Implementation of a rural emergency department-initiated buprenorphine program in the mountain west: a study protocol.

BACKGROUND: Opioid related overdose morbidity and mortality continue to significantly impact rural communities. Nationwide, emergency departments (EDs) have seen an increase in opioid use disorder (OUD)-related visits compared to other substance use disorders (SUD). ED-initiated buprenorphine is associated with increased treatment engagement at 30 days. However, few studies assess rural ED-initiated buprenorphine implementation, which has unique implementation barriers. This protocol outlines the rationale and methods of a rural ED-initiated buprenorphine program implementation study. METHODS: This is a two-year longitudinal implementation design with repeated qualitative and quantitative measures of an ED-initiated buprenorphine program in the rural Mountain West. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework outlines intervention assessments. The primary outcome is implementation measured by ED-initiated buprenorphine protocol core components. Reach, adoption, and maintenance are secondary outcomes. External facilitators from an academic institution with addiction medicine and prior program implementation expertise partnered with community hospital internal facilitators to form an implementation team. External facilitators provide ongoing support, recommendations, education, and academic detailing. The implementation team designed and implemented the rural ED-initiated buprenorphine program. The program includes OUD screening, low-threshold buprenorphine initiation, naloxone distribution and administration training, and patient navigator incorporation to provide warm hand off referrals for outpatient OUD management. To address rural based implementation barriers, we organized implementation strategies based on Expert Recommendations for Implementing Change (ERIC). Implementation strategies include ED workflow redesign, local needs assessments, ED staff education, hospital leadership and clinical champion involvement, as well as patient and community resources engagement. DISCUSSION: Most ED-initiated buprenorphine implementation studies have been conducted in urban settings, with few involving rural areas and none have been done in the rural Mountain West. Rural EDs face unique barriers, but tailored implementation strategies with external facilitation support may help address these. This protocol could help identify effective rural ED-initiated buprenorphine implementation strategies to integrate more accessible OUD treatment within rural communities to prevent further morbidity and mortality. TRIAL REGISTRATION: ClinicalTrials.gov National Clinical Trials, NCT06087991. Registered 11 October 2023 - Retrospectively registered, https://clinicaltrials.gov/study/NCT06087991 .

Maternal psychophysiology profiles: associations with prenatal opioid use, maternal emotion dysregulation, and newborn neurobehavior.

BACKGROUND: Opioid use among pregnant women has more than quadrupled over the past 20 years; however, comorbid risk factors such as emotion dysregulation confound the developmental consequences of prenatal opioid use. Maternal respiratory sinus arrhythmia (RSA) may help to disentangle the comorbid risk factors of prenatal emotion dysregulation and substance use and isolate their consequences on newborn neurobehavior. METHODS: We examined maternal RSA in response to a mild, infant-related stress task in pregnant people (N = 192; 30 on medications for opioid use disorder) recruited from hospitals and a specialty prenatal clinic for substance use disorder. RESULTS: Three latent profiles emerged based on maternal RSA reactivity. Mothers with RSA increasing (Profile 3; more nervous system dysregulation) had higher levels of emotion dysregulation than mothers with RSA decreasing (Profile 1; well-regulated nervous system responses) but were not more likely to use opioids. Additionally, RSA profiles were associated with newborn neurobehavior, including attention, regulation, handling, and arousal. CONCLUSIONS: Given the variability in opioid use across RSA profiles and profile associations with newborn neurodevelopment, future studies should examine protective factors in pregnant individuals using opioids who show more flexible RSA responses. IMPACT: Our study examined maternal psychophysiology and newborn outcomes in a unique population with high levels of emotion dysregulation and opioid use. Three profiles of maternal respiratory sinus arrythmia (RSA) reactivity were identified during pregnancy: decreasing, blunted, and increasing. The RSA increasing and blunted profiles were associated with higher emotion dysregulation than the decreasing profile. Most pregnant people on medications for opioid use disorder (65%) were grouped into the blunted profile, suggesting they might be more at risk for dysregulated RSA reactivity. Differences in RSA profiles were associated with newborn outcomes, with increasing and blunted RSA predicting more newborn neurobehavioral dysregulation.

