A Pilot Study to Evaluate the Use of Automated Nicotine Metabolite Ratio Reporting within Primary Care as an Implementation Strategy to Increase the Use of Tobacco Treatments.

INTRODUCTION: Concerns about safety and effectiveness of tobacco treatments reduce their use. We explored integrating the nicotine metabolite ratio (NMR), and messaging about its potential for improving safety and effectiveness, as a strategy to increase use of tobacco treatments within primary care. METHODS: Through a prospective cohort design, we explored the effects of integrating NMR testing within primary care on the provision of tobacco treatment; 65 patients completed assessments including NMR before a clinic visit. At the clinic visit, patients' clinicians received an electronic health record alert about the patient's NMR and personalized treatment recommendations to improve effectiveness and safety. Being asked about smoking and advised to quit, and a referral for tobacco treatment or medication prescription, were assessed within 30 days of the appointment and were compared to a usual care cohort (N=85). RESULTS: The NMR and usual care cohorts reported similar rates of being asked about smoking (92.3% vs. 92.9%, p=1.0), being advised to quit (72.3% vs. 74.1%, p=0.85), being referred for tobacco treatment (23.1% vs. 36.5%, p=0.11), and receiving tobacco use medications (20% vs. 27.1%, p=0.34). In the NMR cohort, fast vs. slow metabolizers were more likely to receive medication (26% vs. 0%, p=0.003) and all patients who received varenicline (n=8) were fast metabolizers. CONCLUSIONS: NMR results and treatment recommendations did not increase tobacco treatment rates in primary care, although it may increase treatment rates and use of varenicline for fast metabolizers. Future studies could test ways to use the NMR to increase tobacco treatment rates in clinical settings. IMPLICATIONS: This study generated a novel implementation strategy, namely an electronic health record alert about patients' NMR and personalized treatment recommendations, in an effort to increase tobacco treatment rates in primary care. While the strategy did not increase tobacco treatment rates, it may have boosted the rate of varenicline prescription for patients who metabolize nicotine faster, aligning with evidence-based practice.

The Impact of the COVID-19 Pandemic on Stress, Isolation, Smoking Behaviors, and Motivation to Quit in People with HIV Who Smoke.

People with HIV (PWH) smoke at higher rates compared with the general population and have lower cessation rates. The primary aim of this study was to examine the impact of the COVID-19 pandemic on smoking in PWH. A survey was administered to participants in two smoking cessation trials in the United States. Mean cigarettes per day was 13.9 (SD 8.6), and participants reported they had smoked on average for 30.93 years (SD 10.4). More than half (55.7%) of participants (N = 140) reported not changing their smoking during the pandemic, while 15% reported decreasing, and 25% reported increasing their smoking. In bivariate analyses, worrying about food due to lack of money (χ2 = 9.13, df 2, p = 0.01) and greater Covid-related worry (rs = 0.19, p = 0.02) were significantly associated with increased smoking. Qualitative research may be needed to more clearly elucidate factors related to smoking behaviors among PWH.

Seeing Through the Blind: Belief about Treatment Randomization and Smoking Cessation Outcome among People with Current or Past Major Depressive Disorder who Smoke in a Placebo-Controlled Trial of Varenicline.

INTRODUCTION: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial. METHODS: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed. RESULTS: Treatment arm belief was significantly associated with actual arm assignment (χ2(2)=13.0, p=0.002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, vs. "not sure" (RR=3.05 [1.41-6.60], p=0.005). Participants in the placebo arm were just as likely to believe they were taking placebo vs. "not sure" (χ2[2]=0.75, p=0.69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR=5.91 [2.06-16.92], p=0.001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline B=0.077 [0.002-0.192], p <0.05). CONCLUSIONS: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline.

Depression Severity Moderates Reward Learning Among Smokers with Current or Past Major Depressive Disorder in a Smoking Cessation Randomized Clinical Trial.

