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BackgroundOpioid agonist therapy is strongly recommended for pregnant persons with opioid use disorder. Buprenorphine may be associated with more favorable neonatal and maternal outcomes than methadone, but existing data are limited.MethodsWe conducted a cohort study involving pregnant persons who were enrolled in public insurance programs in the United States during the period from 2000 through 2018 in which we examined outcomes among those who received buprenorphine as compared with those who received methadone. Exposure to the two medications was assessed in early pregnancy (through gestational week 19), late pregnancy (gestational week 20 through the day before delivery), and the 30 days before delivery. Risk ratios for neonatal and maternal outcomes were adjusted for confounders with the use of propensity-score overlap weights.ResultsThe data source for the study consisted of 2,548,372 pregnancies that ended in live births. In early pregnancy, 10,704 pregnant persons were exposed to buprenorphine and 4387 to methadone. In late pregnancy, 11,272 were exposed to buprenorphine and 5056 to methadone (9976 and 4597, respectively, in the 30 days before delivery). Neonatal abstinence syndrome occurred in 52.0% of the infants who were exposed to buprenorphine in the 30 days before delivery as compared with 69.2% of those exposed to methadone (adjusted relative risk, 0.73; 95% confidence interval [CI], 0.71 to 0.75). Preterm birth occurred in 14.4% of infants exposed to buprenorphine in early pregnancy and in 24.9% of those exposed to methadone (adjusted relative risk, 0.58; 95% CI, 0.53 to 0.62); small size for gestational age in 12.1% and 15.3%, respectively (adjusted relative risk, 0.72; 95% CI, 0.66 to 0.80); and low birth weight in 8.3% and 14.9% (adjusted relative risk, 0.56; 95% CI, 0.50 to 0.63). Delivery by cesarean section occurred in 33.6% of pregnant persons exposed to buprenorphine in early pregnancy and 33.1% of those exposed to methadone (adjusted relative risk, 1.02; 95% CI, 0.97 to 1.08), and severe maternal complications developed in 3.3% and 3.5%, respectively (adjusted relative risk, 0.91; 95% CI, 0.74 to 1.13). Results of exposure in late pregnancy were consistent with results of exposure in early pregnancy.ConclusionsThe use of buprenorphine in pregnancy was associated with a lower risk of adverse neonatal outcomes than methadone use; however, the risk of adverse maternal outcomes was similar among persons who received buprenorphine and those who received methadone. (Funded by the National Institute on Drug Abuse.).

IntroductionReproductive and sexual health (RSH) are core components of comprehensive care, yet often omitted in addiction treatment. We characterize knowledge of and interest in RSH services and contraceptive method awareness and use in a rural, Appalachian outpatient clinic.Materials and methodsBetween September 2016 and April 2018, a convenience sample of 225 patients receiving treatment for opioid use disorder at an outpatient buprenorphine/naloxone clinic was collected. Participants completed a cross-sectional RSH survey that included demographics, interest in RSH service integration, contraceptive use, and contraceptive knowledge.ResultsA total of 212 people (126 non-pregnant women, 29 pregnant women, and 57 men) completed the survey of whom 45.8% indicated interest in adding RSH services. Services of interest include regular physical exams (44.8%), STI/STD testing (41.0%), and contraception education and administration (38.2%). There were no significant differences between interest in co-located services between women and men (P = 0.327). Current contraceptive use was low (17.9-30.9%) among women and men. Contraceptive method awareness was 43.3% for high efficacy methods and 50.0% for medium efficacy methods. Women and currently pregnant women knew more total, high, and medium efficacy contraceptive method than men (P = 0.029).DiscussionBoth women and men in this sample are interested in co-located RSH services. Current contraceptive use was low among participants. Contraceptive knowledge was lower among men compared to women, and generally low. Providing co-located RSH services may facilitate RSH education, contraceptive method uptake, and promote engagement across various RSH domains.

Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.