Maternal mental health as a major contributor to maternal mortality.

Perinatal mental health conditions affect up to 20 % of pregnant or postpartum individuals, and nearly 15 % of pregnant individuals meet criteria for substance use disorder (SUD). All providers taking care of pregnant or postpartum individuals will encounter patients in these scenarios. Maternal Mortality Review Committees (MMRCs) have determined maternal mental health conditions, including SUD, to be the leading cause of preventable maternal death during pregnancy or in the first year postpartum. Lessons learned from MMRCs to prevent these deaths include the recommendation that screening and identification of mental health conditions need to be linked with evidence-based, patient-centered, and accessible treatments. Obstetricians and gynecologists, midwives, family medicine providers, and pediatricians, are in unique positions not only to screen and diagnose, but also to treat individuals with mental health concerns, including SUD, during pregnancy and postpartum.

Drug Testing Interpretation in the Peripartum Setting: Results of Clinician Survey.

OBJECTIVES: The objectives of this study were to (1) survey obstetrical and pediatric clinicians' experience, confidence, and training in maternal and neonatal drug testing interpretation; (2) determine their proficiency in drug test interpretation; and (3) assess predictors of correct interpretation. METHODS: We conducted a cross-sectional survey of clinicians caring for pregnant people or newborns at an urban academic center. We assessed clinicians' demographic characteristics, experience, confidence, and prior training in interpretation of maternal and newborn drug tests. We assessed proficiency in interpreting drug tests using 11 clinical vignettes and categorized scores as poor (0-2), fair (3-5), and good (≥6) performance to facilitate data interpretation. We used descriptive statistics to summarize responses. Multinomial logistic regression was used to determine associations of clinician characteristics and score category (reference category: poor performance). RESULTS: In total, 103 respondents completed the survey including 60 obstetrical clinicians (58.3%), 19 family medicine physicians (18.5%), 21 pediatric clinicians (20.4%), and 3 social workers (2.9%) (response rate, ~40%). The mean correct response was 4.1 (SD, 2.17; range, 0-11). Most respondent scores were fair (n = 47.6%), followed by good (n = 28.2%) and poor (n = 24.3%). Increased frequency, confidence, and training in interpreting maternal screening and confirmatory tests were associated with higher proficiency. Increased confidence and training in interpreting neonatal screening and confirmatory tests, but not frequency, were associated with higher proficiency. CONCLUSIONS: Most clinicians demonstrated fair proficiency in interpreting drug tests. Predictors of proficiency were confidence and prior training for drug test interpretation, suggesting that educational interventions could improve proficiency.

Optimizing Opioid Prescription Quantity After Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: To test whether an individualized opioid-prescription protocol (IOPP) with a shared decision-making component can be used without compromising postcesarean pain management. METHODS: In this multicenter randomized controlled noninferiority trial, we compared IOPP with shared decision making with a fixed quantity of opioid tablets at hospital discharge. We recruited at 31 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Study participants had uncomplicated cesarean births. Follow-up occurred through 12 weeks postdischarge. Individuals with complicated cesarean births or history of opioid use in the pregnancy were excluded. Participants were randomized 1:1 to IOPP with shared decision making or fixed quantity (20 tablets of 5 mg oxycodone). In the IOPP group, we calculated recommended tablet quantity based on opioid use in the 24 hours before discharge. After an educational module and shared decision making, participants selected a quantity of discharge tablets (up to 20). The primary outcome was moderate to severe pain (score 4 or higher [possible range 0-10]) on the BPI (Brief Pain Inventory) at 1 week after discharge. A total sample size of 5,500 participants was planned to assess whether IOPP with shared decision making was not inferior to the fixed quantity of 20 tablets. RESULTS: From September 2020 to March 2022, 18,990 individuals were screened and 5,521 were enrolled (n=2,748 IOPP group, n=2,773 fixed-quantity group). For the primary outcome, IOPP with shared decision making was not inferior to fixed quantity (59.5% vs 60.1%, risk difference 0.67%; 95% CI, -2.03% to 3.37%, noninferiority margin -5.0) and resulted in significantly fewer tablets received (median 14 [interquartile range 4-20] vs 20, P <.001) through 90 days postpartum. CONCLUSION: Compared with fixed quantity, IOPP with shared decision making was noninferior for outpatient postcesarean analgesia at 1 week postdischarge and resulted in fewer prescribed opioid tablets at discharge. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04296396.

