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Background: Certain health-related risk factors require legal interventions. Medical-legal partnerships (MLPs) are collaborations between clinics and lawyers that address these health-harming legal needs (HHLNs) and have been shown to improve health and reduce utilization., Objective: The objective of this study is to explore the impact, barriers, and facilitators of MLP implementation in primary care clinics., Methods: A qualitative design using a semistructured interview assessed the perceived impact, barriers, and facilitators of an MLP, among clinicians, clinic and MLP staff, and clinic patients. Open AI software (otter.ai) was used to transcribe interviews, and NVivo was used to code the data. Braun & Clarke's framework was used to identify themes and subthemes., Results: Sixteen (n = 16) participants were included in this study. Most respondents were women (81%) and white (56%). Four respondents were clinic staff, and 4 were MLP staff while 8 were clinic patients. Several primary themes emerged including: Patients experienced legal issues that were pernicious, pervasive, and complex; through trusting relationships, the MLP was able to improve health and resolve legal issues, for some; mistrust, communication gaps, and inconsistent staffing limited the impact of the MLP; and, the MLP identified coordination and communication strategies to enhance trust and amplify its impact., Conclusion: HHLNs can have a significant, negative impact on the physical and mental health of patients. Respondents perceived that MLPs improved health and resolved these needs, for some. Despite perceived successes, integration between the clinical and legal organizations was elusive., Competing Interests: Conflict of interest: WL received a gift from Humana, Inc., (© Copyright 2024 by the American Board of Family Medicine.)

Background: Patients with opioid use disorder (OUD) have increased emergency and hospital utilization. The PROUD trial showed that implementation of office-based addiction treatment (OBAT) increased OUD medication treatment compared to usual care, but did not decrease acute care utilization in patients with OUD documented pre-randomization (clinicaltrials.gov/study/NCT03407638). This paper reports secondary emergency and hospital utilization outcomes in patients with documented OUD in the PROUD trial., Methods: This cluster-randomized implementation trial was conducted in 12 clinics from 6 diverse health systems (March 2015-February 2020). Patients who visited trial clinics and had an OUD diagnosis within 3 years pre-randomization were included in primary analyses; secondary analyses added patients with OUD who were new to the clinic or with newly-documented OUD post-randomization. Outcomes included days of emergency care and hospital utilization over 2 years post-randomization. Explanatory outcomes included measures of OUD treatment. Patient-level analyses used mixed-effect regression with clinic-specific random intercepts., Results: Among 1988 patients with documented OUD seen pre-randomization (mean age 49, 53 % female), days of emergency care or hospitalization did not differ between intervention and usual care; OUD treatment also did not differ. In secondary analyses among 1347 patients with OUD post-randomization, there remained no difference in emergency or hospital utilization despite intervention patients receiving 32.2 (95 % CI 4.7, 59.7) more days of OUD treatment relative to usual care., Conclusions: Implementation of OBAT did not reduce emergency or hospital utilization among patients with OUD, even in the sample with OUD first documented post-randomization in whom the intervention increased treatment., Competing Interests: Declaration of Competing Interest All authors reviewed and approved the final article. Jennifer F. Bobb has no disclosures. Andrea Altschuler has no disclosures. Hongxiang Qiu has no disclosures. Abigail G. Matthews has no disclosures. Jennifer McCormack has no disclosures. Dr. Campbell has received support managed through her institution from the Industry PMR Consortium, a consortium of companies conducting post marketing studies required by the Food and Drug Administration that assess risks related to opioid analgesic use. Outside of this study, Paige Wartko received funding in the past year from a contract awarded to the Harvard Department of Population Medicine from GlaxoSmithKline to assess medication use in pregnancy and funding from a research contract awarded to Kaiser Permanente Washington Health Research Institute from Syneos Health to conduct Food and Drug Administration-mandated post-marketing research on the risks of opioid analgesic use. Dr. Saxon has received an honorarium from Indivior, Inc., travel support from Alkermes, Inc., and royalties from UpToDate. Onchee Yu received research grant funded by Bayer. Jeffrey Samet has no disclosures. Dr. Boudreau previously received funding from a research contract awarded to Kaiser Permanente Washington Health Research Institute (KPWHRI) from Syneos Health to conduct Food and Drug Administration-mandated post-marketing research on the risks of opioid analgesic use. Dr. Boudreau was an employee of KPWHRI at the time the study was conducted but is now an employee of Genentech, Inc. Amy K. Lee has no disclosures Dr. Glass reports that Pear Therapeutics Inc provided digital therapeutic prescriptions at no cost to Kaiser Permanente Washington during a quality improvement pilot study that he led. Kathrine A. Bradley has no disclosures., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Introduction: Among women at risk for alcohol-exposed pregnancies (AEP), smoking tobacco may be associated with increased severity of alcohol use, and risk for tobacco-exposed and other substance-exposed pregnancies (TEPs/SEPs). Our secondary data analysis of the 'CHOICES Plus' intervention trial explored AEP and SEP risk by smoking status., Methods: Eligible women (N=261) were recruited from 12 primary care clinics in a public healthcare system, not pregnant, aged 18-44 years, drinking >3 drinks/day or >7 drinks/week, sexually active, and not using effective contraception. We compared women who did and did not smoke tobacco on alcohol and drug severity, and psychological distress (e.g. anxiety) at baseline., Results: Participants were primarily Hispanic (47.1%) or non-Hispanic Black (41.8%) and reported incomes <$20000/year (69.3%). Tobacco smoking prevalence was 45.2%. Compared to non-smokers, those who smoked drank more days/week (mean=3.3, SD=2.0 vs mean=2.7, SD=1.8, p<0.01), had higher alcohol use disorders identification test (AUDIT) scores (mean=12.1, SD=7.6 vs mean=9.8, SD=7.1, p<0.05), were more likely to report current drug use (66.1% vs 48.3%, p<0.01), and had a greater number of (lifetime) drugs used (mean=3.0, SD=2.0 vs mean=2.0, SD=1.5 days, p<0.0001). Also, those who smoked reported greater levels of anxiety (mean=5.9, SD=5.6 vs mean=4.5, SD=4.9, p<0.05), lower confidence to not drink (mean=2.8, SD=0.8 vs mean=3.1, SD=1.0, p<0.01), lower confidence to reduce risky drinking (mean=6.3, SD=3.1 vs mean=7.3, SD=2.8, p<0.0001), greater drinking temptations (mean=3.0, SD=0.9 vs mean=2.6, SD=0.9, p<0.01), and, yet greater readiness to reduce alcohol use (mean=6.2, SD=3.0 vs mean=5.2, SD=3.0, p<0.05)., Conclusions: Women who drink and smoke may have the highest AEP, TEP, and other SEP risk. Primary care providers should screen for alcohol and tobacco co-use and provide brief intervention and/or treatment referral., Clinical Trial Registration: The study was registered on the official website of ClinicalTrials.gov., Identifier: ID NCT01032772., Competing Interests: The authors have each completed and submitted an ICMJE form for disclosure of potential conflicts of interest. The authors declare that they have no competing interests, financial or otherwise, related to the current work. T.F. Northrup reports that since the initial planning of the work, support for the article processing charges was provided by the University of Texas Health Science Center at Houston, Department of Family & Community Medicine. K.L. von Sternberg and M.M. Velasquez report that since the initial planning of the work the original trial from which the data were taken was funded by the CDC (1U84DD000438)., (© 2024 Northrup T.F. et al.)

