Effect of early medication adherence on behavioral treatment utilization and smoking cessation among individuals with current or past major depressive disorder.

SIGNIFICANCE: Little is known about the mechanisms by which medication adherence promotes smoking cessation among adults with MDD. We tested the hypothesis that early adherence promotes abstinence by increasing behavioral treatment (BT) utilization. METHODS: Data for this post-hoc analysis were from a randomized trial of 149 adults with current or past MDD treated with BT and either varenicline (n = 81) or placebo (n = 68). Arms were matched on medication regimen. Early medication adherence was measured by the number of days in which medication was taken at the prescribed dose during the first six of 12 weeks of pharmacological treatment (weeks 2-7). BT consisted of eight 45-minute sessions (weeks 1-12). Bioverified abstinence was assessed at end-of-treatment (week 14). A regression-based approach was used to test whether the effect of early medication adherence on abstinence was mediated by BT utilization. RESULTS: Among 141 participants who initiated the medication regimen, BT utilization mediated the effect of early medication adherence on abstinencea) an interquartile increase in early medication days from 20 to 42 predicted a 4.2 times increase in abstinence (Total Risk Ratio (RR) = 4.24, 95% CI = 2.32-13.37; p <.001); b) increases in BT sessions predicted by such an increase in early medication days were associated with a 2.7 times increase in abstinence (Indirect RR = 2.73, 95% CI = 1.54-7.58; p <.001); and c) early medication adherence effects on abstinence were attenuated, controlling for BT (Direct RR = 1.55, 95% CI = 0.83-4.23, p =.17). CONCLUSIONS: The effect of early medication adherence on abstinence in individuals with current or past MDD is mediated by intensive BT utilization.

Predictors of improved clinician screening, assessment, and treatment for tobacco use for clients in community mental healthcare following training.

Introduction: People with mental illness (MI) are more likely to smoke cigarettes and less likely to receive treatment for tobacco use than the general population. Understanding factors associated with improved staff treatment of tobacco use in community mental health settings has received limited study. Methods: We used data from a completed cluster-randomized clinical trial that tested two interventions designed to increase treatment for tobacco use in mental health clinics. Among 222 clinic staff, we examined demographic and employment characteristics, changes in perceived skills, knowledge, and beliefs using the S-KAP (i.e., perceptions of staff responsibility to treat tobacco use; client quit motivation; client outcomes; and barriers) as predictors of change in clinician reported delivery of tobacco use treatment following training. Results: Clinician reported treatment of client tobacco use significantly increased from baseline to week 52 across both study arms (p<0.001). This increase in reported treatment for tobacco use was associated with increases from baseline to week 52 in clinician reported skills to treat tobacco use, perceptions of responsibility to treat client tobacco use, and perceptions about client motivation to quit smoking (p's<0.05). Conclusions: Training clinicians in community mental healthcare to address client tobacco use may improve outcomes by helping them to develop the needed skills, convincing them that treating tobacco use is part of their role as clinicians, and by helping clinicians to recognize that clients are motivated to quit smoking. These may be targets to improve how clinicians in community health settings address client tobacco use.

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.

A randomized clinical trial testing two implementation strategies to promote the treatment of tobacco dependence in community mental healthcare.

