Case Series of Individuals Treated with Naltrexone during Pregnancy for Opioid and/or Alcohol Use Disorder.

OBJECTIVE: There is a lack of knowledge about the relative safety and efficacy of naltrexone for the treatment of pregnant individuals with opioid and/or alcohol use disorder, including the range of outcomes, in both the pregnant individual and the infant, over the course of peripartum period. Our objective was to describe these outcomes in a cohort of pregnant individuals on naltrexone. METHODS: In this prospective case series, 7 pregnant individuals with opioid use disorder (OUD) or alcohol use disorder (AUD) treated with naltrexone were followed from pregnancy through 12 months after delivery. Clinical treatment protocols and outcomes related to safety and efficacy during pregnancy, delivery, and the postpartum period are described. RESULTS: There were 4 pregnant individuals with OUD and 3 with AUD, of which 3 were managed with oral and 4 with extended-release naltrexone. The mean gestational age at study enrollment was 21.7 (SD, 12) weeks. Of the 7 participants, there was no return to nonprescribed opioid use and 2 who experienced a return to alcohol use over the course of the study. All individuals delivered vaginally at a mean of 37 weeks gestation without any peripartum pain difficulties. Five of the individuals (71.4%) remained on naltrexone 12 months after delivery. There were no reported fetal anomalies and one preterm delivery. None of the infants developed neonatal opioid withdrawal syndrome. CONCLUSIONS: For pregnant individuals with OUD or AUD treated with naltrexone, there were low rates of return to nonprescribed use and reassuring pregnant person and infant outcomes to 12 months postpartum.

First Trimester Use of Buprenorphine or Methadone and the Risk of Congenital Malformations.

Importance: Use of buprenorphine or methadone to treat opioid use disorder is recommended in pregnancy; however, their teratogenic potential is largely unknown. Objective: To compare the risk of congenital malformations following in utero exposure to buprenorphine vs methadone. Design, Setting, and Participants: This population-based cohort study used health care utilization data from publicly insured Medicaid beneficiaries in the US from 2000 to 2018. A total of 13 360 pregnancies with enrollment from 90 days prior to pregnancy start through 1 month after delivery and first trimester use of buprenorphine or methadone were included and linked to infants. Data were analyzed from July to December 2022. Exposure: A pharmacy dispensing of buprenorphine or a code for administration of methadone in the first trimester. Main Outcomes and Measures: Primary outcomes included major malformations overall and malformations previously associated with opioids (any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, clubfoot, and oral clefts). Secondary outcomes included other organ system-specific malformations. Risk differences and risk ratios (RRs) were estimated comparing buprenorphine with methadone, adjusting for confounders with propensity score overlap weights. Results: The cohort included 9514 pregnancies with first-trimester buprenorphine exposure (mean [SD] maternal age, 28.4 [4.6] years) and 3846 with methadone exposure (mean [SD] maternal age, 28.8 [4.7] years). The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone. After confounding adjustment, buprenorphine was associated with a lower risk of malformations compared with methadone (RR, 0.82; 95% CI, 0.69-0.97). Risk was lower with buprenorphine for cardiac malformations (RR, 0.63; 95% CI, 0.47-0.85), including both ventricular septal defect (RR, 0.62; 95% CI, 0.39-0.98) and secundum atrial septal defect/nonprematurity-related patent foramen ovale (RR, 0.54; 95% CI, 0.30-0.97), oral clefts (RR, 0.65; 95% CI, 0.35-1.19), and clubfoot (RR, 0.55; 95% CI, 0.32-0.94). Results for neural tube defects were uncertain given low event counts. In secondary analyses, buprenorphine was associated with a decreased risk of central nervous system, urinary, and limb malformations but a greater risk of gastrointestinal malformations compared with methadone. These findings were consistent in sensitivity and bias analyses. Conclusions and Relevance: In this cohort study, the risk of most malformations previously associated with opioid exposure was lower in buprenorphine-exposed infants compared with methadone-exposed infants, independent of measured confounders. Malformation risk is one factor that informs the individualized patient decision regarding medications for opioid use disorder in pregnancy.

