Minnesota Nicotine Withdrawal Scale Research Articles

Anxiety sensitivity as an amplifier of subjective and behavioral tobacco abstinence effects

BackgroundAnxiety sensitivity, a transdiagnostic cognitive vulnerability factor described as an amplifier of negative emotional states, is implicated in the maintenance of cigarette smoking and cessation difficulties. The current study aimed to examine the role of anxiety sensitivity in predicting abstinence-induced changes in nicotine withdrawal, smoking urges and smoking behavior during an experimental relapse analogue task (RAT). MethodParticipants were 258 non-treatment seeking smokers (M [SD] age=44.0 [10.73]; 69.8% male). Participants attended two counterbalanced experimental sessions including smoking deprivation (16h of smoking abstinence) and smoking as usual. The Minnesota Nicotine Withdrawal Scale (MNWS) and Brief Questionnaire of Smoking Urges (QSU) were completed at each session in addition to the RAT. Hierarchical regressions were conducted to examine the predictive impact of anxiety sensitivity on withdrawal and urges during smoking deprivation. Follow-up mediational analyses were conducted to examine whether abstinence-induced withdrawal and urges mediated responding during the RAT. ResultsAnxiety sensitivity amplified the effects of experimentally manipulated acute abstinence on subjective nicotine withdrawal symptoms and smoking urges. Additionally, higher levels of anxiety sensitivity indirectly predicted shorter latency to smoking initiation after deprivation during the RAT through the effects of greater abstinence-induced nicotine withdrawal and smoking urges. Anxiety sensitivity was unrelated to increased smoking during the RAT, although this may be partially attributed to the type of laboratory assessment employed. ConclusionsElevated anxiety sensitivity appears to impact initiation of smoking after nicotine deprivation through the effects of abstinence-induced withdrawal and smoking urges.

Predictors of Lapse and Relapse to Smoking in Successful Quitters in a Varenicline Post Hoc Analysis in Japanese Smokers

BackgroundThe efficacy of the smoking-cessation agent varenicline has been reported in Asian smokers; however, few studies have investigated factors that contribute to lapse and relapse. ObjectiveThis post hoc analysis aimed to identify predictors of smoking lapse and relapse. MethodsThis was a post-hoc analysis based on a double-blind, placebo-controlled, randomized, parallel-group study in which Japanese smokers (aged 20–75 years) who smoked ≥10 cigarettes/day and were motivated to quit were randomized to receive varenicline (0.25 mg twice daily [BID], 0.5 mg BID, 1 mg BID) or placebo for 12 weeks followed by a 40-week non-treatment follow-up. For inclusion in this analysis, participants must have been nicotine dependent (Tobacco Dependence Screener score ≥5) and must have successfully quit smoking continuously for 4 weeks (weeks 9–12). Lapse was defined by answering yes to ≥1 question in the Nicotine Use Inventory. Relapse was defined by participants having smoked for ≥7 days during follow-up measured by the Nicotine Use Inventory. ResultsOf the 619 randomized individuals, 515 had a Tobacco Dependence Screener score of ≥5, and 277 quit smoking continuously from weeks 9 to 12. Approximately 75% were male, with a mean (SD) BMI of 23.0 (3.0) kg/m2. Maximum length of continuous abstinence (CA) during treatment and age (both P < 0.0001) were significant predictors of lapse. Maximum CA (P < 0.0001), age (P = 0.0002), Minnesota Nicotine Withdrawal Scale (MNWS) score for urge to smoke (P = 0.0019), and having made ≥1 serious quit attempt (P = 0.0063) were significant predictors of relapse. For participants with a maximum CA of 4 to 6 weeks versus those with a maximum CA of 10 to 11 weeks, the ORs for lapse and relapse were 4.649 (95% CI, 2.071–10.434) and 3.337 (95% CI, 1.538–7.239), respectively. In participants aged 21–34 years versus those aged 47–72 years, the ORs for lapse and relapse were 3.453 (95% CI 1.851, 6.441) and 3.442 (95% CI 1.795, 6.597), respectively. Participants with a MNWS urge to smoke score of 2 to 4 versus 0 had an OR for relapse of 3.175 (95% CI, 1.166–8.644). Participants having made ≥1 versus no serious quit attempts had an OR for relapse of 2.108 (95% CI, 1.168–3.805). ConclusionShorter maximum CA and younger age at quit attempt were associated with increased risk of lapse and relapse. Higher MNWS urge to smoke score and having made ≥1 serious quit attempt were associated with increased relapse risk. ClinicalTrials.gov identifier: NCT00139750.

