Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers: A Pilot Study.

INTRODUCTION: Few studies have evaluated exercise interventions for smokers with depression or other psychiatric comorbidities. This pilot study evaluated the potential role of supervised vigorous exercise as a smoking cessation intervention for depressed females. METHODS: Thirty adult women with moderate-severe depressive symptoms were enrolled and randomly assigned to 12 weeks of thrice weekly, in person sessions of vigorous intensity supervised exercise at a YMCA setting (EX; n = 15) or health education (HE; n = 15). All participants received behavioral smoking cessation counseling and nicotine patch therapy. Assessments were done in person at baseline, at the end of 12 weeks of treatment, and at 6 months post-target quit date. Primary end points were exercise adherence (proportion of 36 sessions attended) and biochemically confirmed 7-day point prevalence abstinence at Week 12. Biomarkers of inflammation were explored for differences between treatment groups and between women who smoked and those abstinent at Week 12. RESULTS: Treatment adherence was high for both groups (72% for EX and 66% for HE; p = .55). The Week 12 smoking abstinence rate was higher for EX than HE (11/15 [73%] vs. 5/15 [33%]; p = .028), but no significant differences emerged at 6-month follow-up. Interleukin-6 levels increased more for those smoking than women abstinent at Week 12 (p = .040). CONCLUSIONS: Vigorous intensity supervised exercise is feasible and enhances short-term smoking cessation among depressed female smokers. Innovative and cost-effective strategies to bolster long-term exercise adherence and smoking cessation need evaluation in this population. Inflammatory biomarkers could be examined in future research as mediators of treatment efficacy. IMPLICATIONS: This preliminary study found that vigorous intensity supervised exercise is feasible and enhances short-term smoking cessation among depressed female smokers. This research addressed an important gap in the field. Despite decades of research examining exercise interventions for smoking cessation, few studies were done among depressed smokers or those with comorbid psychiatric disorders. A novel finding was increases in levels of a pro-inflammatory biomarker observed among women who smoked at the end of the intervention compared to those who did not.

Employment Status as an Indicator of Recovery and Function One Year after Hematopoietic Stem Cell Transplantation.

Employment after hematopoietic stem cell transplantation (HSCT) is an indicator of post-transplantation recovery and function, with economic and social implications. As survival rates for HSCT continue to improve, greater emphasis can be placed on factors affecting the quality of post-transplantation survival, including the ability to resume employment. A sample of recipients of autologous or allogeneic HSCT was accrued (n = 1000) to complete a longitudinal lifestyle survey before transplantation and at 1 year after transplantation. The present study examines associations between employment and patient characteristics, disease variables, illness status, and quality of life among 1-year survivors (n = 702). Participants had a mean age of 55 years (range, 18 to 78) and were predominately male (59.7%), married/partnered (77.1%), and non-Hispanic Caucasian (89.5%); most (79.4%) had received autologous transplantation. Of the 690 participants reporting some form of employment before illness diagnosis, 62.4% had returned to work by 1 year after HSCT. Full-time employment at 1 year after HSCT was significantly associated with remission of illness, improved illness, fewer post-transplantation hospitalizations, less fatigue and pain, higher quality of life, and higher rating of perceived health. Those unemployed because of their health reported the highest rates of fatigue and pain and lowest quality of life, and they were most likely to report poor perceived health. These findings highlight work reintegration as an important outcome and marker of survivors' overall adjustment after transplantation. Identifying factors affecting post-transplantation employment offers opportunities for behavioral interventions to target modifiable risk factors to optimize post-transplantation survivorship, inclusive of increased rates of return to work and decreased rates of associated disability.

Tobacco cessation treatment for Alaska native adolescents: group randomized pilot trial.