INTRODUCTION: People with serious mental illness (SMI) are more likely to smoke and less likely to receive tobacco treatment. Implementation strategies may address clinician and organizational barriers to treating tobacco in mental healthcare. METHODS: A cluster-randomized trial (Clinic N=13, Client N=610, Staff N=222) tested two models to promote tobacco treatment in community mental healthcare: standard didactic training vs. Addressing Tobacco Through Organizational Change (ATTOC), an organizational model that provides clinician and leadership training and addresses system barriers to tobacco treatment. Primary outcomes were changes in tobacco treatment from clients, staff, and medical records. Secondary outcomes were changes in smoking, mental health, and quality of life (QOL), and staff skills and barriers to treat tobacco. RESULTS: Clients at ATTOC sites reported a significant increase in receiving tobacco treatment from clinician at weeks 12 and 24 (ps<0.05) and tobacco treatments and policies from clinics at weeks 12, 24, 36, and 52 (ps<0.05), vs. standard sites. ATTOC staff reported a significant increase in skills to treat tobacco at week 36 (p=0.05), vs. standard sites. For both models, tobacco use medications, from clients (week 52) and medical records (week 36), increased (ps<0.05), while perceived barriers decreased at weeks 24 and 52 (ps<0.05); 4.3% of clients quit smoking which was not associated with model. QOL and mental health improved over 24 weeks for both models (ps<0.05). CONCLUSIONS: Standard training and ATTOC improve use of evidence-based tobacco treatments in community mental healthcare without worsening mental health, but ATTOC may more effectively address this practice gap.

Efficacy and safety of combination behavioral activation for smoking cessation and varenicline for treating tobacco dependence among individuals with current or past major depressive disorder: A 2 × 2 factorial, randomized, placebo-controlled trial.

BACKGROUND AND AIMS: Treatment of depression-related psychological factors related to smoking behavior may improve rates of cessation among adults with major depressive disorder (MDD). This study measured the efficacy and safety of 12 weeks of behavioral activation for smoking cessation (BASC), varenicline and their combination. DESIGN, SETTING, PARTICIPANTS: This study used a randomized, placebo-controlled, 2 × 2 factorial design comparing BASC versus standard behavioral treatment (ST) and varenicline versus placebo, taking place in research clinics at two urban universities in the United States. Participants comprised 300 hundred adult smokers with current or past MDD. INTERVENTIONS: BASC integrated behavioral activation therapy and ST to increase engagement in rewarding activities by reducing avoidance, withdrawal and inactivity associated with depression. ST was based on the 2008 PHS Clinical Practice Guideline. Both treatments consisted of eight 45-min sessions delivered between weeks 1 and 12. Varenicline and placebo were administered for 12 weeks between weeks 2 and 14. MEASUREMENTS: Primary outcomes were bioverified intent-to-treat (ITT) 7-day point-prevalence abstinence at 27 weeks and adverse events (AEs). FINDINGS: No significant interaction was detected between behavioral treatment and pharmacotherapy at 27 weeks (χ2 (1) = 0.19, P = 0.67). BASC and ST did not differ (χ2 (1) = 0.43, P = 0.51). Significant differences in ITT abstinence rates (χ2 (1) = 4.84, P = 0.03) emerged among pharmacotherapy arms (16.2% for varenicline, 7.5% for placebo), with results favoring varenicline over placebo (rate ratio = 2.16, 95% confidence interval = 1.08, 4.30). All significant differences in AE rates after start of medication were higher for placebo than varenicline. CONCLUSION: A randomized trial in smokers with major depressive disorder found that varenicline improved smoking abstinence versus placebo at 27 weeks without elevating rates of adverse events. Behavioral activation for smoking cessation did not outperform standard behavioral treatment, with or without adjunctive varenicline therapy.

Change in cardiovascular health among adults with current or past major depressive disorder enrolled in intensive smoking cessation treatment.

