Policy-relevant differences between secondhand and thirdhand smoke: strengthening protections from involuntary exposure to tobacco smoke pollutants.

Starting in the 1970s, individuals, businesses and the public have increasingly benefited from policies prohibiting smoking indoors, saving thousands of lives and billions of dollars in healthcare expenditures. Smokefree policies to protect against secondhand smoke exposure, however, do not fully protect the public from the persistent and toxic chemical residues from tobacco smoke (also known as thirdhand smoke) that linger in indoor environments for years after smoking stops. Nor do these policies address the economic costs that individuals, businesses and the public bear in their attempts to remediate this toxic residue. We discuss policy-relevant differences between secondhand smoke and thirdhand smoke exposure: persistent pollutant reservoirs, pollutant transport, routes of exposure, the time gap between initial cause and effect, and remediation and disposal. We examine four policy considerations to better protect the public from involuntary exposure to tobacco smoke pollutants from all sources. We call for (a) redefining smokefree as free of tobacco smoke pollutants from secondhand and thirdhand smoke; (b) eliminating exemptions to comprehensive smoking bans; (c) identifying indoor environments with significant thirdhand smoke reservoirs; and (d) remediating thirdhand smoke. We use the case of California as an example of how secondhand smoke-protective laws may be strengthened to encompass thirdhand smoke protections. The health risks and economic costs of thirdhand smoke require that smokefree policies, environmental protections, real estate and rental disclosure policies, tenant protections, and consumer protection laws be strengthened to ensure that the public is fully protected from and informed about the risks of thirdhand smoke exposure.

The mastery lifestyle intervention to reduce biopsychosocial risks for pregnant Latinas and African Americans and their infants: protocol for a randomized controlled trial.

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.

Handwashing Results in Incomplete Nicotine Removal from Fingers of Individuals who Smoke: A Randomized Controlled Experiment.

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..

Prevalence and Medication Treatment of Opioid Use Disorder Among Primary Care Patients with Hepatitis C and HIV.

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.

Duration of breastmilk feeding of NICU graduates who live with individuals who smoke.

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.

Thirdhand Smoke Contamination and Infant Nicotine Exposure in a Neonatal Intensive Care Unit: An Observational Study.

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.

Thirdhand smoke associations with the gut microbiomes of infants admitted to a neonatal intensive care unit: An observational study.

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.

Reducing Tobacco Smoke Exposure in High-Risk Infants: A Randomized, Controlled Trial.

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.

Proactive delivery of nicotine replacement therapy to families of hospitalized infants in a NICU: A randomized controlled pilot trial.

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.

A comparison of common practices for identifying substance use during pregnancy in obstetric clinics.

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.

Psychological Flexibility and Depression in New Mothers of Medically Vulnerable Infants: A Mediational Analysis.

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.

The Stimulant Selective Severity Assessment: A replication and exploratory extension of the Cocaine Selective Severity Assessment.

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.

Thirdhand Smoke in the Homes of Medically Fragile Children: Assessing the Impact of Indoor Smoking Levels and Smoking Bans.

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.

Thirdhand smoke contamination in hospital settings: assessing exposure risk for vulnerable paediatric patients.

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.

A qualitative assessment of the perceived risks of electronic cigarette and hookah use in pregnancy.

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.

Randomized, controlled pilot trial of bupropion for pregnant smokers: challenges and future directions.

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.

Families at risk: home and car smoking among pregnant women attending a low-income, urban prenatal clinic.

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.

Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial.

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.

Medical-Legal Partnership Effects on Mental Health, Health Care Use, and Quality of Life in Primary Care: A Randomized Clinical Trial.

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.

Naltrexone plus bupropion reduces cigarette smoking in individuals with methamphetamine use disorder: A secondary analysis from the CTN ADAPT-2 trial.

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.