2 (smoking) × 2 (anxiety) mixed design, 52 undergraduate smokers randomly received a nicotine (21 mg) or placebo patch. After a 4-hr nicotine absorption/deprivation period, participants imagined several scenarios varying in cue content: (a) anxiety plus smoking, (b) anxiety, (c) smoking, and (d) neutral. Although smoking urge increased in both the nicotine and placebo conditions after the absorption/deprivation period, those who received the placebo reported significantly greater urge. During the cue reactivity trials, a significant Patch × Smoking × Anxiety interaction effect was observed for urge. However, participants who received nicotine still experienced moderate urges, indicating that nicotine did not attenuate cue-elicited urge. Transdermal nicotine did not diminish anxiety during the absorption/deprivation period or in response to the cues. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up

OBJECTIVE: To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year. DESIGN: Placebo controlled, double blind trial. SETTING: Reykjavik health centre. SUBJECTS: 237 smokers aged 22-66 years living in or around Reykjavik. INTERVENTIONS: Nicotine patch for 5 months with nicotine nasal spray for 1 year (n=118) or nicotine patch with placebo spray (n=119). Treatment with patches included 15 mg of nicotine for 3 months, 10 mg for the fourth month, and 5 mg for the fifth month, whereas nicotine in the nasal spray was available for up to 1 year. Both groups received supportive treatment. MAIN OUTCOME MEASURE: Sustained abstinence from smoking. RESULTS: Sustained abstinence rates for the patch and nasal spray group and patch only group were 51% v 35% after 6 weeks (odds ratio 1.97, 95% confidence interval 1.17% to 3.32; P=0.011(chi2), 37% v 25% after 3 months (1.76, 1.01 to 3.08; P=0.045), 31% v 16% after 6 months (2.40, 1.27 to 4.50; P=0.005), 27% v 11% after 12 months (3.03, 1.50 to 6.14; P=0.001), and 16% v 9% after 6 years (2.09, 0.93 to 4.72; P=0.08) [corrected]. CONCLUSIONS: Short and long term abstinence rates show that the combination of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year is a more effective method of stopping smoking than using a patch only. The low percentage of participants using the nasal spray at 1 year, and the few relapses during the second year, suggest that it is not cost effective to use a nasal spray for longer than 7 months after stopping a patch.