INTRODUCTION: Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and the potential efficacy of a targeted cessation intervention for AN youth using a group randomized design. METHODS: Eight villages in western Alaska were randomly assigned to receive the intervention (n = 4 villages) or a delayed treatment control condition (written materials only; n = 4 villages). Ten adolescents aged 12-17 years were targeted from each village with a planned enrollment of 80. The intervention was held over a weekend, and youth traveled from their villages to quit tobacco use with other teens. The intervention comprised 8 hr of group-based counseling. Talking circles, personal stories from elders, and recreational activities were included to enhance cultural acceptability and participation. Newsletters were mailed weekly for 5-weeks postprogram. Assessments were conducted at baseline, week 6 (end-of-treatment), and 6 months. Self-reported tobacco abstinence was confirmed with salivary cotinine. RESULTS: Recruitment targets were met in the intervention (41 enrolled) but not in control villages (27 enrolled). All intervention participants attended the weekend program. Retention was high; 98% of intervention and 86% of control participants completed 6-month follow-up. The 7-day point-prevalence self-reported tobacco abstinence rates for intervention and control participants were 10% (4/41) and 0% (0/27) at both week 6 and 6 months (p = .15). Only 1 adolescent in the intervention condition was biochemically confirmed abstinent at week 6 and none at 6 months. CONCLUSION: The intensive individual-focused intervention used in this study was feasible but not effective for tobacco cessation among AN youth. Alternative approaches are warranted.

Effects of menthol on the pharmacokinetics of bupropion among Black smokers.

INTRODUCTION: Despite the widespread use of mentholated cigarettes, lower cessation rates, and disproportionately high smoking-related morbidity among Blacks, the possible role of menthol in smokers' response to pharmacotherapy has not been well-studied. This study examined the effects of menthol on the pharmacokinetic (PK) profiles of bupropion and its principal metabolites, hydroxybupropion, threohydrobupropion, and erythrohydrobupropion among Black smokers. METHODS: After a 7-day placebo run-in period, participants received 150 mg bid sustained-release bupropion for 20-25 days. Blood samples were drawn for PK analysis on 2 occasions, 10-15 days after the commencement of bupropion while participants were still smoking (smoking phase) and at days 20-25 when they were asked not to smoke (nonsmoking phase). RESULTS: 18 smokers of nonmenthol cigarettes and 23 smokers of menthol cigarettes were enrolled in this study. No differences were found by menthol smoking status in the Cmax and area under the plasma concentration versus time curve (AUC) of bupropion and its metabolites in the smoking or nonsmoking phases. However, among menthol smokers, the AUC ratios of metabolite/bupropion were lower in the nonsmoking phase compared with the smoking phase (hydro/bup = 31.49 ± 18.84 vs. 22.95 ± 13.27, p = .04; erythro/bup = 1.99 ± 1.02 vs. 1.76 ± 0.75, p = .016; threo/bup = 11.77 ± 8.90 vs. 10.44 ± 5.63, p = .034). No significant differences were found in the metabolite/bup ratios between smoking and nonsmoking conditions among nonmenthol smokers. CONCLUSIONS: We did not find a significant effect of menthol compared with nonmenthol cigarette smoking on the PKs of bupropion and metabolites at steady state. More research is needed to advance the understanding of mechanisms underlying disparities in smoking cessation outcomes related to smoking of menthol cigarettes.

Design, recruitment, and retention of African-American smokers in a pharmacokinetic study.

BACKGROUND: African-Americans remain underrepresented in clinical research despite experiencing a higher burden of disease compared to all other ethnic groups in the United States. The purpose of this article is to describe the study design and discuss strategies used to recruit and retain African-American smokers in a pharmacokinetic study. METHODS: The parent study was designed to evaluate the differences in the steady-state concentrations of bupropion and its three principal metabolites between African-American menthol and non-menthol cigarette smokers. Study participation consisted of four visits at a General Clinical Research Center (GCRC) over six weeks. After meeting telephone eligibility requirements, phone-eligible participants underwent additional screening during the first two GCRC visits. The last two visits (pharmacokinetic study phase) required repeated blood draws using an intravenous catheter over the course of 12 hours. RESULTS: Five hundred and fifteen African-American smokers completed telephone screening; 187 were phone-eligible and 92 were scheduled for the first GCRC visit. Of the 81 who attended the first visit, 48 individuals were enrolled in the pharmacokinetic study, and a total of 40 individuals completed the study (83% retention rate). CONCLUSIONS: Although recruitment of African-American smokers into a non-treatment, pharmacokinetic study poses challenges, retention is feasible. The results provide valuable information for investigators embarking on non-treatment laboratory-based studies among minority populations.