Objectives: For people with opioid use disorder (OUD), transitioning from pregnancy to postpartum and from incarceration to the community is a time of increased risk for opioid overdose. This prospective project evaluated the extent of Jenna's Project's success in preventing overdoses and improving recovery outcomes by coordinating postrelease care in incarcerated OUD perinatal patients. Methods: Participants (N = 132) were pregnant or postpartum (1 year postdelivery) with OUD during incarceration and self-referred for post-release services. FromMarch 2020 to October 2021, participants could receive up to 6 months of postincarceration care coordination services (eg, regular communication, transportation, emergency housing, SUD treatment), medication to treat OUD (MOUD) and other treatment services. Outcomes included verified overdose (fatal), self-reported nonfatal overdose, reincarceration, active Medicaid, receipt of MOUD, presence of children living with participants, open Child Protective Services cases, and number of referrals for services. Results: There were 0 nonfatal and 0 fatal overdoses at both 1 and 6 months postrelease, and 3 of 132 (2%) returned to incarceration. Significantly fewer participants had Medicaid at release (36%) and at 6 months postrelease (60%) than before incarceration (87%) (P < 0.001 for all 3 pairwise comparisons). At 6 months postrelease, significantly more participants reportedMOUDreceipt (51%) comparedwith before incarceration (39%) (P < 0.001). Therewas no significant change in the number of open Child Protective Services cases. Referrals for childcare or parenting services were the most common referrals provided. Conclusion: Immediate postrelease care coordination for pregnant and postpartum women with OUD was feasible and effective in preventing overdose, reincarceration, and promoting recovery outcomes. [ABSTRACT FROM AUTHOR]

This paper summarizes the development and evaluation of an assessment instrument for children ages 7-12. The CHILD CARRE measure is a semi-structured interview with 7 domains. Children from the USA and Argentina (N = 134) completed baseline and follow-up assessments. Substance use occurred at an average age of 8. Almost 33% of the children were taking medications for medical issues, more than 50% of them said that medical problem gets in the way of doing things they like to to do and almost 64% of the children stated that they would like to feel better. On average, children completed third grade in school, 56% of them knew how to read and 26% of the children started making money at age 8. Most children (74%) saw someone drunk or high and 23% of children reported alcohol or psychoactive substance use. Among these children using substances, such substance use occurred at an average age of 8, and in the past 30 days they used these substances an average for 5 days. The rating of level of risk on the part of the interviewer placed these children in the "risky" to "very risky" categories. Most children reported seeing their family members smoking (83%) or using alcohol (67%), and 49% reported seeing their family members high on drugs. Few children (10%) had conflicts with the law, while 46% of their family members had legal problems. Some children (30%) reported having serious problems getting along with family members, neighbors, or friends. These results suggest that this measure can serve as the first comprehensive measure to assess multiple life domains for young children at risk for or using psychoactive substances.