Comprehensive Treatment for Pregnant and Parenting Women with Substance Use Disorders and Their Children: The UNC Horizons Story.

OBJECTIVES: To describe how the UNC Horizons program, a comprehensive women-centered program for pregnant and parenting women with substance use disorders, and its patient population have changed over time and summarize basic neonatal outcomes for infants born to women in treatment at Horizons. METHODS: Yearly Annual Reports from fiscal years of 1994 to 2017 were abstracted. Patient characteristics and infant outcomes compared to normative North Carolina data were examined. RESULTS: Highlights of findings include: The percentage of women for whom opioids were the primary substance of use increased from 0% in 1995-1996 to 62% in 2016-17, while cocaine decreased from 66 to 12%. Intravenous substance use history increased from 7% in 1994-1995 to 41% in 2016-2017. The number of women reporting a history of incarceration rose from 10-20% in the early years to 40%-50% beginning in 2007-2008. The proportion of women reporting a desire to hurt themselves rose from 20% in 2004-2005 to 40% in 2016-2017. Self-reported suicide attempt history remained consistent at 32% across years. While reporting of childhood physical abuse remained at 38% across years, reporting of sexual abuse and domestic violence trended upward. Horizons did not differ from North Carolina in the likelihood of patients giving birth prematurely [χ2(13) = 20.6,p = .082], or the likelihood of a patient giving birth to a low birthweight infant [χ2(13) = 14.7,p = .333]. CONCLUSIONS FOR PRACTICE: Breaking the cycle of addiction for women and children must focus on helping women with substance use problems develop a sense of hope that their lives can improve, and a sense of feeling safe and nurtured.

Systematic examinations of programs that provide treatment services to pregnant and parenting women with substance use disorders have typically been focused on a limited set of outcomes and have been cross-sectional in nature. The current paper presents a detailed examination of the patient populations over a 23-year period, with particular attention to the changes over time in the women served. The birth weight and prematurity of infants born to the women in this program were likewise examined over time, and in comparison to state-level data.

A Dyadic Framework of Care for Opioid-exposed Birthing Persons and Their Infants and Children.

OBJECTIVE: To develop a dyadic-centered framework focused on clinical care, surveillance, and research for birthing persons with opioid use disorder (OUD) and their infants and children. STUDY DESIGN: Between February and March 2023, an analysis was conducted within the US Department of Health and Human Services (HHS) of activities directed at opioid-exposed birthing persons and their infants and children (the dyad) to identify: 1) number of activities, stratified by type and 2) characteristics across health and supportive activities that serve the dyad vs birthing persons or infants and children individually. Descriptive and thematic analyses were used to assess quantity and characteristics of fiscal year 2023-2024 activities aggregated across eleven HHS agencies. RESULTS: Of 181 activities examined, 75 met inclusion criteria specific to serving birthing persons with OUD and opioid-exposed infants and children. Sixty-two percent of activities were dyad focused. Five categories of dyadic activities were identified: research (45%), education and training (28%), health and supportive services (21%), surveillance (4%), and quality improvement (2%). Eight specific characteristics were key to dyadic activities: a life course and generational approach, emphasis on relationship, dyadic outcomes, service wraparound, payment structures supporting dyadic care, data linkage, and social determinants of health. CONCLUSIONS: This analysis of HHS activities directed at birthing persons with OUD and opioid-exposed infants and children showed that most programs had a dyadic focus. Synthesizing elements identified from activities serving the dyad facilitated the development of a dyadic framework integrating clinical care, public health surveillance, and research.

Hair Cortisol Concentrations in Opioid-Exposed versus Nonexposed Mother-Infant Dyads.