The impact of perceived treatment assignment on smoking cessation outcomes among African-American smokers.

BACKGROUND: The double-blind placebo-controlled design is commonly considered the gold standard in research methodology; however, subject expectation bias could subvert blinding. OBJECTIVE: The primary aim of this study was to examine the impact of expectation bias. Specifically, we examined perceived treatment assignment on smoking cessation outcome rates among participants enrolled in a clinical trial of bupropion (150 mg SR, BID). DESIGN: Analyses were conducted on data collected during "Kick It at Swope," a double-blind, placebo-controlled, randomized trial of 600 African-American smokers. Chi-square and multiple logistic regression analyses were used to examine the impact of perception of assignment on treatment effect and cotinine-verified smoking abstinence rates. PARTICIPANTS: Participants were predominantly middle-aged (mean 44.7, SD 11.2), African-American women (68.6%), who smoked 19 CPD (SD = 8.1). Most had completed at least a high school education or GED (51.6%), and 55% had a monthly family income <$1,800. MEASUREMENTS: At week 6 (end of treatment) and week 26 (end of study), participants were asked to report their perceived treatment group assignment. Self-reported abstinence (weeks 6 and 26) was confirmed using CO and cotinine biochemical verification. RESULTS: After adjusting for actual treatment assignment, age and baseline cotinine, participants who perceived being assigned to bupropion vs. placebo were more likely to be abstinent at weeks 6 (OR = 2.07, 95% CI: 1.29 to 3.33, p = 0.002) and 26 (OR = 1.85, 95% CI: 1.05 to 3.24, p = 0.032). CONCLUSIONS: Results support previous research that expectation bias associated with judgment of treatment assignment is a strong predictor of outcome and confirms this relationship in a smoking cessation trial using bupropion SR among African-American smokers.

Relationship between menthol cigarettes and smoking cessation among African American light smokers.

AIMS: To determine whether African American light smokers who smoked menthol cigarettes had lower cessation when treated with nicotine replacement therapy and counseling. DESIGN: Data were derived from a clinical trial that assessed the efficacy of 2 mg nicotine gum (versus placebo) and counseling (motivational interviewing counseling versus Health Education) for smoking cessation among African American light smokers (smoked < or = 10 cigarettes per day). PARTICIPANTS: The sample consisted of 755 African American light smokers. MEASUREMENTS: The primary outcome variable was verified 7-day point-prevalence smoking cessation at 26 weeks follow-up. Verification was by salivary cotinine. FINDINGS: Compared to non-menthol smokers, menthol smokers were younger and less confident to quit smoking (P = 0.023). At 26 weeks post-randomization, 7-day verified abstinence rate was significantly lower for menthol smokers (11.2% versus 18.8% for non-menthol, P = 0.015). CONCLUSIONS: Among African American light smokers, use of menthol cigarettes is associated with lower smoking cessation rates. Because the majority of African American smokers use menthol cigarettes, a better understanding of the mechanism for this lower quit rate is needed.

Treatment Fidelity Among Family Health Promoters Delivering a Physical Activity and Nutrition Intervention to Immigrant and Refugee Families.

Lack of treatment fidelity can be an important source of variation affecting the credibility and utility of outcomes from behavioral intervention research. Development and implementation of a well-designed treatment fidelity plan, especially with research involving underserved populations, requires careful conceptualization of study needs in conjunction with what is feasible in the population. The purpose of this article is to review a fidelity-monitoring plan consistent with the National Institutes of Health Behavior Change Consortium guidelines (e.g., design, training, delivery, receipt, and enactment) for an intervention trial designed to improve physical activity and nutrition among immigrant and refugee families. Description of the fidelity monitoring plan is provided and challenges related to monitoring treatment fidelity in a community-based participatory intervention for immigrant and refugee families are discussed.

Tobacco use and preferences for wellness programs among health aides and other employees of an Alaska Native Health Corporation in Western Alaska.