INTRODUCTION: Behavioral and pharmacological smoking cessation treatments are hypothesized to increase patients' reward learning to reduce craving. Identifying changes in reward learning processes that support effective tobacco dependence interventions among smokers who experience depression may guide patients towards efficient treatment strategies. The objective was to investigate the extent to which adult daily cigarette smokers with current or past major depressive disorder (MDD) learned to seek reward during 12 weeks of treatment combining behavioral activation and varenicline. We hypothesized that a decline in reward learning would be attenuated (least to most) in the following order: 1) Behavioral activation integrated with ST (BASC) + varenicline, 2) BASC + placebo, 3) Standard behavioral cessation treatment (ST) + varenicline, 4) ST + placebo. METHODS: We ran a Phase 4, placebo-controlled, randomized clinical trial with 300 participants receiving 12 weeks of one of four conditions across two urban medical centers. Depressive symptoms were measured using the Beck Depression Inventory-II (BDI). Reward learning was ascertained at Weeks 1, 7, and 14 using the Probabilistic Reward Task (PRT), a laboratory task that uses an asymmetric reinforcement schedule to assess (a) learning to seek reward (response bias), (b) differentiate between stimuli, and (c) time to react to cues. RESULTS: There was a significant interaction of BDI group x PRT response bias. Response bias declined from Week 7 to 14 among participants with high baseline depression symptoms. The other two BDI groups showed no change in response bias. CONCLUSIONS: Controlling for baseline depression, participants showed a decrease in response bias from Week 1 to 14, and from Weeks 7 to 14. Treatment condition and abstinence status were unassociated with change in reward learning. IMPLICATIONS: Smokers who report greater depression severity show a decline in reward learning despite their participation in smoking cessation treatments, suggesting that depressed populations pose unique challenges with standard smoking cessation approaches.

Evaluating Treatment Mechanisms of Varenicline: Mediation by Affect and Craving.

INTRODUCTION: Negative reinforcement models posit that relapse to cigarette smoking is driven in part by changes in affect and craving during the quit attempt. Varenicline may aid cessation by attenuating these changes; however, this mediational pathway has not been formally evaluated in placebo-controlled trials. Thus, trajectories of negative affect (NA), positive affect (PA), and craving were tested as mediators of the effect of varenicline on smoking cessation. AIMS AND METHODS: Secondary data analysis was conducted on 828 adults assigned to either varenicline or placebo in a randomized controlled trial for smoking cessation (NCT01314001). Self-reported NA, PA, and craving were assessed 1-week pre-quit, on the target quit day (TQD), and 1 and 4 weeks post-TQD. RESULTS: Across time, NA peaked 1-week post-quit, PA did not change, and craving declined. Less steep rises in NA (indirect effect 95% CI: .01 to .30) and lower mean craving at 1-week post-quit (CI: .06 to .50) were mediators of the relationship between varenicline and higher cessation rates at the end of treatment. PA was associated with cessation but was not a significant mediator. CONCLUSIONS: These results partially support the hypothesis that varenicline improves smoking cessation rates by attenuating changes in specific psychological processes and supported NA and craving as plausible treatment mechanisms of varenicline. IMPLICATIONS: The present research provides the first evidence from a placebo-controlled randomized clinical trial that varenicline's efficacy is due, in part, to post-quit attenuation of NA and craving. Reducing NA across the quit attempt and craving early into the attempt may be important treatment mechanisms for effective interventions. Furthermore, post-quit NA, PA, and craving were all associated with relapse and represent treatment targets for future intervention development.

History and Correlates of Smoking Cessation Behaviors Among Individuals With Current or Past Major Depressive Disorder Enrolled in a Smoking Cessation Trial.