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments., Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization., Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after., Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine., Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up., Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70)., Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD., Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Introduction: Methamphetamine (MA) use is marked by high rates of comorbid tobacco smoking, which is associated with more severe drug use and worse clinical outcomes compared to single use of either drug. Research has shown the combination of naltrexone plus oral bupropion (NTX-BUP) improves smoking cessation outcomes in non-MA-using populations. In the Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) study, NTX-BUP successfully reduced MA use. Our aim in this secondary data analysis was to examine changes in cigarette smoking among the subgroup of participants reporting comorbid tobacco use in the ADAPT-2 trial., Methods: The multi-site ADAPT-2 study used a randomized, double blind, sequential parallel comparison design to evaluate treatment with extended-release injectable NTX (380 mg every 3 weeks) combined with once-daily oral extended-release BUP (450 mg/day) vs matching injectable and oral placebo in outpatients with moderate or severe MA use disorder. The study assessed smoking outcomes, based on self-reported timeline followback (TLFB) data, twice/week for 13 weeks., Results: Of the 403 participants in the ADAPT-2 trial, 290 reported being current cigarette smokers (71.9 %). The study found significant differences (p's < 0.0001) for each smoking outcome indicating greater change in the proportion of nonsmoking days, number of cigarettes smoked per week, and consecutive nonsmoking days, all favoring the group receiving NTX-BUP versus placebo., Conclusions: NTX-BUP was associated with significant reductions in self-reported cigarette smoking in the context of concurrent treatment for MA use disorder. These off-target medication effects warrant prospective investigation using biochemically confirmed measures of smoking abstinence. The development of NTX-BUP as a co-addiction treatment strategy has a potential for high public health impact., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Madhukar Trivedi: Within the past 12 months, Dr. Trivedi has provided consulting services to Axsome Therapeutics, Biogen MA Inc., Cerebral Inc., Circular Genomics Inc, Compass Pathfinder Limited, Daiichi Sankyo Inc, GH Research Limited, Heading Health Inc, Janssen, Legion Health Inc, Merck Sharp & Dohme Corp., Mind Medicine (MindMed) Inc, Merck Sharp & Dhome LLC, Naki Health, Ltd., Neurocrine Biosciences Inc, Otsuka American Pharmaceutical Inc, Otsuka Pharmaceutical Development & Commercialization Inc, Praxis Precision Medicines Inc, Relmada Therapeutics, Inc, SAGE Therapeutics, Signant Health, Sparian Biosciences Inc, Takeda Pharmaceutical Company Ltd, and WebMD. He sits on the Scientific Advisory Board of Alto Neuroscience Inc, Cerebral Inc., Compass Pathfinder Limited, Heading Health, GreenLight VitalSign6 Inc, Legion Health Inc, and Merck Sharp & Dohme Corp. He holds stock in Alto Neuroscience Inc, Cerebral Inc, Circular Genomics Inc, GreenLight VitalSign6 Inc, Legion Health Inc. Additionally, he has received editorial compensation from American Psychiatric Association, and Oxford University Press. Dr. Thomas Carmody: Dr. Carmody has served as a consultant for Alkermes, Inc. Dr. Stephen Shoptaw: Dr. Shoptaw has received clinical supplies for this research from Alkermes, Inc., (Copyright © 2023. Published by Elsevier Inc.)

Purpose: To determine whether an immediate referral to a medical-legal partnership (MLP), compared with a 6-month waitlist control, improved mental health, health care use, and quality of life., Methods: This trial randomly assigned individuals to an immediate referral or a wait-list control. The MLP involved a collaboration between the primary care clinic and a legal services organization. The primary outcome was stress (6 months) as measured by the Perceived Stress Scale (PSS). Secondary measures included the Center for Epidemiologic Studies Depression Scale; Generalized Anxiety Disorder scale (GAD-7); Patient-Reported Outcomes Measurement Information System (PROMIS); and emergency department (ED), urgent care, and hospital visits. Assessments were at baseline and 3-, 6-, and 9-month follow-ups. Bayesian statistical inference and a 75% posterior probability threshold were used to identify noteworthy differences., Results: Immediate referral was associated with lower PSS scores and higher GAD-7 scores. PROMIS scores were higher for the immediate referral group with respect to several subdomains. At 6 months, the immediate referral group demonstrated 21% fewer ED visits and 75.6% more hospital visits., Conclusion: Immediate referral to the MLP was associated with lower stress and a lower rate of ED visits but higher anxiety and a higher rate of hospital visits., Trial Registration: ClinicalTrials.gov Identifier: NCT03805126., Competing Interests: Conflict of interest: None., (© Copyright by the American Board of Family Medicine.)

Background: Hypoglycemia in neonates is common and contributes to 4.0-5.8% of neonatal intensive care unit (NICU) admissions. In utero nicotine exposure is underexplored as a potential contributor to neonatal hypoglycemia. Rat models have shown that in utero nicotine exposure can be associated with a reduction in pancreatic beta cell mass, leading to glucose dysregulation. The primary aim of this work is to study the risk of developing hypoglycemia after birth in a population of in utero nicotine-exposed neonates., Methods: We conducted a retrospective matched cohort study that augmented an existing dataset of neonates admitted to a level IV NICU with household-based in utero nicotine exposure (N = 335). Neonates in the control group parents denied household smoking (N = 325), were born within a 6-month timeframe, and were within a birthweight of 50 grams of a nicotine-exposed neonate. Data reviewed included gestational age, growth parameters, maternal history of diabetes, and glucose levels within the first three hours of life per unit protocol., Results: 660 neonates were included in the analysis. In utero nicotine exposure demonstrated a 94.3% posterior probability (PP) for greater hypoglycemia risk (RR = 1.185, 95% CrI = [0.953, 1.445]). A 94.6% PP was demonstrated when neonates who were small for gestational age, intrauterine growth-restricted, and born to diabetic mothers were excluded (n = 482; RR = 1.271, 95% CrI = [0.946, 1.669])., Conclusion: Nicotine exposure in utero was found to be a potential risk factor for developing hypoglycemia after birth. Mechanisms of action should be explored, and additional research on in utero nicotine exposure risks should follow.

Background: Pregnant Mexican Americans (hereafter called Latinas) and Black/African American women are at increased risk for psychological distress, contributing to preterm birth and low birthweight; acculturative stress combined with perceived stress elevates depressive symptoms in Latinas. Based on our prior research using a psychoneuroimmunology framework, we identified psychological and neuroendocrine risk factors as predictors of preterm birth in Latina women that are also identified as risk factors for Black/African American women., Methods/design: In this prospective, randomized controlled trial with parallel group design we will explore psychosocial, neuroendocrine, and birth outcome effects of the Mastery Lifestyle Intervention (MLI). The MLI is a culturally relevant, manualized, psychosocial, group intervention integrating two cognitive behavioral therapies for both pregnant Latinas and Black/African American women (total n = 221). Study inclusion criteria are: women with current pregnancy at 14-20 weeks gestation, ability to read and speak English or Spanish, self-identify as Latina of Mexican heritage or Black/African American, 18-45 years old, born in the US or Mexico, and currently living in the US. Participants must receive Medicaid or other government-supported insurance, and meet screening criteria for anxiety, depressive symptoms, or stress. Participants are randomly assigned to either the intervention (MLI) or usual care group (UCG) in groups of 6-8 participants that occur over 6 consecutive weeks. Data are collected at 3 time points: enrollment (14-20 weeks gestation), following treatment (20-26 weeks), and 6 weeks after treatment (32-36 weeks gestation). Additional outcome, mediating, and moderating data are collected from the electronic health record during pregnancy and at birth. Analyses will primarily use generalized linear mixed modeling (GLMM) to evaluate the relationships between predictors and outcomes., Discussion: This RCT will test the efficacy of two combined third generation cognitive behavioral therapies (the MLI), given in a group format over 6 sessions, as compared to a usual prenatal care group, for both Latina and African American pregnant women. If efficacious, it may be provided as an adjunct to routine prenatal care and improve mental health, as well as babies being born too small and too soon., Trial Registration: The trial was retrospectively registered at ClinicalTrials.gov . Bethesda (MD): National Library of Medicine. Identifier NCT05012072 , Reducing Pregnancy Risks: The Mastery Lifestyle Intervention (MLI); August 19, 2021. The trial is currently recruiting participants., (© 2022. The Author(s).)

