Outcomes after chimeric antigen receptor T-cell therapy across large B-cell lymphoma subtypes.

Not available.

Biobehavioral and affective stress responses during nicotine withdrawal: Influence of regular cannabis co-use.

BACKGROUND: Co-use of cannabis is increasing in nicotine users and presents additional challenges in addressing nicotine dependence. This study examined the links between regular co-use of cannabis and nicotine with biobehavioral and affective changes in response to stress during nicotine withdrawal and ad libitum use. METHODS: Participants (N = 79) who regularly used nicotine-only, cannabis-only, both substances, or neither substance were invited to attend two laboratory stress assessment sessions. For nicotine users, one session occurred during ad libitum nicotine use and one occurred after abstinence from nicotine. During the stress sessions, participants provided saliva samples for cortisol assay and completed measures of subjective states. Cardiovascular measures were collected during resting baseline, exposure to acute stressors, and a recovery rest period. RESULTS: Nicotine-only users had higher average cortisol levels in the second lab session (nicotine withdrawal) relative to the first lab session (ad libitum nicotine use). Compared to nicotine non-users, nicotine users reported less positive affect and exhibited attenuated cortisol and systolic blood pressure (BP) stress responses. Cannabis users exhibited exaggerated diastolic BP responses to stress compared to cannabis non-users, and co-users of nicotine and cannabis had higher levels of cannabis craving than cannabis-only users (p < .01). CONCLUSIONS: This study partially replicated earlier findings on the effects of chronic nicotine use and provided novel results regarding the influence of cannabis co-use on physiological and affective responses to stress in nicotine users during nicotine withdrawal.

Delay discounting demonstrates lower impulsivity linked to a higher likelihood of succeeding at smoking cessation.

Sixty-eight percent of smokers want to quit, but only one in 10 are successful at smoking cessation. Recently, impulsivity has been studied in relation to smoking cessation with measures like the delay discounting task (DDT). We aimed to build on the robust literature that has already revealed the association between impulsivity and smoking cessation, as well as look at the differences between sexes for which there is conflicting evidence. We hypothesized that lower impulsivity would be positively associated with cessation success. In the parent cessation trial, participants were randomized to 12 weeks of progesterone or placebo. Participants were asked to quit smoking, and their smoking status was monitored via expired carbon monoxide throughout the study. Participants completed a DDT at screening, week 4, and week 8 using the 27-item Monetary Choice Questionnaire, where participants decided between a small immediate reward or a larger delayed reward (LDR). The effective delay 50 (ED50), which is the delay at which the LDR loses half its value, was analyzed. To estimate the association between ED50 and cessation, a logistic mixed model with a participant random intercept was fit, controlling for study week, randomization, sex, and age. For the 181 participants, a doubling of the ED50 was associated with an 18% increase in the odds of tobacco cessation (95% confidence interval: 0.2-38% increase; p=0.05). In agreement with our hypothesis, lower impulsivity correlated to greater tobacco cessation success. Our study also showed no evidence of sex differences in the association between ED50 and smoking cessation.

Bibliometric Approach to Evaluating the Impact of a Building Interdisciplinary Research Careers in Women's Health K12 Research Career Development Program.

Background: Mentored research career development programs are excellent training opportunities for junior faculty/early-stage investigators to transition into independent research careers. However, there is limited evidence that provides guidance on best practices for measuring the impact and reach of these programs, both for individual Scholars and the program as a whole. This article evaluates both the individual and overall impact of the Building Interdisciplinary Research Careers in Women's Health (BIRCWH) National Institutes of Health research career development award at the University of Minnesota. Materials and Methods: BIRCWH Scholars (n = 16) and a comparison group (n = 17) were evaluated on traditional metrics (e.g., publications, grant funding) in addition to bibliometrics (e.g., network growth, interdisciplinary collaborations, international reach, policy impact). Results: Traditional metric findings showed that BIRCWH Scholars had significantly more publications from pre- to post-BIRCWH experience than the comparison group and more grant funding. Bibliometric findings showed exponential network growth, interdisciplinary collaborations, international citations, and policy impact from pre- to post-BIRCWH Scholar experience. Conclusion: Findings from this evaluation have potential important implications. At the Scholar level, the results can be used to provide evidence of research impact in materials developed for merit review and promotion as well as in job and research grant applications. At the program level, the results can be used at the institutional level to gain broad administrative support and leverage additional funds for program activities and for evidence of program success for continuation funding from federal agencies.

