A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse

AIM: To investigate the efficacy of maintenance treatment with bupropion and/or nicotine gum for reducing smoking relapse. DESIGN, SETTING AND PARTICIPANTS: A 48-week study was conducted at a university-based smoking cessation clinic between February 2001 and October 2005. A total of 588 smokers received bupropion and nicotine patch in 8 weeks of open-label treatment (OLT); 289 abstainers during the last 4 weeks of OLT were randomized in double-blind placebo-controlled fashion to one of four arms for 16 weeks of maintenance treatment (MT) followed by 24 weeks of non-treatment follow-up (NTFU). INTERVENTION: Bupropion (300 mg/day) and 2 mg nicotine gum, used alone or combined, and comparable placebo pill and placebo gum. Behavioral counseling at all visits. OUTCOME: Time to relapse (TTR) from randomization. Relapse is defined as the first 7 consecutive days of smoking. Abstinence verified by carbon monoxide 相似文献   

The effects of nicotine gum and counseling among African American light smokers: a 2 x 2 factorial design

AIM: Approximately 50% of African American smokers are light smokers (smoke < or = 10 cigarettes a day). The prevalence of light smoking in the United States is increasing, yet there has not been a single smoking cessation clinical trial targeting light smokers. The purpose of this 2 x 2 factorial, randomized clinical trial was to evaluate the efficacy of nicotine gum (2 mg versus placebo) and counseling (motivational interviewing versus health education) for African American light smokers. DESIGN: Participants were assigned randomly to one of four study arms: 2 mg nicotine gum plus health education (HE); 2 mg nicotine gum plus motivational interviewing (MI); placebo gum plus HE; and placebo gum plus MI. PARTICIPANTS AND SETTING: A total of 755 African American light smokers (66% female, mean age = 45) were enrolled at a community health center over a 16-month period. INTERVENTION AND MEASUREMENTS: Participants received an 8-week supply of nicotine gum and six counseling sessions during the course of the 26-week study. Biochemical measures included expired carbon monoxide (CO) and serum and salivary cotinine. FINDINGS: Seven-day quit rates for nicotine gum were no better than for the placebo group (14.2% versus 11.1%, P = 0.232) at 6 months. However, a counseling effect emerged, with HE performing significantly better than MI (16.7% versus 8.5%, P < 0.001). These results were consistent across outcome time-points (weeks 1, 8, and 26). CONCLUSIONS: Results highlight the potential positive impact of directive information and advice-oriented counseling on smoking cessation. Studies are needed to assess other interventions that may further improve quit rates among African American light smokers who are motivated to quit.     

Probabilities of alcohol high-risk drinking,abuse or dependence estimated on grounds of tobacco smoking and nicotine dependence

Aims  To estimate probabilities of alcohol high-risk drinking, alcohol abuse and alcohol dependence on grounds of smoking-behaviour related variables and single nicotine dependence criteria.
Design  Cross-sectional population-based study.
Setting  Adult population of a region in north Germany.
Participants  Cigarette smokers ( n  = 2437) among a random sample of 4075 females and males aged 18–64, drawn in 1996.
Measurement  Smoking, nicotine dependence according to the Diagnostic and Statistical Manual of Psychiatric Disorders (DSM-IV) and the Fagerström Test for Nicotine Dependence (FTND); increasing alcohol-related harm (ARH): high-risk drinking, DSM-IV alcohol abuse, remitted and current alcohol dependence diagnosed by the Composite International Diagnostic Interview (CIDI).
Findings  Having smoked 30 cigarettes or more per day, onset of smoking at the age of 17 or younger, nicotine dependence and single nicotine dependence criteria revealed odds ratios higher than 4.0 for alcohol dependence. For alcohol dependence, a logistic regression model showed an increased odds ratios for male gender, smoking for 25 years or more, no attempt to quit or cut down, continuation of smoking despite problems, craving for nicotine, withdrawal experience 1 day or longer, smoking first cigarette in the morning 5 minutes or less after waking. The probability of increasing ARH was more likely in males, smokers for 25 years or more, no attempt to quit or cut down, continuation of smoking despite problems and smoking first cigarette in the morning 5 minutes or less after waking.
Conclusions  Gender and single nicotine dependence criteria show particularly high probabilities of alcohol dependence and increasing ARH. Interventions need to take these connections into account.     