BACKGROUND: Elevated depressive symptoms and cigarette smoking are independently associated with poorer cardiovascular health (CVH), but it is unknown whether their treatment can synergistically improve CVH. We sought to characterize CVH of adults with comorbid depression and smoking and examine changes in CVH associated with changes in smoking and depression. METHODS: Participants (N = 300, 55 % women) were adult smokers (≥ 1 cigarette/day) with lifetime major depressive disorder enrolled in a 12-week intervention trial targeting depression and smoking. Multiple linear regression examined prospective associations between changes in depression (Beck Depression Inventory-II), smoking (past 24-hour cigarettes or smoking abstinence), and modified CVH score (per American Heart Association, excluding smoking: diet, physical activity, body mass index, blood glucose, cholesterol, blood pressure). RESULTS: Baseline mean CVH score was 5.87/12 points (SD = 2.13). No participants met "ideal" on all CVH components (blood glucose: 48 %, cholesterol: 46 %, physical activity: 38 %, body mass index: 24 %, blood pressure: 22 %, diet: 3 %). CVH scores did not change from baseline to end-of-treatment (M = 0.18 points, SD = 1.36, p = .177), nor did change in depression × smoking predict change in CVH (p = .978). However, greater reductions in depression were significantly associated with greater improvements in CVH (ß = -0.04, SE = 0.01, p = .015). LIMITATIONS: This study was limited by a short follow-up period, missing blood glucose and cholesterol data, and treatment-seeking smokers. CONCLUSIONS: Adults with comorbid depression and smoking had poor CVH. Although integrated treatment for depression and smoking improved both conditions, only reductions in depression were associated with improvements in CVH. These findings have implications for integrating psychosocial treatment into CVH promotion efforts. REGISTRATION: NCT02378714 (clinicaltrials.gov).

A Clinical Decision Support System for Motivational Messaging and Tobacco Cessation Treatment for Parents: Pilot Evaluation of Use and Acceptance.

BACKGROUND: Research is needed to identify how clinical decision support (CDS) systems can support communication about and engagement with tobacco use treatment in pediatric settings for parents who smoke. We developed a CDS system that identifies parents who smoke, delivers motivational messages to start treatment, connects parents to treatment, and supports pediatrician-parent discussion. OBJECTIVE: The objective of this study is to assess the performance of this system in clinical practice, including receipt of motivational messages and tobacco use treatment acceptance rates. METHODS: The system was evaluated at one large pediatric practice through a single-arm pilot study from June to November 2021. We collected data on the performance of the CDS system for all parents. Additionally, we surveyed a sample of parents immediately after the clinical encounter who used the system and reported smoking. Measures were: (1) the parent remembered the motivational message, (2) the pediatrician reinforced the message, and (3) treatment acceptance rates. Treatments included nicotine replacement therapy, quitline referral (phone counseling), and/or SmokefreeTXT referral (text message counseling). We described survey response rates overall and with 95% confidence intervals (CIs). RESULTS: During the entire study period, 8,488 parents completed use of the CDS: 9.3% (n = 786) reported smoking and 48.2% (n = 379) accepted at least one treatment. A total of 102 parents who smoke who used the system were approached to survey 100 parents (98% response rate). Most parents self-identified as female (84%), aged 25 to 34 years (56%), and Black/African American (94%), and had children with Medicaid insurance (95%). Of parents surveyed, 54% accepted at least one treatment option. Most parents recalled the motivational message (79%; 95% CI: 71-87%), and 31% (95% CI: 19-44%) reported that the pediatrician reinforced the motivational message. CONCLUSION: A CDS system to support parental tobacco use treatment in pediatric primary care enhanced motivational messaging about smoking cessation and evidence-based treatment initiation.

Brief Report: HIV Infection Does Not Explain Higher Nicotine Metabolism in People Living With HIV.

BACKGROUND: Smoking contributes to significant morbidity and mortality in people with HIV. People with HIV have relatively high nicotine metabolism rates, as measured by the nicotine metabolite ratio (NMR, 3-hydroxycotinine/cotinine). A higher NMR is associated with difficulty quitting smoking. We hypothesized that HIV infection might upregulate nicotine metabolism. SETTING: A retrospective study of male current smokers in the Multicenter AIDS Cohort Study who HIV seroconverted between 1985 and 1993. METHODS: Eligibility included having plasma stored before and after confirmed HIV seroconversion and current tobacco use. Samples were selected from the closest available visits before (median 3.3 months) and after (median 9.4 months) seroconversion. Antiretroviral therapy use was exclusionary. Cotinine and 3-hydroxycotinine were measured using liquid chromatography-tandem mass spectrometry. We compared NMR from plasma pre-HIV and post-HIV infection using signed-rank tests. We targeted a sample size of 71 pairs to achieve 80% power to detect a 0.1 unit increase in NMR with P = 0.05. RESULTS: We analyzed paired samples from 78 participants; the median age was 34.5 years [interquartile range (IQR 29-40 years)]. The median NMR pre-HIV and post-HIV was 0.45 (IQR 0.32-0.54) and 0.46 (IQR 0.34-0.56), respectively. The median change in NMR postseroconversion was +0.01 (IQR -0.05, +0.09), P = 0.25. Stratification of median change in NMR by timing between samples or time since HIV seroconversion did not alter this finding. CONCLUSIONS: Acquiring HIV had no measurable effect on NMR. We postulate that upregulation of the NMR may be due to direct pharmacologic effects of HIV medications or metabolic changes in response to HIV infection.