OBJECTIVE: To pilot measurement of hair cortisol concentration (HCC) in pregnant women with opioid use disorder and their infants over time and study the potential utility of hair cortisol as a biomarker of chronic stress in this population. STUDY DESIGN: In this pilot prospective cohort study of mother-infant dyads with and without prenatal opioid exposure, we obtained mother-infant HCCs at delivery and again within 1 to 3 months' postpartum. HCCs were compared between the opioid and control groups and between the two time points. RESULTS: There were no significant differences between opioid and control group maternal or infant HCCs at either time point. However, within the opioid-exposed group, there was a significant increase in infant HCCs across the two time points. CONCLUSION: This pilot study describes our experience with the measurement of HCCs in opioid-exposed mother-infant dyads. KEY POINTS: · Maternal stress impacts fetal and child health.. · Many stressors in pregnant women with opioid use disorder.. · Hair cortisol may be a useful stress biomarker..

Sex and Female Empowerment (SAFE): Learning from health care providers, men and women to design a sexual health intervention for women with substance use disorders.

BACKGROUND: Substance Use Disorder (SUD) treatment is a promising setting to provide sexual health education to women. This study examined barriers and possible solutions to effectively providing sexual health education and services during SUD treatment. METHODS: To obtain a full picture of the barriers and solutions, 29 cisgender women and 17 cisgender men in treatment for a SUD and four health care providers in North Carolina were interviewed regarding the domains of pregnancy-planning, barriers to reproductive health services and contraception, selecting a method of contraception and desired aspects and elements of a sexual health intervention. RESULTS: Eight themes and 12 sub-themes emerged that included how addiction impacts pregnancy planning and pregnancy motivations, the stigma and fear regarding accessing health services, the lack of accurate knowledge of the human reproductive cycle and contraceptive methods and worries about contraception side-effects. Recommendations for interventions to reduce unintended pregnancy in this treatment population included the need for simple and focused information given by trusted communicators in a short time frame in accessible locations, and offering incentives for participation such as food and transportation. CONCLUSION: As SUD treatment providers and programs look to improve access to sexual health and contraceptive options for women with SUD, these eight themes provide helpful guidance in crafting future interventions.

National Provider Survey: Use of Naltrexone for Pregnant Individuals with Substance Use Disorders.

OBJECTIVES: A national survey evaluated the availability of naltrexone as a treatment for alcohol use disorder and/or opioid use disorder for pregnant individuals. Provider perceptions of barriers to treatment with naltrexone during pregnancy were also examined. METHODS: Sites were selected from a national registry of naltrexone prescribers (N = 5208). A 10% sampling of sites within 150 miles of each state's capital was selected (n = 2073). Survey of 11 questions included availability of naltrexone for pregnant individuals, standard practices for treating pregnant individuals already on naltrexone, and barriers to treatment. Survey responses were summarized to identify top barriers and national trends in service availability. RESULTS: Of the 236 sites contacted, 78 (33.1%) completed the survey. There was significant geographic variation in number of available sites, with Northeast United States having the most sites. Of the 78 responding sites, only 23 (35.9%) offered naltrexone for pregnant individuals. The most common barriers to prescribing naltrexone included the following: sites without pregnant patients (15.6%), lack of national guidelines in using naltrexone for pregnant patients (14.1%), providers' discomfort with prescribing naltrexone during pregnancy due to safety concerns (9.4%), and providers' discomfort due to inexperience (4.7%). CONCLUSIONS: Accessibility of naltrexone and related care for pregnant individuals with alcohol use disorder and opioid use disorder varies greatly across the United States with numerous barriers and educational gaps identified. Additional research and resources are needed to expand naltrexone treatment access for pregnant individuals.

Neonatal Outcomes after Medications for Opioid Use Disorder during Pregnancy in a State Women's Prison Facility, 2016-2019.