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.

Keywords: smoking cessation;  nicotine patches     

Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up

Aim To test the effect of nicotine gum and placebo in smokers not motivated or not able to quit smoking with regard to smoking reduction and smoking cessation. Design This randomized study evaluated nicotine gum versus placebo for up to 1 year in 411 healthy smokers highly motivated to reduce cigarette use. Smoking reduction was defined as self‐reported daily smoking less than 50% of baseline and any decrease (1 p.p.m. or more) in carbon monoxide. Setting Pulmonary department, Copenhagen, Denmark. Findings The overall success rate for sustained smoking reduction was significantly higher at all time‐points for active versus placebo gum (6.3% versus 0.5% after 24 months). Nicotine gum achieved significantly higher point prevalence cessation rates than placebo at 12 and 24 months [11.2% versus 3.9% (odds ratio = 3.1; 95% CI, 1.4–7.2 and 9.3% versus 3.4% (odds ratio = 2.9; 95% CI, 1.2–7.1), respectively]. There was a linear relationship between decrease in number of daily cigarettes and decrease in plasma cotinine, exhaled carbon monoxide and plasma thiocyanate, with significantly greater reduction in the nicotine gum group after 4 and 12 months (maximum treatment duration) but not after 24 months. The decrease in toxin intake was smaller than the decline in daily cigarette consumption, suggesting that compensatory smoking occurred. Conclusions Nicotine gum promoted cessation in this population of smokers unwilling to quit. Among reducers, the toxin intake correlated with reduced cigarette consumption although some compensatory smoking occurred.     

Successful treatment with a nicotine lozenge of smokers with prior failure in pharmacological therapy

Aims To assess the influence of unsuccessful past quit attempts using pharmacological treatment on smoking cessation when using a new nicotine lozenge. Design A double‐blind, randomized, placebo‐controlled trial. Setting Fifteen sites in the United Kingdom and the United States. Participants A total of 1818 smokers seeking smoking cessation treatment; 1145 had had previous pharmacological treatment with nicotine polacrilex lozenge. Intervention Lozenge, 2 mg or 4 mg (or matched placebo); a higher dose was assigned to smokers who smoked their first cigarette of the day within 30 minutes, a sign of dependence. Smokers received minimal instruction and counseling. Measurement Outcome was 28‐day, CO‐verified continuous abstinence at 6 weeks. Past use of medications was ascertained by self‐report. Findings Lozenge was efficacious among smokers with prior pharmacotherapy as well as among those without such history. The effect of lozenge (versus placebo) was significantly greater among those with previous treatment experience, because previous treatment was associated with significantly poorer outcome on placebo, and active lozenge treatment corrected this imbalance. Lozenge efficacy was similar whether smokers had previously tried patch or acute forms of nicotine replacement therapy (gum, inhaler and spray), and also similar for past use of Zyban (bupriopion). Conclusions Smokers with a history of past failure of pharmacological treatment have lower success rates without pharmacological treatment, but equally good outcomes with active lozenge treatment. Smokers who previously tried pharmacological treatments but resumed smoking should be encouraged to try quitting again with the new nicotine lozenge.     

Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption

Aims   To evaluate the effect of repeated high-frequency transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC), combined with either smoking or neutral cues, on cigarette consumption, dependence and craving.
Design   Participants were divided randomly to real and sham stimulation groups. Each group was subdivided randomly into two subgroups presented with either smoking-related or neutral pictures just before the daily TMS intervention. Ten daily rTMS sessions were applied every week-day and then a maintenance phase was conducted in which rTMS sessions were less frequent.
Setting   Single-site, out-patient, randomized, double-blind, sham-controlled.
Participants   Forty-eight chronic smokers who smoked at least 20 cigarettes per day and were motivated to quit smoking. Healthy males and females were recruited from the general population using advertisements in newspapers and on internet websites.
Intervention   Ten daily rTMS sessions were administered using a standard figure-8 coil over the DLPFC. Stimulation included 20 trains/day at 100% of motor threshold. Each train consisted of 50 pulses at 10 Hz with an inter-train interval of 15 seconds.
Measurements   Cigarette consumption was evaluated objectively by measuring cotinine levels in urine samples and subjectively by participants' self-reports. Dependence and craving were evaluated by standard questionnaires.
Findings   Ten daily rTMS sessions over the DLPFC reduced cigarette consumption and nicotine dependence. Furthermore, treatment blocked the craving induced by daily presentation of smoking-related pictures. However, these effects tended to dissipate over time.
Conclusions   Multiple high-frequency rTMS of the DLPFC can attenuate nicotine craving.     