This study assessed health behaviors and preferences for wellness programs among employees of a worksite serving Alaska Native-people. Village-based Community Health Aides/Practitioners (CHA/Ps) were compared with all other employees on health indicators and program preferences. Using a cross-sectional design, all 1290 employees at the Yukon Kuskokwim Health Corporation (YKHC) in Western Alaska were invited in 2015 to participate in a 30-item online survey. Items assessed health behaviors, perceived stress, resiliency, and preferences for wellness topics and program delivery formats. Respondents (n = 429) were 77% female and 57% Alaska Natives. CHA/Ps (n = 46) were more likely than all other employees (n = 383) to currently use tobacco (59% vs. 36%; p = 0.003). After adjusting for covariates, greater stress levels were associated (p = 0.013) with increased likelihood of tobacco use. Employees reported lower than recommended levels of physical activity; 74% had a Body Mass Index (BMI) indicating overweight or obese. Top preferences for wellness topics were for eating healthy (55%), physical activity (50%), weight loss (49%), reducing stress (49%), and better sleep (41%). CHA/Ps reported greater interest in tobacco cessation than did other employees (37% vs. 21%; p = 0.016). Preferred program delivery format among employees was in-person (51%). The findings are important because tailored wellness programs have not been previously evaluated among employees of worksites serving Alaska Native people. Promoting healthy lifestyles among CHAP/s and other YKHC employees could ultimately have downstream effects on the health of Alaska Native patients and communities.

Effect of bupropion on physiological measures of stress in smokers during nicotine withdrawal.

Studies suggest that among cigarette smokers trying to quit, stress undermines abstinence. Little research has assessed if therapies that increase smoking cessation rates impact physiological measures of stress response. Forty-three subjects completed this repeated-measures study in which a laboratory assessment was completed at baseline and after 17 days of treatment with either placebo (n=15), bupropion sustained release (150 mg twice daily) (n=14) or bupropion with stress reduction counseling (n=14). All subjects quit smoking 3 days prior to the second laboratory assessment. At each laboratory assessment physiological measures of stress (i.e. blood pressure, heart rate, plasma epinephrine, norepinephrine and cortisol concentrations) were measured during rest periods and in response to a speech, a math and a cold pressor task. Among subjects taking placebo, physiological measures of stress were generally lower at rest and during the stressors after smoking cessation. In those taking bupropion these measures were equivalent at the two assessments. Additionally, compared to placebo, those on bupropion had a greater diastolic blood pressure response to the speech stressor and greater systolic blood pressure response to the math stressor during the second laboratory session. This study suggests that bupropion may be maintaining physiological measures of stress during the nicotine withdrawal period.

Reported distress associated with concern about a cigarette smoker.

It is well documented that concerned others of alcohol abusers report distress associated with the substance user's behavior. No previous study has examined distress associated with concern for someone who smokes cigarettes. To investigate this association, college students, ages 18-24 (N=1719), completed a survey assessing whether or not they were close to someone who smokes whom they thought should quit and the level of distress they experienced regarding this person's smoking. 827 (48.1%) respondents endorsed knowing a smoker whom they thought should quit and 60% reported experiencing at least some distress regarding this person's smoking. From multivariate analysis, the presence of distress (any vs. none) was associated with female gender (OR=1.8, 95% C.I. 1.2, 2.5, p=0.001), never tobacco user (OR=2.0, 95% C.I. 1.4, 2.9, p<0.001), and elevated Perceived Stress Scale score (OR=1.05, 95% C.I. 1.02, 1.08, p<0.001, per 1 unit increase in PSS score). These findings contribute to our understanding of how smoking impacts the psychological well being of another and is intended to stimulate future research investigating the potential for distressed individuals to serve as change agents in tobacco control efforts.

Measuring nicotine dependence among smokeless tobacco users.

The objective of this study was to assess the concurrent validity of the FTQ-ST and the DIS-IV diagnosis of nicotine dependence among 68 adult ST users enrolled in a randomized, controlled clinical trial of bupropion SR. FTQ-ST scores were not found to differ between those with and without a current DIS-IV diagnosis of nicotine dependence (7.4+/-2.1 vs. 6.8+/-2.8, P=0.325). For all possible FTQ-ST cutoff scores, the observed agreement between the FTQ-ST and the DIS-IV was not found to be different from that expected due to chance. FTQ-ST total scores were positively correlated with serum cotinine (Spearman's r=0.40, P<0.001), amount of tobacco used (r=0.51 and r=0.41 for average dips/chews per day; average tins/pouches per week, respectively, P<0.001), and a reduced likelihood of abstinence at 3 months (OR=0.76, 95% C.I. 0.61-0.96; P=0.019). Participants meeting DIS-IV criteria had lower cotinine concentrations than those without this diagnosis (411+/-263 ng/ml vs. 493+/-246 ng/ml; P=0.042). Poor concordance was observed between the FTQ-ST and the DIS-IV in the assessment of nicotine dependence in ST users.