Electronic Health Record-Embedded, Behavioral Science-Informed System for Smoking Cessation for the Parents of Pediatric Patients.

BACKGROUND: Helping parents quit smoking is a public health priority. However, parents are rarely, if ever, offered tobacco use treatment through pediatric settings. Clinical decision support (CDS) systems developed for the workflows of pediatric primary care may support consistent screening, treatment, and referral. OBJECTIVES: This study aimed to develop a CDS system by using human-centered design (HCD) that identifies parents who smoke, provides motivational messages to quit smoking (informed by behavioral science), and supports delivery of evidence-based tobacco treatment. METHODS: Our multidisciplinary team applied a rigorous HCD process involving analysis of the work environment, user involvement in formative design, iterative improvements, and evaluation of the system's use in context with the following three cohorts: (1) parents who smoke, (2) pediatric clinicians, and (3) clinic staff. Participants from each cohort were presented with scenario-based, high-fidelity mockups of system components and then provided input related to their role in using the CDS system. RESULTS: We engaged 70 representative participants including 30 parents, 30 clinicians, and 10 clinic staff. A key theme of the design review sessions across all cohorts was the need to automate functions of the system. Parents emphasized a system that presented information in a simple way, highlighted benefits of quitting smoking, and allowed direct connection to treatment. Pediatric clinicians emphasized automating tobacco treatment. Clinical staff emphasized screening for parent smoking via several modalities prior to the patient's visit. Once the system was developed, most parents (80%) reported that it was easy to use, and the majority of pediatricians reported that they would use the system (97%) and were satisfied with it (97%). CONCLUSION: A CDS system to support parental tobacco cessation in pediatric primary care, developed through an HCD process, proved easy to use and acceptable to parents, clinicians, and office staff. This preliminary work justifies evaluating the impact of the system on helping parents quit smoking.

Stakeholders' Views on Reducing Psychological Distress in Chronic Obstructive Pulmonary Disease.

CONTEXT: Psychological distress is highly prevalent among patients with chronic obstructive pulmonary disease (COPD), the top palliative care priority identified by such patients, and associated with poor outcomes. However, patients with COPD rarely receive care for psychological distress. OBJECTIVES: To identify the barriers and opportunities to reducing psychological distress among patients with COPD in the specialty pulmonary setting. METHODS: We conducted semi-structured interviews based on Consolidated Framework for Implementation Research constructs with key stakeholders at two pulmonary clinics, including clinicians, staff, patients, and caregivers. We focused on the relevance, identification, and management of psychological distress in COPD care. We identified emergent patterns and concepts, developed and applied codes to the text, and examined the content in each code to identify key themes. RESULTS: Thirty-one stakeholders participated in interviews (RR=64.6%). Nearly all pulmonary clinicians felt that psychological well-being was a critical, unmet patient need. Yet, most pulmonary clinicians reported that they lacked sufficient training and available resources to support patients, prioritized physical symptoms and medication management over emotional concerns, and perceived limited cultural support for such efforts in the pulmonary clinic setting. Patient and caregiver participants desired integration and prioritization of care addressing psychological distress into routine pulmonary care. CONCLUSION: Mitigating psychological distress is a palliative care priority in COPD. Integrating efficient, effective resources, such as tools or programs that address psychological distress, into pulmonary clinic settings serving a high volume of patients with COPD may improve the provision of supportive care to patients typically underserved by specialty palliative care.

