Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments

OBJECTIVE: To assess the effectiveness of transdermal nicotine therapy for smoking cessation and suppression of withdrawal severity in conjunction with two different adjuvant counseling treatments. DESIGN: Two independent randomized placebo-controlled double-blind trials. SETTING: Smoking cessation clinic. SUBJECTS: Eighty-eight (study 1) and 112 (study 2) adult volunteers motivated to quit smoking. INTERVENTIONS: Eight weeks of 22-mg transdermal nicotine therapy with group counseling (study 1); 4 weeks of 22 mg followed by 2 weeks of 11-mg transdermal nicotine therapy with brief individual counseling (study 2). MAIN OUTCOME MEASURES: Modified point prevalence (7 consecutive days of nonsmoking) at the end of patch treatment and 6 months after treatment initiation was assessed by self-report and biochemically confirmed; survival analyses were also conducted for both studies to compare treatment efficacy. Also, we examined the impact of the nicotine patch on specific withdrawal symptoms (anger, anxiety, awakening, difficulty concentrating, depression, hunger, impatience, and craving). RESULTS: Transdermal nicotine treatment produced higher cessation rates at the end of treatment than did placebo with both adjuvant counseling interventions: 59 percent vs 40 percent (p < 0.05 in study 1) and 37 percent vs 20 percent (p < 0.05 in study 2), respectively. Smoking cessation efficacy was maintained 6 months after initiation of treatment: 34 percent vs 21 percent (p = 0.08 in study 1) and 18 percent vs 7 percent (p = 0.05 in study 2). Survival analyses also revealed significant group differences in efficacy in both studies. Nicotine patches also suppressed a variety of withdrawal symptoms, including craving in the first weeks after patients quit smoking. CONCLUSION: Transdermal nicotine effectively augments smoking cessation rates with two different types of counseling treatment. Overall, the nicotine patch approximately doubles the sustained rate of smoking cessation. Additionally, the nicotine patch provides relief from some tobacco withdrawal symptoms.     

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.     

Sequential bilateral adnexal torsion after a single cycle of gonadotropin ovulation induction with intrauterine insemination

As part of a programme for the implementation of a Smoking Control Policy in our hospital, an open study, without randomization, of 65 hospital workers, who wanted to give up smoking, was carried out. The characteristics of smoking in each subject were recorded. The Fagerstrom Questionnaire was used to measure the degree of dependence on nicotine. The treatment consisted of the daily use of 16 h nicotine patches for 12 weeks. During the first 4 weeks, the patches contained 15 mg of nicotine, for the second 4 weeks, 10 mg, and for the last 4 weeks 5 mg (per patch and day). Five visits were scheduled during the 26 week study period: at the start of the study and after 4, 8, 12 and 26 weeks. The abstinence was checked by measuring carbon monoxide in end-expiratory air. The success rate was 31% after 12 weeks, and decreased to 29% after 26 weeks. In conclusion, the nicotine patches appeared safe and effective in this study.     

Factors associated with participation, attrition, and outcome in a smoking cessation program at the workplace.

Of 66 24–58 yr old smokers in 2 worksites, 67% participated in a smoking cessation program. 55% completed the program. Of those, 29% had quit smoking by posttest, and 17% were abstinent at the 6-mo follow-up. Different variables predicted participation, attrition, and outcome. Significant predictors of smokers who participated were length of cessation in previous abstinence attempts, number of years they smoked, and belief regarding personal vulnerability in contracting a smoking-related disease. Levels of pretest carbon monoxide and attitudes regarding adoption of smoking restrictions in the worksite predicted attrition. Posttest cessation was related to nicotine levels of cigarette brand smoked at pretest and pretest beliefs regarding postcessation weight gain. Abstinence at the 6-mo follow-up was predicted by number of co-workers who smoked and pretest concerns related to postcessation weight gain. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

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)     

The striatum in the system of the central mechanisms of biorhythm control

BACKGROUND: This study was undertaken to assess the safety and efficacy of a treatment involving brief counseling and the nicotine patch among hospital inpatients and to identify variables associated with long-term smoking cessation following hospitalization. METHODS: One hundred eighty-five patients were randomly assigned to one of three smoking cessation interventions: (1) A Minimal Care (MC) condition, consisting of a brief physician-delivered motivational message to stop smoking, (2) a Counseling + Active Nicotine Patch (CAP) condition in which patients received the motivational message, a 6-week supply of nicotine patches, and extended bedside and telephone counseling, and (3) a Counseling + Placebo Patch (CPP) condition identical to the CAP condition except the supplied patches contained no nicotine. RESULTS: At 6-month follow-up, abstinence rates for the three treatments were 4.9, 6.5, and 9.7% for the MC, CPP, and CAP treatments, respectively. These differences were not statistically significant. Patients admitted for respiratory disease were more likely to quit than patients with any other diagnosis. The nicotine patch was well tolerated by hospital inpatients. CONCLUSIONS: The initiation of nicotine patch therapy during hospitalization appears to be safe when used among patients carrying a wide range of diagnoses. Our study provided no evidence of the superiority of nicotine patches versus placebo, but this does not preclude the possibility that future research using larger samples might detect differences between patch groups. Hospital interventions for smoking cessation may be most effective among patients hospitalized for a smoking-related illness such as respiratory disease.     