Evaluation of the Psychometric Properties of the Malay Version of the Minnesota Nicotine Withdrawal Scale

ObjectivesAssessment of nicotine withdrawal symptoms is an essential part of tobacco dependence treatment. This study aimed to evaluate the psychometric properties of a Malay translated version of the Minnesota Nicotine Withdrawal Scale (MNWS). MethodsThe original scale was translated into Malay following the standard guidelines proposed for translation studies. The reliability and validity of the Malay version scale were evaluated on the basis of data collected from 133 participants. The Cronbach’s alpha coefficient was calculated to assess the reliability. To validate the psychometric properties of the scale, factor analysis and construct validity were used. This study was conducted at the Quit Smoking Clinic at Penang General Hospital, Penang, Malaysia. ResultsThe translated scale has excellent reliability, with total Cronbach’s alpha of 0.91. The test-retest reliability for the scale presented an excellent reliability and stability of the translated scale with Spearman’s rank correlation coefficient (r = 0.876; P < 0.001). There was a significant positive correlation between the exhaled carbon monoxide level, Fagerstrom Test for Nicotine Dependence total score, and number of cigarettes smoked per day and the MNWS total score (r = 0.72, 0.68, and 0.68, respectively; P < 0.001). A principal-components analysis with orthogonal rotation yielded a unidimensional model that includes all the items of the MNWS. ConclusionsThe Malay version of the MNWS is a reliable and valid measure of withdrawal symptoms as well as the smoking urge, and it is applicable to clinical practice and research study.

Massive withdrawal symptoms and affective vulnerability are associated with variants of the CHRNA4 gene in a subgroup of smokers.

Heterogeneous phenotypes of complex disorders pose a great challenge for genetic association studies and for the development of personalized treatment strategies. Cluster analysis of phenotypic data has been recently proposed as a reliable auxiliary method for such studies. A cohort of 236 treatment-seeking smokers was investigated after overnight nicotine abstinence. Alpha4 nicotinic acetylcholine receptor (nAChR) subunit-related phenotypes were assessed by the Fagerström Test for Nicotine Dependence (FTND), exhaled carbon monoxide (CO) measurements, the Minnesota Nicotine Withdrawal Scale (MNWS) and the Zung Self-Rating Depression Scale (ZSDS). Seven tag SNPs (single-nucleotide polymorphisms) across CHRNA4 (the gene encoding alpha4 subunit of the nicotinic acetylcholine receptor) were genotyped and two-step cluster analysis was used for phenotypic cluster characterization. Haplotype estimation was determined by HapStat module of R 2.0 software. Three different phenotypic clusters were identified and the C3 cluster was characterized by the highest ZSDS and MNWS scores compared to others. Furthermore, lifetime prevalence of major depression was significantly higher in the C3 cluster (p = 0.019). In genetic association tests, this cluster was also significantly associated with rs3787138 genotypes (p = 0.004) while haplotype analyses of three SNPs (rs3787138, rs1044396, rs3787140) revealed that the risk for C3 phenotype was almost three times higher in GCC haplotype carriers compared to others (pperm = 0.013). This is the first report on a significant association between CHRNA4 variants and a subgroup of smokers characterized by massive withdrawal symptoms and affective vulnerability. Identification of such a phenotypic cluster can be a pivotal step for further pharmacogenetic studies on ligands of the alpha4 nAChR subunit. Our results suggest that performing cluster analysis in genetic association studies can be proposed for complex disorders.

Effect of Varenicline on Individual Nicotine Withdrawal Symptoms: A Combined Analysis of Eight Randomized, Placebo-Controlled Trials