OBJECTIVE: Although medications for opioid use disorder improve both maternal and neonatal outcomes, little is known about opioid-exposed infants born during episodes of incarceration. The study sought to examine birth outcomes for infants born with opioid exposure during perinatal incarceration. METHODS: Participants were identified from clinic rosters in a Southeastern women's prison (2016-2019). Included infants born to pregnant people with opioid use disorder incarcerated in the study facility at the time of delivery. We abstracted hospital length of stay, neonatal opioid withdrawal syndrome (NOWS) severity, and discharge plan from hospital records and report descriptive statistics, analysis of variance F tests, and chi-square tests to compare outcomes by opioid exposure type. RESULTS: There were 125 infants born after exposure to methadone (n = 34), buprenorphine (n = 15), oxycodone (n = 22), or no opioid medication (n = 54) during prenatal incarceration. Most infants exposed to methadone or buprenorphine had difficulty with eating, sleeping, or consoling (97% and 80%), and 59% and 47% were treated with medication for NOWS, respectively. The majority with prenatal opioid exposure required intervention for NOWS symptoms after their birthing parent was discharged to the prison. The average hospital length of stay was different for infants with no opioid, methadone, buprenorphine, and oxycodone exposure during incarceration (4, 15, 12, and 9 days, respectively, P < 0.001). CONCLUSIONS: Neonatal hospitalization experiences of infants with perinatal opioid exposures during maternal incarceration mirror those of similarly exposed infants born outside the context of incarceration, except for hospital length of stay. Consideration of avoiding separation of the parent-infant dyad may be needed to improve outcomes for these infants.

Racial and Ethnic Inequities in Buprenorphine and Methadone Utilization Among Reproductive-Age Women with Opioid Use Disorder: an Analysis of Multi-state Medicaid Claims in the USA.

BACKGROUND: Associations between race/ethnicity and medications to treat OUD (MOUD), buprenorphine and methadone, in reproductive-age women have not been thoroughly studied in multi-state samples. OBJECTIVE: To evaluate racial/ethnic variation in buprenorphine and methadone receipt and retention in a multi-state U.S. sample of Medicaid-enrolled, reproductive-age women with opioid use disorder (OUD) at the beginning of OUD treatment. DESIGN: Retrospective cohort study. SUBJECTS: Reproductive-age (18-45 years) women with OUD, in the Merative™ MarketScan® Multi-State Medicaid Database (2011-2016). MAIN MEASURES: Differences by race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, "other" race/ethnicity) in the likelihood of receiving buprenorphine and methadone during the start of OUD treatment (yes/no) were estimated using multivariable logistic regression. Differences in time to medication discontinuation (days) by race/ethnicity were evaluated using multivariable Cox regression. RESULTS: Of 66,550 reproductive-age Medicaid enrollees with OUD (84.1% non-Hispanic White, 5.9% non-Hispanic Black, 1.0% Hispanic, 5.3% "other"), 15,313 (23.0%) received buprenorphine and 6290 (9.5%) methadone. Non-Hispanic Black enrollees were less likely to receive buprenorphine (adjusted odds ratio, aOR = 0.76 [0.68-0.84]) and more likely to be referred to methadone clinics (aOR = 1.78 [1.60-2.00]) compared to non-Hispanic White participants. Across both buprenorphine and methadone in unadjusted analyses, the median discontinuation time for non-Hispanic Black enrollees was 123 days compared to 132 days and 141 days for non-Hispanic White and Hispanic enrollees respectively (χ2 = 10.6; P = .01). In adjusted analyses, non-Hispanic Black enrollees experienced greater discontinuation for buprenorphine and methadone (adjusted hazard ratio, aHR = 1.16 [1.08-1.24] and aHR = 1.16 [1.07-1.30] respectively) compared to non-Hispanic White peers. We did not observe differences in buprenorphine or methadone receipt or retention for Hispanic enrollees compared to the non-Hispanic White enrollees. CONCLUSIONS: Our data illustrate inequities between non-Hispanic Black and non-Hispanic White Medicaid enrollees with regard to buprenorphine and methadone utilization in the USA, consistent with literature on the racialized origins of methadone and buprenorphine treatment.

Prescribed and Penalized: The Detrimental Impact of Mandated Reporting for Prenatal Utilization of Medication for Opioid Use Disorder.