Brief Report: Nicotine Metabolism Ratio Increases in HIV-Positive Smokers on Effective Antiretroviral Therapy: A Cohort Study.

BACKGROUND: People with HIV (PWH) smoke tobacco at much higher rates than the general population. Previous research has shown that PWH have faster nicotine metabolism than HIV-uninfected individuals, which may underlie this disparity, but the cause is unknown. We investigated whether higher nicotine metabolite ratio (NMR; 3-hydroxycotinine:cotinine), a validated biomarker of nicotine metabolism through CYP2A6, was associated with antiretroviral use among HIV-infected smokers. METHODS: We conducted a retrospective cohort study of HIV-positive smokers in the University of Pennsylvania Center for AIDS Research cohort. We compared the NMR before viral suppression (>10,000 copies/mL) and after viral suppression on antiretroviral therapy (<200 copies/mL). We used mixed-effects linear regression to analyze the change in NMR after viral suppression and assessed for effect modification by efavirenz use. RESULTS: Eighty-nine individuals were included in the study. We observed effect modification by efavirenz use (interaction term for efavirenz use, P < 0.001). Among those on nonefavirenz regimens, the mean NMR increased by 0.14 (95% confidence interval: 0.05 to 0.23, P = 0.002). Among those on efavirenz-containing regimens, the mean NMR increased by 0.53 (95% confidence interval: 0.39-0.66, P < 0.001). CONCLUSIONS: We observed a clinically and statistically significant increase in NMR after viral suppression among smokers with HIV, which more than doubled among those on efavirenz-based regimens. Higher NMR among HIV-positive smokers on antiretroviral therapy may help explain the higher rates of tobacco use and lower quit rates among PWH in care. These findings suggest that regimen choice and other modifiable factors may be targets for future attempts to increase success rates for tobacco cessation among PWH.

Effectiveness and Ethics of Incentives for Research Participation: 2 Randomized Clinical Trials.

Importance: Incentivizing research participation is controversial and variably regulated because of uncertainty regarding whether financial incentives serve as undue inducements by diminishing peoples' sensitivity to research risks or unjust inducements by preferentially increasing enrollment among underserved individuals. Objective: To determine whether incentives improve enrollment in real randomized clinical trials (RCTs) or serve as undue or unjust inducements. Design, Setting, and Participants: Two RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020. Interventions: Patients were randomly assigned to incentives of $0, $200, or $500 for participating in the smoking cessation trial and $0, $100, or $300 for the ambulation trial. Main Outcomes and Measures: The primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Each trial was powered to test the hypotheses that incentives served neither as undue inducements (based on the interaction between incentive size and perceived research risk, as measured using a 10-point scale, on the primary outcome), nor unjust inducements (based on the interaction between incentive size and participants' self-reported income). Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes. Results: There were a total of 654 participants (327 women [50.0%]; mean [SD] age, 50.6 [12.1] years; 394 Black/African American [60.2%], 214 White [32.7%], and 24 multiracial individuals [3.7%]) in the smoking trial, and 642 participants (364 women [56.7%]; mean [SD] age, 46.7 [15.6] years; 224 Black/African American [34.9%], 335 White [52.2%], and 5 multiracial individuals [0.8%]) in the ambulation trial. Incentives significantly increased consent rates among those in the smoking trial in 47 of 216 (21.8%), 78 of 217 (35.9%), and 104 of 221 (47.1%) in the $0, $200, and $500 groups, respectively (adjusted odds ratio [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P < .001). Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P = .45). In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P < .001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P = .01 and P < .001, respectively). There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions. Conclusions and Relevance: In these 2 randomized clinical trials, financial incentives increased trial enrollment in 1 of 2 trials and did not produce undue or unjust inducement or other unintended consequences in either trial. Trial Registration: ClinicalTrials.gov Identifier: NCT02697799.