Biological Testing and Interpretation of Laboratory Results Associated with Detecting Newborns with Substance Exposure.

BACKGROUND: Substance use during pregnancy is common, as is biological testing that is intended to help identify prenatal exposures. However, there is no standardized requirement for biological testing with either maternal or newborn specimens, nor is there standardization related to when testing occurs, how frequently testing occurs, what specimen(s) to test, what substances to test for, or how to perform testing. CONTENT: We review common specimen types tested to detect maternal and newborn substance exposure with a focus on urine, meconium, and umbilical cord tissue. We also review common analytical methods used to perform testing, including immunoassay, and mass spectrometry platforms. Considerations regarding the utilization of testing relative to the purpose of testing, the drug analyte(s) of interest, the specific testing employed, and the interpretation of results are emphasized to help guide decisions about clinical utilization of testing. We also highlight specific examples of unexpected results that can be used to guide interpretation and appropriate next steps. SUMMARY: There are strengths and limitations associated with all approaches to detecting substance exposure in pregnant persons as well as biological testing to evaluate a newborn with possible substance exposure. Standardization is needed to better inform decisions surrounding evaluation of substance exposures in pregnant people and newborns. If biological sampling is pursued, testing options and results must be reviewed in clinical context, acknowledging that false-positive and -negative results can and do occur.

Naltrexone Compared With Buprenorphine or Methadone in Pregnancy: A Systematic Review.

OBJECTIVE: Although naltrexone is an evidence-based medication for opioid use disorder (MOUD), few data are available with use in pregnancy. Our objective was to assess outcomes of pregnant individuals with opioid use disorder (OUD) taking naltrexone compared with those taking methadone or buprenorphine. DATA SOURCES: We undertook a systematic review using electronic database search (PubMed, CINAHL, EMBASE, PsycInfo), conference proceedings, and trial registries including ClinicalTrials.gov . METHODS OF STUDY SELECTION: We conducted an electronic search of research articles through May 2023 for randomized controlled trials, prospective cohort, and retrospective cohort studies of naltrexone (oral, implant, or extended release) compared with methadone or buprenorphine (sublingual or extended release) among pregnant individuals with OUD. After double review of all articles, we abstracted obstetric (primary outcome: gestational age at delivery), neonatal (primary outcome: neonatal abstinence syndrome [NAS]), and substance use outcomes. TABULATION, INTEGRATION, AND RESULTS: Five studies met eligibility criteria; four were retrospective cohort studies, and one was a prospective cohort study. Four studies included data on gestational age at delivery (weeks) with no difference detected between the two groups in any study (mean difference ranging -0.20, 95% CI, -1.49-1.09 to 0.8, 95% CI, -0.15 to 1.75). Three studies included data on NAS with all studies detecting a lower risk in the naltrexone group compared with methadone or buprenorphine (relative risk ranging from 0.08, 95% CI, 0.01-1.16 to 0.15, 95% CI, 0.06-0.36). Most studies (four of five) had a moderate or high potential for selection bias primarily driven by small sample size and lack of controlling for confounders. CONCLUSION: Although the evidence base is limited, available data suggest that naltrexone use in pregnancy is a reasonable MOUD option with reassuring perinatal outcomes. To enhance confidence in this conclusion and to assess substance use outcomes, further comparative studies of pregnant people with OUD taking naltrexone and other MOUD types are needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, 42017074249.

