The nicotine inhaler in smoking cessation

BACKGROUND: Nicotine replacement therapy has been shown to improve success rates in smoking cessation treatment. However, the available products cause adverse effects, which prevent some smokers from using them. A new method of delivering nicotine via inhaler supplies nicotine orally through inhalation from a plastic tube. This mode of delivering nicotine resembles smoking, as it includes handling and active inhalation. OBJECTIVES: To assess the efficacy and safety of the nicotine inhaler as an aid in smoking cessation. METHODS: A 1-year, randomized, double-blind, placebo-controlled study was conducted in a smoking cessation clinic. Two hundred forty-seven smokers who smoked at least 10 cigarettes per day and who had previously made a serious attempt to stop smoking using nicotine chewing gum were recruited through advertisements. Randomization to treatment or control conditions were made at the first group session, with 123 participants receiving nicotine inhalers and 124 receiving placebo inhalers. The inhalers were distributed at the second session and participants were allowed to use the inhalers for 6 months. MAIN OUTCOME MEASURE: Biochemically verified continuous abstinence from smoking after 2 and 6 weeks and at 3, 6, and 12 months. RESULTS: Significantly more participants who had used the nicotine inhalers were continuously abstinent compared with those who had used the placebo inhalers. The respective success rates after 12 months were 28% and 18% (P = .046). At 6 months, 20 participants (16%) in the nicotine group were still using the inhaler, compared with 4 (3%) in the control group (P < .001). CONCLUSION: The nicotine inhaler was an effective smoking cessation aid that produced a few mild and transient adverse effects.     

Effects of transdermal nicotine on symptoms, moods, and cardiovascular activity in the everyday lives of smokers and nonsmokers with attention-deficit/hyperactivity disorder.

The aim of the study was to test the self-medication hypothesis by examining the effects of nicotine in the everyday lives of smokers and nonsmokers with attention-deficit/hyperactivity disorder (ADHD). Fifty-two adults with ADHD (25 abstinent smokers and 27 nonsmokers) participated in a double-blind placebo controlled study with one nicotine patch condition and one placebo patch condition in counterbalanced order. Each condition continued for two consecutive days in which patches were administered each morning. The effects of nicotine on ADHD symptoms, moods, and side effects were assessed with electronic diaries. Cardiovascular activity was recorded with ambulatory blood pressure monitors and physical activity was monitored with actigraphs. Nicotine reduced reports of ADHD symptoms by 8% and negative moods by 9%, independent of smoking status. In addition, nicotine increased cardiovascular activity during the first 3 to 6 hours after nicotine patch administration. The results support the self-medication hypothesis for nicotine in adults with ADHD and suggest that smoking cessation and prevention efforts for individuals with ADHD will need to address both the symptom reducing and mood enhancing effects of nicotine. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Smoking abstinence, eating style, and food intake.

Individual differences in weight gain after smoking cessation may reflect differences in eating restraint that exist before cessation. It was hypothesized that abstinent smokers with high scores on the Eating Inventory Disinhibition Scale would be more likely to overeat than nonabstinent smokers with lower Disinhibition Scale scores. Forty smokers completed the Eating Inventory and the Profile of Mood States (POMS). Subjects were randomly assigned to 24-hr cigarette abstinence or to continued smoking. Subjects then participated in an ice cream tasting task, after which they were free to eat as much ice cream as they wanted. The hypothesis was confirmed. Exploratory analyses indicated that eating behavior items predicted the amount eaten and that weight fluctuation items did not. The POMS Confusion Scale scores were highest for abstinent subjects who scored high on the Disinhibition Scale. A parallel but nonsignificant relation was observed for POMS Tension Scale scores. The meaning of these data for the relation between smoking cessation and weight gain is discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Low-dose nicotine nasal spray use and effects during initial smoking cessation.

The purposes of this study were to determine if smokers wanting to quit smoking would use a low-dose nicotine nasal spray (i.e., acceptability) and what effect this spray use would have on withdrawal during the 1st week of cessation. Smokers (n?=? 52) were assigned double-blind to either placebo or nicotine spray (1.5 μg/kg. or approx. 0.1 mg, per spray) for ad lib use during the first week of cessation. All received group behavioral counseling. There was no difference in continuous 1-week abstinence (daily COa?     

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.     

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)     

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?     