Development and preliminary evaluation of a measure of support provided to a smoker among young adults.

Most studies indicate a positive association between social support and smoking cessation. However, clinic-based interventions to increase support for stopping smoking have had limited success. Prior research has emphasized the smoker's perceptions of support received for smoking cessation while less attention has focused on support persons' reports of supportive behaviors provided to a smoker. This study examined select psychometric properties of the Support Provided Measure (SPM), a self-report questionnaire designed by the investigative team to assess supportive behaviors provided to a smoker. The SPM was administered to a college sample (N=771; 67% female) of young adults, aged 18 to 24 years, who reported knowing a smoker whom they thought should quit smoking. Results indicate that, in this sample, the SPM has a two-factor structure with good internal consistency reliability (Cronbach's alpha=0.77) and appears to assess a wide range of individual differences in the provision of support. Demographic correlates associated with SPM scores are described and suggestions for future research are offered.

Examining Smoking Dependence Motives among African American Light Smokers.

INTRODUCTION: Despite smoking fewer cigarettes per day, African American smokers have greater difficulty quitting compared to Caucasian smokers. Further elucidating the impact of smoking motivations on smoking behavior would contribute to understanding the factors that maintain smoking. AIMS: This study examined the factor structure of a brief assessment examining smoking dependence motives among a sample of African American light smokers. METHODS: Data from a double-blind, placebo-controlled randomized smoking cessation trial involving 540 participants. Results were analyzed using an exploratory factor analysis (EFA) and a randomly split EFA. RESULTS/FINDINGS: Findings from the initial EFA analysis produced an 8-factor model, explaining 69% of the variation in responses. The overall Measure of Sampling Adequacy (MSA) was 0.88 with item level MSA ranging 0.68-0.94 across the 30 items. Results from the randomly split EFA replicated the findings of the original EFA; with the exception of the item "I smoke within the first 30 minutes of awakening in the morning". CONCLUSIONS: These findings support the hypothesis of a multidimensional approach to conceptualizing nicotine dependence, and provide information regarding characteristics of nicotine dependence in African American light smokers which may be helpful in identifying targets for cessation treatment in this population of smokers.

Improving Spiritual Well-Being in Patients with Lung Cancers.

Patients with lung cancer report more disease burden and lower spiritual well-being (SWB) compared with other cancer patients. Understanding variables that lessen disease burden and improve SWB is essential. The aim of this study was to explore the relationship between motivational level for physical activity and SWB in patients with lung cancer. Linear regression showed increased SWB as stage of change for physical activity increased (p < 0.0001), even after adjusting for multiple demographic variables.

Assessment of depression among African American light smokers.

Given the relationship between depression and smoking, we compared the two-item Patient Health Questionnaire (PHQ-2) and 10-item Center for Epidemiological Studies Depression Scale (CESD-10) in assessing depressive symptoms among African American light smokers in a clinical trial of bupropion. Of 539 participants, 21.3 percent reported significant depressive symptoms on the PHQ-2, 31.0 percent screened positive per CESD-10, 36.8 percent reported symptoms on either, and 15.6 percent screened positive on both (r = 0.47, p < .001). Having depressive symptoms was associated with less education, decreased positive affect and social support, and greater levels of negative affect and perceived stress. Cessation treatment should assess depression and address these symptoms.

Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data.