Effects of regular cannabis and nicotine use on acute stress responses: chronic nicotine, but not cannabis use, is associated with blunted adrenocortical and cardiovascular responses to stress.

RATIONALE: Cannabis is one of the most prevalent substances used by tobacco smokers and, in light of the growing list of states and territories legalizing cannabis, it is expected that co-use of cannabis and nicotine will escalate significantly and will lead to continuing challenges with tobacco use. OBJECTIVES: This study was conducted to examine the interactive effects of chronic cannabis and nicotine use on adrenocortical, cardiovascular, and psychological responses to stress and to explore sex differences in these effects. METHODS: Participants (N = 231) included cannabis-only users, nicotine-only users, co-users of both substances, and a non/light-user comparison group. After attending a medical screening session, participants completed a laboratory stress session during which they completed measures of subjective states, cardiovascular responses, and salivary cortisol during baseline (rest) and after exposure to acute stress challenges. RESULTS: Nicotine use, but not cannabis use, was associated with blunted cortisol and cardiovascular responses to stress across both men and women. Men exhibited larger cortisol responses to stress than women. Co-users had significantly larger stress-related increases in cannabis craving than cannabis-only users. Cannabis users reported smaller increases in anxiety during stress than cannabis non/light-users, and both male nicotine-only users and male cannabis-only users experienced significantly smaller increases in stress than their non/light-user control counterparts. CONCLUSIONS: This study replicates and extends earlier research on the impacts of sex and nicotine use on stress responses, and it provides novel findings suggesting that when co-used with nicotine, cannabis use may not confer additional alterations to physiological nor subjective responses to stress. Co-use, however, was associated with enhanced stress-related craving for cannabis.

Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial.

INTRODUCTION: Menstrual phase influences cigarette smoking-related outcomes. Telephone-based cessation programs (e.g., quitlines) may incorporate the role of the menstrual cycle in an effort to tailor interventions for women. PURPOSE: The goal of this preliminary randomized clinical trial was to examine the feasibility and acceptability of timing quit date to menstrual phase in women in a quitline setting. METHODS: We recruited treatment-seeking women with regular menstrual cycles between the ages of 18-40 years. Participants were randomized to the follicular phase (FP; quit date set 6-8 days post onset of menses) or standard of care (SC; no menstrual timing of quit date). All participants received four weeks of nicotine replacement therapy transdermal patch concurrent with six weeks of telephone-based counseling. We explored self-reported and biochemically-verified seven-day point prevalence abstinence at end-of-treatment and three-month follow-up. RESULTS: Participants (n = 119; FP: n = 58, SC: n = 61) were, on average, 33.4 years old and smoked 13.6 cigarettes/day. The median number of counseling sessions completed was 6 out of 6 available, and 66% of participants completed the intervention. Over 90% of participants reported they would recommend this study to friends/family. Cessation rates did not significantly vary by randomization. CONCLUSIONS: Results of this preliminary trial indicate that timing quit date to FP is an acceptable and feasible approach to address smoking cessation in women of reproductive age. While we observed similar smoking cessation rates between groups, this preliminary study was not fully powered to determine efficacy. Therefore, the feasibility and acceptability results indicate that a fully-powered efficacy trial is warranted.

Knowledge, Attitudes, and Beliefs about Relapse Prevention Research Involving Bupropion among Current and Former Pregnant Individuals Who Smoke.