Concerns exist that varenicline may cause neuropsychiatric side effects. Some of these symptoms (e.g., depression, irritability) have been measured in clinical trials using nicotine withdrawal scales. This study assessed the effect of varenicline on neuropsychiatric and other symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). We analyzed weekly individual MNWS symptom ratings in 8 randomized double-blind, placebo-controlled smoking cessation trials funded by Pfizer with similar methodology (n = 2,403 varenicline; n = 1,434 placebo). Ratings for the past 24hr were obtained prior to quitting and starting treatment and at Weeks 1-6 and 11 after the quit date. In repeated measures analyses controlling for baseline values, ratings for 5 neuropsychiatric symptoms (depressed mood, irritability, anxiety, difficulty concentrating, and restlessness) and urge to smoke were lower (p < .01) for varenicline than placebo at each timepoint. Worsening in scores from 0-2 (baseline) to 4 was less frequent on varenicline than placebo for all ratings except appetite- (significantly more frequent for varenicline, p < .0001) and sleep-related items. Repeated measures analysis for individuals with low levels of exhaled carbon monoxide revealed similar patterns except for a nonsignificant difference for increased appetite. Use of varenicline while trying to quit smoking reduces and does not increase neuropsychiatric symptoms such as depressed mood and irritability measured on the MNWS in smokers without current psychiatric disorders. It is associated with increases in sleep disturbance and appetite although the latter appears due to enabling more subjects to abstain from smoking.

Predicting smoking relapse with a multidimensional versus a single-item tobacco craving measure

BackgroundResearch suggests that craving is a predictor of smoking relapse. Craving can be assessed by multiple item or multifactorial scales or by single items. However, no systematic comparisons of their prognostic validity or accuracy have been published. MethodsThe French versions of the 12-item Tobacco Craving Questionnaire (FTCQ-12) and the single craving item on the Minnesota Nicotine Withdrawal Scale (MNWS) are brief, valid, and reliable self-report measures of tobacco craving. In this secondary study, we analyzed data from French smokers with health-related problems enrolled in the Adjustment of DOses of NIcotine in Smoking (ADONIS) cessation trial. We estimated prediction models for each measure and compared their ability to distinguish correctly participants who relapsed from those who did not at 1–8 weeks after their quit date. ResultsAdjusted for all potential confounders FTCQ-12 risk score (RS; Factor 2, Expectancy plus Factor 4, Purposefulness) and MNWS craving were valid predictors of smoking relapse at endpoints measured 1–7 weeks apart. Prognostic accuracy of FTCQ-12 RS was greatest at 1–2 weeks follow-up compared to only 1 week for MNWS craving. Sensitivity for FTCQ-12 RS and MNWS craving was 85% and 53%, respectively. ConclusionsFTCQ-12 RS suggests a relapse process involving urges and desires in anticipation of the positive benefits of smoking linked with intent and planning to smoke. Findings also suggest that FTCQ-12 RS may be a better predictor instrument for smoking relapse than MNWS craving.

Tobacco withdrawal symptoms and urges to smoke in pregnant versus non-pregnant smokers

We compared tobacco withdrawal in pregnant and non-pregnant smokers abstaining from smoking for 24h. Female smokers completed an internet-based questionnaire, including the Minnesota Nicotine Withdrawal Scale—Revised (MNWS). They also rated additional withdrawal items and strength of urge to smoke. Consenting women were randomized to either: (i) abstain from smoking for 24h or (ii) smoke as usual. After 24h they rated their withdrawal again. We included a ‘smoking as usual’ group as we wished to establish that smoking abstinence increased withdrawal symptoms. Two-hundred and seventy-five women completed both the initial and the 24h questionnaire and reported abstaining (n=115, 17% pregnant) or smoking (n=160, 21% pregnant) as requested. Exclusively among abstinent smokers, we compared symptoms for the pregnant and non-pregnant groups. After 24h pregnant women had significantly lower scores than non-pregnant women for the mean MNWS (p=0.004) and for three individual MNWS symptoms (angry, p=0.010; anxious, p=0.048; impatient, p=0.011), with adjustments for baseline cigarette consumption and baseline withdrawal scores. Overall, on the first day of smoking abstinence, pregnant women are likely to report less severe tobacco withdrawal than non-pregnant women.

