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Introduction Females, versus males, have shown a slower decline in smoking prevalence, greater smoking-related mortality and morbidity, and tend to have more difficulty achieving and maintaining abstinence. Identifying sex-specific risk factors is needed to improve outcomes. Though ovarian hormones have been evaluated for their role in smoking and relapse, measures tend to be static and infrequent, failing to capture the influence of increasing or decreasing levels. Aims and Methods The present study evaluated the effect of static and fluctuating levels of ovarian hormones (ie, progesterone, estradiol, and estrogen to progesterone [E/P] ratio) on stress reactivity, cigarette craving, and smoking during a laboratory relapse paradigm. Female participants (assigned female at birth) reporting daily cigarette smoking (N  = 91, ages 18–45) were recruited from the community. Participants provided daily salivary ovarian hormone levels leading up to a laboratory session, in which stress was induced and stress reactivity, cigarette craving, latency to smoke, and ad-libitum smoking were measured. Results Static levels of estradiol were associated with stress reactivity (β  = 0.28, SE = 0.13) and static E/P ratio was associated with smoking in the laboratory (HR = 1.4). Preceding 3-day changes in estradiol and E/P ratio, but neither static levels nor preceding 3-day changes in progesterone were associated with stress reactivity, cigarette craving, or smoking in a relapse paradigm. Conclusions Ovarian hormones are among several sex-specific factors involved in the complex neuroendocrine response to stress, and their interaction with other biological, social, and psychological factors in the real-world environment is not yet fully understood. Implications Findings of the present study provide novel information regarding the role of ovarian hormones among female participants who smoke daily in stress reactivity and smoking in the context of a laboratory relapse paradigm and highlight several avenues for future research. We found that same-day estradiol levels were associated with increased subjective stress reactivity and same-day estrogen to progesterone ratio was associated with increased likelihood of smoking in a relapse paradigm. Ovarian hormones are among several sex-specific factors contributing to the complex neuroendocrine response to stress, and their interaction with other biological, social, and psychological factors in the real-world environment is not yet fully understood. [ABSTRACT FROM AUTHOR]

Introduction This study sought to compare medication efficacy in participants with medical comorbidities who smoke in the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) trial, a double-blind, triple-dummy, placebo- and active-controlled randomized controlled trial. Aims and Methods Participants were from the U.S. cohort of the main trial and randomized (1:1:1:1) to varenicline, bupropion, nicotine replacement therapy (NRT) patch, or placebo for 12 weeks with follow-up through week 24. Medical comorbidity data were derived from the baseline medical screening questionnaire and categorized into four subgroups (cardiac, respiratory, vascular, and diabetes). Within each comorbidity, generalized linear mixed models were used to assess the association between treatment and continuous abstinence rates from weeks 9–12 to 9–24. Similar models were used to test the effect of number of comorbidities on abstinence. Results Varenicline resulted in the highest week 12 abstinence rates across all pharmacotherapies and compared to placebo in all comorbidity subgroups: Cardiac (40.0% vs. 3.6%; odds ratios [OR] = 23.3 [5.1–107.1]), respiratory (24.7% vs. 12.8%; OR = 2.2 [1.3–3.8]), vascular (29.1% vs. 10.4%; OR = 3.6 [2.3–5.7]), and diabetes (30.9% vs. 8.3%; OR = 6.5 [2.3–19.0]). This was maintained at week 24 for those with cardiac (23.3% vs. 1.8%; OR = 21.7 [2.7–178.2]), vascular (18.9% vs. 7.1%; OR = 3.1 [1.8–5.3]), and diabetes (20.6% vs. 4.2%; OR = 8.4 [2.1–33.7]) comorbidities. Treatment contrasts within some comorbidity subgroups revealed superior efficacy of varenicline over other pharmacotherapies. All pharmacotherapies increased the odds of abstinence regardless of number of comorbidities. Conclusions Varenicline is the most efficacious option for patients with manageable cardiac, respiratory, vascular, and diabetes conditions to quit smoking, supporting recent clinical practice guidelines that recommend varenicline as first-line pharmacotherapy. Bupropion and NRT demonstrated efficacy for some comorbidity subgroups. Implications This secondary analysis of the EAGLES trial demonstrated that varenicline is the most efficacious option for patients with cardiac, respiratory, vascular, and diabetes diagnoses to quit smoking. This demonstration of varenicline efficacy among individuals with comorbid medical conditions supports recent clinical practice guidelines that recommend varenicline as a first-line pharmacotherapy for smoking cessation. [ABSTRACT FROM AUTHOR]