INTRODUCTION: Smoking among adults with major depressive disorder (MDD) is at least double that of the general US population. More effective smoking cessation interventions for depressed smokers may be facilitated through a better understanding of the smoking and depression-related characteristics of this population. METHODS: We used baseline data from 300 participants enrolled in randomized clinical trial for smokers with current or past MDD. We described history of smoking cessation behaviors (ie, quit attempts, quit motivation, and cessation treatment utilization) and used multivariate regression to identify demographic and depression-related correlates of these behaviors. RESULTS: Sixty-eight percent of participants reported at least one quit attempt in the past year, nearly 51% reported motivation to quit in the subsequent 30 days, and 83% reported prior use of a nicotine replacement therapy. A greater readiness to quit smoking was associated with increased age (p = .04) and lower cigarettes per day (p = .01). Greater use of smoking cessation medication was associated with greater education and nicotine dependence, minority race, and greater use of complementary reinforcers (eg, activities associated with increased reinforcing value of smoking; p's < .05). CONCLUSIONS: These data indicate that smokers with current or past MDD are highly motivated to quit smoking and have a history of engaging in efforts to quit. Interventions to promote smoking cessation behaviors should address younger and lighter smokers, who may perceive less risk from tobacco use, and efforts to promote smoking cessation medications and counseling should address minority smokers who are engaging in complementary reinforcers. IMPLICATIONS: These data are inconsistent with the assumption that smokers with serious mental illness are not willing to quit smoking and suggest the need for studies that test behavioral interventions that address complementary reinforcers to treat tobacco use in this community.

The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV.

The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. IMPLICATIONS: This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

Comparing the Rate of Nicotine Metabolism Among Smokers With Current or Past Major Depressive Disorder.

BACKGROUND AND OBJECTIVES: Persons with current or past major depressive disorder (MDD) vs those without have higher smoking rates. The nicotine metabolite ratio (NMR) represents variation in the rate of nicotine metabolism and has been associated with smoking behaviors and response to tobacco treatments. We compared NMR between smokers with current or past MDD (MDD+) vs smokers without MDD (MDD-). We also assessed correlates of NMR and compared withdrawal and craving between MDD+ and MDD- smokers. METHODS: Using baseline data from two clinical trials and propensity score weighting based on sex, race, body mass index, and smoking rate, we compared NMR between MDD+ (N = 279) and MDD- (N = 1575) smokers. We also compared groups on and nicotine withdrawal and craving. RESULTS: Mean NMR (ß = -.02, 95% confidence interval [CI]: -0.05 to 0.01, P = .13) and the distribution of smokers across NMR quartiles (odds ratio [OR] = 0.76, 95% CI: 0.50 to 1.16, P = .21) were similar between MDD+ and MDD- samples. This relationship was not affected by antidepressant medication. In the MDD+ sample, African Americans had significantly lower mean NMR, while older smokers and smokers with lower education had higher mean NMR (Ps < .05). MDD+ smokers had significantly higher withdrawal and craving than MDD- smokers (Ps < .05). DISCUSSION AND CONCLUSIONS: While variability in NMR may not explain differences in smoking rates between MDD+ and MDD- smokers, MDD+ smokers report increased withdrawal and craving. SCIENTIFIC SIGNIFICANCE: In this first study to assess NMR among MDD+ smokers, the findings underscore the need to address withdrawal and craving within smoking cessation treatments for those with MDD. (Am J Addict 2021;00:00-00).

Improved clinical outcomes among persons with HIV who quit smoking.

Quitting smoking among people living with HIV/AIDS (PLWHA) is a priority. However, PLWHA and clinicians working with PLWHA are reluctant to use tobacco use treatments out of concern that smoking cessation can diminish anti-retroviral therapy (ART) adherence and quality of life (QoL) and increase psychiatric symptoms. This secondary analysis from a placebo-controlled varenicline trial for tobacco dependence among PLWHA (N = 179) examined if smoking cessation at the end of treatment (EOT) was associated with changes in ART adherence, QoL, anxiety and depression symptoms, and varenicline side effects. ART adherence was not affected by smoking cessation (p > 0.05), remaining ≥98% for all participants. Across 8 QoL subscales, 7 remained unchanged over time across smokers and abstainers; side effects were not associated with cessation. Controlling for baseline smoking rate, adherence to varenicline/placebo and counseling, and treatment arm, participants who had quit smoking at EOT reported a significant reduction in depression (ß = -1.657, 95% CI: -2.893, -0.422, p = .009) and anxiety (ß = -1.434, 95% CI: -2.812, -0.56, p = .041) and increased life satisfaction (ß = 0.88, 95% CI: 0.21, 3.275, p = .027). When PLWHA quit smoking they may not experience adverse clinical outcomes including ART non-adherence and may experience beneficial psychological effects, supporting the use of FDA-approved smoking cessation treatments among PLWHA.