A Pilot Examination of Stress-Related Changes in Impulsivity and Risk Taking as Related to Smoking Status and Cessation Outcome in Adolescents

Psychosocial stress and impulsivity are each associated with smoking in adolescents. There is also evidence that stress can increase impulsive responding, and impulsive adolescent smokers attempting cessation are at greater risk of relapse. We performed a pilot investigation to examine stress-induced changes in response inhibition, inattention, and risk taking as related to smoking status and posttreatment smoking abstinence. Twelve adolescent smokers participating in a smoking cessation intervention and 15 adolescent nonsmokers completed a 2-session protocol assessing stress-related change in response inhibition and inattention (on the Conners' Continuous Performance Test-II), risk taking (on the Balloon Analogue Risk Task), nicotine withdrawal symptoms, and self-reported stress. At baseline, smokers had greater inattentive responding and risk taking when compared with nonsmokers. Stress exposure led to significant increases in stress, anger, and depression in all participants and also increased nicotine craving (on the Minnesota Nicotine Withdrawal Scale item) and impulsive responding in smokers. After covarying for baseline differences in impulsivity/risk taking, smokers who were not abstinent at the end of treatment experienced greater stress-induced risk taking when compared with those who were abstinent. In all, it appears that response inhibition and risk taking may be differentially altered by stress exposure in adolescent smokers and nonsmokers and that adolescent smoking cessation success may be associated with less risk taking in the face of stress.

Genetic Variation in Three Candidate Genes and Nicotine Dependence, Withdrawal and Smoking Cessation in Hospitalized Patients

This study evaluates the relationship of six polymorphisms found in the CHRNA3, DRD2 and COMT genes with nicotine dependence, the ability to quit smoking and the occurrence of withdrawal symptoms after short-term use of nicotine patch in hospitalized patients. The study included 233 participants from a double-blind, placebo-controlled trial of nicotine patch substitution with a 6-month follow-up period. Nicotine dependence was assessed by the Fagerström Test for Nicotine Dependence (FTND) questionnaire, withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale questionnaire and smoking cessation by self-reported abstinence at 1 week, 1 month and 6 months after treatment. After correcting for multiple testing, three polymorphisms in the DRD2 gene (Taq1A, Taq1B and Pro319Pro) were significantly associated with nicotine dependence (p = 0.018, p = 0.048 and p = 0.006, respectively). Using a cutoff point for the FTND score, the CHRNA3 Tyr215Tyr (rs1051730) polymorphism was also associated with nicotine dependence (p = 0.037 and p = 0.074 after correction for multiple testing). No association of any of the studied polymorphisms was observed with either smoking cessation or the occurrence of withdrawal symptoms. This study confirms the reported association of the CHRNA3 locus with nicotine dependence and shows the involvement of two independent DRD2 polymorphisms in nicotine dependence.

Attention‐Deficit/Hyperactivity Disorder Confounds Nicotine Withdrawal Self‐Report in Adolescent Smokers

Individuals with attention-deficit/hyperactivity disorder (ADHD) are more likely than those without ADHD to initiate smoking and develop nicotine dependence. Recent research indicates that adults with ADHD experience more severe nicotine withdrawal symptoms than those without ADHD. However, little is known about nicotine withdrawal in adolescent smokers with history of ADHD. Among a sample of 134 nicotine-dependent adolescents entering a smoking cessation research study, participants completed the Minnesota Nicotine Withdrawal Scale (MNWS) and lifetime diagnostic assessment for ADHD during the baseline visit. Responses on individual items and MNWS total score were compared between participants with and without history of ADHD. In addition, correlations between MNWS responses and current ADHD symptoms were investigated among participants with history of ADHD. Forty-eight participants (36%) met lifetime ADHD criteria. Adolescent smokers with history of ADHD scored significantly higher on MNWS than those without history of ADHD. Among participants with history of ADHD, responses on the MNWS difficulty concentrating, restlessness/impatience, and anxiety/nervousness items each correlated positively with several current ADHD symptoms. Treatment-seeking adolescent smokers with history of ADHD are more likely to endorse nicotine withdrawal symptoms than those without history of ADHD. However, it does not appear that the symptoms reported in this sample represent a valid "withdrawal syndrome," particularly because these smokers had not yet formally attempted to quit. Rather, the data likely reflect common features between ADHD and nicotine withdrawal. Smoking research, particularly among adolescents in whom ADHD is so common, should carefully consider the complex issue of comorbid ADHD and nicotine dependence.