Consensus pregnancy-related criteria for suicide and unintentional overdoses using a Delphi process.

Suicide and unintentional overdose are leading manners of preventable death during and within a year of pregnancy. Recently, the Utah Maternal Mortality Review Committee (MMRC) developed 10 criteria to guide pregnancy-related classification of these deaths. Our objective was to (1) evaluate if consensus could be reached across experts in maternal mortality review when applying criteria to the determination of pregnancy-relatedness in mock MMRC case evaluation and (2) assess how additional case information shifted participants' determination of pregnancy-relatedness in these mock cases. We used a modified Delphi process to evaluate criteria for pregnancy-related suicides and unintentional overdose. The study team developed base case scenarios to reflect the 10 proposed criteria. Base scenarios varied in timing of death (prenatal or delivery, early postpartum (<6 months), late postpartum (6-12 months)) and level of additional information available (e.g., informant interviews, social media posts). Consensus in favor of a criterion was met when ≥75% of participants identified a case as pregnancy-related in at least 1 scenario. Fifty-eight participants, representing 48 MMRCs, reviewed scenarios. Of 10 proposed criteria, 8 reached consensus. Overall, participants classified 19.4% of base case scenarios as pregnancy-related, which increased to 56.8% with additional information. Pregnancy-related classification changed across timing of death and with availability of additional information (prenatal or delivery 27.7% versus 84.6%; early postpartum 30.0% versus 58.3%; late postpartum 0.0% versus 25.0%, respectively). We identified consensus supporting the application of 8 standardized criteria in MMRC determinations of pregnancy-relatedness among suicide and unintentional overdose deaths.

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.

BACKGROUND AND AIMS: Patient navigation (PN) may benefit pregnant individuals with opioid use disorder (OUD) by improving treatment adherence. We examined participant enrollment, session delivery and assessment feasibility for a PN intervention among pregnant participants and compared PN preliminary effectiveness for OUD treatment engagement with participants in usual care (UC). DESIGN: This study was a pilot single-blinded multi-site randomized trial. SETTING: Two academic medical centers in Pennsylvania (n = 57) and Utah (n = 45), United States participated. PARTICIPANTS: One hundred and two pregnant adult participants unestablished (fewer than 6 weeks) on medication for OUD (MOUD) were randomized to PN (n = 53) or UC (n = 49). INTERVENTION: PN was composed of 10 prenatal sessions (delivered after baseline but before the prenatal assessments) and four postnatal sessions (delivered before the 2- and 6-month postpartum assessments) focused upon OUD treatment and physical/mental health needs. UC involved brief case management. MEASUREMENTS: Feasibility assessments included consent, session delivery and assessment rates. Mixed-effect models for intent-to-treat (ITT) and per protocol (PP, received six or more sessions) populations were estimated to compare outcomes of MOUD use, secondary outcomes of substance use disorder (SUD) treatment attendance and non-prescribed opioid use, and exploratory outcome of overdose at baseline, predelivery and 2 and 6 months postpartum. FINDINGS: We consented 87% (106 of 122) of the proposed target, delivered ~60% of sessions delivered and completed ≥ 75% assessments. PN ITT and PP had better MOUD adherence, SUD treatment attendance, non-prescribed opioid use and overdose outcomes than UC. Notable changes included good evidence for greater percentage change in days for PN PP MOUD use from baseline to 2 months postpartum [PN = 28.0 versus UC = -10.9, 95% confidence interval (CI) = 9.7, 62.1] and some evidence for baseline to 6 months postpartum (PN = 45.4 versus UC = 23.4, 95% CI = -0.7, 48.2). PN PP percentage change in days for SUD treatment attendance also showed good evidence for improvements from baseline to prenatal assessment (PN = 7.4 versus UC = -21.3, 95% CI = 3.3, 53.5). PN compared to UC participants reported fewer overdoses at 2 months (PN = 11.9%/UC = 16.1%) and at 6 months postpartum (PN = 3.8%/UC = 6.2%). CONCLUSIONS: Patient navigation appears to be associated with improvements in opioid use disorder treatment engagement and overdoses during pregnancy. This pilot trial shows the feasibility of the intervention and a future large-scale trial.