The Network Structure of Tobacco Withdrawal in a Community Sample of Smokers Treated With Nicotine Patch and Behavioral Counseling.

INTRODUCTION: Network theories of psychopathology highlight that, rather than being indicators of a latent disorder, symptoms of disorders can causally interact with one another in a network. This study examined tobacco withdrawal from a network perspective. METHODS: Participants (n = 525, 50.67% female) completed the Minnesota Tobacco Withdrawal Scale four times (2 weeks prior to a target quit day, on the target quit day, and 4 and 8 weeks after the target quit day) over the course of 8 weeks of treatment with nicotine patch and behavioral counseling within a randomized clinical trial testing long-term nicotine patch therapy in treatment-seeking smokers. The conditional dependence among seven withdrawal symptoms was estimated at each of the four measurement occasions. Influential symptoms of withdrawal were identified using centrality indices. Changes in network structure were examined using the Network Comparison Test. RESULTS: Findings indicated many associations among the individual symptoms of withdrawal. The strongest associations that emerged were between sleep problems and restlessness, and associations among affective symptoms. Restlessness and affective symptoms emerged as the most central symptoms in the withdrawal networks. Minimal differences in the structure of the withdrawal networks emerged across time. CONCLUSIONS: The cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal rather than simply reflecting passive indicators of a latent disorder. Findings encourage greater consideration of individual withdrawal symptoms and their potential interactions and may be used to generate hypotheses that may be tested in future intensive longitudinal studies. IMPLICATIONS: This study provides a novel, network perspective on tobacco withdrawal. Drawing on network theories of psychopathology, we suggest that the cooccurrence of withdrawal symptoms may result from interactions among symptoms of withdrawal over time, rather than simply reflecting passive indicators of a latent disorder. Results indicating many associations among individual symptoms of withdrawal are consistent with a network perspective. Other results of interest include minimal changes in the network structure of withdrawal across four measurement occasions prior to and during treatment with nicotine patch and behavioral counseling.

Menthol Cigarettes, Tobacco Dependence, and Smoking Persistence: The Need to Examine Enhanced Cognitive Functioning as a Neuropsychological Mechanism.

INTRODUCTION: Despite the overall decline in the prevalence of cigarette use in the United States, menthol cigarette use among smokers is rising, and evidence shows that it may lead to more detrimental effects on public health than regular cigarette use. One of the mechanisms by which nicotine sustains tobacco use and dependence is due to its cognitive enhancing properties, and basic science literature suggests that menthol may also enhance nicotine's acute effect on cognition. AIMS AND METHODS: The purpose of this review is to suggest that the cognitive enhancing effects of menthol may be a potentially important neuropsychological mechanism that has yet to be examined. In this narrative review, we provide an overview of basic science studies examining neurobiological and cognitive effects of menthol and menthol cigarette smoking. We also review studies examining menthol essential oils among humans that indicate menthol alone has acute cognitive enhancing properties. Finally, we present factors influencing the rising prevalence of menthol cigarette use among smokers and the importance of this gap in the literature to improve public health and smoking cessation treatment. CONCLUSIONS: Despite the compelling evidence for menthol's acute cognitive enhancing and reinforcing effects, this mechanism for sustaining tobacco dependence and cigarette use has yet to be examined and validated among humans. On the basis of the basic science evidence for menthol's neurobiological effects on nicotinic receptors and neurotransmitters, perhaps clarifying menthol's effect on cognitive performance can help to elucidate the complicated literature examining menthol and tobacco dependence. IMPLICATIONS: Menthol cigarette use has continued to be a topic of debate among researchers and policy makers, because of its implications for understanding menthol's contribution to nicotine dependence and smoking persistence, as well as its continued use as a prevalent flavoring in tobacco and nicotine products in the United States and internationally. As international tobacco regulation policies have begun to target menthol cigarettes, research studies need to examine how flavoring additives, specifically menthol, may acutely influence neurobiological and cognitive functioning as a potential mechanism of sustained smoking behavior to develop more effective treatments.

Pregnant Smokers Receiving Opioid Agonist Therapy Have an Elevated Nicotine Metabolite Ratio: A Replication Study.