OBJECTIVES: Some states, including Massachusetts, require automatic filing of child abuse and neglect for substance-exposed newborns, including infants exposed in-utero to clinician-prescribed medications to treat opioid use disorder (MOUD). The aim of this article is to explore effects of these mandated reporting policies on pregnant and postpartum people receiving MOUD. METHODS: We used modified grounded research theory, literature findings, and constant comparative methods to extract, analyze and contextualize perinatal experiences with child protection systems (CPS) and explore the impact of the Massachusetts mandated reporting policy on healthcare experiences and OUD treatment decisions. We drew from 26 semi-structured interviews originally conducted within a parent study of perinatal MOUD use in pregnancy and the postpartum period. RESULTS: Three themes unique to CPS reporting policies and involvement emerged. First, mothers who received MOUD during pregnancy identified mandated reporting for prenatally prescribed medication utilization as unjust and stigmatizing. Second, the stress caused by an impending CPS filing at delivery and the realities of CPS surveillance and involvement after filing were both perceived as harmful to family health and wellbeing. Finally, pregnant and postpartum individuals with OUD felt pressure to make medical decisions in a complex environment in which medical recommendations and the requirements of CPS agencies often compete. CONCLUSIONS FOR PRACTICE: Uncoupling of OUD treatment decisions in the perinatal period from mandated CPS reporting at time of delivery is essential. The primary focus for families affected by OUD must shift from surveillance and stigma to evidence-based treatment and access to supportive services and resources.

What is already known on this subject? Child protection systems (CPS) reporting is associated with barriers to prenatal care and family resources and services. Some state policies in the United States mandate reporting to CPS for prenatal substance exposure, including prescribed medications for opioid use disorder.What this study adds? This study centers the experiences of pregnant and postpartum people with opioid use disorder with mandated reporting policies for prenatal substance exposure, describes the harms to families associated with these policies, and makes recommendations for policy change. Findings emphasize the need to uncouple medical decisions from CPS reporting and involvement.

Initiation and Treatment Discontinuation of Medications for Opioid Use Disorder in Pregnant People Compared With Nonpregnant People.

OBJECTIVE: To examine the association between pregnancy and medications for opioid use disorder (MOUD) initiation and discontinuation among reproductive-aged people receiving treatment for opioid use disorder (OUD) in the United States. METHODS: We conducted a retrospective cohort study of people with gender recorded as female, aged 18-45 years, in the Merative TM MarketScan ® Commercial and Multi-State Medicaid Databases (2006-2016). Opioid use disorder and pregnancy status were identified based on inpatient or outpatient claims for established International Classification of Diseases, Ninth and Tenth Revision diagnosis and procedure codes. The main outcomes were buprenorphine and methadone initiation and discontinuation, determined by using pharmacy and outpatient procedure claims. Analyses were conducted at the treatment episode level. Adjusting for insurance status, age, and co-occurring psychiatric and substance use disorders, we used logistic regression to estimate MOUD initiation and used Cox regression to estimate MOUD discontinuation. RESULTS: Our sample included 101,772 reproductive-aged people with OUD, encompassing 155,771 treatment episodes (mean age 30.8 years, 64.4% Medicaid insurance, 84.1% White), of whom 2,687 (3.2%, encompassing 3,325 episodes) were pregnant. In the pregnant group, 51.2% of treatment episodes (1,703/3,325) involved psychosocial treatment without MOUD, in comparison with 61.1% (93,156/152,446) in the nonpregnant comparator group. In adjusted analyses assessing likelihood of initiation for individual MOUD, pregnancy status was associated with an increase in buprenorphine (adjusted odds ratio [aOR] 1.57, 95% CI 1.44-1.70) and methadone initiation (aOR 2.04, 95% CI 1.82-2.27). Discontinuation rates of MOUD at 270 days were high for both buprenorphine (72.4% for nonpregnant episodes vs 59.9% for pregnant episodes) and methadone (65.7% for nonpregnant episodes vs 54.1% for pregnant episodes). Pregnancy was associated with a decreased likelihood of discontinuation at 270 days for both buprenorphine (adjusted hazard ratio [aHR] 0.71, 95% CI 0.67-0.76) and methadone (aHR 0.68, 95% CI 0.61-0.75), in comparison with nonpregnant status. CONCLUSION: Although a minority of reproductive-aged people with OUD in the United States are initiated on MOUD, pregnancy is associated with a significant increase in treatment initiation and a reduced risk of medication discontinuation.