A comparison of sustained-release bupropion and placebo for smoking cessation

BACKGROUND AND METHODS: Trials of antidepressant medications for smoking cessation have had mixed results. We conducted a double-blind, placebo-controlled trial of a sustained-release form of bupropion for smoking cessation. We excluded smokers with current depression, but not those with a history of major depression. The 615 subjects were randomly assigned to receive placebo or bupropion at a dose of 100, 150, or 300 mg per day for seven weeks. The target quitting date (or "target quit date") was one week after the beginning of treatment. Brief counseling was provided at base line, weekly during treatment, and at 8, 12, 26, and 52 weeks. Self-reported abstinence was confirmed by a carbon monoxide concentration in expired air of 10 ppm or less. RESULTS: At the end of seven weeks of treatment, the rates of smoking cessation as confirmed by carbon monoxide measurements were 19.0 percent in the placebo group, 28.8 percent in the 100-mg group, 38.6 percent in the 150-mg group, and 44.2 percent in the 300-mg group (P<0.001). At one year the respective rates were 12.4 percent, 19.6 percent, 22.9 percent, and 23.1 percent. The rates for the 150-mg group (P=0.02) and the 300-mg group (P=0.01) -- but not the 100-mg group (P=0.09) -- were significantly better than those for the placebo group. Among the subjects who were continuously abstinent through the end of treatment, the mean absolute weight gain was inversely associated with the dose (a gain of 2.9 kg in the placebo group, 2.3 kg in 100-mg and 150-mg groups, and 1.5 kg in the 300-mg group; P= 0.02). No effects of treatment were observed on depression scores as measured serially by the Beck Depression Inventory. Thirty-seven subjects stopped treatment prematurely because of adverse events; the frequency was similar among all groups. CONCLUSIONS: A sustained-release form of bupropion was effective for smoking cessation and was accompanied by reduced weight gain and minimal side effects. Many participants in all groups were smoking at one year.     

The influence of caffeine on nicotine's discriminative stimulus, subjective, and reinforcing effects.

Caffeine may acutely alter the discriminative stimulus and subjective effects of nicotine, perhaps explaining the association of coffee intake with smoking status. In this study, smokers were initially trained to discriminate 20 μg/kg nicotine by nasal spray from placebo (0). Then, generalization of nicotine discrimination was tested, using both 2- and 3-choice ("novel" option) procedures, across a range of doses (0-20 μg/kg) following pretreatment with 0, 2.5, and 5.0 mg/kg caffeine p.o. Nicotine reinforcement was assessed after the end of generalization testing using a choice procedure. Caffeine pretreatment did not alter nicotine discrimination and self-administration. Caffeine and nicotine influenced some subjective and cardiovascular responses, but there were no interaction effects except for diastolic blood pressure. These results do not support the notion that caffeine acutely alters nicotine's discriminative stimulus, subjective, or reinforcing effects. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A systematic review of evidence for the appropriateness of neonatal screening programmes for inborn errors of metabolism

The nicotinic antagonist mecamylamine was evaluated in a randomized smoking cessation trial. Four groups of participants (n = 20 per group) received nicotine plus mecamylamine, nicotine alone, mecamylamine alone, or no drug for 4 weeks before cessation. After the quit-smoking date, all subjects received nicotine plus mecamylamine treatment for 6 weeks. Nicotine skin patches (21 mg/24 hr) and mecamylamine capsules (2.5-5.0 mg twice per day) were used. Precessation mecamylamine significantly prolonged the duration of continuous smoking abstinence; abstinence rates at the end of treatment were 47.5% with mecamylamine and 27.5% without mecamylamine. Nicotine + mecamylamine reduced ad lib smoking, smoking satisfaction, and craving more than either drug alone. Moreover, the orthostatic decrease in blood pressure caused by mecamylamine was offset by nicotine. Mecamylamine before smoking cessation may be an effective adjunct to nicotine patch therapy.     

Nicotine–mecamylamine treatment for smoking cessation: The role of pre-cessation therapy.

The nicotinic antagonist mecamylamine was evaluated in a randomized smoking cessation trial. Four groups of participants (n?=?20 per group) received nicotine plus mecamylamine, nicotine alone, mecamylamine alone, or no drug for 4 weeks before cessation. After the quit-smoking date, all subjects received nicotine plus mecamylamine treatment for 6 weeks. Nicotine skin patches (21 mg/24 hr) and mecamylamine capsules (2.5–5.0 mg twice per day) were used. Precessation mecamylamine significantly prolonged the duration of continuous smoking abstinence; abstinence rates at the end of treatment were 47.5% with mecamylamine and 27.5% without mecamylamine. Nicotine + mecamylamine reduced ad lib smoking, smoking satisfaction, and craving more than either drug alone. Moreover, the orthostatic decrease in blood pressure caused by mecamylamine was offset by nicotine. Mecamylamine before smoking cessation may be an effective adjunct to nicotine patch therapy. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effect of high-dose nicotine patch on the characteristics of lapse episodes.