Introduction: While many individuals quit smoking during pregnancy, most relapse within one year postpartum. Research into methods to decrease smoking relapse postpartum has been hampered by difficulties with recruitment. Method: We conducted individual interviews with pregnant women (N = 22) who were interested in quitting smoking while pregnant about their attitudes regarding smoking and quitting during pregnancy, clinical trial participation, and smoking cessation medication use. Results: Participants were aware of the risks of smoking while pregnant. Many wanted to quit smoking before delivery. Few used empirically supported treatments to quit. While research was viewed positively, interest in taking on new commitments postpartum and taking a medication to prevent relapse was low. Medication concerns were evident among most participants, especially among those planning to breastfeed. Further, several women noted medication was unnecessary, as they did not believe they would relapse postpartum. Financial incentives, childcare, and fewer and/or remote visits were identified as facilitators to participating in research. However, these factors did not outweigh women's concerns about medication use and time commitments. Conclusions: Women are aware that quitting smoking during pregnancy and remaining smoke-free postpartum are important. However, beliefs that personal relapse risk is low and that medications are dangerous reduced enthusiasm for taking medication for postpartum relapse prevention. Future medication trials should educate women about the high likelihood of relapse, prepare to answer detailed questions about risks of cessation medications, and connect with participants' clinicians. For new mothers, studies conducted remotely with few scheduled appointments would reduce barriers to participation.

Tobacco withdrawal increases junk food intake: The role of the endogenous opioid system.

BACKGROUND: The aims of this study were to 1) determine whether acute nicotine withdrawal increases the intake of junk food (high in salt, fat, and sugar) and 2) assess whether the endogenous opioid system is involved in junk food intake during nicotine withdrawal using naltrexone as a pharmacological probe. METHODS: Smokers were randomly assigned to 24-hr withdrawal from tobacco products (n = 42) or smoking ad libitum (n = 34). A non-smoking group (n = 29) was included. Participants completed two laboratory sessions where a placebo or 50 mg of naltrexone was administered. At the end of each session, participants were given a tray of snack items that differed in high to low energy density and dimensions of salty, sweet, and fat. Self-reported mood and withdrawal measures were collected immediately before the snacks were offered. Generalized linear and logistic models were used to assess the effects of acute smoking withdrawal, drug, and sex on the intake of snack items and self-reported measures. RESULTS: Choice and consumption of food items were impacted by smoking condition (withdrawal > ad lib smoking and non-smokers; p < .05), the opioid blockade (naltrexone < placebo; p < .05), and sex (male > female; p < .05). The effects were evidenced in high sweet and high fat foods. No differences were found in low sweet and fat foods. CONCLUSIONS: These findings extend earlier studies indicating impact of tobacco use on appetite, and identify the regulatory influence of the endogenous opioid system on appetite during nicotine withdrawal.

Bupropion for postpartum smoking relapse: A remote protocol for a two-arm, double-blind, placebo-controlled randomized clinical trial.

Cigarette smoking among postpartum women remains a significant public health problem despite known health risks to women and their newborns. It is estimated that over 50% of women quit smoking during pregnancy but 90% relapse by one year. Safe and effective postpartum relapse prevention strategies are urgently needed. In an attempt to address this deficit, we will investigate the efficacy of bupropion vs. placebo as a smoking relapse prevention aid in postpartum women. The objective of this paper is to detail an approach to investigate bupropion's efficacy for preventing postpartum smoking relapse among women who quit smoking during pregnancy. Specifically, we designed a two-arm, double-blind, placebo-controlled randomized trial testing the efficacy of bupropion vs. placebo as a relapse prevention tool. Mothers of healthy infants who quit smoking while pregnant will be stratified based on current or past history of major depressive disorder or persistent depressive disorder and randomized to receive either active (bupropion XL 300 mg/day) or placebo medication for 12 weeks. To respond to safety concerns associated with participant and staff exposure to COVID-19, we revised our original protocol and present procedures which allow our trial to be conducted entirely remotely. Primary and secondary outcomes will be assessed at weeks 12, 24, 36 and 52 post-randomization. The primary outcome is 7-day point prevalence abstinence at 24 weeks. Results of this work have the potential to positively impact women and their children by promoting lifelong cessation, eliminating secondhand smoke exposure, and modelling of abstinence to children.

Early life adversity and appetite hormones: The effects of smoking status, nicotine withdrawal, and relapse on ghrelin and peptide YY during smoking cessation.