Kratom Use Among Pregnant and Lactating Individuals With Substance Use Disorder.

OBJECTIVE: Kratom ( Mitragyna speciosa ) use in pregnancy is associated with maternal and neonatal opioid withdrawal syndrome. However, kratom use patterns in the population of peripartum and postpartum individuals with substance use disorder (SUD) are unknown. The aim of this study was to determine the proportion of pregnant and postpartum individuals with SUD who report using kratom in pregnancy or lactation and the reasons for their use. METHODS: We conducted an anonymous survey of pregnant and postpartum individuals receiving care at a single center's multidisciplinary prenatal clinic for individuals with SUD. We collected participants' demographic and pregnancy characteristics. We assessed ever use of kratom, kratom use during pregnancy or lactation, and reasons for kratom use. Descriptive statistics were used to summarize the data. RESULTS: From January 2021 to May 2021, a total of 80 surveys were collected (81% response rate of 98 eligible individuals). Most respondents were pregnant (n = 50 [62.5%]). The most frequent substance(s) of use were opioids (n = 50 [62.5%]) and methamphetamine (n = 39 [48.8%]). Many (n = 26 [32.5%]) reported ever use of kratom use. Of all respondents, 4 (5%) reported use during pregnancy, and 1 (1%) reported use during lactation. Kratom was primarily used to relieve opioid withdrawal symptoms and for relaxation, pain control, and stress relief. CONCLUSION: In a survey of pregnant and postpartum individuals with SUD at a single high-risk pregnancy clinic, ever use of kratom was frequent, whereas peripartum use was rare.

Postpartum Extended-Release Buprenorphine Tissue Necrosis.

BACKGROUND: Extended-release buprenorphine (XRB) may improve medication for opioid use disorder continuation among postpartum individuals. However, obstetric clinicians have relatively little experience with XRB. We describe two cases of XRB-related tissue necrosis in postpartum individuals to highlight recommended injection technique and management strategies for this rare complication. CASES: One patient developed tissue necrosis after her initial injection. Her wound was expectantly managed. Another patient on long-term XRB developed tissue necrosis within 1 day of injection. General surgery excised the depot. Both instances were attributed to injection of XRB intradermally rather than subcutaneously. Both patients continued monthly XRB without recurrence, suggesting that this complication is not an allergy. CONCLUSION: Clinicians should be able to prevent, recognize, and manage tissue necrosis, a rare complication of XRB injection.

The Fall of Roe v. Wade : The Addiction Specialist's Role in Championing Reproductive Rights.

Reproductive age-pregnant individuals who use substances are disproportionately impacted by the US Supreme Court reversal of Roe v. Wade . Because of historic and ongoing discrimination against pregnant individuals who use substances, this group is at high risk for inadequate pregnancy options counseling and lack of access to safe and legal abortions. Fetal rights laws set a concerning precedent that further criminalize and penalize substance use in pregnancy. As addiction specialists, we have the professional responsibility to champion the reproductive freedoms of pregnant individuals who use substances. There are several ways that addiction specialists can uphold the reproductive rights of patients on an individual, state, and federal level, including the following: incorporate reproductive healthcare into addiction practices, help those seeking abortion navigate barriers, partner with perinatal healthcare clinicians to provide evidence-based addiction treatment during pregnancy, and support decriminalization and destigmatization of substance use, especially in pregnancy.

Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device.