Objective: Nicotine patch improves treatment outcomes, but lapses are still common. To understand the process of relapse on patch, we investigated differences in the antecedents (withdrawal, setting, triggers) of lapse episodes experienced on high-dose (35 mg) nicotine patches versus placebo. Design: Participants were smokers who lapsed during a randomized, double-blind trial of active patches (n = 100) versus placebo (n = 85). Participants used electronic diaries to monitor their smoking, affect, and activities in real time for 5 weeks during their cessation attempt. Results: We analyzed 490 lapse episodes (active: 266; placebo: 224). Lapses on nicotine patch were characterized by significantly lower positive affect and higher negative affect than placebo lapses. Participants treated with high-dose patch were also significantly more likely to lapse in situations involving little or no craving. Situational antecedents of lapses on patch resembled those on placebo. Conclusion: The results suggest that treatment with patch may set a higher threshold for affective stimuli to provoke lapses, but does not change the proximal cues that trigger lapses. This suggests that behavioral relapse-prevention strategies developed for unmedicated smokers should also apply to those treated with nicotine patch. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Facial EMG as an index of affective response to nicotine.

Negative affect reduction has been postulated to be a key feature of cigarette smoking. In the present study, facial electromyography (EMG), heart rate (HR), and skin conductance response (SCR) were used to evaluate the affective significance of acute nicotine administration and overnight withdrawal. Smokers (N = 115) attended four 90-min laboratory assessment sessions scheduled approximately 3 days apart. The sessions provided a complete crossing of 2 prelaboratory deprivation conditions (12-hr deprived vs. nondeprived) with 2 drug conditions (nicotine vs. placebo nasal spray). During each session, smokers viewed affective slides while facial EMG, HR, and SCR were recorded. Results indicated that for women, nicotine nasal spray resulted in lower corrugator EMG activity during both smoking-deprived and nondeprived sessions, compared with placebo. However, nondeprived women also showed an increase in zygomaticus EMG when given nicotine compared with placebo spray, whereas smoking-deprived women demonstrated a decrease in the zygomaticus response to nicotine compared with placebo. With men, nicotine also appeared to lower corrugator during deprivation, but not nondeprivation, compared with placebo spray, though the contrast only approached significance. With zygomaticus EMG, nicotine spray decreased men's zygomaticus responding during nondeprivation but not during deprivation, compared with placebo spray. The HR results reflected the stimulatory properties of the drug rather than nicotine's affective properties, whereas SCR was unresponsive to our experimental manipulations. The corrugator EMG results support negative reinforcement models of smoking that postulate that acute nicotine use reduces withdrawal-driven negative affect. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Characterizing nicotine withdrawal in pregnant cigarette smokers.

Maternal smoking is a leading preventable cause of poor pregnancy outcomes and infant morbidity and mortality. Whereas pregnancy has been thought of as a "window of opportunity" when women are more motivated to change health behaviors such as smoking, only 20% of pregnant women quit smoking upon learning they are pregnant and remain abstinent at the end of the pregnancy. Greater understanding of possible obstacles to smoking during pregnancy, such as nicotine withdrawal, is needed. The symptoms of nicotine withdrawal have been well characterized in nonpregnant smokers, but there has been only 1 report conducted during pregnancy, and that was a retrospective study. The aim of the present study was to characterize nicotine withdrawal and craving in pregnant cigarette smokers. These data were collected as part of prospective clinical trials assessing the efficacy of voucher-based incentives to promote abstinence from cigarette smoking during pregnancy and postpartum. The authors examined results from the Minnesota Nicotine Withdrawal Scale (J. R. Hughes & D. K. Hatsukami, 1998) in 27 abstainers (reported no or very low levels of smoking, which was confirmed biochemically) and 21 smokers (smoked at >80% of their baseline smoking level) during the first 5 days of a cessation attempt. Abstainers reported more impatience, anger, and difficulty concentrating than did smokers. The results also suggest that pregnant smokers generally may have elevated baseline levels of withdrawal, which need to be considered in the design and analysis of future studies. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

An open trial of transdermal nicotine replacement therapy for smoking cessation among alcohol- and drug-dependent inpatients