Objective: Tobacco residue, also known as third-hand smoke (THS), contains toxicants and lingers in dust and on surfaces and clothes. THS also remains on hands of individuals who smoke, with potential transfer to infants during visitation while infants are hospitalized in neonatal intensive care units (NICUs), raising concerns (e.g., hindered respiratory development) for vulnerable infants. Previously unexplored, this study tested handwashing (HW) and sanitization efficacy for finger-nicotine removal in a sample of adults who smoked and were visiting infants in an NICU., Study Design: A cross-sectional sample was recruited to complete an interview, carbon monoxide breath samples, and three nicotine wipes of separate fingers (thumb, index, and middle). Eligible participants ( n  = 14) reported current smoking (verified with breath samples) and were randomly assigned to 30 seconds of HW ( n  = 7) or alcohol-based sanitization ( n  = 7), with the order of finger wipes both counterbalanced and randomly assigned. After randomization, the first finger was wiped for nicotine. Participants then washed or sanitized their hands and finger two was wiped 5 minutes later. An interview assessing tobacco/nicotine use and exposure was then administered, followed by a second breath sample and the final finger wipe (40-60 minutes after washing/sanitizing)., Results: Generalized linear mixed models found that HW was more effective than sanitizer for nicotine removal but failed to completely remove nicotine., Conclusions: Without proper protections (e.g., wearing gloves and gowns), NICU visitors who smoke may inadvertently expose infants to THS. Research on cleaning protocols are needed to protect vulnerable medical populations from THS and associated risks., Key Points: · NICU infants may be exposed to THS via visitors.. · THS is not eliminated by HW or sanitizing.. · THS removal protections for NICU infants are needed.., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: For non-treatment-seeking women who use substances during pregnancy, immediately postpartum may be an optimum time for intervention. Our study tested a novel, brief, hospital-initiated, adaptive motivational interviewing plus acceptance and commitment therapy (MIACT) intervention to facilitate treatment initiation and reproductive planning postpartum among mothers who used substances during pregnancy., Methods: Mothers (N = 64) with an infant admitted to a neonatal intensive care unit were enrolled if they or their infant tested positive for an illicit substance at delivery or had a documented positive drug screen during pregnancy. A parallel group, randomized controlled design assigned participants to MIACT or conventional care (CC), with assessments at week 2 and 4 during treatment and follow-up at 2 and 6 months post treatment. Bayesian generalized linear modeling was used to evaluate outcomes as a function of treatment., Results: Results indicated that during treatment the MIACT group demonstrated an 84% probability of benefit relative to CC with regard to initiating treatment (RR=1.5), however the effect was not seen at follow-up. MIACT was also associated with an increased probability of attending a postpartum obstetrics visit (RR=1.4), and receiving contraception during treatment and at both follow-ups, with posterior probabilities of 96% or higher and relative risks ranging from 1.5 to 5.1 at varying timepoints. Substance use rates for the MIACT versus CC were higher at follow-up., Conclusions: Brief, hospital-initiated interventions can assist postpartum mothers who use substances to enter treatment and obtain contraception in order to reduce future substance-exposed pregnancies., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Introduction: Microbiome differences have been found in adults who smoke cigarettes compared to non-smoking adults, but the impact of thirdhand smoke (THS; post-combustion tobacco residue) on hospitalized infants' rapidly developing gut microbiomes is unexplored. Our aim was to explore gut microbiome differences in infants admitted to a neonatal ICU (NICU) with varying THS-related exposure., Methods: Forty-three mother-infant dyads (household member[s] smoke cigarettes, n = 32; no household smoking, n = 11) consented to a carbon monoxide-breath sample, bedside furniture nicotine wipes, infant-urine samples (for cotinine [nicotine's primary metabolite] assays), and stool collection (for 16S rRNA V4 gene sequencing). Negative binomial regression modeled relative abundances of 8 bacterial genera with THS exposure-related variables (i.e., household cigarette use, surface nicotine, and infant urine cotinine), controlling for gestational age, postnatal age, antibiotic use, and breastmilk feeding. Microbiome-diversity outcomes were modeled similarly. Bayesian posterior probabilities (PP) ≥75.0% were considered meaningful., Results: A majority of infants (78%) were born pre-term. Infants from non-smoking homes and/or with lower NICU-furniture surface nicotine had greater microbiome alpha-diversity compared to infants from smoking households (PP ≥ 75.0%). Associations (with PP ≥ 75.0%) of selected bacterial genera with urine cotinine, surface nicotine, and/or household cigarette use were evidenced for 7 (of 8) modeled genera. For example, lower Bifidobacterium relative abundance associated with greater furniture nicotine (IRR<0.01 [<0.01, 64.02]; PP = 87.1%), urine cotinine (IRR = 0.08 [<0.01,2.84]; PP = 86.9%), and household smoking (IRR<0.01 [<0.01, 7.38]; PP = 96.0%; FDR p < 0.05)., Conclusions: THS-related exposure was associated with microbiome differences in NICU-admitted infants. Additional research on effects of tobacco-related exposures on healthy infant gut-microbiome development is warranted., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Breast milk has many benefits for infants, but initiating breastfeeding/pumping can be difficult for mothers of preterm infants, especially those who smoke (or live with individuals who smoke). The primary aim of this study was to identify risks for breastfeeding/pumping cessation with neonatal intensive care unit (NICU) infants' mothers who smoke or live with individuals who smoke, using a novel survival-analytic approach., Methods/design: Mothers (N = 360) were recruited for a secondhand smoke prevention intervention during infants' NICU hospitalizations and followed for ~6 months after infant discharge. Data were obtained from medical records and participant self-report/interviews., Results: The sample was predominantly ethnic/racial minorities; mean age was 26.8 (SD = 5.9) years. One-fifth never initiated breastfeeding/pumping (n = 67; 18.9%) and mean time-to-breastfeeding cessation was 48.1 days (SD = 57.2; median = 30.4 [interquartile range: 6.0-60.9]). Education, length of stay, employment, race/ethnicity, number of household members who smoke, and readiness-to-protect infants from tobacco smoke were significantly associated with breastfeeding cessation. Further, infants fed breast milk for ≥4 months had 42.7% more well-child visits (p < 0.001) and 50.0% fewer respiratory-related clinic visits (p < 0.05)., Conclusions: One-quarter of infants admitted to NICUs will be discharged to households where individuals who smoke live; we demonstrated that smoking-related factors were associated with mothers' breastfeeding practices. Infants who received breast milk longer had fewer respiratory-related visits., Impact: One-quarter of NICU infants will be discharged to households where smokers live. Initiating/sustaining breastfeeding can be difficult for mothers of preterm NICU infants, especially mothers who smoke or live with others who smoke. Education, employment, race/ethnicity, length of stay, household member smoking, and readiness-to-protect infants from tobacco smoke were significantly associated with time-to-breastfeeding cessation. Infants fed breast milk for ≥4 months had 42.7% more well-child visits and 50.0% fewer respiratory-related clinic visits, compared to infants fed breast milk <4 months. Data support intervention refinements for mothers from smoking households and making NICU-based healthcare workers aware of risk factors for early breastfeeding cessation.

Background: Hepatitis C and HIV are associated with opioid use disorders (OUD) and injection drug use. Medications for OUD can prevent the spread of HCV and HIV., Objective: To describe the prevalence of documented OUD, as well as receipt of office-based medication treatment, among primary care patients with HCV or HIV., Design: Retrospective observational cohort study using electronic health record and insurance data., Participants: Adults ≥ 18 years with ≥ 2 visits to primary care during the study (2014-2016) at 6 healthcare systems across five states (CO, CA, OR, WA, and MN)., Main Measures: The primary outcome was the diagnosis of OUD; the secondary outcome was OUD treatment with buprenorphine or oral/injectable naltrexone. Prevalence of OUD and OUD treatment was calculated across four groups: HCV only; HIV only; HCV and HIV; and neither HCV nor HIV. In addition, adjusted odds ratios (AOR) of OUD treatment associated with HCV and HIV (separately) were estimated, adjusting for age, gender, race/ethnicity, and site., Key Results: The sample included 1,368,604 persons, of whom 10,042 had HCV, 5821 HIV, and 422 both. The prevalence of diagnosed OUD varied across groups: 11.9% (95% CI: 11.3%, 12.5%) for those with HCV; 1.6% (1.3%, 2.0%) for those with HIV; 8.8% (6.2%, 11.9%) for those with both; and 0.92% (0.91%, 0.94%) among those with neither. Among those with diagnosed OUD, the prevalence of OUD medication treatment was 20.9%, 16.0%, 10.8%, and 22.3%, for those with HCV, HIV, both, and neither, respectively. HCV was not associated with OUD treatment (AOR = 1.03; 0.88, 1.21), whereas patients with HIV had a lower probability of OUD treatment (AOR = 0.43; 0.26, 0.72)., Conclusions: Among patients receiving primary care, those diagnosed with HCV and HIV were more likely to have documented OUD than those without. Patients with HIV were less likely to have documented medication treatment for OUD.