Quitting chew: Results from a randomized trial using nicotine patches.

The authors examined the efficacy of transdermal nicotine replacement for cessation in 410 adult nonsmoking chewing tobacco users. Participants were randomly assigned to 6 weeks of 15-mg nicotine patch plus behavioral treatment or placebo patch plus behavioral treatment. All participants received the same behavioral treatment of 2 pharmacy visits, 2 support calls, and self-help materials. At 6 months after treatment, biochemically confirmed point-prevalence rates (no chewing in the last 7 days) in the active (38%) and placebo (34%) groups were high and not significantly different. The difference in relapse (no chewing for 7 consecutive days) between the active patch group (33%) and placebo group (48%) was significant at 6 months (p?=?.003). Nicotine dependence and age predicted nonrelapse at 6 months. The results suggest that nicotine replacement may improve chewers' chances of abstinence. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

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.     

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.     

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.     

Cognitive–behavioral therapy to promote smoking cessation among African American smokers: A randomized clinical trial.

Objective: The health consequences of tobacco smoking disproportionately affect African Americans, but research on whether efficacious interventions can be generalized to this population is limited. This study examined the efficacy of group-based cognitive–behavioral therapy (CBT) for smoking cessation among African Americans. Method: Participants (N = 154; 65% female, M = 44 years old, mean cigarettes/day = 13) were randomly assigned to either (a) group CBT or (b) group general health education (GHE). Participants in both conditions received 6 sessions of counseling and 8 weeks of transdermal nicotine patches. The primary outcome variable was 7-day point prevalence abstinence (ppa), assessed at the end of counseling (2 weeks) and at 3- and 6-month follow-ups. Secondary outcomes included 24-hr ppa and 28-day continuous abstinence (assessed at 3 and 6 months). Results: Intent-to-treat analyses demonstrated the hypothesized effects, such that 7-day ppa was significantly greater in the CBT than the GHE condition at the end of counseling (51% vs. 27%), at 3 months (34% vs. 20%), and at 6 months (31% vs. 14%). Results of a generalized linear mixed model demonstrated a significant effect of CBT versus GHE on 7-day ppa (odds ratio = 2.57, 95% CI [1.40, 4.71] and also an effect of time (p     

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)     

Evaluating initial reach and robustness of a practical randomized trial of smoking reduction.

Objective: This study evaluated the reach, initial effectiveness, and potential moderators and mediators of results of a smoking reduction program. Design: A generally representative sample of 320 adult smokers from an HMO, scheduled for outpatient surgery or a diagnostic procedure, were randomized to enhanced usual care or a theory-based smoking reduction intervention that combined telephone counseling and tailored newsletters. Main Outcome Measures: Self-reported number of cigarettes smoked and carbon monoxide levels. Results: The intervention enrolled 30% of known eligible smokers and produced reductions of 3 cigarettes per day greater than enhanced usual care. Intervention participants were significantly more likely than control participants to achieve at least a 50% reduction in self-reported number of cigarettes using complete cases, imputation analyses, and intent-to-treat procedures. Similar patterns were seen for carbon monoxide results but were significant only in complete case analyses. The intervention was generally robust across patient characteristics (e.g., education, ethnicity, health literacy, and dependence) and phone counselors. Conclusion: Initial results suggest that this program has potential to reach and assist smokers who may not participate in cessation programs. Additional research is indicated to enhance intervention effects, assess maintenance, and evaluate public health impact. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized trial of self-help materials, personalized feedback, and telephone counseling with nonvolunteer smokers.

The incremental effects of (a) a self-help booklet alone, (b) self-help booklet with computer-generated personalized feedback, and (c) self-help booklet, personalized feedback, and outreach telephone counseling were evaluated in a population-based, nonvolunteer sample of smokers. Smokers (N?=?1 ,137) were identified through a telephone survey of a random sample of 5,903 enrollees in a health maintenance organization and randomized to a no-treatment control group or I of the 3 intervention conditions. Smoking status was ascertained 3, 12, and 21 months postrandomization. Cotinine validation of self-reported cessation was obtained at the 12-month follow-up. Overall, the telephone counseling significantly increased smoking cessation at the 3-month follow-up, but not at 12 or 21 months. Among smokers who were precontemplative at baseline, telephone counseling significantly increased prevalent abstinence at 3 and 12 months and continuous abstinence at 21 months (defined as self-reported abstinence at 3, 12, and 21 months (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A Randomized Trial Comparing the Effects of Self-Help Materials and Proactive Telephone Counseling on Teen Smoking Cessation.

