Stevens S. Smith

A controlled trial of sustained - Release bupropion, a nicotine patch, or both for smoking cessation

BACKGROUND AND METHODS Use of nicotine-replacement therapies and the antidepressant bupropion helps people stop smoking. We conducted a double-blind, placebo-controlled comparison of sustained-release bupropion (244 subjects), a nicotine patch (244 subjects), bupropion and a nicotine patch (245 subjects), and placebo (160 subjects) for smoking cessation. Smokers with clinical depression were excluded. Treatment consisted of nine weeks of bupropion (150 mg a day for the first three days, and then 150 mg twice daily) or placebo, as well as eight weeks of nicotine-patch therapy (21 mg per day during weeks 2 through 7, 14 mg per day during week 8, and 7 mg per day during week 9) or placebo. The target day for quitting smoking was usually day 8. RESULTS The abstinence rates at 12 months were 15.6 percent in the placebo group, as compared with 16.4 percent in the nicotine-patch group, 30.3 percent in the bupropion group (P<0.001), and 35.5 percent in the group given bupropion and the nicotine patch (P<0.001). By week 7, subjects in the placebo group had gained an average of 2.1 kg, as compared with a gain of 1.6 kg in the nicotine-patch group, a gain of 1.7 kg in the bupropion group, and a gain of 1.1 kg in the combined-treatment group (P<0.05). Weight gain at seven weeks was significantly less in the combined-treatment group than in the bupropion group and the placebo group (P<0.05 for both comparisons). A total of 311 subjects (34.8 percent) discontinued one or both medications. Seventy-nine subjects stopped treatment because of adverse events: 6 in the placebo group (3.8 percent), 16 in the nicotine-patch group (6.6 percent), 29 in the bupropion group (11.9 percent), and 28 in the combined-treatment group (11.4 percent). The most common adverse events were insomnia and headache. CONCLUSIONS Treatment with sustained-release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation than use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant.

Time to First Cigarette in the Morning as an Index of Ability to Quit Smoking: Implications for Nicotine Dependence

An inability to maintain abstinence is a key indicator of tobacco dependence. Unfortunately, little evidence exists regarding the ability of the major tobacco dependence measures to predict smoking cessation outcome. This paper used data from four placebo-controlled smoking cessation trials and one international epidemiological study to determine relations between cessation success and the Fagerström Test for Nicotine Dependence (FTND), the Heaviness of Smoking Index, the Nicotine Dependence Syndrome Scale, and the Wisconsin Inventory of Smoking Dependence Motives. Results showed that much of the predictive validity of the FTND could be attributed to its first item, time to first cigarette in the morning, and this item had greater validity than any other single measure. Thus the time-to-first-cigarette item appears to tap a pattern of heavy, uninterrupted, and automatic smoking and may be a good single-item measure of nicotine dependence.

A multiple Motives approach to tobacco dependence: The Wisconsin Inventory of Smoking Dependence Motives (WISDM-68)

The dependence construct fills an important explanatory role in motivational accounts of smoking and relapse. Frequently used measures of dependence are either atheoretical or grounded in a unidimensional model of physical dependence. This research creates a multidimensional measure of dependence that is based on theoretically grounded motives for drug use and is intended to reflect mechanisms underlying dependence. Data collected from a large sample of smokers (N = 775) indicated that all 13 subscales of the Wisconsin Inventory of Smoking Dependence Motives (WISDM-68) have acceptable internal consistency, are differentially present across levels of smoking heaviness, and have a multidimensional structure. Validity analyses indicated the WISDM-68 subscales are significantly related to dependence criteria such as smoking heaviness and to 4th edition Diagnostic and Statistical Manual of Mental Disorders symptoms of dependence and relapse.

Evaluating the construct validity of psychopathy in Black and White male inmates: Three preliminary studies.

Although Black inmates represent almost half the population of United States prisons and have been included in several studies of psychopathy, there appear to be no published studies to date addressing the validity of the psychopathy construct in Black inmates. Three studies were conducted to assess the validity of the construct in Black male inmates using Hares Psychopathy Checklist (PCL). In Study 1, we examined the internal structure of the PCL and the relation of checklist scores to several constructs relevant to psychopathy. We observed differences between Blacks and Whites in the distribution of psychopathy scores, in the relation of psychopathy to measures of impulsivity, and in the congruence of the underlying factor structure of the PCL. In Study 2, Black psychopaths were found to manifest a pattern of passive avoidance deficits similar but not identical to that reported for White psychopaths in Newman and Kossons study. Study 3 demonstrated that psychopaths of both races receive more criminal charges in a wider variety of offense categories than do nonpsychopaths. The psychopathy construct appears tentatively applicable to Blacks, although its components may be somewhat different than for Whites.