Introduction: Thirdhand smoke (THS) is ultrafine particulate matter and residue resulting from tobacco combustion, with implications for health-related harm (eg, impaired wound healing), particularly among hospitalized infants. Project aims were to characterize nicotine (THS proxy) transported on neonatal intensive care unit (NICU) visitors and deposited on bedside furniture, as well as infant exposure., Methods: Cross-sectional data were collected from participants in a metropolitan NICU. Participants completed a survey and carbon monoxide breath sample, and 41.9% (n = 88) of participants (n = 210) were randomly selected for finger-nicotine wipes during a study phase when all bedside visitors were screened for nicotine use and finger-nicotine levels. During an overlapping study phase, 80 mother-infant dyads consented to bedside furniture-nicotine wipes and an infant urine sample (for cotinine analyses)., Results: Most nonstaff visitors' fingers had nicotine above the limit of quantification (>LOQ; 61.9%). Almost all bedside furniture surfaces (93.8%) and infant cotinine measures (93.6%) had values >LOQ, regardless of household nicotine use. Participants who reported using (or lived with others who used) nicotine had greater furniture-nicotine contamination (Mdn = 0.6 [interquartile range, IQR = 0.2-1.6] µg/m2) and higher infant cotinine (Mdn = 0.09 [IQR = 0.04-0.25] ng/mL) compared to participants who reported no household-member nicotine use (Mdn = 0.5 [IQR = 0.2-0.7] µg/m2; Mdn = 0.04 [IQR = 0.03-0.07] ng/mL, respectively). Bayesian univariate regressions supported hypotheses that increased nicotine use/exposure correlated with greater nicotine contamination (on fingers/furniture) and infant THS exposure., Conclusions: Potential furniture-contamination pathways and infant-exposure routes (eg, dermal) during NICU hospitalization were identified, despite hospital prohibitions on tobacco/nicotine use. This work highlights the surreptitious spread of nicotine and potential THS-related health risks to vulnerable infants during critical stages of development., Implications: THS contamination is underexplored in medical settings. Infants who were cared for in the NICU are vulnerable to health risks from THS exposure. This study demonstrated that 62% of nonstaff NICU visitors transport nicotine on their fingers to the NICU. Over 90% of NICU (bedside) furniture was contaminated with nicotine, regardless of visitors' reported household-member nicotine use or nonuse. Over 90% of infants had detectable levels of urinary cotinine during NICU hospitalizations. Results justify further research to better protect infants from unintended THS exposure while hospitalized., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Neonatal ICU (NICU) hospitalizations provide opportunities to engage individuals/families who smoke with evidence-based cessation treatments to protect infants from tobacco smoke exposure. The aim of this pilot study was to establish the feasibility and potential efficacy of providing motivational advice and NRT (MA+NRT) to families of NICU infants. RCT methodology equally allocated participants who reported ≥1 household smoker (N=32) from a large NICU to MA+NRT or referral to a Quitline. The primary outcome was accepting NRT patches (MA+NRT) and use of NRT. Bayesian analyses modeled NRT use as a function of treatment group. Most MA+NRT participants (81.3%; n=13) accepted the patches. No Quitline participants called the Quitline. NRT use differed across groups, indicating a 0.907 posterior probability that a positive effect for MA+NRT exists (RR=2.32, 95% CI=[0.68-11.34]). This study demonstrated feasibility and acceptability for offering NRT and motivational advice to NICU parents and supports further intervention refinement with NICU families., Competing Interests: Conflict of interest statement: The authors have no conflicts of interest to declare.

Objective: To evaluate a hospital-initiated intervention to reduce tobacco smoke exposure in infants in the neonatal intensive care unit., Study Design: A randomized, controlled trial compared motivational interviewing plus financial incentives with conventional care on infant urine cotinine at 1 and 4 months' follow-up. Mothers of infants in the neonatal intensive care unit (N = 360) who reported a smoker living in the home were enrolled. Motivational interviewing sessions were delivered in both the hospital and the home. Financial incentives followed session attendance and negative infant cotinine tests postdischarge., Results: The intervention effect on infant cotinine was not significant, except among mothers who reported high baseline readiness/ability to protect their infant (P ≤ .01) and mothers who completed the study within 6 months postdischarge (per protocol; P ≤ .05). Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01). More mothers in the motivational interviewing plus financial incentives group reported a total home and car smoking ban at follow-up (P ≤ .05)., Conclusions: Motivational interviewing combined with financial incentives reduced infant tobacco smoke exposure in a subset of women who were ready/able to protect their infant. The intervention also resulted in less maternal smoking postpartum. More robust interventions that include maternal and partner/household smoking cessation are likely needed to reduce the costly effects of tobacco smoke exposure on children and their families., Trial Registration: ClinicalTrials.gov: NCT01726062., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Introduction: The National Drug Abuse Treatment Clinical Trials Network (CTN) was initiated by the National Institute on Drug Abuse (NIDA) in 2000 with the aim of improving substance use treatment and reducing the time between the discovery of effective treatments and their implementation into clinical practice. While initial trials were conducted almost exclusively in specialty addiction treatment settings, the CTN began evolving strategically in 2010 to conduct research in general medical settings, including healthcare systems, primary care settings, emergency departments, and pharmacies, to broaden impact. The advantages of a research network like the CTN is not only the collective content expertise that investigators contribute to the network, but the collective experience gained by conducting studies in the network and then applying those lessons to future studies., Objective: To summarize trial implementation challenges encountered, and the process by which solutions were identified and implemented, within one of the last early-phase CTN Stage II behavioral intervention studies conducted in a specialty addiction treatment setting., Method and Results: We describe the implementation of the CTN-0037 STimulant Reduction Intervention using Dosed Exercise (STRIDE) trial. Issues encountered during study implementation are categorized into four major areas, described in terms useful to future study teams: 1) study team infrastructure challenges, 2) participant- and site- level challenges, 3) intervention-related challenges, and 4) longitudinal study design challenges. Potential consequences of identified problems and the solutions developed to manage these problems are discussed within the context of these four areas. We propose how to extend these implementation lessons and apply them in other healthcare settings to expand the CTN., Conclusions: Effective study management allows for flexible, collaborative solutions to expected and unexpected obstacles to study success. Implementation strategies derived from the first 15 to 20 years of CTN studies are a result of working with providers and participants, and the ongoing collaboration among CTN investigators and network staff. Timely identification and response to problems during study implementation are critical to the success of a trial, regardless of its design. We believe a collaborative approach to identifying and responding to study implementation challenges will increase the likelihood of successful adoption of relevant, efficacious interventions. As the CTN continues to expand, the wealth of successful trial implementation strategies developed during the first 20 years of the CTN need to be applied and adapted to studies in broader network settings, and considered in conjunction with more formalized implementation science processes that are currently available., Competing Interests: Declaration of competing interest Drs. Shores-Wilson, Walker, Rethorst, Northrup, Silverstein, Horigian, and Stotts have no conflicting interests to declare. Dr. Greer has received research funding from NARSAD and contracted research support from Janssen Research & Development, LLC. She has received consultant fees from H. Lundbeck A/S and Takeda Pharmaceuticals International, Inc. Dr. Warden has owned stock in Pfizer, Inc. and Bristol-Myers Squibb Company within the last five years and has received funding from NARSAD. Dr. Trivedi has served as an adviser or consultant for Abbott Laboratories, Abdi Ibrahim, Akzo (Organon Pharmaceuticals), Alkermes, AstraZeneca, Axon Advisors, Bristol-Myers Squibb, Cephalon, Cerecor, CME Institute of Physicians, Concert Pharmaceuticals, Eli Lilly, Evotec, Fabre Kramer Pharmaceuticals, Forest Pharmaceuticals, GlaxoSmithKline, Janssen Global Services, Janssen Pharmaceutica Products, Johnson & Johnson PRD, Libby, Lundbeck, Meade Johnson, MedAvante, Medtronic, Merck, Mitsubishi Tanabe Pharma Development America, Naurex, Neuronetics, Otsuka Pharmaceuticals, Pamlab, Parke-Davis Pharmaceuticals, Pfizer, PgxHealth, Phoenix Marketing Solutions, Rexahn Pharmaceuticals, Ridge Diagnostics, Roche Products, Sepracor, Shire Development, Sierra, SK Life and Science, Sunovion, Takeda, Tal Medical/Puretech Venture, Targacept, Transcept, VantagePoint, Vivus, and Wyeth-Ayerst Laboratories; he has received grants or research support from the Agency for Healthcare Research and Quality, Cyberonics, NARSAD, NIDA, and NIMH., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Substance use during pregnancy has been linked to adverse birth and other outcomes. Screening and intervention in the prenatal clinic are recommended, and reliance on patient reports or selective urine drug screening is inadequate. The aim of this prospective project was to determine substance use identification rates associated with common screening practices, compared to universal screening, among pregnant women seeking care at an urban, academic obstetric clinic., Methods: Women attending their first prenatal visit (N = 275) completed a self-report questionnaire on lifetime and current substance use. A urine drug screening was also conducted, the results of which were not reported to providers. Participants' charts were reviewed to obtain the results of provider-ordered screens., Results: The sample was primarily African-American and Latino, with Medicaid insurance. Ten women (4.6%) reported current marijuana use, while more than double that number (n = 27; 11.6%) screened positive for marijuana via universal screening. The majority of women who screened positive via universal screening did not have a provider-ordered urine drug screening, and less than one-third (29.3%) of clinician-ordered screens were positive for at least one substance. Finally, 90% of women who reported they were using marijuana were not selected by providers for a screen., Discussion: Data demonstrate the high proportion of women using marijuana and the limitations of patient self-report and selective, nonroutine screening to identify substance use during pregnancy. Effective, standardized, clinic-wide strategies are needed to support providers in identifying pregnant women who use substances in order to increase the frequency of education and intervention., (© 2019 Wiley Periodicals, Inc.)