The co-occurrence of smoking and alcohol use disorder in a hospital-based population: Applying a multimorbidity framework using geographic information system methods.

Tobacco and alcohol use are leading causes of premature mortality in the US and concurrent use is associated with even greater health risks. A cross-sectional study of 20,310 patients admitted to a Mid-Atlantic acute health care system between July 1, 2018 and June 30, 2019 were categorized according to smoking and alcohol use disorder (AUD) status. Of the total admissions, 1464 (7.2%) were current smokers with an AUD. These patients were younger (52.4 vs. 63.9), more likely to be male (64.1% vs. 38.0%) and covered by Medicaid (46.9% vs. 11.6%), and resided in proximity to higher counts of tobacco (10.3 vs. 4.72) and alcohol (2.24 vs. 1.14) retailers than never smokers without an AUD. Clinically, these patients had higher rates of other substance use disorders (60.4% vs. 6.1%), depression (64.6% vs. 34.8%), HIV/AIDS (3.3% vs. 0.6%), and liver disease (40.7% vs. 13.2%) than never smokers without an AUD. Patients who concurrently smoke and have an AUD face unique and serious health risks. A multimorbidity framework can guide clinical and community-based interventions for individuals with concurrent psychiatric and chronic medical conditions, complex social needs, and adverse environmental exposures.

Placebo-controlled trial of bupropion for smoking cessation in pregnant women.

BACKGROUND: Although a relatively small proportion of women who become pregnant continue to smoke cigarettes, no smoking cessation medication has been shown to be effective for this subgroup of smokers. Bupropion, a nonnicotine-based medication, is approved for the promotion of smoking cessation in nonpregnant individuals. We chose to study it in pregnant smokers because, although pregnancy increases nicotine metabolism, it does not affect the metabolism of bupropion. OBJECTIVE: We evaluated the efficacy and safety of sustained-release bupropion for smoking cessation among pregnant women. STUDY DESIGN: We conducted a multiple site, placebo-controlled, randomized clinical trial of bupropion for tobacco use among pregnant women (N=129) (clinical trial number NCT02188459). We enrolled women during the second trimester and randomly assigned them to receive 10 weeks of treatment with either bupropion or placebo, accompanied by a total of 6 smoking cessation counseling sessions (4 during treatment and 2 postpartum). The primary outcome was 7-day point prevalence smoking abstinence, confirmed with breath carbon monoxide measurements, at the end of treatment (week 10) and at week 24. Group differences were assessed as a binary abstinence outcome using a repeated measure generalized estimating equations model with a logit link. Prolonged abstinence and smoking rates were secondary outcomes. Safety measures included maternal treatment-related adverse events, gestational age, the rate of overall and spontaneous preterm births and infant birthweight and size for gestational age, head circumference, and 5-minute Apgar scores. RESULTS: There were no significant differences in the safety measures across the treatment arms and bupropion was not efficacious in promoting smoking cessation at the end of treatment (7-day point prevalence quit rates: bupropion, 11.0%; placebo, 18.5%) or week 24 (7-day point prevalence quit rates: bupropion, 9.4%; placebo, 21.5%) (P>.05). African American women and women with a lower severity of nicotine dependence had significantly higher quit rates overall and women with an opioid use disorder who were being treated with opioid agonist therapy had significantly lower quit rates overall, irrespective of the treatment group (all P values <.05). CONCLUSION: Although bupropion use was not associated with an elevated risk for pregnancy complications when initiated in the second trimester, it did not increase the likelihood of smoking cessation in this cohort of pregnant women. Because smoking is the major preventable source of poor pregnancy outcomes and psychosocial interventions have only modest beneficial effects, additional studies are needed to identify safe and efficacious smoking cessation medications for pregnant women who continue to smoke.

Knowledge and self-efficacy among healthcare providers towards novel tobacco products in Japan.