Postpartum Opioid-Related Mortality in Patients With Public Insurance.

OBJECTIVE: To assess the incidence and risk factors for postpartum opioid overdose death and describe other causes of postpartum death in individuals with opioid use disorder (OUD). METHODS: We conducted a cohort study that used health care utilization data from the Medicaid Analytic eXtract linked to the National Death Index in the United States from 2006 to 2013. All pregnant individuals with live births or stillbirths and continuous enrollment for 3 months before delivery were eligible, including 4,972,061 deliveries. A subcohort of individuals with a documented history of OUD in the 3 months before delivery was identified. We estimated the cumulative incidence of death as occurring between delivery and 1 year postpartum among all individuals and individuals with OUD. Risk factors for opioid overdose death were assessed using odds ratios (ORs) and descriptive statistics, including demographics, health care utilization, obstetric conditions, comorbidities, and medications. RESULTS: The incidence of postpartum opioid overdose death per 100,000 deliveries was 5.4 (95% CI 4.5-6.4) among all individuals and 118 (95% CI 84-163) among individuals with OUD. Individuals with OUD had a sixfold higher incidence of all-cause postpartum death than all individuals. Common causes of death in individuals with OUD were other drug- and alcohol-related deaths (47/100,000), suicide (26/100,000), and other injuries, including accidents and falls (33/100,000). Risk factors strongly associated with postpartum opioid overdose death included mental health and other substance use disorders. Among patients with OUD, postpartum use of medication to treat OUD was associated with 60% lower odds of opioid overdose death (OR 0.4, 95% CI 0.1-0.9). CONCLUSION: Postpartum individuals with OUD have a high incidence of postpartum opioid overdose death and other preventable deaths, including nonopioid substance-related injuries, accidents, and suicide. Use of medications for OUD is strongly associated with lower opioid-related mortality.

Gabapentin Use During Pregnancy and Lactation With and Without Concurrent Opioid Exposure: Considerations and Future Directions.

Gabapentin is a γ-aminobutyric acid analog formally indicated for the treatment of epilepsy and neuropathic pain that is gaining increased popularity. Gabapentin has been historically considered a safe medication, including during pregnancy and lactation, with low reported concerns for misuse and use disorders. However, new empirical efforts are revealing concerns regarding the safety of widespread gabapentin use, particularly in pregnancy and for individuals with a propensity toward substance misuse. The Food and Drug Administration's full prescribing information report on gabapentin provides concerning preclinical data and then states that gabapentin is potentially "developmentally toxic" and has an unknown risk of birth impacts. Concerns have also been raised surrounding in utero exposure to gabapentin due to the onset and presentation of atypical and/or difficult to control withdrawal signs and symptoms in neonates, including those dually exposed to opioids, as well as neonatal exposure to gabapentin via breastmilk. Moreover, nonprescribed gabapentin use has become an increasing problem, with opioid use disorder being the greatest risk factor for such misuse. This article summarizes the current literature regarding gabapentin use during pregnancy and related prenatal and neonatal exposure outcomes with special consideration for interactions between gabapentin and opioid use. Taken together, the current literature suggests that gabapentin use should be considered with caution during pregnancy and during the post-partum period. Well-controlled, prospective research studies are needed to determine the extent of the risks and benefits of prescribed and nonprescribed gabapentin exposure to pregnant people and their neonates.