OBJECTIVE: To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)-cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management. METHODS: Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success , defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red blood cell, intensive care unit admission, and hysterectomy) were evaluated by blood loss before insertion. To assess safety, serious adverse events (SAEs) and adverse device effects were collected. All outcomes were summarized by mode of delivery; treatment success was summarized by bleeding cause (all causes, any atony, isolated atony, nonatony). RESULTS: In total, 800 individuals (530 vaginal births, 270 cesarean births) were treated with the device; 94.3% had uterine atony (alone or in combination with other causes). Median total blood loss at device insertion was 1,050 mL in vaginal births and 1,600 mL in cesarean births. Across all bleeding causes, the treatment success rate was 92.5% for vaginal births and was 83.7% for cesarean births (95.8% [n=307] and 88.2% [n=220], respectively, in isolated atony). Median indwelling time was 3.1 hours and 4.6 hours, respectively. In vaginal births, 14 SAEs were reported among 13 individuals (2.5%). In cesarean births, 22 SAEs were reported among 21 individuals (7.8%). Three (0.4%) SAEs were deemed possibly related to the device or procedure. No uterine perforations or deaths were reported. CONCLUSION: For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04995887.

Polysubstance Use in Pregnancy: Surveillance, Interventions, and Next Steps.

Substance use during pregnancy increases risk for a wide range of adverse maternal and neonatal health outcomes. Polysubstance use is common among people who use substances during pregnancy; however, the risks of combined substance exposures during pregnancy are poorly understood. In this report, we provide an overview of the activities of the Centers for Disease Control and Prevention (CDC) and partners and identified gaps related to (1) surveillance, (2) routine screening, and (3) prevention of polysubstance use during pregnancy. Efforts by CDC and other partners to reduce polysubstance use during pregnancy can improve the health of pregnant people and their infants and children.

Office-Based Management of Perinatal Substance Use and Substance Use Disorder for the General Obstetrician-Gynecologist.

This is a review of substance use and substance use disorder in pregnancy, intended for the generalist obstetrician-gynecologist. Herein, the authors discuss legal considerations, outline definitions, review screening tools, introduce special considerations and harm reduction, caution the use of urinary toxicology testing, and touch on the screening, brief intervention, and referral to treatment model. Furthermore, the authors provide a brief overview of the prevalence, maternal and neonatal risks, and treatment approaches for commonly used substances.

Pregnant and Postpartum Individuals' Knowledge, Attitudes, and Perceptions of Extended-release Buprenorphine for Treatment of Opioid Use Disorder.

OBJECTIVE: The objective of this study is to explore pregnant and postpartum individuals' knowledge, attitudes, and perceptions regarding extended-release buprenorphine (XR-BUP) treatment for opioid use disorder. METHODS: We conducted a paper-based survey of pregnant or postpartum individuals with opioid use disorder attending a multidisciplinary perinatal addiction specialty care clinic where XR-BUP is available. Participants' nonidentifiable demographic and treatment characteristics were collected, including duration and satisfaction of current medication for opioid use disorder. Participants' knowledge, attitudes, and perceptions about XR-BUP were assessed using a 5-point Likert scale. Descriptive statistics were used to summarize the data. RESULTS: From February 2021 to August 2021, 79 of 98 eligible participants completed the survey (81% response rate). More than 9 of 10 participants were currently taking medication for opioid use disorder, and 7 individuals (8.9%) were taking XR-BUP. Nearly half (49.4%) had never heard of XR-BUP, and 84.8% did not personally know anyone taking XR-BUP. However, 45.6% and 29.1% would consider an injectable medication for opioid use disorder to avoid trouble remembering to take their daily medications and avoid opioid withdrawal symptoms, respectfully. CONCLUSIONS: In a population of pregnant and postpartum individuals, nearly half were unaware of a monthly XR-BUP option for the treatment of opioid use disorder. Many were interested in considering this medication. Future studies are needed to rigorously assess outcomes associated with XR-BUP among pregnant and postpartum individuals with opioid use disorder.

Prospective acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder: A multisite qualitative study.