Introduction Contingency management (CM) interventions deliver monetary reinforcers contingent upon biochemically verified abstinence from smoking. CM has been found to be effective, however, individual participant, analyses are warranted to further elucidate how individual-level behavior patterns vary during the intervention period, both within and across treatment groups. Aims and Methods This is a secondary analysis of a randomized controlled pilot trial of presurgical cancer patients who smoke (RCT N = 40). All participants were current everyday smokers and were enrolled in cessation counseling, offered nicotine replacement therapy, and submitted breath CO testing 3 times per week for 2–5 weeks. Participants randomized to CM received monetary reinforcers for breath CO ≤6 ppm on an escalating schedule of reinforcement with a reset for positive samples. Sufficient breath CO data exist for 28 participants (CM = 14; monitoring only [MO] = 14). Effect size was calculated for differences in negative CO tests. Time to first negative test was tested using survival analysis. Fisher's exact test was used to assess relapse. Results The CM group achieved abstinence more quickly (p <.05), had a lower percentage of positive tests (h = 0.80), and experienced fewer lapses following abstinence (p =.00). While 11 of 14 participants in the CM group achieved and sustained abstinence by their third breath test, this was only true for 2 of the 14 MO participants. Conclusions Those in CM achieved abstinence quicker and with fewer lapses than those engaged in MO speaking to the efficacy of the schedule of financial reinforcement. This is particularly important within presurgical populations given the potential benefits to postoperative cardiovascular and wound infection risk. Implications While the efficacy of CM as an intervention is well established, this secondary analysis provides insight into the individual behavior patterns underlying successful abstinence. Those assigned to CM were not only more likely to achieve abstinence, but did so more quickly and with fewer instances of relapse. This is of particular importance to those scheduled for surgery where achieving abstinence as early as possible impacts on the risk of postoperative complications. CM interventions may be particularly well suited for critical windows in which timely and sustained abstinence is advantageous. [ABSTRACT FROM AUTHOR]

Introduction: Fluctuations in ovarian hormones have been associated with changes in cigarette smoking behavior, which can be measured through both serum or less invasive salivary procedures. The primary aim of this exploratory study is to characterize the progesterone profiles of salivary progesterone measurements and to compare that with the profiles estimated from a previously measured serum sample.Aims and Methods: Nontreatment-seeking, cigarette smoking women (n = 82; ages 18-45 years) provided daily salivary hormone samples every morning for 14 consecutive days. Time-dependent random effects functions were used to approximate daily salivary progesterone (ng/mL) levels over the course of a standardized menstrual cycle. Serum measures of progesterone from a previous study of female cigarette smokers were examined for consistency with established profiles and compared with the salivary profile using the same methodology.Results: The salivary model fit exhibits relative stability during the follicular phase and a clear unimodal peak during the luteal phase. Parameter estimates from the non-linear function show correspondence to serum data. Although the profiles estimated from salivary and serum data agree in functional form, we observed larger between-subject heterogeneity both in the follicular level and the peak luteal level in salivary measures.Conclusions: The pattern of salivary and serum progesterone measured across the menstrual cycle is similar in form, which is noteworthy given that the saliva and serum samples were drawn from independent sample of female smokers. Inter- and intra-individual variation in salivary measures may be greater than in serum measures.Implications: Measuring progesterone level variation across the menstrual cycle via saliva samples has several benefits relative to serum sampling methods in that they are easily obtained, noninvasive, and low-cost. Inter- and intra-individual variation in measurements may be greater than those in serum measurements. However, the functional form of the salivary progesterone profile is isomorphic to serum progesterone. [ABSTRACT FROM AUTHOR]