There is evidence suggesting that ghrelin and peptide YY (PYY) modulate stress responses and the rewarding effects of drugs, although no research has examined the impact of exposure to early life stress on these hormones in smokers nor during smoking cessation. This study examined the relationships between early life adversity (ELA) and circulating ghrelin and PYY during ad libitum smoking and early withdrawal in tobacco smokers (N = 98) who were interested in cessation. We also included a comparison group of nonsmokers (N = 36). We prospectively compared levels of hormones between smokers who were successful in quitting within a 2-week period, smokers who relapsed during that period, and nonsmokers. Results showed that ELA was positively associated with elevated ghrelin in nonsmokers. Among those reporting no ELA, successful quitters had higher ghrelin levels than nonsmokers during ad libitum smoking, while relapsers had higher ghrelin levels than nonsmokers during withdrawal. In addition, having no ELA was associated with a decline in ghrelin from the ad libitum to abstinence sessions in successful quitters; this withdrawal-related decline was not found in relapsers. Although effects of ELA, smoking group, and time on PYY were not significant, greater PYY was associated with reduced urges to smoke during withdrawal. These findings suggest the importance of considering changes in appetite-related hormones in individuals who are dependent on tobacco. This research provides additional indications for effects of ELA on appetite-stimulating hormones.

Blunted opioid regulation of the HPA stress response during nicotine withdrawal: therapeutic implications.

Endogenous opioids regulate pain, drug reward, and stress responses. We have previously shown reduced hypothalamic-pituitary-adrenal (HPA) responses to psychological stress and to opioid blockade among dependent smokers. In this study, we examined the extent to which biologically confirmed nicotine withdrawal alters endogenous opioid regulation of HPA axis functioning during rest and in response to acute stress. Smokers were randomly assigned to one of two conditions; 24 h withdrawal from all nicotine-containing products (n = 62) or smoking ad libitum (n = 44). A nonsmoking comparison group (n = 43) was also included. Participants (85 males and 64 females) completed two acute stress sessions during which a placebo or 50 mg of naltrexone (opioid antagonist) were administered using a double-blind design. Blood and saliva samples (assayed for cortisol and adrenocorticotropic hormone, i.e. ACTH) and mood measures were obtained during a resting absorption period, after acute stress (public speaking, mental arithmetic, and cold pressor tasks), and during an extended recovery period. Results indicated that opioid blockade (naltrexone) was associated with increased ACTH and cortisol responses to stress, and tobacco withdrawal was associated with blunted hormonal responses. A pattern of sex differences also emerged, with women exhibiting reduced ACTH responses to stress and higher ACTH and plasma cortisol responses to opioid blockade. These results indicated that compared to ad libitum smoking, nicotine withdrawal is associated with blunted opioid modulation of the HPA axis. Sex may modulate these effects. Blunted endogenous opioid regulation may underlie an incentive process that reinforces smoking behavior and may warrant therapeutic attention.

Effect of exogenous progesterone administration on smoking topography.

INTRODUCTION: Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect. METHODS: This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes. RESULTS: Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes. CONCLUSIONS: Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.

Improving Self-Care Management in Low-Income Latinos With Type 2 Diabetes Using Peer-Led U.S. Conversation Maps: A Quality Improvement Project in a Free Clinic.

A culturally sensitive Healthy Interactions Conversations Maps program was implemented for teaching diabetes self-management education (DSME) to Latinos with type 2 diabetes using peer-led educators in a community health center. Patients were invited to participate in a group care setting to improve access to providers and DSME. Goals were to improve diabetes distress, self-efficacy, and glycemic control as measured by A1C. Significant improvements were found for mean diabetes self-efficacy scores from before (2.53 ± 0.59) to after (2.91 ± 0.50) DSME (P <0.001). Mean A1C decreased significantly from before (9.51 ± 1.72%) to after (8.79 ± 1.68%) DSME (P = 0.043) at the end of the 6-month intervention. Thus, this program was found to be a useful tool for providing DSME in community health clinics serving low-income Latinos.

Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Protocol of a pilot randomized controlled trial.