Objectives Maternal depression in the postpartum period is prevalent and associated with negative child outcomes, including behavior problems and cognitive delays. Mothers of children admitted directly after birth to the neonatal intensive care unit (NICU) are at even higher risk for depressive symptoms and infants born premature and/or at low birth weight may be more vulnerable to the adverse effects of maternal depression. Understanding mechanisms, particularly modifiable mechanisms, involved in the development or persistence of depressive symptoms is critically important for developing effective treatments. Methods The longitudinal, secondary analysis investigated the role of psychological inflexibility (rigidly avoiding or attempting to control distressing internal experiences, precluding present moment awareness of contingencies and engagement with important values) as a mediator of the relationship between early (1-2 weeks postpartum) and later (3 and 6 months postpartum) depressive symptoms among mothers with an infant in the NICU. Results Psychological inflexibility measured 2 weeks after infant discharge from the hospital fully mediated the relationship between early and later depressive symptoms at 3 months postpartum, with partial mediation at 6 months, while controlling for factors previously found predictive of postpartum depression. Conclusions for Practice Psychological inflexibility may be a mechanism by which postpartum depressive symptoms persist after hospital discharge among new mothers with a NICU infant. Acceptance and Mindfulness therapies which specifically target psychological inflexibility may be promising interventions to reduce depressive symptoms postpartum.

Background: Hydrocodone-combination analgesics were changed from Schedule III to Schedule II to discourage the prescribing of these analgesics. Our primary aim was to explore the effect of hydrocodone rescheduling on opioid prescribing within an urban safety-net health care system., Methods and Design: Data were extracted from electronic records of ambulatory patients (N = 82,432 patients) prescribed hydrocodone-combination, codeine-combination, or tramadol opioid analgesics (N = 200,675 prescriptions) between October 6, 2013 and October 6, 2015. Data analyses modeled predicted probabilities of hydrocodone-combination prescriptions (HCPs). Chronic opioid therapy (COT) for chronic pain (ie, ≥3 opioid prescriptions/12 months) and morphine milligram equivalency (MME) levels were also examined., Results: The probability of providers writing HCPs decreased significantly from pre- to postrescheduling (0.525 vs 0.158, respectively, P < .0001). However, this coincided with large probability increases in codeine-combination (0.064 vs 0.269) and tramadol prescriptions (0.412 vs 0.573). The probability of HCPs varied across physician specialty ( P < .0001), patient diagnoses ( P < .0001), COT versus non-COT patients ( P < .0001), and patient characteristics (sex, race/ethnicity, and age; P < .05). COT patients received significantly more opioid prescriptions in the postrescheduling period ( M = 4.81 vs M = 4.27; P < .0001). Patients on <20 MME/day increased slightly from pre- to postrescheduling ( P < .0001)., Discussion: Significant declines in HCPs occurred after rescheduling; however, one third of patients prescribed opioids remained on doses ≥20 MME/day. Codeine- and tramadol-prescription probabilities increased significantly and providers may have an increased perception of safety about these medications. Physicians and health care systems must reduce their overreliance on opioids in treating pain, especially chronic pain, as all opioids incur some level of risk., Competing Interests: Conflict of interest: none declared., (© Copyright 2019 by the American Board of Family Medicine.)

Introduction: Non-smoking policies are strictly enforced in neonatal intensive care units (NICUs), which may still become contaminated by thirdhand smoke (THS), posing potential health risks to medically fragile infants. Study aims were to explore contamination routes by characterizing nicotine levels (THS proxy) found on the fingers of NICU medical staff and to assess finger-nicotine correlates., Methods: NICU medical staff were surveyed regarding smoking and electronic nicotine devices (ENDS) use/exposure, and household characteristics. Approximately 35% of staff were randomly selected for a finger-nicotine wipe. Three separate quantile regressions modeled percentiles associated with: presence of any finger nicotine, finger-nicotine levels above the median field blank level (i.e. 0.377 ng/wipe), and finger-nicotine levels two times the median blank., Results: The final sample size was 246 (n=260 approached; n=14 refusals). Over three-quarters (78.5%) reported some exposure to tobacco smoke or ENDS vapor/aerosols. After field-blank adjustments, the median nicotine level (ng/finger wipe) was 0.232 (IQR: 0.021-0.681) and 78.3% of medical staff had measurable finger-nicotine levels. Both being near smoking in friends'/family members' homes and finger-surface area were related to elevated finger-nicotine levels (p<0.05) in the median blank model., Conclusions: Almost four in five NICU staff had measurable finger nicotine, with finger surface area and frequency of reported exposure to tobacco smoke in friends'/family members' homes emerging as important correlates. Future research will determine the impact of THS on NICU infants. Medical personnel working in a NICU should be cognizant of secondhand smoke and THS, particularly inside friends'/family members' homes, to reduce potential NICU contamination and infant exposures., Competing Interests: The authors declare that they have no competing interests, financial or otherwise, related to the current work. The authors TF Northrup, AL Stotts, R Suchting, AM Khan, C Green, E Hoh, MF Hovell, GE Matt, declare grants from various organizations detailed under Funding. PJE Quintana has also completed and submitted an ICMJE form for disclosure of potential conflicts of interest.

Background: Cocaine and methamphetamine have similar withdrawal symptoms and many individuals concurrently use both substances; however, no measures concurrently assess withdrawal from multiple stimulants., Objectives: This study's aim was to explore the Stimulant Selective Severity Assessment (SSSA), a modified version of the Cocaine Selective Severity Assessment (CSSA), in a sample of stimulant users to determine if it can assess withdrawal symptoms in users of one or more stimulants., Methods: Baseline data were analyzed from the STimulant Reduction Intervention using Dosed Exercise trial, a multisite randomized clinical trial that evaluated exercise versus health education on drug use outcomes in individuals with stimulant use disorders. Data were analyzed for internal consistency, construct validity, and scale dimensionality., Results: Internal consistency for the full sample was good (α = 0.81; N = 302), with similar alphas in Cocaine (0.81; n = 177) and Cocaine/Other Stimulant (0.82; n = 92) groups, but with much lower alpha for the group without cocaine use (Other Stimulant, i.e., primarily methamphetamine, α = 0.66; n = 32). Support for construct validity was evidenced by significant positive correlations (r = 0.17 to 0.67) with measures of stimulant craving, depressive symptoms, and pain. Four factors were revealed. Conclusions/Importance: The Stimulant Selective Severity Assessment is a new measure that can be used to assess withdrawal symptoms in users of cocaine or cocaine plus methamphetamine, but it should not be administered to users of methamphetamine only.

Hepatitis C virus (HCV) in the U.S. has tripled in the prior five years, and injecting drug use is the primary risk for HCV, with up to 90% of older and former people who inject drugs (PWIDs) testing positive. Laboratory testing of HCV for any PWIDs is the gold standard, however many PWIDs lack access to health treatment or services. Identifying risks of HCV via a data science approach would aid community health workers (CHW) to rapidly link those most at risk of infection with treatment. This study employed a data-science approach to determine the strongest risk factors of HCV in a sample of Mexican-Americans WIDs n = 221 (96 negative/125 positive). Data included 238 demographic and psychosocial predictors. A Random Forest machine learning algorithm demonstrated significant prediction improvement over baseline no information rate comparison. Strongest risks for positive HCV included sharing drug-use equipment and younger age at first heroin use; receiving drug-education during incarceration was protective. A ROC curve fit to the prediction yielded an area under the curve of 0.77. Predictive variables of HCV in the present analysis can be obtained via screening by CHW. Identification of patients most at risk of HCV within community settings can maximize treatment utilization.