INTRODUCTION: Pregnant women exposed chronically to opioids smoked more cigarettes per day (CPD) and had a higher nicotine metabolite ratio (NMR), 3-hydroxycotinine/cotinine, a biomarker of nicotine metabolism and clearance, than those not receiving opioids. We examined CPD and NMR in a group of pregnant smokers, a quarter of whom were receiving opioid agonist therapy (OAT). AIMS AND METHODS: Pregnant smokers recruited to participate in a placebo-controlled trial of bupropion for smoking cessation provided a blood sample for measurement of NMR. RESULTS: Half (52.4%) of the 124 women with NMR data were African American. OAT-treated women (n = 34, 27.4%; 27 receiving methadone and 7 buprenorphine) were more likely to be white (79% vs. 30%, p < .001) and to have a lower mean PHQ-9 total score (2.91 [SD = 2.83] vs. 4.83 [SD = 3.82], p = .007). OAT-treated women reported smoking more CPD (9.50 [SD = 5.26] vs. 7.20 [SD = 3.65], p = .005) and had higher NMR (0.78 [SD = 0.36] vs. 0.56 [SD = 0.25], p = .001) than the non-OAT-treated group. In a linear regression analysis adjusting for race, depression severity, and CPD, NMR was greater in the OAT group (p = .025), among whom the daily methadone-equivalent dosage correlated with NMR (Spearman's ρ = 0.49, p = .003). CONCLUSIONS: Consistent with the findings of Oncken et al. (2019), we found that OAT smokers smoked more and had higher NMR than non-OAT smokers. As higher NMR is associated with a reduced likelihood of smoking cessation, the effects on NMR of both pregnancy and OAT could contribute to a lower smoking cessation rate in pregnant smokers receiving chronic opioid therapy. IMPLICATIONS: We replicated the finding that the NMR is significantly greater among pregnant smokers receiving OAT than those not receiving this treatment for opioid use disorder. Furthermore, we found that the dosage of the OAT was significantly associated with the NMR level. These findings may contribute to a poorer response to smoking cessation treatment in pregnant women treated with OAT, particularly those receiving high-dose therapy, and raise the question of whether novel approaches are needed to treat smoking in this subgroup of pregnant smokers.

Extended Nicotine Patch Treatment Among Smokers With and Without Comorbid Psychopathology.

INTRODUCTION: Individuals with psychiatric conditions smoke at higher rates than the general population and may need more intensive treatment to quit. We examined whether or not extended treatment with nicotine patch, combined with behavior counseling, would disproportionally benefit smokers with versus without a lifetime psychiatric condition. METHODS: We conducted a secondary analysis of data from an effectiveness trial of treatment with 12 counseling sessions (48 weeks) and 21-mg nicotine patch (8, 24, or 52 weeks) among 525 adult daily smokers. A structured clinical interview assessed past and current psychiatric disorders (major depression, generalized anxiety disorder, alcohol abuse and/or dependence, and substance abuse and/or dependence), as described in the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition). Abstinence was bioverified at week 52. Logistic regression evaluated the effect of the psychiatric status × treatment duration interaction on abstinence at week 52, covarying for sociodemographics, baseline psychological symptoms, and treatment adherence. RESULTS: At baseline, 115 (21.9%) participants were diagnosed with one or more psychiatric conditions. The psychiatric status × treatment duration interaction was significant for week 52 abstinence (p = .027). Abstinence rates between smokers with versus without a psychiatric condition in the 24-week treatment arm (9.3% vs. 31.5% abstinent) significantly differed from the 8-week treatment arm (18.8% vs. 22.3%), p = .017. Abstinence rates for smokers with (22.5%) versus without a psychiatric condition (19.7%) in the 52-week treatment arm did not differ from those in the 8-week arm. CONCLUSIONS: Targeted smoking cessation treatment, rather than extending treatment duration, may be especially warranted to optimize treatment for smokers with comorbid mood, anxiety, and substance use disorders. IMPLICATIONS: Individuals with psychiatric conditions smoke at higher rates and have greater difficulty quitting compared to those in the general population, but little is known about how to best optimize treatment for this high tobacco burden population. The present study found that cessation response to extended duration treatment with the transdermal nicotine patch did not differ for smokers with versus without comorbid anxiety, mood, and substance use disorders in a large-scale clinical effectiveness trial. Development of targeted behavioral treatments may be required to optimize abstinence outcomes for this high-risk population, rather than simply extending the duration of pharmacotherapy treatments.