Efficacy of nicotine patch in smokers with a history of alcoholism

BACKGROUND: Smokers with a history of alcohol dependence may have more difficulty quitting, might relapse to alcohol use, and might especially benefit from nicotine replacement therapy for smoking cessation. METHODS: One hundred fifteen smokers with a history of alcohol dependence (median of 5 years previously) were randomly assigned to either a 21-mg nicotine patch or placebo in a trial designed to be as similar as possible to a prior study that examined smokers with no history of alcoholism. Both studies were of heavy smokers with similar levels of nicotine dependence; thus, any differences in trials would be due to a history of alcohol problems per se. RESULTS: In the current trial, adjusted prolonged smoking abstinence in those with a history of alcohol dependence was higher in the active than the placebo group at end-of-treatment (28% vs. 11%; odds ratio, 3.2; p = 0.04) and at 6-month follow-up (24% vs. 6%; odds ratio, 4.9; p = 0.02). Among subjects not lost to follow-up, none reported drinking problems or increases in craving for alcohol. Smoking abstinence was not lower and the odds ratio for nicotine patch therapy was not greater in smokers with a history of alcohol dependence than in smokers with no such history. CONCLUSIONS: Heavy smokers with a history of alcoholism benefit from nicotine patch treatment. A history of alcohol problems after a period of stable sobriety does not appear to influence smoking outcomes or response to nicotine replacement. Although no smokers relapsed to alcohol use, a trial that follows up all subjects is needed to verify this.     

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.     

Weight change after smoking cessation using variable doses of transdermal nicotine replacement

OBJECTIVE: Examine weight change in subjects receiving variable doses of transdermal nicotine replacement for smoking cessation. DESIGN: Randomized, double-blind clinical trial. SETTING: One-week inpatient treatment with outpatient follow-up through 1 year. INTERVENTION: This report examines weight change after smoking cessation for 70 subjects randomized to placebo or to 11, 22, or 44 mg/d doses of transdermal nicotine. The study included 1 week of intensive inpatient treatment for nicotine dependence with active patch therapy continuing for another 7 weeks. Counseling sessions were provided weekly for the 8 weeks of patch therapy and with long-term follow-up visits at 3, 6, 9, and 12 months. MEASUREMENTS AND MAIN RESULTS: Forty-two subjects were confirmed biochemically (i.e., by expired carbon monoxide) to be nonsmokers at all weekly visits during patch therapy. Their 8-week weight change from baseline was 3.0±2.0 kg. For these subjects, 8-week weight change was found to be negatively correlated with percentage of cotinine replacement (r=−.38, p=.012) and positively correlated with baseline weight (r=0 .48, p=.001), and age (r=.35, p=.025). Men had higher (p=.003) 8-week weight gain (4.0±1.8 kg) than women (2.1±1.7 kg). Of the 21 subjects who abstained continuously for the entire year, 20 had their weight measured at 1-year follow-up. Among these 20 subjects, 1-year weight change was not found to be associated with gender, baseline weight, baseline smoking rate, total dose of transdermal nicotine, or average percentage of cotinine replacement during the 8 weeks of patch therapy. CONCLUSIONS: This study suggests that higher replacement levels of nicotine may delay postcessation weight gain. This effect is consistent for both men and women. We could not identify any factors that predict weight change with long-term abstinence from smoking. Presented at the American Society of Addiction Medicine 8th national conference on Nicotine Dependence, Toronto, Ont., Canada, October 12–15, 1995. Supported by a grant from Lederle Laboratories, Pearl River, NY.     