Objective: Assess perceptions of prevalence, safety, and screening practices for cigarettes and secondhand smoke exposure (SHSe), marijuana (and synthetic marijuana), electronic nicotine delivery systems (ENDS; eg, e-cigarettes), nicotine-replacement therapy (NRT), and smoking-cessation medications during pregnancy, among primary care physicians (PCPs) providing obstetric care., Methods: A web-based, cross-sectional survey was e-mailed to 3750 US physicians (belonging to organizations within the Council of Academic Family Medicine Educational Research Alliance). Several research groups' questions were included in the survey. Only physicians who reported providing "labor and delivery" obstetric care responded to questions related to the study objectives., Results: A total of 1248 physicians (of 3750) responded (33.3%) and 417 reported providing labor and delivery obstetric care. Obstetric providers (N = 417) reported cigarette (54%), marijuana (49%), and ENDS use (24%) by "Some (6% to 25%)" pregnant women, with 37% endorsing that "Very Few (1% to 5%)" pregnant women used ENDS. Providers most often selected that very few pregnant women used NRT (45%), cessation medications (ie, bupropion or varenicline; 37%), and synthetic marijuana (23%). Significant proportions chose "Do not Know" for synthetic marijuana (58%) and ENDS (27%). Over 90% of the sample perceived that use of or exposure to cigarettes (99%), synthetic marijuana (99%), SHS (97%), marijuana (92%), or ENDS (91%) were unsafe during pregnancy, with the exception of NRT (44%). Providers most consistently screened for cigarette (85%) and marijuana use (63%), followed by SHSe in the home (48%), and ENDS (33%) and synthetic marijuana use (28%). Fewer than a quarter (18%) screened consistently for all substances and SHSe. One third (32%) reported laboratory testing for marijuana and 3% reported laboratory testing for smoking status., Conclusion: This sample of PCPs providing obstetric care within academic settings perceived cigarettes, marijuana, and ENDS use to be prevalent and unsafe during pregnancy. Opportunities for increased screening during pregnancy across these substances were apparent., Competing Interests: Conflict of interest: none declared., (© Copyright 2017 by the American Board of Family Medicine.)

Background and Objectives: Obesity is widely underdiagnosed among Asians, due in part to a lack of physician awareness of the modified diagnostic criteria for Asians. This study investigated the effect of a physician training on accurately diagnosing obesity among and providing weight counseling to overweight and obese Asian patients., Methods: Physicians (N = 16) from five primary care practices received 1 h of face-to-face training and other reminder resources (e.g., wallet card) describing the guidelines for the diagnosis of overweight/obesity among Asians, as well as weight counseling instruction. Chart reviews of overweight/obese Asian patients were conducted for the 12 months before the training (n = 198) and 3 months following the training (n = 163). Physician race (Asian/non-Asian) and clinic setting (private/academic) were included as outcome moderators., Results: Patients were predominantly male (63.1 %), with a mean age of 46.0 years (SD = 14.9) and an average BMI of 28.2 (SD = 3.8). Across all physicians, 26.8 and 45.1 % of patients were accurately diagnosed as overweight or obese before and after the training, respectively (p < 0.05). The odds of a physician correctly diagnosing Asian patients as overweight or obese were 102 % higher at post-training after accounting for nesting of patients within physicians. Similarly, weight counseling was higher (65.0 %) following training compared to pre-training levels (43.9 %) but failed to reach significance (p = 0.06)., Conclusions: Accurate identification and counseling of overweight/obese Asian patients can be improved by education and training. Universal adoption of race-specific guidelines will ensure more successful weight management and reduced morbidity in a rapidly growing Asian population.

Background: Missing data in substance use disorder (SUD) research pose a significant threat to internal validity. Participants terminate involvement or become less likely to attend intervention and research visits for many reasons, which should be addressed prior to becoming problematic. During a 9-month study targeting stimulant abuse, early dropouts and participant reported attendance barriers led to implementing a structured, pre-randomization protocol with participants about retention and solution-focused strategies (the "Fireside Chat"). Our aim is to outline this approach and present data on intervention participation and research visit attendance after implementation., Methods/design: STimulant Reduction using Dosed Exercise (STRIDE) was a two-arm, multisite randomized clinical trial testing treatment-as-usual for stimulant abuse/dependence augmented by Exercise or Health Education. For both groups, study intervention visits at the site were scheduled 3/week for 12weeks followed by 1/week for 24weeks. During The Chat, research staff thoroughly reviewed participants' expectations, and barriers and solutions to retention. Fifteen participants were randomized (to Exercise or Health Education) prior to and fourteen were randomized after Chat implementation. Intervention and monthly follow-up attendance (before and after implementation) were compared at the site (N=29) that developed and rigorously implemented The Chat., Results: Individuals who participated in The Chat (n=14) attended significantly more intervention visits during weeks 1-12 (p<0.001) and weeks 13-36 (p<0.05) and attended more research visits (p<0.001)., Discussion: Proactive discussion of expectations and barriers prior to randomization was associated with greater study attendance. SUD researchers should consider tailoring this approach to suit their needs. Further investigation is warranted., Competing Interests: Drs. Northrup, Walker, Rethorst, Warden, & Stotts declare that they have no conflicts of interest., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Tobacco has regained the status of the world's number two killer behind heart/vascular disease. Thirdhand smoke (THS) residue and particles from secondhand smoke (SHS) are suspected health hazards (eg, DNA damage) that are likely to contribute to morbidity and mortality, especially in vulnerable children. THS is easily transported and deposited indoors, where it persists and exposes individuals for months, creating potential health consequences in seemingly nicotine-free environments, particularly for vulnerable patients. We collected THS data to estimate infant exposure in the neonatal ICU (NICU) after visits from household smokers. Infant exposure to nicotine, potentially from THS, was assessed via assays of infant urine., Methods: Participants were mothers who smoked and had an infant in the NICU (N=5). Participants provided surface nicotine samples from their fingers, infants' crib/incubator and hospital-provided furniture. Infant urine was analysed for cotinine, cotinine's major metabolite: trans -3'-hydroxycotinine (3HC) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a metabolite of the nicotine-derived and tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)., Results: Incubators/cribs and other furniture had detectable surface nicotine. Detectable levels of cotinine, 3HC and NNAL were found in the infants' urine., Discussion: THS appears to be ubiquitous, even in closely guarded healthcare settings. Future research will address potential health consequences and THS-reduction policies. Ultimately, hospital policies and interventions to reduce THS transport and exposure may prove necessary, especially for immunocompromised children., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective: Secondhand smoke exposure (SHSe) poses risks to hospitalized children upon discharge and no uniformly effective interventions have been identified. Understanding change-related processes and social-contextual factors related to motivation for implementing home and car smoking bans may inform interventions to reduce infant SHSe among mothers with a hospitalized infant., Methods: In this cross-sectional, secondary analysis, mothers of neonatal ICU infants who reported smoking or living with a smoker (N=205) were assigned to stages of change (pre-contemplation, contemplation, preparation, or action) based on behaviors and intentions for establishing smoking bans in their homes and cars. Processes of change (POC) for SHSe reduction practices, self-efficacy, depressive symptoms, generalized anxiety, and social support for not smoking in the home were examined across all four stages., Results: The majority of mothers were in the action stage for having a home smoking ban in place (55%); only 35% of participants were in action for a car smoking ban. POC use differed across the stages of change for having a home ban (p=0.004) and car ban (p=0.02), with earlier stages using fewer overall and relatively fewer cognitive/affective processes. Earlier stage women also reported lower self-efficacy to change, less familial and partner support for in-home smoking bans, and more depressive symptoms., Conclusions: Novel intervention targets were identified, including cognitive/affective change processes, mental health, and familial/social contingencies for implementing SHSe protective practices. Creative ways in which to affect change at the individual and household level are needed in order to fully address the complexity of child SHSe., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Introduction: Thirdhand smoke (THS) residue results from secondhand smoke, and is emerging as a distinct public health hazard, particularly for medically fragile pediatric patients living with smokers. THS is difficult to remove and readily reacts with other pollutants to form carcinogens and ultrafine particles. This study investigated THS found in homes of high-risk infants admitted to a neonatal intensive care unit and their association with characteristics (eg, number of household smokers) hypothesized to influence THS., Methods: Baseline data from 141 hospitalized infants' homes were analyzed, along with follow-up data (n = 22) to explore household smoking characteristics and THS changes in response to indoor smoking ban policies., Results: Households with an indoor ban, in which not more than 10 cigarettes/d were smoked, had the lowest levels of THS contamination compared to homes with no ban (P < .001) and compared to homes with an indoor ban in which greater numbers of cigarettes were smoked (P < .001). Importantly, homes with an indoor ban in which at least 11 cigarettes/d were smoked were not different from homes without a ban. The follow-up sample of 22 homes provided initial evidence indicating that, unless a ban was implemented, THS levels in homes continued to increase over time., Conclusions: Preliminary longitudinal data suggest that THS may continue to accumulate in homes over time and household smoking bans may be protective. However, for homes with high occupant smoking levels, banning indoor smoking may not be fully adequate to protect children from THS. Unless smoking is reduced and bans are implemented, medically fragile children will be exposed to the dangers of THS., (© The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Studies reveal that electronic cigarette (e-cigarette) and hookah use are increasing among adolescents and young adults. However, the long-term health effects are unknown, especially with regards to pregnancy. Because of the increased use in women of reproductive age, and the unknown long-term health risks, our primary objectives were to determine the perceived risks of e-cigarette and hookah use in pregnancy, and learn common colloquial terms associated with e-cigarettes. Furthermore, we sought to determine if there is a stigma associated with e-cigarette use in pregnancy., Methods: Eleven focus groups including 87 participants were conducted immediately following regularly scheduled CenteringPregnancy® prenatal care with women at three different clinics in the greater Houston area. A minimum of two facilitators led the groups, using ten lead-in prompts, with Spanish translation as necessary. Facilitators took notes which were compared immediately following each group discussion and each group was audio recorded and transcribed. Three facilitators utilized NVivo 9.0 software to organize the transcribed data into nodes to identify major themes. To increase rigor, transcripts were further analyzed by two obstetricians who were instructed to find the major themes., Results: Analyses revealed contradicting themes concerning e-cigarette use. In general, e-cigarettes were perceived as safer alternatives to regular tobacco cigarettes, especially if used as smoking cessation devices. A major theme is that use in pregnancy is harmful to the fetus. However, it was perceived that use for smoking cessation in pregnancy may have fewer side effects. We found that a common term for e-cigarettes is "Blu." In our discussion of hookah use, participants perceived use as popular among teenagers and that use in pregnancy is dangerous for the fetus., Conclusions: Although a strong theme emerged against hookah use, we found contradicting themes in our discussions on e-cigarette use in pregnancy. It is possible that e-cigarette use will not carry the same stigma as regular cigarette smoking in pregnancy. In addition, the impression of e-cigarettes as a healthier alternative to smoking may influence use in pregnancy. Clinicians need to be prepared for questions of e-cigarette safety and efficacy as smoking cessation devices from their pregnant patients who smoke, and women who smoke and are planning to become pregnant.