Buprenorphine versus Methadone for Opioid Use Disorder in Pregnancy.

BACKGROUND: Opioid 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. METHODS: We 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. RESULTS: The 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. CONCLUSIONS: The 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.).

Supporting perinatal individuals with opioid use disorder and their newborns experiencing neonatal abstinence syndrome: impressions from patients and healthcare providers.

Background: Facilitating maternal-newborn involvement and care is critical for improving outcomes for perinatal individuals receiving opioid agonist therapy (OAT) and newborns experiencing Neonatal Abstinence Syndrome (NAS). Comprehensive education strategies are needed to prepare pregnant individuals receiving OAT for navigating the perinatal period.Objectives: Identify facilitators to successful care of perinatal individuals receiving OAT and newborns experiencing NAS via interviews with perinatal individuals and healthcare providers. The goal of identifying this information is to inform a future educational tool development.Methods: Ten perinatal individuals receiving OAT and ten healthcare providers participated in interviews conducted via phone or video conference using semi-structured, open-ended questions. Data were analyzed separately for the two groups and later merged across samples using a qualitative descriptive content analysis approach to identify themes.Results: Under the overarching theme of empowerment to improve outcomes for perinatal women, four themes arose from perinatal and provider interviews: 1) Preparation for Child Protective Services (CPS) involvement, 2) Healthcare providers shape experience through stigma and support 3) Caring for newborns with NAS, and 4) Managing health and resources during postpartum.Conclusion: Perinatal participants emphasized the importance of self-advocacy while navigating healthcare and social systems. Providers highlighted the importance of communicating expectations to empower patients. Education is needed for pregnant individuals receiving OAT on what to expect during pregnancy and postpartum, as well as for providers to help them optimally support their perinatal patients receiving OAT.

Beyond opioid prescribing: Evaluation of a substance use disorder curriculum for OBGYN residents.

OBJECTIVE: Amidst the current opioid crisis, there is a need for better integration of substance use disorder screening and treatment across specialties. However, there is no consensus regarding how to best instruct OBGYN trainees in the clinical skills related to opioid and other substance use disorders (SUD). Study objectives were (1) to assess the effectiveness a SUD curriculum to improve self-reported competence among OBGYN residents and (2) to explore its effectiveness to improve attending evaluations of residents' clinical skills as well as its feasibility and acceptability from the resident perspective. METHODS: A pilot 3-session curriculum was developed and adapted to SUD screening and treatment which included readings, didactics, and supervised outpatient clinical experiences for OBGYN post-graduate year 1 (PGY-1) residents rotating through an integrated OBGYN-SUD clinic. Eighteen residents completed pre and post clinical skills self-assessments (SUD screening, counseling, referring, Motivational Interviewing) using an adapted Zwisch Rating Scale (range 1-5). Scores were compared between time points using paired t-tests. Sub-samples also (a) were evaluated by the attending on three relevant Accreditation Council for Graduate Medical Education Milestones (ACGME) milestone sets using the web-based feedback program, myTIPreport (n = 10) and (b) completed a qualitative interview (n = 4). RESULTS: All PGY-1s (18/18) across three academic years completed the 3-session SUD curriculum. Clinical skill self-assessments improved significantly in all areas [SUD Screening (2.44 (0.98) vs 3.56 (0.62), p = <0.01); Counseling (1.81 (0.71) vs 3.56 (0.51), p = < .01; Referring (2.03 (0.74) vs 3.17 (0.71), p = < .01; Motivational Interviewing (1.94 (1.06) vs 3.33 (0.69), p = < .01)]. Milestone set levels assigned by attending evaluations (n = 10) also improved. Qualitative data (n = 4) revealed high acceptability; all curriculum components were viewed positively, and feedback was provided (e.g., desire for more patient exposures). CONCLUSION: A pilot SUD curriculum tailored for OBGYN PGY-1 residents that goes beyond opioid prescribing to encompass SUD management is feasible, acceptable and likely effective at improving SUD core clinical skills.