BACKGROUND: African Americans experience significant tobacco-related health disparities despite the fact that over half of African American smokers are light smokers (use ≤ 10 cigarettes per day). African Americans have been under-represented in smoking cessation research, and few studies have evaluated treatment for light smokers. This paper describes the study design, measures, and baseline characteristics from Kick It at Swope III (KIS-III), the first treatment study of bupropion for African American light smokers. METHODS: Five hundred forty African American light smokers were randomly assigned to receive bupropion (150 mg bid) (n = 270) or placebo (n = 270) for 7 weeks. All participants received written materials and health education counseling. Participants responded to survey items and provided blood samples for evaluation of phenotype and genotype of CYP2A6 and CYP2B6 enzymes involved in nicotine and bupropion metabolism. Primary outcome was cotinine-verified 7-day point prevalence smoking abstinence at Week 26 follow-up. RESULTS: Of 2,628 individuals screened, 540 were eligible, consented, and randomized to treatment. Participants had a mean age of 46.5 years and 66.1% were women. Participants smoked an average of 8.0 cigarettes per day, had a mean exhaled carbon monoxide of 16.4 ppm (range 1-55) and a mean serum cotinine of 275.8 ng/ml. The mean Fagerström Test for Nicotine Dependence was 3.2, and 72.2% of participants smoked within 30 minutes of waking. The average number of quit attempts in the past year was 3.7 and 24.2% reported using pharmacotherapy in their most recent quit attempt. Motivation and confidence to quit were high. CONCLUSION: KIS-III is the first study designed to examine both nicotine and bupropion metabolism, evaluating CYP2A6 and CYP2B6 phenotype and genotype in conjunction with psychosocial factors, in the context of treatment of African American light smokers. Of 1629 smokers screened for study participation, only 18 (1.1%) were ineligible to participate in the study because they refused blood draws, demonstrating the feasibility of recruiting and enrolling African American light smokers into a clinical treatment trial involving biological data collection and genetic analyses. Future evaluation of individual factors associated with treatment outcome will contribute to advancing tailored tobacco use treatment with the goal of enhancing treatment and reducing health disparities for African American light smokers. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00666978.

Psychometric properties of a Brief Smoking Consequences Questionnaire for Adults (SCQ-A) among African American light smokers.

Despite a decline in cigarette smoking over the past few decades, rates remain unacceptably high for certain segments of the population, such as urban African Americans (AAs). AA smokers, on average, smoke fewer cigarettes per day than European American samples; however, AA smokers are less likely to achieve abstinence during a quit attempt. Outcome expectancies have previously been association with cessation outcomes, but prior research has not examined expectancies among treatment-seeking AA light smokers. The 33-item Smoking Consequences Questionnaire-Adult (SCQ-A) was evaluated among 751 AA light smokers (i.e.,

Achieving high rates of consent for genetic testing among African American smokers.

Genetic factors play an important role in smoking behavior. Although African Americans are at disproportionately increased risk for tobacco-related morbidity and mortality, limited attention has been given to genetic investigation of tobacco use in this population. The present study examined consent for genetic testing among African American smokers enrolled in a smoking cessation clinical trial. African American light smokers (

Inhibition of CYP2D6 activity by bupropion.

The purpose of this study was to assess the effect of bupropion on cytochrome P450 2D6 (CYP2D6) activity. Twenty-one subjects completed this repeated-measures study in which dextromethorphan (30-mg oral dose) was administered to smokers at baseline and after 17 days of treatment with either bupropion sustained-release (150 mg twice daily) or matching placebo. Subjects quit smoking 3 days before the second dextromethorphan administration. To assess CYP2D6 activity, urinary dextromethorphan/dextrorphan metabolic ratios were calculated after an 8-hour urine collection. Thirteen subjects received bupropion, and 8 received placebo. In those receiving active medication, the dextromethorphan/dextrorphan ratio increased significantly at the second assessment relative to the first (0.012 +/- 0.012 vs. 0.418 +/- 0.302; P < 0.0004). No such change was observed in those randomized to placebo (0.009 +/- 0.010 vs. 0.017 +/- 0.015; P = NS). At baseline, all subjects were phenotypically extensive CYP2D6 metabolizers (metabolic ratio <0.3); after treatment, 6 of 13 subjects receiving bupropion, but none of those receiving placebo, had metabolic ratios consistent with poor CYP2D6 metabolizers. Bupropion is therefore a potent inhibitor of CYP2D6 activity, and care should be exercised when initiating or discontinuing bupropion use in patients taking drugs metabolized by CYP2D6.