Background: While medications for opioid use disorder (MOUD) effectively treat OUD during pregnancy and the postpartum period, poor treatment retention is common. Digital phenotyping, or passive sensing data captured from personal mobile devices, namely smartphones, provides an opportunity to understand behaviors, psychological states, and social influences contributing to perinatal MOUD non-retention. Given this novel area of investigation, we conducted a qualitative study to determine the acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder (PPP-OUD). Methods: This study was guided by the Theoretical Framework of Acceptability (TFA). Within a clinical trial testing a behavioral health intervention for PPP-OUD, we used purposeful criterion sampling to recruit 11 participants who delivered a child in the past 12 months and received OUD treatment during pregnancy or the postpartum period. Data were collected through phone interviews using a structured interview guide based on four TFA constructs (affective attitude, burden, ethicality, self-efficacy). We used framework analysis to code, chart, and identify key patterns within the data. Results: Participants generally expressed positive attitudes about digital phenotyping and high self-efficacy and low anticipated burden to participate in studies that collect smartphone-based passive sensing data. Nonetheless, concerns were noted related to data privacy/security and sharing location information. Differences in participant assessments of burden were related to length of time required and level of remuneration to participate in a study. Interviewees voiced broad support for participating in a digital phenotyping study with known/trusted individuals but expressed concerns about third-party data sharing and government monitoring. Conclusion: Digital phenotyping methods were acceptable to PPP-OUD. Enhancements in acceptability include allowing participants to maintain control over which data are shared, limiting frequency of research contacts, aligning compensation with participant burden, and outlining data privacy/security protections on study materials.

Nonfatal Overdoses Among Pregnant Individuals With Opioid Use Disorder.

Little is understood about overdose history among pregnant individuals with opioid use disorder (OUD). We performed a cross-sectional secondary analysis of data from the OPTI-Mom 2.0 (Optimizing Pregnancy and Treatment Interventions for Moms 2.0) study (NCT03833245), a multi-site randomized controlled trial of patient navigation and usual care. We summarized participant demographics, overdose history, and substances involved in most recent overdose. Of the 102 participants with severe OUD included, 64.7% (95% CI 54.8-73.4%) had a reported a history of an overdose event and 41.2% (95% CI 31-52%) reported at least one overdose within the past year. In the most recent overdose, 81.8% (95% CI 70.4-89.5%) reported using opioids and 30.3% (95% CI 20.3-42.6%) reported using sedatives. These findings suggest need for heightened awareness of overdose-reduction and harm-reduction strategies in this population.

Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study.

INTRODUCTION: Pregnant individuals with substance use disorders face complex issues that may serve as barriers to treatment entry and retention. Several professional organizations have established recommendations on comprehensive, collaborative approaches to treatment to meet the needs of this population, but information on real-world application is lacking. Sites participating in the NIDA CTN0080 "Medication treatment for Opioid use disorder in expectant Mothers (MOMs)"-a randomized clinical trial of extended release compared to sublingual buprenorphine among pregnant and postpartum individuals (PPI)-were selected, in part, because they have a collaborative approach to treating PPI with opioid use disorder (OUD). However, organizational differences among sites and how they implement expert recommendations for collaborative care could impact study outcomes. METHODS: Prior to study launch at each of the 13 MOMs sites, investigators used the Pregnancy and Addiction Services Assessment (PAASA) to collect information about organizational factors. Input from a team of addiction, perinatal, and economic evaluation experts guided the development of the PAASA. Investigators programmed the PAASA into a web-based data system and summarized the resultant site data using descriptive statistics. RESULTS: Study sites represented four US census regions. Most sites were specialty obstetrics & gynecology (OB/GYN) programs providing OUD services (n = 9, 69.2 %), were affiliated with an academic institution (n = 11, 84.6 %), and prescribed buprenorphine in an ambulatory/outpatient setting (n = 11, 84.6 %); all sites offered access to naloxone. Sites reported that their population was primarily White, utilized public insurance, and faced numerous psychosocial barriers to treatment. Although all sites offered many services recommended by expert consensus groups, they varied in how they coordinated these services. CONCLUSIONS: By providing the organizational characteristics of sites participating in the MOMs study, this report assists in filling the current gap in knowledge regarding similar programs providing services to PPI with OUD. Collaborative care programs such as those participating in MOMs are uniquely positioned to participate in research to determine the most effective models of care and to determine how research can be integrated into those clinical care settings.