Introduction: The purpose of this study was to evaluate a pilot preoperative contingency management (CM) intervention for smoking abstinence.Aims and Methods: This multisite pilot study was conducted at two cancer center-based tobacco treatment programs. Participants who were smoking, diagnosed with or suspected to have any type of operable cancer, and had a surgical procedure scheduled in the next 10 days to 5 weeks (N = 40) were randomized to receive standard care plus monitoring only (MO) or CM prior to surgery. All patients received breath carbon monoxide (CO) tests 3 times per week, nicotine patches, and counseling. The CM group also earned payments for self-reported smoking abstinence confirmed by CO breath test ≤6 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Seven-day point prevalence abstinence rates on the day of surgery and at 3-month follow-up were compared between groups using repeated measures log-linear regression models utilizing generalized estimating equations. Participants lost to follow-up are assumed to have returned to smoking.Results: The sample was 50% female and 75% White. In covariate adjusted models, patients in the CM group had a greater probability of reported abstinence. On the day of surgery (end of treatment), 52% of CM patients were abstinent compared with 16% of patients in MO (risk ratio = 3.2 [1.1-9.3]; p = .03). At the 3-month follow-up, 43% of CM patients were abstinent compared with 5% in MO (risk ratio = 8.4 [1.5-48.3]; p = .02).Conclusions: Providing monetary incentives contingent on abstinence prior to cancer surgery may produce significant improvements in smoking abstinence rates relative to breath CO MO.Implications: In this pilot preoperative CM intervention for smoking abstinence, patients receiving a CM intervention prior to cancer surgery had a greater probability of smoking abstinence at the end of treatment compared with a breath MO group (52% vs. 16%, respectively). Thus, providing monetary incentives contingent on abstinence may produce significant improvements in smoking abstinence rates prior to cancer surgery relative to breath CO monitoring. [ABSTRACT FROM AUTHOR]

Introduction: The co-use of cannabis and alcohol among tobacco-using youth is common. Alcohol co-use is associated with worse tobacco cessation outcomes, but results are mixed regarding the impact of cannabis on tobacco outcomes and if co-use leads to increased use of non-treated substances. This secondary analysis from a youth smoking cessation trial aimed to (1) evaluate the impact of cannabis or alcohol co-use on smoking cessation, (2) examine changes in co-use during the trial, and (3) explore secondary effects of varenicline on co-use.Methods: The parent study was a 12-week, randomized clinical trial of varenicline for smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White). Daily cigarette, cannabis, and alcohol use data were collected via daily diaries during treatment and Timeline Follow-back for 14 weeks post-treatment.Results: Baseline cannabis co-users (68%) had double the odds of continued cigarette smoking throughout the trial compared with noncannabis users, which was pronounced in males and frequent cannabis users. Continued smoking during treatment was associated with higher probability of concurrent cannabis use. Baseline alcohol co-users (80%) did not have worse smoking outcomes compared with nonalcohol users, but continued smoking was associated with higher probability of concurrent drinking. Varenicline did not affect co-use.Conclusions: Inconsistent with prior literature, results showed that alcohol co-users did not differ in smoking cessation, whereas cannabis co-users had poorer cessation outcomes. Youth tobacco treatment would benefit from added focus on substance co-use, particularly cannabis, but may need to be tailored appropriately to promote cessation.Implications: Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation. [ABSTRACT FROM AUTHOR]