Several new tobacco products, including e-cigarettes and heated tobacco products (HTPs), have become highly prevalent in Japan. As safety data continues to evolve, healthcare providers are considered important sources for product use, yet little is known about provider knowledge or self-efficacy to counsel patient about novel tobacco product use. This cross-sectional study used data from a Japanese Association of Smoking Control Science (JASCS) online survey of physicians, pharmacists, nurses, and public health practitioners (N = 277) to assess provider knowledge of novel tobacco products and self-efficacy to counsel patients about product use. Correlates of knowledge and self-efficacy were also assessed. More than half the sample had received previous training in treating tobacco use, but 62% of respondents had no knowledge of HTPs; 80% of respondents indicated that they occasionally or always provide smoking cessation support. Overall knowledge of HTPs was low (41.4% correct) with higher knowledge for HTPs containing nicotine (89% correct) vs. HTPs emitting no carbon monoxide (25%). Self-efficacy to counsel patients about novel tobacco products was low on a scale ranging from 10 to 70 (Mean = 31.2; Standard Deviation = 16.7). Greater knowledge of HTPs was associated with male gender, higher rates of training at JASCS and previous learning about HTPs at JASCS. (p < 0.05). The results suggested that healthcare providers' knowledge and self-efficacy regarding novel tobacco products remains low in Japan, but additional training may improve it.

Pediatrician Delivered Smoking Cessation Messages for Parents: A Latent Class Approach to Behavioral Phenotyping.

OBJECTIVE: Message framing can be leveraged to motivate adult smokers to quit, but its value for parents in pediatric settings is unknown. Understanding parents' preferences for smoking cessation messages may help clinicians tailor interventions to increase quitting. METHODS: We conducted a discrete choice experiment in which parent smokers of pediatric patients rated the relative importance of 26 messages designed to increase smoking cessation treatment. Messages varied on who the message featured (child, parent, and family), whether the message was gain- or loss-framed (emphasizing benefits of engaging or costs of failing to engage in treatment), and the specific outcome included (eg, general health, cancer, respiratory illnesses, and financial impact). Participants included 180 parent smokers at 4 pediatric primary care sites. We used latent class analysis of message ratings to identify groups of parents with similar preferences. Multinomial logistic regression described child and parent characteristics associated with group membership. RESULTS: We identified 3 groups of parents with similar preferences for messages: Group 1 prioritized the impact of smoking on the child (n = 92, 51%), Group 2 favored gain-framed messages (n = 63, 35%), and Group 3 preferred messages emphasizing the financial impact of smoking (n = 25, 14%). Parents in Group 2 were more likely to have limited health literacy and have a child over age 6 and with asthma, compared to Group 1. CONCLUSIONS: We identified 3 groups of parent smokers with different message preferences. This work may inform testing of tailored smoking cessation messages to different parent groups, a form of behavioral phenotyping supporting motivational precision medicine.

Assessing barriers to providing tobacco use disorder treatment in community mental health settings with a revised version of the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument.

BACKGROUND: Tobacco use disorder (TUD) rates are 2-3 times higher among people with serious mental illness (SMI) than the general population. Clinicians working in outpatient community mental health clinics are well positioned to provide TUD treatment to this group, but rates of treatment provision are very low. Understanding factors associated with the provision of TUD treatment by mental health clinicians is a priority. METHODS: This study used baseline data from an ongoing cluster-randomized clinical trial evaluating two approaches to training clinicians to increase TUD treatment. Following a psychometric assessment of our assessment tool, the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument, a new factor structure was evaluated utilizing confirmatory factor analysis. Structural equation modeling was then used to examine the associations between TUD treatment practices and clinician, setting, and patient characteristics in a sample of 182 mental health clinicians across 10 mental health clinics. RESULTS: Clinician but not setting or patient characteristics emerged as significant correlates of providing TUD treatment. Specifically, clinicians' general ethical commitment to providing TUD services and perceptions of their skills in providing this type of care were associated with providing TUD treatment. In contrast, clinician perceptions of patient motivation, anticipated quit rates, or available setting resources were not significantly associated with providing TUD treatment. CONCLUSIONS: Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI. Future studies should evaluate interventions that target these factors.