BACKGROUND: Compared to men, women have unique barriers to smoking cessation and are less likely to utilize quitline services. While current clinical recommendations have called for sex/gender-specific smoking cessation protocols, quitlines have not been expanded protocols to address the unique needs of women. Menstrual cycles (and/or ovarian hormones) influence quit outcomes in women. This paper presents the study design and protocol for a randomized control trial (Project Phase) designed to test the feasibility and acceptability of utilizing menstrual cycle timing to improve quit outcomes in women of reproductive age. METHODS/DESIGN: Participants include treatment-seeking women (n = 116), between the ages of 18-40 with regular and naturally-occurring menstrual cycles. Eligible participants are randomized to either the mid-Follicular Phase (FP) or Standard Care (SC-control) group. Counseling includes six weekly telephone sessions with four weeks of nicotine replacement therapy. The timing and frequency of sessions is identical to both conditions, with the exception of the quit day (week 3 of counseling). In addition to providing education on menstrual cycle and quitting, quit day for FP participants is set within 6-8 days post onset of menses; the SC group quit day is set for Week 3 of counseling regardless of their menstrual cycle phase. Dried blood spots will be used to bioverify menstrual cycle phase and smoking status. DISCUSSION: If feasible and acceptable, our behavioral counseling intervention that times the quit day to the mid-follicular phase of the menstrual may increase quit outcomes among women of reproductive age and has potential for dissemination across quitlines nationally.

Cannabis use and stressful life events during the perinatal period: cross-sectional results from Pregnancy Risk Assessment Monitoring System (PRAMS) data, 2016.

AIMS: We aimed to determine the association between stressful life events (SLEs) in the year prior to childbirth with (1) pre-pregnancy cannabis use, (2) cessation of cannabis use during pregnancy and (3) postpartum relapse to cannabis use. DESIGN: We used data from the Pregnancy Risk Assessment Monitoring System (PRAMS) 2016, a cross-sectional, population-based surveillance system. SETTING: Mailed and telephone surveys conducted in five states-Alaska, Colorado, Maine, Michigan and Washington-in the United States. PARTICIPANTS: Women (n = 6061) who delivered a live infant within the last 6 months and had data on cannabis use. MEASUREMENTS: Self-reported data included SLEs (yes/no response for 14 individual events in the 12 months prior to childbirth) and cannabis use [yes/no prior to pregnancy, during pregnancy, and at the time of the survey (approximately 2-6 months postpartum)]. The associations between SLEs and cannabis use (primary outcomes) were examined in logistic regression models adjusted for maternal demographics (e.g. age, race, education), geography (i.e. state of residence) and cigarette smoking. FINDINGS: Pre-pregnancy, 16.4% (997/6061) of respondents endorsed using cannabis, with 36.4% (363/997) continuing cannabis use during pregnancy. Among the 63.6% (634/997) who did not report use during pregnancy, 23.2% (147/634) relapsed to cannabis use during the postpartum. Nine of the 14 possible SLEs were associated with increased odds of pre-pregnancy cannabis use [e.g. husband/partner or mother went to jail, adjusted odds ratio (aOR) = 2.16, 95% confidence interval (CI) = 1.30-3.62] and four were associated with increased odds of continued cannabis use during pregnancy (e.g. husband/partner lost job, aOR = 2.19, 95% CI = 1.21-3.96). The odds of postpartum relapse to cannabis were significantly associated with two SLEs (husband/partner said they did not want pregnancy, aOR = 2.86, CI = 1.10-7.72; husband/partner or mother went to jail, aOR = 0.37, 95% CI = 0.13-1.00). CONCLUSIONS: Stressful life events during the year prior to childbirth appear to be linked to greater odds of women's cannabis use during the perinatal period, especially during pre-pregnancy.

Exercise for Smoking Cessation in Postmenopausal Women: A Randomized, Controlled Trial.