Key Points: Question: Does prenatal exposure to the combination of buprenorphine and naloxone compared with buprenorphine alone increase the risk of adverse neonatal and maternal outcomes? Findings: This observational study noted similar and, in some instances, more favorable neonatal and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone. Meaning: The findings demonstrate comparative safety for the combination of buprenorphine with naloxone for the outcomes considered, supporting both formulations as reasonable options for treating opioid use disorder during pregnancy. Importance: Buprenorphine combined with naloxone is commonly used to treat opioid use disorders outside of pregnancy. In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product. Objective: To compare perinatal outcomes following prenatal exposure to buprenorphine with naloxone vs buprenorphine alone. Design, Settings, and Participants: Population-based cohort study using health care utilization data from Medicaid-insured beneficiaries in the US from 2000 to 2018. The cohort was restricted to pregnant individuals linked to their liveborn infants, with maternal Medicaid enrollment from 3 months before pregnancy to 1 month after delivery and infant enrollment for the first 3 months after birth, unless they died sooner. Exposure: Use of buprenorphine with naloxone vs buprenorphine alone during the first trimester based on outpatient dispensings. Main Outcomes and Measures: Outcomes included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity. Confounder-adjusted risk ratios were calculated using propensity score overlap weights. Results: This study identified 3369 pregnant individuals exposed to buprenorphine with naloxone during the first trimester (mean [SD] age, 28.8 [4.6] years) and 5326 exposed to buprenorphine alone or who switched from the combination to buprenorphine alone by the end of the first trimester (mean [SD] age, 28.3 [4.5] years). When comparing buprenorphine combined with naloxone with buprenorphine alone, a lower risk for neonatal abstinence syndrome (absolute risk, 37.4% vs 55.8%; weighted relative risk, 0.77 [95% CI, 0.70-0.84]) and a modestly lower risk for neonatal intensive care unit admission (absolute risk, 30.6% vs 34.9%; weighted relative risk, 0.91 [95% CI, 0.85-0.98]) and small for gestational age (absolute risk, 10.0% vs 12.4%; weighted relative risk, 0.86 [95% CI, 0.75-0.98]) was observed. For maternal morbidity, the comparative rates were 2.6% vs 2.9%, respectively, and the weighted relative risk was 0.90 (95% CI, 0.68-1.19). No differences were observed with respect to major congenital malformations overall, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery. Results were consistent across sensitivity analyses. Conclusions and Relevance: There were similar and, in some instances, more favorable neonatal and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone. For the outcomes assessed, compared with buprenorphine alone, buprenorphine with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for the treatment of opioid use disorder in pregnancy, affirming flexibility in collaborative treatment decision-making. This population-based cohort study uses health care utilization data for pregnant individuals with opioid use disorder to compare neonatal and maternal outcomes following prenatal exposure to buprenorphine combined with naloxone vs buprenorphine alone. [ABSTRACT FROM AUTHOR]

BackgroundThe United States continues to experience an alarming rise in opioid use that includes women who become pregnant and related neonatal abstinence syndrome (NAS) in newborns. Most newborns experiencing NAS require nonpharmacological care, which entails, most importantly, maternal involvement with the newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies when they are pregnant; however, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, partly because no education, training, or other interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. ObjectiveIn this paper, we describe a mixed methods, multistage study to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled trial. MethodsStage 1 will include 20 semistructured interviews with a panel of neonatology experts, NAS care providers, and mothers with experience caring for NAS-affected newborns to gather their recommendations on the management of NAS and explore their perspectives on the care of these newborns. The findings will guide the adaptation of existing mobile NAS tools for high-risk pregnant women. In stage 2, we will test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with 10 pregnant women receiving opioid agonist therapy (OAT). Finally, in stage 3, we will randomize 30 high-risk pregnant women receiving OAT to either receive the adapted mobile NAS caregiving tool or usual care. We will compare these women on primary outcomes—maternal drug relapse and OAT continuation—and secondary outcomes—maternal-newborn bonding; length of newborn hospital stays; readmission rates; breastfeeding initiation and duration; and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum. ResultsThis project was funded in July 2020 and approved by the institutional review board in April 2020. Data collection for stage 1 began in December 2020, and as of January 2021, we completed 18 semistructured interviews (10 with NAS providers and 8 with perinatal women receiving OAT). Common themes from all interviews will be analyzed in spring 2021 to inform the adaptation of the NAS caregiving tool. The results from stage 1 are expected to be published in summer 2021. Stage 2 data collection will commence in fall 2021. ConclusionsThe findings of this study have the potential to improve NAS care and maternal-newborn outcomes and lead to commercialized product development. If effective, our new tool will be well suited to tailoring for other high-risk perinatal women with substance use disorders. Trial RegistrationClinicalTrials.gov NCT04783558; https://clinicaltrials.gov/ct2/show/NCT04783558 International Registered Report Identifier (IRRID)DERR1-10.2196/27382