This study evaluated the efficacy of education versus audit and feedback in decreasing vancomycin utilization. Data were collected prospectively from October 1, 2012-April 30, 2014 over the following 3 periods: baseline, after education and introduction of a late-onset sepsis treatment guideline, and after prospective audit-feedback to physicians. Vancomycin utilization and administration duration >3 days significantly decreased with education and guideline use, but it was not affected by addition of audit and feedback., (Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: The neonatal intensive care unit (NICU) is an ideal setting to intervene with an under served population on secondhand smoke exposure (SHSe). Unfortunately, attrition may compromise outcomes. Baseline characteristics associated with intervention and follow-up attendance were investigated in mothers who participated in a novel SHSe prevention study designed for households with a smoker and a NICU-admitted infant., Methods: Intervention participants received two motivational, NICU-based counseling sessions; usual care participants received pamphlets. Home-based follow-up assessments occurred at 1, 3 and 6 months. Sociodemographic, smoking history, and psychosocial factors were analyzed., Results: Mothers from households with greater numbers of cigarettes smoked and fewer children had higher odds of both intervention and follow-up attendance. Maternal smoking abstinence (lifetime), more adults in the home and higher perceived interpersonal support were also associated with higher odds of follow-up visit completion., Conclusions: Innovative strategies are needed to engage mothers in secondhand smoke interventions, especially mothers who smoke, have lower levels of social support and have greater childcare responsibilities.

Substance use disorders are common and frequently complex, with overlapping medical, legal, social and psychiatric problems. Innovative treatment models to address the full range of problems in new ways using common principles are needed. Third wave behavior therapies such as Acceptance and Commitment Therapy (ACT) and Dialectical Behavior Therapy (DBT) comprise novel approaches and methods that have great potential to address complex substance abuse cases. These treatment models derive from contextual and behavioral science and have a common emphasis on developing empirical, principle-driven methods for approaching unwanted or distressing psychological and physical experiences common to substance use and other disorders. Randomized controlled trials targeting substance use with ACT and DBT have been conducted across varying populations, including various target substances (opiates, methamphetamine, polysubstance) and settings (prisons, methadone clinics, residential treatment, and outpatient). Despite methodological heterogeneity, ACT and DBT have compared favorably to passive and active control conditions. Further research is needed, however, with larger samples and active control conditions, along with studies of treatment mechanisms, to inform and shape theoretical models and substance abuse treatment protocols for enhanced efficacy.

Objective: The aim of the study is to conduct an initial pilot trial evaluating the feasibility, safety, and efficacy of bupropion for smoking cessation in pregnancy., Study Design: A randomized, double-blind, parallel-group pilot study of bupropion versus placebo with 50 pregnant smokers was planned. Eligibility criteria were restrictive (e.g., 14-26 weeks' gestation; no psychiatric conditions or medications) due to the unknown safety, tolerability, and side effect profile of bupropion in pregnancy. Bayesian analyses were planned to provide probability of benefit., Results: Significant challenges were encountered with regard to trial feasibility. Of 820 women screened, 112 were current smokers, but only 11 women were eligible and consented to participate in the study. Excluded women most often had a psychiatric disorder (23%); were outside the gestational range (14%); or declined to participate (11%)., Conclusions: This initial attempt to evaluate bupropion for smoking cessation during pregnancy will inform future trial methodology. Because of the unknown safety profile, conservative eligibility criteria were used and resulted in a large portion of this high-risk, low-income smoker population being excluded from the trial, raising questions regarding broad applicability, and highlighting the need to balance patient safety and trial feasibility. Large multisite studies will likely be needed to conduct definitive pharmacotherapy studies., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Background: The rapid rise in the number of methamphetamine users, relative to cocaine users, has brought the number of each to nearly equal levels, making research on similarities and differences across these groups a needed area of exploration. Craving is postulated to play a significant role in relapse for both user types, yet group differences on observed scale scores have been reported without first assessing the prerequisite measurement equivalence (invariance) of the items, which is essential for meaningful group comparisons., Methods/design: Baseline data from stimulant users in residential treatment (N=301; n=177 cocaine; n=124 methamphetamine) were used to assess the measurement invariance of the 10-item Stimulant Craving Questionnaire (STCQ), which was adapted from a cocaine-specific measure., Results: The unifactorial STCQ demonstrated measurement invariance across cocaine and methamphetamine users for factor loadings (metric), common residual covariances between item pairs, and item intercepts (scalar), as determined by fit indices (RMSEA<0.05; CFI & TLI>0.95; SRMR<0.10). The latent mean, as well as 5 (out of 10) item means and the overall composite scale score, was significantly greater for methamphetamine users compared to cocaine users., Discussion: Results indicate the STCQ is an invariant tool for the assessment of stimulant craving across the two most prevalent user types. Methamphetamine users had significantly higher levels of observed and latent craving than cocaine users, demonstrating a potentially meaningful difference in craving between users of these two stimulants. Future research will determine if treatments and statistical models need to account for craving variations across methamphetamine and cocaine users., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Introduction: Most patients relapse to opioids within one month of opioid agonist detoxification, making the antecedents and parallel processes of first use critical for investigation. Craving and withdrawal are often studied in relationship to opioid outcomes, and a novel analytic strategy applied to these two phenomena may indicate targeted intervention strategies., Methods: Specifically, this secondary data analysis of the Prescription Opioid Addiction Treatment Study used a discrete-time mixture analysis with time-to-first opioid use (survival) simultaneously predicted by craving and withdrawal growth trajectories. This analysis characterized heterogeneity among prescription opioid-dependent individuals (N=653) into latent classes (i.e., latent class analysis [LCA]) during and after buprenorphine/naloxone stabilization and taper., Results: A 4-latent class solution was selected for overall model fit and clinical parsimony. In order of shortest to longest time-to-first use, the 4 classes were characterized as 1) high craving and withdrawal, 2) intermediate craving and withdrawal, 3) high initial craving with low craving and withdrawal trajectories and 4) a low initial craving with low craving and withdrawal trajectories. Odds ratio calculations showed statistically significant differences in time-to-first use across classes., Conclusions: Generally, participants with lower baseline levels and greater decreases in craving and withdrawal during stabilization combined with slower craving and withdrawal rebound during buprenorphine taper remained opioid-free longer. This exploratory work expanded on the importance of monitoring craving and withdrawal during buprenorphine induction, stabilization, and taper. Future research may allow individually tailored and timely interventions to be developed to extend time-to-first opioid use., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Introduction: Secondhand smoke exposure (SHSe) has been identified as a distinct risk factor for adverse obstetric and gynecological outcomes. This study examined the prevalence of SHSe reduction practices (i.e., home and car smoking bans) among pregnant women in a large U.S. prenatal clinic serving low-income women., Methods: Pregnant women (N = 820) attending a university-based, urban prenatal clinic in Houston, Texas, completed a prenatal questionnaire assessing bans on household and car smoking and a qualitative urine cotinine test as part of usual care. Data were collected from April 2011 to August 2012., Results: Nearly one-third (n = 257) of the sample reported at least 1 smoker living in the home. About a quarter of the women in the full sample did not have a total smoking ban in their home and car. Within smoking households, 44% of the pregnant women reported smoking, 56% reported smoking by another household member, and in 26% of smoking households both the pregnant woman and at least one other person were smoking. Only 43% of women with a household smoker reported a total ban on smoking, with higher rates among Hispanic women. Smoking bans were less common when the pregnant women smoked, when more than 1 smoker resided in the home, and when pregnant with her first child., Conclusions: SHSe among low-income pregnant women is high, and interventions to raise awareness and increase the establishment of smoking bans in homes and cars are warranted., (© The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aim: Mothers of infants in the neonatal intensive care unit (NICU) have very low breastfeeding rates and these high-respiratory-risk (HRR) NICU infants may benefit from breastfeeding through decreased risk for respiratory illnesses. This population's increased risk for maternal depression and high rates (22%) of maternal smoking may negatively affect breastfeeding., Objective: This exploratory study investigated associations of breastfeeding with depressive symptoms and maternal smoking in mothers of HRR NICU infants (i.e. presence of one household smoker and birth weight <1500 g or mechanical ventilation ≥12 h)., Methods: Breastfeeding, depression and smoking data were collected from 104 mothers in the NICU following delivery., Results: Fifty-five (52.9%) mothers reported breastfeeding, 39 (37.5%) had a Center for Epidemiological Studies Depression Scale (CES-D) score (≥16) suggestive of depression, and 36 (34.6%) reported smoking. Mothers with CES-D scores ≥16 were less likely to breastfeed compared to those with scores <16 (38.5% versus 61.5%; p = 0.02). Breastfeeding and smoking were not significantly associated (p < 0.10). Mothers of HRR infants with significant depressive symptoms who smoke have significantly lower breastfeeding rates (21%) than mothers who are not depressed and do not smoke (65%)., Conclusions: Interventions to improve breastfeeding initiation and continuation that target depression and smoking are necessary.