Predicting relapse back to smoking: Contrasting affective and physical models of dependence

Traditional models of physical dependence suggest that nicotine dependence should be reflected by the extent of drug exposure (e.g., smoking rate) and by evidence of physiological adaptation (e.g., withdrawal severity). An affective model suggests that nicotine dependence should be related to an individuals tendency to experience negative affect and expectations that nicotine use would ameliorate such affect. This research investigated the ability of these 2 models to predict relapse back to smoking at 6 months postquit. Logistic regression models were developed and tested in 505 heavy smokers participating in nicotine patch clinical trials. Results supported both models, but the most potent predictor of outcome was postquit negative affect, which accounted for much of the predictive validity of traditional measures of nicotine dependence. Affective reactivity appears to be a core constituent of dependence.

Prevalence and predictors of transitions in smoking behavior among college students.

The prevalence of smoking among college students is surprisingly high and represents a significant public health issue. However, there are few longitudinal studies of smoking in this population. This study examined the prevalence and predictors of transitions in smoking behavior among a cohort of 548 college students. Over the course of 4 years, 87% of daily smokers and almost 50% of occasional smokers continued to smoke. Among nonsmokers, 11.5% began smoking occasionally and none became daily smokers. In general, predictors of smoking behavior change were significant only among baseline occasional smokers and included gender, smoking outcome expectancies, and affect regulation expectations. Peer and parental smoking, demographics, affect, stress, and alcohol use were generally not predictive of change. Tobacco control interventions targeted at college students are clearly warranted.

Alcohol and drug abuse-dependence disorders in psychopathic and nonpsychopathic criminal offenders.

Co-occurrence of psychopathy (assessed with the Psychopathy Checklist) and lifetime Diagnostic and Statistical Manual of Mental Disorders (3rd ed.) alcohol and drug disorders (assessed with the National Institute of Mental Health Diagnostic Interview Schedule) was examined in a sample of 360 male inmates. Consistent with previous research that used diagnoses of antisocial personality disorder, psychopaths were more likely than nonpsychopaths to have lifetime diagnoses of alcoholism, any drug disorder, and multiple drug disorders. We also examined the relation between substance abuse and the 2 factors of the Psychopathy Checklist. Substance abuse was significantly related to general social deviance (Factor 2) but was unrelated to core personality features of psychopathy (Factor 1). We present two possible models of psychopathy (unitary syndrome vs. dual-diathesis model) that may account for the association between psychopathy and substance abuse.

Development and validation of the Wisconsin Smoking Withdrawal Scale.

The accurate assessment of nicotine withdrawal is important theoretically and clinically. A 28-item scale, the Wisconsin Smoking Withdrawal Scale, was developed that contains 7 reliable subscales tapping the major symptom elements of the nicotine withdrawal syndrome. Coefficients alpha for the subscales range from .75 to .93. This scale is sensitive to smoking withdrawal, is predictive of smoking cessation outcomes, and yields data that conform to a 7-factor structure. The 7 scales predicted intratreatment smoking, chi2(7, N = 163) = 15.19, p = .034. Moreover, the questionnaire is sufficiently brief so that it can be used in both clinical and research contexts.

The Reliability and Validity of the Psychopathy Checklist–Revised in a Sample of Female Offenders

The reliability and validity of the Psychopathy Checklist–Revised (PCL–R) was examined in a sample of 528 nonpsychotic female offenders participating in a study assessing the generalizability of the instrument to females using personality, attitudinal, and laboratory behavioral measures. Results showed good interrater reliability and adequate internal consistency. Correlations with a number of self-report validity measures and previous criminal behavior provide support for the convergent validity of the instrument. A lack of association with general psychopathology provides support for the discriminant validity of the instrument. However, significant correlations with anxiety, negative affectivity, and intelligence run counter to expectations and to findings with male offenders. Furthermore, the low base rate of psychopathy in this sample, relative to base rates among male prisoners, raises the concern that either psychopathy is less prevalent in females than in males or the PCL–R is not adequately assessing the construct in female offenders.

A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies

CONTEXT Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use. OBJECTIVE To assess the relative efficacies of 5 smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons. DESIGN A randomized, double-blind, placebo-controlled clinical trial. SETTING Two urban research sites. PATIENTS One thousand five hundred four adults who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications. INTERVENTIONS Participants were randomized to 1 of 6 treatment conditions: nicotine lozenge, nicotine patch, sustained-release bupropion, nicotine patch plus nicotine lozenge, bupropion plus nicotine lozenge, or placebo. In addition, all participants received 6 individual counseling sessions. MAIN OUTCOME MEASURES Biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse. RESULTS All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (odds ratios, 1.63-2.34). With such protection, only the nicotine patch plus nicotine lozenge (odds ratio, 2.34, P < .001) produced significantly higher abstinence rates at 6-month postquit than did placebo. CONCLUSION While the nicotine lozenge, bupropion, and bupropion plus lozenge produced effects that were comparable with those reported in previous research, the nicotine patch plus lozenge produced the greatest benefit relative to placebo for smoking cessation.