We conducted a 2-arm randomized trial to test the efficacy of self-help materials with or without proactive telephone counseling to increase cessation among teen smokers. Teen smokers (N = 402) recruited from 11 shopping malls and 1 amusement park in the southeastern United States were randomized to 1 of 2 groups: written self-help material plus video; or written self-help material, video, and telephone counseling. Cessation rates based on 7-day point-prevalent abstinence for the self-help and counseling arms were 11% and 16%, respectively (p = .25), at 4 months postbaseline and 19% and 21%, respectively (p = .80), at 8 months postbaseline. Sustained abstinence, reflecting 7-day abstinence at both time points, in the self-help and counseling arms was 7% and 9% (p = .59). Results suggest that minimal self-help cessation approaches that target youth have comparable success to that shown among adult smokers. However, refinements in telephone-counseling approaches may be needed to achieve the success observed in adult populations. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Randomized Clinical Trial of the Efficacy of Bupropion Combined With Nicotine Patch in the Treatment of Adolescent Smokers.

Adolescent smokers (N = 211) were randomized to 1 of 2 groups: (a) nicotine patch plus bupropion SR (sustained release; 150 mg per day) or (b) nicotine patch plus placebo. Group skills training sessions were conducted each week by research staff. Abstinence rates at Weeks 10 and 26 were as follows: (a) patch plus bupropion, 23% and 8%, (b) patch plus placebo, 28% and 7%. Despite the lack of a treatment effect, a large majority of adolescents in both treatment groups reduced their consumption to a few cigarettes per day or less and maintained this reduction over time. Similarly, an examination of survival curves revealed that by the end of treatment many had managed to avoid a return to daily smoking. These findings are encouraging and suggest new avenues for research. For example, treatments of the kind examined in this report, augmented by extended maintenance therapies, may yield higher long-term success rates. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effectiveness of physicians-in-training counseling for smoking cessation in African Americans

This study examined the effectiveness of smoking cessation counseling by physicians-in-training (residents) with African-American patients. One hundred fifty-eight family and internal medicine residents at a large urban public general hospital participated in the study; two thirds of the residents underwent a 2-hour smoking cessation training program. Ninety-two of the trained physicians counseled from 1 to 18 patients. The majority of physicians were male, with 8% being current smokers. Over a 26-month period, 1086 patients were randomly assigned to intervention and control (usual care) groups. Mean patient age was 44 years, mean years smoking was 25, and mean number of cigarettes smoked per day was 14. There were no differences in biochemically validated smoking cessation rates between the intervention and control groups at 3 or 12 months postenrollment (2% versus 1.8% and 2.2% versus 2.8%, respectively). Losses to follow-up were high at both 3 and 12 months (38% and 40% respectively). Implications for future trials in minority populations are discussed. A brief physician-based smoking cessation message does not appear to be an effective strategy for use with African-American smokers in a large urban public general hospital.     

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.     

Effectiveness of Payment for Reduced Carbon Monoxide Levels and Noncontingent Payments on Smoking Behaviors in Cocaine-Abusing Outpatients Wearing Nicotine or Placebo Patches.

In a 2-week intervention to reduce cigarette smoking among outpatients in treatment for cocaine addiction, 20 subjects were randomly assigned to a contingent group, receiving monetary vouchers for breath samples with carbon monoxide (CO) levels of 8 ppm or less, or to a noncontingent group, receiving vouchers regardless of CO level. Subjects wore either nicotine or placebo patches in a randomized crossover design. Contingent subjects had significantly lower CO levels and met the 8 ppm target significantly more often than did noncontingent subjects; however, number of cigarettes reported smoked did not differ between groups. Use of nicotine patches resulted in CO levels significantly lower than did use of placebo patches, but levels still exceeded 8 ppm regardless of type of patch. Because contingent reward helped cocaine-dependent smokers achieve nonsmoking CO targets, behavioral antismoking interventions merit continued study in similar populations. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Prospective evaluation of three smoking interventions in 205 recovering alcoholics: One-year results of Project SCRAP-Tobacco.

205 (113 male, 92 female) nonhospitalized recovering alcoholics with >3 mo of continuous abstinence from alcohol and drugs and relatively heavy tobacco dependence (Fagerstrom Tolerance Questionnaire score?=? 7.7; mean number of cigarettes per day, 26.8; mean number of years smoked, 24.4) were randomized to standard treatment (ST) American Lung Association quit program plus nicotine anonymous meetings (n?=?70), behavioral counseling plus physical exercise (BEX; n?=?72), or behavioral counseling plus nicotine gum (BNIC; n?=?63). A 3?×?4 repeated measures design was used to evaluate the effectiveness of the interventions on smoking outcome at baseline, posttreatment, and 6- and 12-mo follow-ups. Self-reported smoking status was verified with biochemical and informant report. Verified self-report indicated that significantly more smokers in BEX quit by posttreatment (60%) than in either BNIC (52%) or ST (31%), χ–2(2, N?=?205)?=?17.85, p?