Withdrawal Symptom, Treatment Mechanism, and/or Side Effect? Developing an Explicit Measurement Model for Smoking Cessation Research.

INTRODUCTION: Assessment of withdrawal symptoms, treatment mechanisms, and side effects is central to understanding and improving smoking cessation interventions. Though each domain is typically assessed separately with widely used questionnaires to separately assess each domain (eg, Minnesota Nicotine Withdrawal Scale = withdrawal; Questionnaire of Smoking Urges-Brief = craving; Positive and Negative Affect Schedule = affect; symptom checklist = side effects), there are substantial problems with this implicit "one questionnaire equals one construct" measurement model, including item overlap across questionnaires. This study sought to clarify the number and nature of constructs assessed during smoking cessation by developing an explicit measurement model. METHODS: Two subsamples were randomly created from 1246 smokers in a clinical trial. Exploratory and confirmatory factor analyses were conducted to identify and select a model that best represented the data. Measurement invariance was assessed to determine if the factors and their content were consistent prior to and during the quit. Improvement in construct overlap within this model was compared against the implicit measurement model using correlational analyses. RESULTS: A 5-factor measurement model composed of negative affect, somatic symptoms, sleep problems, positive affect, and craving fits the data well prior to and during quitting. All factor content except somatic symptoms was consistent over time. Correlational analyses indicated that the 5-factor model attenuated construct overlap compared to the implicit model. CONCLUSIONS: The models generated from data-driven approaches (eg, the 5-factor model) reduced overlap and better represented the constructs underlying these measures. This approach created distinct, stable constructs that span over measures of side effects and potential treatment mechanisms. IMPLICATIONS: This study demonstrated that measures assessing treatment mechanisms, withdrawal symptoms, and side effects contain problematic overlap that reduces the clarity of these key constructs. The use of data-driven approaches showed that these measures do not map on to their posited latent constructs (eg, the Minnesota Nicotine Withdrawal Scale does not yield a withdrawal factor). Rather, these measures form distinct, basic processes that may represent more meaningful constructs for future research on cessation and treatment. Assessments designed to individually examine these processes may improve the study of treatment mechanisms.

History and Correlates of Smoking Cessation Behaviors Among Smokers With Serious Mental Illness.

INTRODUCTION: Individuals with serious mental illness (SMI) smoke at rates two to three times greater than the general population but are less likely to receive treatment. Increasing our understanding of correlates of smoking cessation behaviors in this group can guide intervention development. AIMS AND METHODS: Baseline data from an ongoing trial involving smokers with SMI (N = 482) were used to describe smoking cessation behaviors (ie, quit attempts, quit motivation, and smoking cessation treatment) and correlates of these behaviors (ie, demographics, attitudinal and systems-related variables). RESULTS: Forty-three percent of the sample did not report making a quit attempt in the last year, but 44% reported making one to six quit attempts; 43% and 20%, respectively, reported wanting to quit within the next 6 months or the next 30 days. Sixty-one percent used a smoking cessation medication during their quit attempt, while 13% utilized counseling. More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking. Greater quit motivation was associated with lower carbon monoxide, minority race, benefits of cessation counseling, and importance of counseling within the clinic. A greater likelihood of using smoking cessation medications was associated with being female, smoking more cigarettes, and receiving smoking cessation advice. A greater likelihood of using smoking cessation counseling was associated with being male, greater academic achievement, and receiving smoking cessation advice. CONCLUSIONS: Many smokers with SMI are engaged in efforts to quit smoking. Measures of smoking cessation behavior are associated with tobacco use indicators, beliefs about smoking, race and gender, and receiving cessation advice. IMPLICATIONS: Consideration of factors related to cessation behaviors among smokers with SMI continues to be warranted, due to their high smoking rates compared to the general population. Increasing our understanding of these predictive characteristics can help promote higher engagement in evidence-based smoking cessation treatments among this subpopulation.

A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence.