Introduction: Some evidence suggests that female smokers may show more context-dependent smoking and that males may show more stereotyped smoking (regardless of stress or cue exposure). The goal of this study was to characterize sex differences in response to stressful and smoking cues ecologically presented in daily life and variability in day-to-day smoking behavior.Methods: Adult smokers (N = 177) provided ratings of mood and cigarette craving before and after stress and smoking cues were presented four times daily for 14 days via a mobile device. Linear mixed models tested whether (1) female smokers exhibited greater reactivity to stressful cues than male smokers; (2) pre-cue negative affect increased reactivity to smoking cues more in female smokers than male smokers; (3) across both sexes, greater reactivity to stressful and smoking cues correlated with greater quantity of smoking within a day; and (4) female smokers exhibited greater variability in cigarettes per day (CPD) relative to males.Results: Relative to male smokers, female smokers reported greater negative affect, stress, and craving in response to stressful cues, but not smoking cues, after accounting for time since last cigarette and pre-cue responding. No sex differences in CPD or variability in CPD were detected. Days with higher subjective reactivity to cues were not associated with increased smoking, in either males or females.Conclusions: Sex differences were observed in response to stress but not smoking cues in the natural environment of regular cigarette smokers. Further research is necessary to evaluate whether stress reactivity in female smokers is associated with reduced latency to smoke following stress exposure in daily life.Implications: This study provides naturalistic evidence that female smokers may not be more reactive to smoking cues than males, but experience heightened stress and craving following stress exposure. There was no evidence to support the hypothesis that amount smoked per day varied more for females, relative to males, as a result of more context-driven smoking for females. [ABSTRACT FROM AUTHOR]

Introduction: Preclinical and human laboratory research suggests that (a) progesterone may decrease drug reward, craving, and smoking behavior, and (b) estradiol may enhance drug reward and smoking behavior. A modest majority of treatment research examining the relationship between menstrual cycle phase and outcomes suggests that the luteal menstrual phase, with its uniquely higher progesterone levels, is associated with better cessation outcomes. However, no studies to date have examined the effects of naturally occurring variation in progesterone and estradiol levels on medication-assisted smoking cessation. The present study sought to fill this notable gap in the treatment literature. Methods: Weekly plasma progesterone and estradiol levels were obtained from nicotine-dependent female smokers enrolled in a 4-week cessation trial. Participants (N = 108) were randomized to receive a 4-week course of either varenicline (VAR) tablets and placebo patches or placebo tablets and nicotine patches. Plasma samples were obtained 1 week before their cessation attempt and weekly during medication administration. Abstinence was assessed weekly. Results: Weekly hormone data replicated commonly observed menstrual cycle patterns of progesterone and estradiol levels. Importantly, increases in progesterone level were associated with a 23% increase in the odds for being abstinent within each week of treatment. This effect was driven primarily by nicotine patch-treated versus VAR-treated females. Conclusions: This study was the first to identify an association between progesterone level (increasing) and abstinence outcomes in free-cycling women smokers who participated in a medication-based treatment. Furthermore, the potential benefits of progesterone may vary across different pharmacotherapies. Implications of these findings for smoking cessation intervention are discussed. [ABSTRACT FROM AUTHOR]

Background. Modified low-density lipoprotein (LDL) immune complexes (IC) have proinflammatory properties and play a role in albuminuria development. Methods. We measured oxidized LDL (oxLDL) and advanced glycation end-product (AGE)–LDL in IC isolated from sera of Type 1 diabetic subjects followed for 14–20 years and studied their association with abnormal albuminuria. Patients with albumin excretion rates (AER) <40 mg/24 h at baseline and follow-up (n = 302) were deemed resistant to developing abnormal albuminuria. Patients with AER <40 mg/24 h at baseline whose AER levels progressed to >40 mg/24 h were considered prone to abnormal albuminuria (n = 185), those who progress to AER >299 mg/24 h were considered as having macroalbuminuria (n = 57). The odds of developing abnormal albuminuria were estimated by logistic regression based on natural log-transformed levels of oxLDL and AGE–LDL in IC and stratified by baseline AER decile. Results. OxLDL and AGE–LDL were significantly higher in IC isolated from patients progressing to abnormal albuminuria. In unadjusted conditional logistic analysis, an increase of 1 SD in oxLDL and AGE–LDL levels in IC significantly increased the odds ratio (OR) for development of macroalbuminuria, respectively, by a factor of 2.5 and 1.8 (P < 0.001, P = 0.008). The increased odds of developing macroalbuminuria remained significant when adjusted for treatment group, diabetes duration, retinopathy, baseline hemoglobin A1c and LDL (OR = 2.5 and 1.8, respectively, P < 0.01). Conclusion. Higher levels of oxLDL and AGE–LDL in circulating IC were associated with increased odds to develop abnormal albuminuria. [ABSTRACT FROM PUBLISHER]