Evaluation of the Chinese versions of the Minnesota Nicotine Withdrawal Scale and the Questionnaire on Smoking Urges-Brief

To evaluate the reliability and validity of the Chinese versions of Minnesota Nicotine Withdrawal Scale and Questionnaire on Smoking Urges-Brief (MNWS-C and QSU-Brief-C) in Chinese smokers. MNWS and QSU-Brief were translated into Chinese version through 10 steps. The reliability and validity of Chinese versions of the two scales were evaluated based on the data collected from 354 subjects. Cronbach's alpha coefficient was calculated to assess the reliability. Construct validity were evaluated with confirmatory factor analysis. Criteria validity was examined with correlation analysis between scale scores and patient-evaluated scores of craving and tobacco withdrawal symptoms. Cronbach's alpha coefficient of QSU-Brief-C was .96. Confirmatory factor analysis demonstrated that the fit indexes (adjusted goodness-of-fit index [AGFI], comparative fit index [CFI], normed fit index [NFI], and non-normed fit index [NNFI]) exceeded or approached 0.9. The correlation between QSU-Brief-C scores and patient-evaluated craving scores were statistically significant(r = .75, p < .0001). Cronbach's alpha coefficient of MNWS-C was .90. Confirmatory factor analysis demonstrated that the fit indexes (AGFI, CFI, NFI, and NNFI) exceeded 0.9. The correlation between MNWS-C scores and patient-evaluated discomfort scores were statistically significant(r = .68, p < .0001). Both QSU-Brief-C and MNWS-C have satisfactory validity and reliability and retain the two dimensions identified in their corresponding original English versions, which suggest that QSU-Brief-C and MNWS-C can be used in further research and clinical evaluation in Chinese smoking population with acceptable validity and reliability.

Is the ten-item Questionnaire of Smoking Urges (QSU-brief) more sensitive to abstinence than shorter craving measures?

The Questionnaire on Smoking Urges is now very widely used as a measure of craving but is considerably longer than alternatives in current use. Longer scales carry a significant cost in studies and clinical practice. This study compared the ten-item Questionnaire on Smoking Urges (QSU-brief) with six shorter measures of craving in terms of sensitivity to abstinence and reliability. Sixty smokers were randomly assigned to continue smoking (N = 30) or abstain completely for 24 h (n = 30), by which time the craving would be expected to have increased. Craving was measured at baseline and after 24 h. The craving measures tested were the QSU-brief, the Minnesota Nicotine Withdrawal Scale (MNWS), the Mood and Physical Symptoms Scale (MPSS), the Shiffman Scale (SS), the Wisconsin Smoking Withdrawal Scale and the Cigarette Withdrawal Scale and a simple rating of 'craving' (CR). All measures showed significant increases in scores following smoking abstinence. The two-item MPSS measure was similar to the QSU-brief (eta-squared 0.41 versus 0.45, respectively), and the CR was only slightly lower (eta-squared 0.37). The MNWS showed the least sensitivity (eta-squared 0.22). Stability while still smoking was good with the exception of the SS which showed a significant reduction on retest. The ten-item QSU-brief is not more sensitive to abstinence or reliable than the two-item MPSS or a single rating of craving.

Evaluating the validities of different DSM‐IV‐based conceptual constructs of tobacco dependence*

To compare the concurrent and predictive validities of two subsets of DSM-IV criteria for nicotine dependence (tolerance and withdrawal; withdrawal; difficulty controlling use; and use despite harm) to the concurrent and predictive validity of the full DSM-IV criteria. Analysis of baseline and outcome data from three randomized clinical trials of cigarette smoking treatment. San Francisco, California. Two samples of cigarette smokers (n = 810 and 322), differing with regard to baseline characteristics and treatment received, derived from three randomized clinical trials. DSM-IV nicotine dependence criteria were measured at baseline with a computerized version of the Diagnostic Interview Schedule for DSM-IV (DIS-IV). Additional baseline measures included the Fagerström Test of Nicotine Dependence (FTND), number of cigarettes smoked per day, breath carbon monoxide (CO) level, the Minnesota Nicotine Withdrawal Scale (MNWS), the Michigan Nicotine Reinforcement Questionnaire (M-NRQ) and the Profile of Mood States (POMS). Seven-day point-prevalence abstinence was assessed at week 12. Full DSM-IV criteria displayed greater concurrent validity than either of the two subsets of criteria. However, DSM-IV symptoms accounted for only a nominal amount of the variance in baseline smoking-related characteristics and were unrelated to smoking abstinence at week 12. Cigarettes smoked per day was the only significant predictor of abstinence at week 12. Although the findings do not provide a compelling alternative to the full set of DSM-IV nicotine dependence criteria, its poor psychometric properties and low predictive power limit its clinical and research utility.