OBJECTIVE: Continuing to smoke after a cancer diagnosis undermines prognosis. Yet few trials have tested Food and Drug Administration (FDA)-approved tobacco use medications in this population. Extended use varenicline may represent an effective treatment for cancer patients who smoke given barriers to cessation including a prolonged time line for relapse. METHODS: A placebo-controlled randomized trial tested 12 weeks of varenicline plus 12 weeks of placebo (standard [ST]) vs 24 weeks of varenicline (extended [ET]) with seven counseling sessions for treatment-seeking cancer patients who smoke (N = 207). Primary outcomes were 7-day biochemically confirmed abstinence at weeks 24 and 52. Treatment adherence and side effects, adverse and serious adverse events, and blood pressure were assessed. RESULTS: Point prevalence and continuous abstinence quit rates at weeks 24 and 52 were not significantly different across treatment arms (P's > 0.05). Adherence (43% of sample) significantly interacted with treatment arm for week 24 point prevalence (odds ratio [OR] = 2.31; 95% confidence interval [CI], 1.15-4.63; P = 0.02) and continuous (OR = 5.82; 95% CI, 2.66-12.71; P < 0.001) abstinence. For both outcomes, adherent participants who received ET reported higher abstinence (60.5% and 44.2%) vs ST (44.7% and 27.7%), but differences in quit rates between arms were not significant for nonadherent participants (ET: 9.7% and 4.8%; ST: 12.7% and 10.9%). There were no significant differences between treatment arms on side effects, adverse and serious adverse events, and rates of high blood pressure (P's > 0.05). CONCLUSIONS: Compared with ST, ET varenicline does not increase patient risk and increases smoking cessation rates among patients who adhere to treatment. Studies are needed to identify effective methods to increase medication adherence to treat patient tobacco use effectively.

Predictors of Varenicline Adherence Among Cancer Patients Treated for Tobacco Dependence and its Association With Smoking Cessation.

INTRODUCTION: The degree to which smokers adhere to pharmacotherapy predicts treatment success. The development of interventions to increase adherence requires identification of predictors of treatment adherence, particularly among specific clinical populations. METHODS: Using data from a 12-week open-label phase of a clinical trial of varenicline for tobacco dependence among cancer patients (N = 207), we examined: (1) the relationship between self-reported varenicline adherence and verified smoking cessation and (2) demographic and disease-related variables, and early changes in cognition, affect, withdrawal, the reinforcing effects of smoking, and medication side effects, as correlates of varenicline adherence. RESULTS: At the end of 12 weeks, 35% of the sample had quit smoking and 52% reported taking ≥80% of varenicline. Varenicline adherence was associated with cessation (p < .001): 58% of participants who were adherent had quit smoking versus 11% of those who were not. Participants who experienced early reductions in depressed mood and satisfaction from smoking and experienced an increase in the toxic effects of smoking, showed greater varenicline adherence (p < .05); the relationship between greater adherence and improved cognition, reduced craving, and reduced sleep problems and vomiting approached significance (p < .10). CONCLUSIONS: Among cancer patients treated for tobacco dependence with varenicline, adherence is associated with smoking cessation. Initial changes in depressed mood and the reinforcing effects of smoking are predictive of adherence. IMPLICATIONS: The benefits of varenicline for treating tobacco dependence among cancer patients may depend upon boosting adherence by addressing early signs of depression and reducing the reinforcing dimensions of cigarettes.

A Cluster-Randomized Clinical Trial Testing the Effectiveness of the Addressing Tobacco Through Organizational Change Model for Improving the Treatment of Tobacco Use in Community Mental Health Care: Preliminary Study Feasibility and Baseline Findings.