An open trial of transdermal nicotine replacement for smoking cessation was conducted. Over a 7-month period, all patients admitted to the inpatient alcohol and drug treatment unit of the Seattle Veterans Affairs Medical Center, (n = 207) were offered the opportunity to participate in an open trial of transdermal nicotine replacement for smoking cessation. Forty-nine (23.7%) elected to attempt cessation with transdermal nicotine during their inpatient treatment episodes. These subjects received no psychosocial treatments directed specifically at smoking cessation. They smoked a mean of 28.5 (SD = 16.4) cigarettes per day and obtained a mean score of 8.3 (SD = 1.9) on the Fagerstrom Test for Nicotine Dependence. Subjects remained on transdermal nicotine an average of 18.8 (SD = 8.2) days with desire to resume smoking the major reason for discontinuation. Seven subjects (14.3%) self-reported tobacco abstinence at 21 days, and 5 (10.2%) self-reported abstinence as outpatients at 6 weeks. These results show that a substantial proportion of alcohol- and drug-dependent patients entering inpatient treatment are willing to attempt alcohol and illicit drug cessation and tobacco cessation simultaneously and that transdermal nicotine holds promise as a treatment modality in this population.     

Greater sensitivity to subjective effects of nicotine in nonsmokers high in sensation seeking.

The personality characteristic of sensation seeking is associated with risk of smoking, perhaps because of greater initial sensitivity to nicotine. Young healthy nonsmokers (N?=?37) were administered 0, 10, and 20 μg/kg nicotine by nasal spray in 3 separate sessions, and subjective responses were assessed. Sensation-Seeking Scale (SSS) scores were then correlated with these responses. A comparison group of smokers (N?=?55) was included to determine whether sensation seeking was associated specifically with initial sensitivity to nicotine or with general sensitivity regardless of past nicotine exposure. SSS subscales, particularly Experience Seeking and Disinhibition, were correlated with subjective responses to nicotine in nonsmokers but generally not in smokers. These findings indicate that sensation seeking is associated with greater initial sensitivity to nicotine's subjective effects and may provide directions for further study of individual-differences characteristics that predispose people to the risk of becoming smokers. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effects of nicotine on thermal pain detection in humans.

Pain detection threshold (latency in seconds) was repeatedly assessed by a standardized, computer-controlled radiant heat stimulus applied to the skin before and after nicotine intake in 3 studies of smokers and nonsmokers. Placebo or doses of nicotine corrected for body weight were administered by measured-dose nasal spray. Nicotine increased pain latency (i.e., decreased pain sensitivity) significantly in each study, although effects were modest and somewhat inconsistent. Nicotine had no effect on skin temperature at the site of stimulation, arguing against an indirect effect on nociception through peripheral cardiovascular changes. Overall, there were no significant differences as a result of smoking status, indicating that nicotine's influence on pain sensitivity is a "true" drug effect and is not due to withdrawal relief. Findings suggest that nicotine produces an antinociceptive effect in humans, but its relationship to nicotine reinforcement is unclear. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

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.     

Efficacy of forced smoking cessation and an adjunctive behavioral treatment on long-term smoking rates.

This study evaluated the efficacy of a 6-week forced ban on smoking and brief behavioral counseling on long-term smoking rates. Participants were active-duty enrollees in U.S. Air Force basic military training over a 1-year period (N?=?25,996). All participants were under a 6-week ban from tobacco products, and 75% were randomized to a brief smoking cessation intervention, with the other 25% randomized to a control condition. At 1-year follow-up, 18% of smokers were abstinent; women, ethnic minorities, and those intending to stay quit at baseline were more likely to be abstinent. Among smokers not planning to remain abstinent at baseline, those receiving the intervention were 1.73 times more likely to be abstinent. Over time, substantial smoking initiation occurred among nonsmokers (8% of never smokers, 26% of experimental smokers, and 43% of ex-smokers). Forced cessation is associated with good levels of long-term cessation, and brief behavioral interventions enhance cessation in certain subgroups. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Three year continuous abstinence in a smoking cessation study using the nicotine transdermal patch

A total of 305 subjects from Sydney were randomly allocated to receive either an active (24 hour transdermal nicotine patch over a 10 week course) or placebo nicotine patch. All subjects participated in a multicomponent cognitive-behavioural smoking cessation programme over five weeks in two-hour group sessions. The continuous abstinence rates at three years (validated by expired carbon monoxide) were 13.8% for the active group and 5.2% for placebo group (p = 0.011). The active nicotine patch with behavioural therapy achieved more than double the abstinence rates early in treatment compared with placebo and this difference was maintained throughout the three year follow up.