Correspondence of interactive voice response (IVR) reports of nicotine withdrawal, craving, and negative mood with questionnaire ratings

This study focuses on comparing reports of nicotine withdrawal, craving, and depressive symptoms obtained using an Interactive Voice Response (IVR) system and several questionnaires. As part of a smoking cessation trial, daily reports of withdrawal, craving, and negative mood were collected using an IVR system for 7 days after participants attempted to quit smoking, and several pencil and paper questionnaires (i.e., the Minnesota Nicotine Withdrawal Scale, the Questionnaire on Smoking Urges, and the Center for Epidemiological Studies-Depression) were completed a week after the target quit date. The sample was composed of 378 daily smokers. Moderate to high correlations were found between the research questionnaires obtained at the end of the week and the corresponding daily IVR reports of nicotine withdrawal, craving, and depressive symptoms. However, the sample size decreased on each day of IVR reporting due to attrition. Thus, an appealing aspect of daily assessment using an IVR system is that it can provide additional data that are not obtained with paper and pencil assessments given once per week, but it will be important for future studies to concentrate on improving adherence with the IVR system in this population.

Psychometric Properties of the Minnesota Nicotine Withdrawal Scale: A Korean Version

Smoking is considerably more common among Korean American male individuals compared with all U.S. males, but no reliable and valid nicotine withdrawal scale has been available to measure withdrawal symptoms from the Korean American perspective, which is the aim of the present study. Translation and back-translation of the Minnesota Nicotine Withdrawal Scale (MNWS) was conducted to obtain a measure consistent with the Korean cultural understanding of smoking withdrawal symptoms. Following satisfactory interrater agreements, the Korean version (MNWS-K) was administered to 118 Korean American male smokers. Data were analyzed for internal consistency reliability and stability as well as construct validity. Internal consistency reliability was satisfactory for the total scale and factors (.88, .88, .79) and intraclass correlation coefficient (ICC) for the total score over a 1-month period was fair (r = .51). Exploratory factor analysis with orthogonal rotation yielded two factors. Together, Factor I, early-occurring disturbances in mental functioning, and Factor II, disturbances in physiological functioning and late-occurring disturbances in mental functioning, explained 66% of the variance in the scale. Theoretically related variables to the MNWS-K, number of smoking quit attempts and self-efficacy, showed modest but statistically significant correlations with the MNWS-K total and factored scales. Satisfactory internal consistency coefficients together with the validity findings suggest the MNWS-K warrants use with the Korean American population.

Confirmatory factor analysis of the Minnesota Nicotine Withdrawal Scale.

The authors examined the factor structure of the Minnesota Nicotine Withdrawal Scale (MNWS) using confirmatory factor analysis in 3 clinical research samples of smokers trying to quit (N = 723). Three confirmatory factor analytic models, based on previous research, were tested with each of the 3 study samples at multiple points in time. A unidimensional model including all 8 MNWS items was found to be the best explanation of the data. This model produced fair to good internal consistency estimates. Additionally, these data revealed that craving should be included in the total score of the MNWS. Factor scores derived from this single-factor, 8-item model showed that increases in withdrawal were associated with poor smoking outcome for 2 of the clinical studies. Confirmatory factor analyses of change scores showed that the MNWS symptoms cohere as a syndrome over time. Future investigators should report a total score using all of the items from the MNWS.

Cognitive Behavioral Therapy and Nicotine Replacement for Smoking Cessation in Psychiatric Outpatients With Major Depression

Objective The over-representation of major depressive disorder (MDD) in cigarette smokers makes it imperative to understand the effects of common treatments for smoking cessation on subjects with current depression. We assessed the feasibility of cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) versus CBT alone in subjects with MDD. Methods In this case series, 9 smokers (7 female and 2 male) in an outpatient psychiatry clinic responded to an advertisement and were enrolled in January 2005. The CBT-only group received 8 weekly 60-minute CBT sessions and CBT+NRT group received the CBT sessions and wore a 14 mg nicotine patch for 8 weeks. Cigarette use and scores on the Beck Depression Inventory, Fagerstrom Test for Nicotine Dependence, and Minnesota Nicotine Withdrawal Scale were determined serially over 12 weeks from enrollment. Results All 3 subjects in the CBT+NRT group completed the study, whereas only 67% (4 of 6) in the CBT-only group did so. Both groups showed reductions in cigarette use, in nicotine dependence and withdrawal, and in symptoms of MDD. The CBT-only group smoked 17.1±3.38 cigarettes/d at baseline and 7.53±3.13 cigarettes/d at 3 months, whereas the CBT+NRT group smoked 24.3±9.81 cigarettes/d at baseline and 9.67±2.47 cigarettes/d at 3 months. Between-group differences on outcome measures did not reach statistical significance. Conclusions Our findings showing feasibility of smoking cessation programs in cigarette smokers with current MDD suggest that clinicians should include this group in comprehensive smoking cessation programs.