INTRODUCTION: People with mental illness are more likely to smoke and less likely to receive tobacco treatment than the general population. The Addressing Tobacco Through Organizational Change (ATTOC) approach supports organizational change to increase tobacco treatment in this population. We describe preliminary study feasibility and baseline behaviors and attitudes among clients and staff regarding tobacco treatment, and assesse correlates of treatment of smoking. METHODS: Preliminary accrual, engagement, and baseline data are reported from a cluster-randomized trial comparing ATTOC to usual care. Feasibility, thus far, was the rate of site and participant accrual and engagement (eg, participants remaining in the trial). Correlates of assessing smoking, advising cessation, and providing treatment were assessed. RESULTS: Site and participant accrual is 80% (8/10) and 86% (456/533), and engagement is 100% and 82%. "Staff asking about smoking" was reported by 63% of clients and 38% of staff; "staff advising cessation" was reported by 57% of clients and 46% of staff; staff report "assisting clients with any medication" at most 22% of the time, whereas at most 18% of clients report receiving a cessation medication; 59% of clients want tobacco treatment, but 36% of staff think that it is part of their job. "Staff assisting with medications" is related to more training, believing treating smoking is part of their job, and believing patients are concerned about smoking (ps < .05). CONCLUSIONS: This trial of training in tobacco treatment within mental health care is feasible thus far; self-reported rates of tobacco treatment are low and associated with clinician attitudes and barriers. IMPLICATIONS: Evaluation of ways to help address tobacco use treatment in community mental health care is feasible and needed, including the use of technical assistance and training guided by an organizational change approach.

Cancer-related disease factors and smoking cessation treatment: Analysis of an ongoing clinical trial.

OBJECTIVE: Smoking cessation treatment should be an important aspect of cancer care. In this study, we evaluated whether cancer-related disease factors adversely influence smoking cessation treatment. METHODS: Smokers with cancer (within 5 years of diagnosis, any tumor site) were recruited for an ongoing trial of varenicline for smoking cessation. Disease factors, assessed at baseline, included tumor site, cancer treatment, time since diagnosis, and health-related quality of life. Medication adherence was defined by 132 of 165 pills taken and counseling adherence was defined by 4 of 4 behavioral counseling sessions attended. Abstinence was bioverified at Week 12. Using logistic regression analysis, we assessed the relationship between disease factors and 12-week medication adherence, counseling adherence, and abstinence. RESULTS: Of 144 participants, 56% were medication adherent, 74% were counseling adherent, and 39% were abstinent. Health-related quality of life predicted medication adherence (OR: 1.08, 95% CI, 1.01-1.16, P = .019, d = 0.20) but not counseling adherence or 12-week abstinence. Tumor site, cancer treatment, and time since diagnosis did not predict any smoking cessation treatment outcomes. CONCLUSIONS: Cancer-related disease factors did not predict cancer survivors' engagement or success in smoking cessation treatment. Findings support National Comprehensive Cancer Network Clinical Practice guidelines that recommend smoking cessation treatment for all smokers with cancer, regardless of time since diagnosis.

The nature and consequences of cognitive deficits among tobacco smokers with HIV: a comparison to tobacco smokers without HIV.

HIV-infected smokers lose more years of life to tobacco-related disease than HIV. Since neurocognitive deficits are common among those with HIV and are associated with smoking persistence, these deficits may be a unique barrier to smoking cessation among HIV-infected smokers. Documenting unique differences in and correlates of cognition among HIV-infected smokers is a critical step towards developing a population-specific tobacco cessation treatment. We compared neurocognitive function between HIV-infected (n = 103) and HIV-uninfected smokers (n = 70), accounting for demographic and smoking-related variables. We also evaluated whether HIV-related health outcomes (e.g., CD4 count, viral load, depression ratings, quality of life [QoL]) and HAART adherence were associated with cognition. Participants completed neurocognitive tasks (N-back and Continuous Performance Task [CPT]) measuring working memory, attention, and processing speed, and intra-individual variability. Stepwise regression models were conducted and validated with resampling techniques. HIV-infected smokers performed worse than HIV-uninfected smokers on working memory, processing speed, and intra-individual variability (all p < 0.01). ROC analysis for the model including cognitive measures demonstrated 85% area under the curve, which indicates "good prediction" for distinguishing between HIV-infected and HIV-uninfected smokers. This was a significant improvement over the model including demographic and smoking-related variables only (p = 0.0003). Among HIV-infected smokers, neurocognitive performance was negatively associated with QoL and depression ratings. Smoking cessation interventions for HIV-infected smokers should consider cognitive neurorehabilitation as a potential strategy to decrease the likelihood of nicotine relapse and decrease tobacco-related morbidity in this population.