Background: Over one-third of all children live with at least one parent who smokes cigarettes, which is associated with compromised child health. The impact of secondhand smoke exposure (SHSe) in medically fragile infants born prematurely is likely to be much higher. The Baby's Breath II study tests whether a hospital-initiated, motivational-enhancement program will result in less SHSe relative to conventional care in high-risk, low birthweight (LBW) infants discharged from a neonatal intensive care unit (NICU). The design and protocol for the ongoing BBII trial is described., Methods/design: Eligible participants are: (1) primary caregivers (typically mothers) of NICU infants who were born at LBW (<2500g) or ventilated for more than 12h; and (2) who smoke or live with at least one smoker. This randomized controlled trial has two conditions: Motivational interviewing plus incentives (MI+) and conventional care (CC). MI+ participants receive two hospital-based and two home-based counseling sessions, as well as incentives (i.e., prize-based draws) for (a) intervention attendance and (b) biochemical validation (i.e., urine cotinine dipstick) indicative of low or no infant SHSe. Participants in the control group receive conventional education-based care. Assessments are completed at baseline, mid-point, and 1- and 4-months post-intervention., Discussion: This study is the first to determine the efficacy of a brief intervention for reducing SHSe among high-risk, LBW infants discharged from a NICU, with the potential for saving lives and healthcare costs. Strengths, limitations and challenges to the conduct of this trial are discussed., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Purpose: This study investigated potential associations between maternal depression and specific infant health conditions, smoking, and socioeconomic characteristics among mothers of high-risk infants during medical follow-up visits., Study Design and Methods: Cross-sectional self-report, and interview data were collected from 114 mothers of high-risk infants previously discharged from a neonatal intensive care unit. Mothers were assessed at a postdischarge clinic visit., Results: Prevalence rates for a Center for Epidemiological Studies-Depression Scale score ≥ 16) suggestive of a depressive disorder exceeded 20% at all time points for this sample of predominantly low-income, minority-race mothers. A greater number of mothers who had infants with a highly visible illness (e.g., surgical necrotizing enterocolitis) were depressed. Depression was also associated with the presence of a household smoker, younger age, and less education and income., Clinical Implications: Given the prevalence rates, routine screening for postpartum depression in mothers of high-risk infants is imperative, with particular attention to the infant's health, smoking, and socioeconomic variables.

Background: While agonist replacement therapies are effective for managing opioid dependence, community treatment programs are increasingly choosing detoxification. Unfortunately, success rates for opioid detoxification are very low, in part, due to physical and psychological symptoms associated with opioid withdrawal. Few behavior therapies specifically address the distressing experiences specific to opioid withdrawal. A novel behavioral treatment, acceptance and commitment therapy (ACT), works from the premise that the avoidance of unpleasant private experiences (thoughts, feelings, bodily sensations) is ubiquitous yet may be pathogenic, resulting in treatment drop-out and further drug use., Methods: This Stage I pilot study developed and tested an ACT-based opioid detoxification behavioral therapy. Opioid dependent patients (N=56) who were attending a licensed methadone clinic were randomized to receive either 24 individual therapy sessions of ACT or drug counseling (DC) in the context of a 6-month methadone dose reduction program., Results: While no difference was found on opioid use during treatment, 37% of participants in the ACT condition were successfully detoxified at the end of treatment compared to 19% of those who received DC. Fear of detoxification was also reduced across time in the ACT condition relative to DC., Conclusion: This first study of ACT to assist opioid detoxification indicates promise. Research is needed to refine specific treatment strategies for this population to further strengthen effects., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: The relation between early and frequent alcohol use and later difficulties is quite strong. However, the degree that alcohol use persists, which is often a necessary cause for developing alcohol-related problems or an alcohol use disorder, is not well studied, particularly with attention to race and gender. A novel statistical approach, the Multi-facet Longitudinal Model, enables the concurrent study of age of initiation and persistence., Methods: The models were applied to longitudinal data on youth alcohol use from ages 12 through 19, collected in the (U.S.) National Longitudinal Survey of Youth 1997 cohort (N=8984)., Results: Results confirmed that Black adolescents initiate alcohol use at later ages than do White youth. Further, after initiation, White adolescents were substantially more likely than Black adolescents to continue reporting alcohol use in subsequent years. Hispanic teens showed an intermediate pattern. Gender differences were more ambiguous, with a tendency for boys to be less likely to continue drinking after initiation than were girls., Conclusions: Novel findings from the new analytic models suggest differential implications of early alcohol use by race and gender. Early use of alcohol might be less consequential for males who initiate alcohol use early, Black, and Hispanic youth than for their female and White counterparts., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Introduction: Secondhand smoke exposure (SHSe) threatens fragile infants discharged from a neonatal intensive care unit (NICU). Smoking practices were examined in families with a high respiratory risk infant (born at very low birth weight; ventilated > 12 hr) in a Houston, Texas, NICU. Socioeconomic status, race, and mental health status were hypothesized to be related to SHSe and household smoking bans., Methods: Data were collected as part of The Baby's Breath Project, a hospital-based SHSe intervention trial targeting parents with a high-risk infant in the NICU who reported a smoker in the household (N = 99). Measures of sociodemographics, smoking, home and car smoking bans, and depression were collected., Results: Overall, 26% of all families with a high-risk infant in the NICU reported a household smoker. Almost half of the families with a smoker reported an annual income of less than $25,000. 46.2% of families reported having a total smoking ban in place in both their homes and cars. Only 27.8% families earning less than $25,000 reported having a total smoking ban in place relative to almost 60% of families earning more (p < .01). African American and Caucasian families were less likely to have a smoking ban compared with Hispanics (p < .05). Mothers who reported no smoking ban were more depressed than those who had a household smoking ban (p < .02)., Conclusions: The most disadvantaged families were least likely to have protective health behaviors in place to reduce SHSe and, consequently, are most at-risk for tobacco exposure and subsequent tobacco-related health disparities. Innovative SHSe interventions for this vulnerable population are sorely needed.

The gateway drug model is a popular conceptualization of a progression most substance-users are hypothesized to follow as they try different legal and illegal drugs. Most forms of the gateway hypothesis are that "softer" drugs lead to "harder," illicit drugs. However, the gateway hypothesis has been notably difficult to directly test - i.e., to test as competing hypotheses in a single model that licit drug use might lead to illicit drug use or the reverse. This article presents a novel statistical technique, dual-process discrete-time survival analysis, which enables this comparison. This method uses mixture-modeling software to estimate two concurrent time-to-event processes and their effects on each other. Using this method, support for the gateway hypothesis in the National Longitudinal Survey of Youth 1997 was weak. However, this paper was not designed as a strong test of causal direction but more as a technical demonstration, and suffered from certain technological limitations. Both these limitations and future directions are discussed.