Efficacy and tolerability of varenicline, an α 4β 2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers

Varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, has been developed specifically for smoking cessation. In Japan, 39.3% of men smoke and this is a major public health concern. The primary objective of this study was to evaluate the efficacy and dose-response relationship of varenicline in Japanese smokers. In this double-blind, placebo-controlled, randomized, parallel-group study, subjects were randomized to receive varenicline at 0.25 mg BID, 0.5 mg BID, 1 mg BID, or placebo for 12 weeks followed by a 40-week, nontreatment follow-up phase. The primary efficacy variable was the continuous abstinence rate (CAR), defined as no reported smoking (not even a puff) or other nicotine use and confirmed by end-expiratory carbon monoxide level <or=10 ppm, during the last 4 weeks of treatment (weeks 9-12). Secondary end points included CARs for weeks 9-24 and 9-52. Craving, withdrawal, and smoking satisfaction were determined by the Minnesota Nicotine Withdrawal Scale, the Brief Questionnaire on Smoking Urges, and the modified Cigarette Evaluation Questionnaire. The tolerability of varenicline was also evaluated. Of 618 subjects who received treatment, 515 (83.3%) were classified as nicotine dependent (scoring >or=5 on the Tobacco Dependence Screener), and constituted the primary analysis group. Of these, 385 (74.8%) subjects were male, and the mean age was within the range of 39.0 to 40.2 years. Across treatment groups, subjects claimed to have smoked a mean of 23.1 to 24.9 cigarettes per day in the preceding 30 days, and the mean score on the Fagerström Test for Nicotine Dependence was within the range from 5.4 to 5.7. The CAR for weeks 9-12 was significantly higher for all doses of varenicline compared with placebo (39.5% [51/129]). The highest CAR of 65.4% (85/130) was achieved with varenicline 1 mg BID (odds ratio [OR] [95% CI] = 2.98 [1.78-4.99]; P < 0.001). The CAR for weeks 9-52 was significantly greater for varenicline 1 mg BID than placebo (34.6% [45/130] vs 23.3% [30/129]; OR [95% CI] = 1.81 [1.04-3.17]; P = 0.036). The CARs for weeks 9-24 at 0.25, 0.5, and 1 mg BID were 33.6% (43/128), 35.2% (45/128), 37.7% (49/130), and for weeks 9-52 at 0.25 and 0.5 mg BID were 27.3% (35/128) and 28.9% (37/128) but failed to reach significance versus the placebo (29.5% [38/129] for weeks 9-24 and 23.3% [30/129] for weeks 9-52). Treatment-emergent adverse events (AEs) were more prevalent among varenicline-treated subjects (79.1% [121/153] at 0.25 mg BID, 80.6% [125/155] at 0.5 mg BID, and 80.1% [125/156] at 1 mg BID) than placebo subjects (71.4% [110/154]). The 3 most prevalent AEs at varenicline 1 mg BID were nasopharyngitis (35.9% [56/156]), nausea (24.4% [38/156]), and headache (10.3% [16/156]), all of which were of mild or moderate intensity. Nausea was the only AE that appeared dose related (7.2% [11/153] at 0.25 mg BID, 9.7% [15/155] at 0.5 mg BID, and 24.4% [38/156] at 1 mg BID) versus placebo (7.8% [12/154]). Varenicline was associated with dose-dependent improvement in smoking abstinence rates during the last 4 weeks of treatment and in the longer term over 40 weeks of nontreatment follow-up. The dose associated with the highest efficacy was varenicline 1 mg BID.