Interest in Co-located Reproductive and Sexual Health Services Among Women and Men Receiving Medication for Opioid Use Disorder in an Outpatient Treatment Clinic.

Introduction: Reproductive 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 Methods: Between 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. Results: A 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). Discussion: Both 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.

Cultural Adaptation and Validation of the Urdu Version of the Cognitive Emotion Regulation Questionnaire (CERQ) in Male Patients With Substance Use Disorders (SUDs) in Pakistan.

Background: Adults with substance use disorders (SUDs) often have co-occurring mental health problems. Emotion regulation may play a vital role in mental health problems. The Cognitive Emotion Regulation Questionnaire (CERQ) is a widely used measure for assessing cognitive emotion regulation. However, it has not been used in Pakistan on patients with co-occurring SUDs and mental health issues. The present study aims to translate and adapt the CERQ into the Urdu language and to determine its reliability and convergent validity in a sample of male patients with SUDs in Pakistan. Method: Participants completed a demographic information form, the CERQ, the Depression, Anxiety, and Stress Scale Short Form [DASS-21)], and the Rosenberg Self-Esteem Scale [RSES)] in Urdu. Results: Male participants (N = 237) 18-50 years of age (M = 29.8, SD = 8.1) were recruited from four substance use disorder treatment centers and hospitals in Karachi. The reliability of the Urdu version of the CERQ was based on an examination of its internal consistency reliability (Cronbach's α) and test-retest reliability for both the total scale and its subscales. Internal consistency for the CERQ total (α = 0.80) was adequate, as it was for subscales of self-blame, (0.76) acceptance (0.78), rumination (0.72), positive refocusing (0.79), focus on planning (0.89), positive reappraisal (0.81), putting into perspective (0.83), catastrophizing (0.73), and other blame (0.70). The 10-14 day test-retest reliability of the CERQ total score was 0.86. Higher CERQ scores were significantly (ps < 0.001) negatively associated with DASS-21depression (r = -0.24), anxiety (r = -0.23), and stress (r = -0.27) subscales, as well as the DASS-21 total score (r = -0.26) and positively associated with the RSES self-esteem score (r = 0.30). Conclusion: The Urdu version of the CERQ is a reliable measure for investigating cognitive emotion regulation strategies related to mental health and SUDs in Pakistan.

A mixed methods study of provider factors in buprenorphine treatment retention.

BACKGROUND: Low retention is a persistent challenge in the delivery of buprenorphine treatment for opioid use disorder (OUD). The goal of this study was to identify provider factors that could drive differences in treatment retention while accounting for the contribution of patient characteristics to retention. METHODS: We developed a novel a mixed-methods approach to explore provider factors that could drive retention while accounting for patient characteristics. We used Medicaid claims data from North Carolina in the United States to identify patient characteristics associated with higher retention. We then identified providers who achieved high and low retention rates. We matched high- and low-retention providers on their patients' characteristics. This matching created high- and low-retention provider groups whose patients had similar characteristics. We then interviewed providers while blinded to which belonged in the high- and low-retention groups on aspects of their practice that could affect retention rates, such as treatment criteria, treatment cost, and services offered. RESULTS: Less than half of patients achieved 180-day treatment retention with large differences by race and ethnicity. We did not find evidence that providers who achieved higher retention consistently did so by providing more comprehensive services or selecting for more stable patients. Rather, our findings suggest use of "high-threshold" clinical approaches, such as requiring participation in psychosocial services or strictly limiting dosages, explain differences in retention rates between providers whose patients have similar characteristics. All low-retention providers interviewed used a high-threshold practice compared to half of high-retention providers interviewed. Requiring patients to participate in psychosocial services, which were often paid out-of-pocket, appeared to be especially important in limiting retention. CONCLUSION: Providers who adopt low-threshold approaches to treatment may achiever higher retention rates than those who adopt high-threshold approaches. Addressing cost barriers and systemic racism are likely also necessary for improving buprenorphine treatment retention.