Naltrexone Decreases Heavy Drinking Rates in Smoking Cessation Treatment: An Exploratory Study

Background:  There is mixed support for the efficacy of the opioid antagonist naltrexone in the treatment of nicotine dependence. One potential unexplored mechanism underlying naltrexone's effects in smoking cessation may be in its ability to reduce alcohol consumption.
Methods:  Alcohol consumption and liver enzyme levels (aspartate aminotransferase and alanine transaminase) were examined in a sample of 78 nonalcoholic social drinking smokers (34 naltrexone, 44 placebo) enrolled in a double-blind randomized clinical trial of naltrexone in smoking cessation. Naltrexone or placebo began 3 days prior to the quit date (25 mg daily) and continued for 8 weeks (50 mg daily). All participants received nicotine patches and behavioral counseling up through 4 weeks after the quit date.
Results:  Naltrexone significantly reduced weekly heavy drinking rates. This effect was associated with greater nausea and pill taking adherence within the naltrexone group. Within heavy drinkers, naltrexone also directionally improved smoking quit rates compared with placebo. Liver enzyme levels did not differ during treatment with naltrexone compared with placebo.
Conclusions:  Naltrexone may reduce the frequency of heavy drinking in nonalcoholics attempting to quit smoking. Further, naltrexone may preferentially improve smoking quit rates within heavy drinkers who smoke, and further investigation in larger sample sizes is warranted.     

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.     

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, nicotine dependence and mental health among young adults: a 13-year population-based longitudinal study

Aims   To investigate prospectively the associations between daily smoking and nicotine dependence and anxiety, depression and suicide attempts.
Methods   Data were from the Young in Norway Longitudinal Study. A population-based sample ( n  = 1501) was followed for 13 years from ages 13–27 years. Data were gathered on smoking patterns and nicotine dependence; and depression, anxiety and parasuicide. Extensive information on socio-demographic factors, parental and family conditions, parental rearing practices, educational career, conduct problems, alcohol problems and use of illegal substances was also collected.
Results   Young adults who were nicotine-dependent had clearly elevated rates of anxiety, depression and parasuicide. These rates declined after controlling for a previous history of mental health problems and potential confounding factors. After adjustment, nicotine dependence was still associated with anxiety, depression and parasuicide. There was also a significant association with later depression in the group of non-dependent daily smokers. Measures of reduced mental health did not predict later smoking initiation or the development of nicotine dependence.
Conclusions   Mental health was reduced more seriously in nicotine-dependent smokers than in non-dependent smokers. These findings are consistent with the hypothesis that smoking, in particular nicotine dependence, influences mental health.     

The impact of depressive symptoms on alcohol and cigarette consumption following treatment for alcohol and nicotine dependence

Background:  Although depression is common among alcohol and tobacco dependent patients, its impact on treatment outcomes is not well established. The purpose of this study was to examine the impact of depressive symptoms on abstinence from tobacco and alcohol after treatment for alcohol dependence and nicotine dependence.
Methods:  The Timing of Alcohol and Smoking Cessation Study (TASC) randomized adults receiving intensive alcohol dependence treatment, who were also smokers, to concurrent or delayed smoking cessation treatment. The sample consisted of 462 adults who completed depression and substance use (alcohol and smoking) assessments at treatment entry and 6, 12, and 18 months posttreatment. Longitudinal regression models were used to examine the relationships between depression and subsequent abstinence from alcohol and tobacco after baseline characteristics, including alcohol and smoking histories, were considered.
Results:  Depressive symptoms were prospectively related to nonabstinence from alcohol. Depressive symptoms at the previous assessment increased the odds of drinking at the subsequent time point by a factor of 1.67 (95% CI 1.14, 2.43), p  < 0.01. Depressive symptoms were not significantly related to subsequent abstinence from cigarettes.
Conclusions:  Depression is an important negative predictor of the ability to maintain abstinence from alcohol within the context of intensive alcoholism and smoking treatment. It may be important to include depression-specific interventions for alcohol and tobacco dependent individuals to facilitate successful drinking treatment outcomes.     

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.     

Comparative efficacy of rapid-release nicotine gum versus nicotine polacrilex gum in relieving smoking cue-provoked craving