A randomized, placebo-controlled trial of varenicline, a selective α 4β 2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers

Rates of smoking in East Asian men range from >35% to >60%, and are increasing in women and the young. This study evaluated the efficacy and tolerability of 1 mg BID varenicline, a novel alpha4beta2 nicotinic acetylcholine receptor partial agonist, for smoking cessation in smokers in Taiwan and Korea. A randomized, double-blind, placebo-controlled, 12-week treatment, 12-week follow-up trial was conducted at 5 sites each in Korea and Taiwan. Eligible subjects, smoking >or=10 cigarettes/d, received brief smoking-cessation counseling and were randomly assigned in a 1:1 ratio to varenicline 1 mg BID (titrated during the first week) or placebo. Smoking status was established by self-report and confirmed at clinic visits by end-expiratory carbon monoxide <or=10 ppm. The primary end point was continuous abstinence rate (CAR) during the last 4 weeks of treatment. Secondary end points included CAR from weeks 9 to 24 and 7-day point prevalence (PP) of abstinence at weeks 12 and 24. Craving, withdrawal, and smoking satisfaction were determined by the Minnesota Nicotine Withdrawal Scale, the Brief Questionnaire of Smoking Urges, and the modified Cigarette Evaluation Questionnaire. Observed or volunteered adverse-event data were recorded at clinic visits. Overall, 126 subjects (84.9% male) received varenicline, and 124 (92.7% male) received placebo, Subjects were aged 21 to 73 years (mean age, 39.7 and 40.9 years for varenicline and placebo groups, respectively), and the mean (range) body weights were 69.0 (44.8-110.0) kg and 71.4 (45.5-102.0) kg, respectively. Subjects had smoked for 3 to 52 years (mean, 20.2 and 22.1 years in the varenicline and placebo groups, respectively). Subjects had smoked a mean of 23 cigarettes/d over the past month, with 51.6% (varenicline) and 46.0% (placebo) having made 1 or more prior serious quit attempts. Smoking-cessation rates at the end of treatment were 59.5% with varenicline versus 32.3% with placebo (P < 0.001). CARs through 12 weeks post-treatment (weeks 9-24) were 46.8% with varenicline and 21.8% with placebo (P < 0.001). The 7-day PP was 67.5% with varenicline versus 36.3% with placebo at week 12, and 57.1% versus 29.0% with placebo at week 24 (both, P < 0.001). Treatment-emergent, all-causality adverse events with an incidence >or= 5% for varenicline were nausea (43.7% for varenicline vs 11.3% placebo), insomnia (15.1% vs 13.7%), increased appetite (7.9% vs 6.5%), constipation (7.1% vs 2.4%), anxiety (5.6% vs 2.4%), and abnormal dreams (5.6% vs 0.8%). Adverse events resulted in <10% treatment discontinuations overall. Varenicline was an efficacious and well-tolerated pharmacotherapy for smoking cessation in this group of Asian smokers over a 12-week treatment period, and its effects persisted for a further 12-week follow-up period.

Reliability of the Fagerström Test for Nicotine Dependence, Minnesota Nicotine Withdrawal Scale, and Tiffany Questionnaire for Smoking Urges in Smokers with and without Schizophrenia

Few studies have examined the psychometrics of smoking-related behavioral measures in schizophrenia and questions have been raised about the applicability to smokers with schizophrenia. We examined the reliability of the Fagerström Test for Nicotine Dependence (FTND), Minnesota Nicotine Withdrawal Scale (M-NWS), and the Tiffany Questionnaire for Smoking Urges (TQSU) for smokers with schizophrenia (SS; n = 151) and nonpsychiatric smokers (CS; n = 181) recruited into three studies with similar inclusion criteria. SS and CS did not differ on a number of demographic and smoking variables (e.g., age). SS reported higher carbon monoxide (CO) levels, plasma cotinine levels, FTND, M-NWS, and TQSU Factor 1 scores. The internal consistencies (Cronbach's α) of the smoking measures were found to be high and comparable between diagnostic groups for the FTND, M-NWS total scores, and TQSU Factor 2 (all α's > 0.70) but higher for the CS than SS for the TQSU Factor 1 (0.86 versus 0.79). Test–retest correlations were lower for SS than CS on the FTND (0.65 versus 0.82), TQSU Factor 1 (0.65 versus 0.79), and TQSU Factor 2 (0.69 versus 0.81), but did not differ between diagnostic groups for M-NWS (0.58 versus 0.64). Our findings suggest that these measures may be reliable for use in smokers with schizophrenia.