BACKGROUND: Postmenopausal smokers have difficulty quitting smoking and experience considerable weight gain with smoking cessation. We examined whether adjunctive smoking treatment with exercise, compared to a relaxation control condition, could improve cigarette abstinence, decrease cigarettes smoked per day (CPD), and ameliorate changes in body mass index (BMI) in postmenopausal smokers. METHODS: Women (N = 301) signed informed consent and were randomized to treatment at two sites (Universities of Connecticut and Minnesota). We randomized groups of participants to a comprehensive group treatment program that included 12 weeks of varenicline and either a moderate exercise or relaxation component for 6 months. Participants were followed for a year after medication treatment. RESULTS: Overall, 17.3% of patients reported carbon monoxide-verified continuous abstinence for the 9- to 12-week period, and 11.6% reported prolonged abstinence at 1 year, with no significant differences between treatment conditions. CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment. The Exercise condition reported smoking fewer CPD over time, and that advantage widened over time. In terms of BMI, significant effects for time in weeks, and for the interaction of Week × Treatment condition, reflected gradually increasing BMI in these women over time, but with the increase in BMI slower in the Exercise condition. CONCLUSIONS: Exercise, compared to relaxation, was associated with a reduced BMI and CPD in postmenopausal women, but did not increase end of treatment or prolonged abstinence. Further research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women. IMPLICATIONS: This study adds to the literature on the effectiveness of a moderate exercise intervention compared to a relaxation control condition as an adjunctive treatment for smoking cessation in postmenopausal women. Our exercise program did not increase end of treatment or prolonged abstinence rates in postmenopausal women; however, there was a beneficial effect on smoking reduction and reduced body mass index. Additional research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.

Response to nicotine following overnight smoking abstinence during short-term progesterone treatment in women.

Preclinical and clinical literature suggest that sex hormones impact tobacco use behaviors in women. The goal of this double-blind crossover laboratory study was to examine the effect of oral exogenous progesterone (200 mg twice per day) versus placebo on nicotine response using measures of motor speed and cognitive function in women following overnight smoking abstinence. We hypothesized that increased progesterone would blunt the nicotine response whereby producing less change in motor speed and cognition in response to nicotine exposure. Female smokers, age 18-35, were randomized to participate in two 9-day crossover testing weeks. Participants completed a lab session following overnight abstinence where they were administered nicotine nasal spray and asked to complete measures of immediate memory (IMT), delayed memory (DMT), word recall (WR), and finger tapping speed (FT). After the first 9-day testing week, participants resumed smoking and returned the following month to complete the identical lab session in the crossover condition. Forty-seven women were included in this analysis (n = 47). We found no differences in the magnitude of response for IMT, DMT, and WR between conditions. For FT, women had a blunted response to nicotine during the placebo condition. When examining the association between hormone levels and relative performance, we found increases in DMT, WR, and FT but decreases in IMT during the progesterone condition. We observed differences between progesterone versus placebo in relative change in some measures of nicotine response following overnight abstinence. Future studies are needed to further characterize this response. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Smoking-related symptomatology in pregnant smokers during ad libitum smoking and following overnight smoking abstinence.

OBJECTIVE: Current literature suggests there may be a relationship between sex hormones, which dramatically increase during pregnancy, and nicotine use behaviors. We hypothesized that higher progesterone and progesterone:estradiol ratio (P/E2) would be associated with less smoking-related symptomatology (SRS), better mood and fewer cigarettes smoked per day (CPD) during ad libitum smoking and following overnight abstinence in pregnant women. Associations between SRS, mood, smoking behavior and sex hormones were estimated using multiple linear regression with adjustment for CPD and pregnancy trimester. RESULTS: There were 35 second trimester and 42 third trimester participants. Participants mean age was 26.2 (SD: 4.1), they smoked 11.3 CPD (SD: 4.4) and the mean nicotine dependence score was 4.94 (SD: 1.98). There were no statistically significant associations between progesterone levels, estradiol levels, or the P/E2 ratio and SRS or mood measures during ad libitum smoking or following overnight abstinence in this sample of pregnant women. Similarly, there were no associations between sex hormone levels and number of CPD smoked during the ad libitum period. Contrary to our hypothesis, we found no significant associations between sex hormones and SRS, mood or smoking behavior in this sample of pregnant women. Trial registration ClinicalTrials.gov (NCT01811225), December 6, 2012.