AIMS: Most relapse episodes occur when smokers are confronted with craving provoked by situational cues. Current nicotine gum can help relieve cue-provoked cravings, but faster effects may result in more rapid relief. We tested a prototype formulation of a new rapid-release nicotine gum (RRNG) that provides more rapid release and absorption of nicotine, for its ability to provide faster and better craving relief compared to current nicotine polacrilex gum (NPG). DESIGN: Random assignment to RRNG or NPG, used during a smoking cue provocation procedure. Participants and setting A total of 319 smokers were exposed to a smoking cue in the laboratory by being asked to light but not smoke a cigarette of their preferred brand. Subjects then chewed a piece of 2 mg RRNG (n = 159) or 2 mg NPG (n = 160) according to randomized assignment. MEASUREMENTS: Craving assessments were completed at regular intervals before and after cue exposure (baseline, pre-cue, and 3, 6, 9, 12, 15, 18, 21, 25, 30 and 35 minutes after the cue). FINDINGS: Smokers chewing RRNG showed significantly lower craving than NPG subjects starting with the first assessment at 3 minutes (P < 0.025). Repeated-measures ANOVA revealed a significant treatment x time interaction (P < 0.05)-craving scores dropped more rapidly in RRNG subjects compared to NPG subjects. Survival analyses also indicated superiority of RRNG in achieving more rapid self-reported meaningful relief (P < 0.05) and complete relief (P < 0.05) of craving. CONCLUSIONS: Rapid-release nicotine gum reduced cue-provoked craving more rapidly compared to NPG, and thus merits further study in cessation efficacy trials.     

Effects of different pharmacologic smoking cessation treatments on body weight changes and success rates in patients with nicotine dependence: A network meta‐analysis

Smoking cessation is a public health priority to reduce smoking‐related morbidity and mortality. However, weight gain is a known primary reason for not trying to quit smoking. The aim of the current study was to investigate differences in weight gain associated with different pharmacological smoking cessation interventions. Randomized controlled trials (RCTs) that reported weight gain related to pharmacologic treatments for smoking cessation were analysed using network meta‐analysis with a random effects model. Thirty‐one RCTs with 5650 participants were included. Ten drugs and 22 regimens were identified. Nicotine patches plus fluoxetine, topiramate with/without nicotine patches, nicotine patches plus methylphenidate, nicotine spray/gum/lozenges, high‐dose nicotine patches (42 mg/21 mg), naltrexone with/without nicotine patches, or bupropion with/without nicotine patches were associated with less weight gain than the placebo/control arm. Nicotine patches plus fluoxetine were associated with the least weight gain of all smoking cessation treatments. In addition, the nicotine patch plus topiramate and nicotine inhaler was associated with the best success rate and the least dropout rate, respectively. Overall, the nicotine patch 14 mg plus fluoxetine 40 mg, nicotine patch 14 mg plus fluoxetine 20 mg, and topiramate 200 mg would be the three best pharmacologic treatments based upon both weight gain effect and success rate.     

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial

BACKGROUND: Nicotine replacement therapy is an effective treatment for nicotine-dependent smokers. However, cessation rates are modest, and preliminary studies suggest that combination therapy may be superior. We compared the efficacy of the nicotine inhaler plus nicotine patch vs nicotine inhaler plus placebo patch for smoking cessation. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in 400 subjects who had smoked 10 or more cigarettes per day for 3 years or longer. Group 1 (n = 200) received the nicotine inhaler plus nicotine patch (delivering 15 mg of nicotine per 16 hours) for 6 weeks, then inhaler plus placebo patch for 6 weeks, then inhaler alone for 14 weeks. Group 2 (n = 200) received the nicotine inhaler plus placebo patch for 12 weeks, then inhaler for 14 weeks. Inhaler was used at a rate of 6 to 12 cartridges per day ad libitum for 3 months and then tapered off. Main outcome measures were complete abstinence (self-reported) and expired carbon dioxide concentration less than 10 ppm. RESULTS: Group 1 vs group 2 complete abstinence rates were 60.5% and 47.5% at 6 weeks (P =.009), 42.0% and 31.0% at 12 weeks (P =.02), 25.0% and 22.5% at 6 months (P =.56), and 19.5% and 14.0% at 12 months (P =. 14). One-year survival analysis showed a significant association between abstinence and treatment with nicotine inhaler plus nicotine patch (P =.04). Mean nicotine substitution at week 6 was 60.1% (group 1) and 24.6% (group 2) (P<.001). At 12 months, the frequency of respiratory symptoms in abstinent subjects fell significantly and lung function showed a trend toward improvement. The most common adverse events were throat irritation (inhaler) and itching (patch). CONCLUSIONS: Treatment with the nicotine inhaler plus nicotine patch resulted in significantly higher cessation rates than inhaler plus placebo patch.