Perspectives of Clinicians and Staff at Community-Based Opioid Use Disorder Treatment Settings on Linkages With Emergency Department-Initiated Buprenorphine Programs.

Importance: An increasing number of emergency departments (EDs) are initiating buprenorphine for opioid use disorder (OUD) and linking patients to ongoing community-based treatment, yet community-based clinician and staff perspectives regarding this practice have not been characterized. Objective: To explore perspectives and experiences regarding ED-initiated buprenorphine among community-based clinicians and staff in geographically distinct regions. Design, Setting, and Participants: This qualitative study reports findings from Project ED Health, a hybrid type 3 effectiveness-implementation study designed to evaluate the impact of implementation facilitation on ED-initiated buprenorphine with referral to ongoing medication treatment. Clinicians and staff from community-based treatment programs were identified by urban academic EDs as potential referral sites for ongoing OUD treatment in 4 cities across the US in a formative evaluation as having the capability to continue medication treatment. Focus groups were held from April 1, 2018, to January 11, 2019, to examine community OUD treatment clinician and staff perspectives on accepting patients who have received ED-initiated buprenorphine. Data were analyzed from August 2020 to August 2022. Main Outcomes and Measures: Data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework, focusing on domains including evidence, context, and facilitation. Results: A total of 103 individuals (mean [SD] age, 45.3 [12.0] years; 76 female and 64 White) participated in 14 focus groups (groups ranged from 3-22 participants). Participants shared negative attitudes toward buprenorphine and variable attitudes toward ED-initiated buprenorphine. Prominent barriers included the community site treatment capacity and structure as well as payment and regulatory barriers. Perceived factors that could facilitate this model included additional substance use disorder training for ED staff, referrals and communication, greater inclusion of peer navigators, and addressing sociostructural marginalization that patients faced. Conclusions and Relevance: In this study of community-based clinicians and staff positioned to deliver OUD treatment, participants reported many barriers to successful linkages for patients who received ED-initiated buprenorphine. Strategies to improve these linkages included educating communities and programs, modeling low-barrier philosophies, and using additional staff trained in addiction as resources to improve transitions from EDs to community partners.

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.

Implementation Facilitation to Promote Emergency Department-Initiated Buprenorphine for Opioid Use Disorder.

Importance: Emergency department (ED)-initiated buprenorphine for the treatment of opioid use disorder (OUD) is underused. Objective: To evaluate whether provision of ED-initiated buprenorphine with referral for OUD increased after implementation facilitation (IF), an educational and implementation strategy. Design, Setting, and Participants: This multisite hybrid type 3 effectiveness-implementation nonrandomized trial compared grand rounds with IF, with pre-post 12-month baseline and IF evaluation periods, at 4 academic EDs. The study was conducted from April 1, 2017, to November 30, 2020. Participants were ED and community clinicians treating patients with OUD and observational cohorts of ED patients with untreated OUD. Data were analyzed from July 16, 2021, to July 14, 2022. Exposure: A 60-minute in-person grand rounds was compared with IF, a multicomponent facilitation strategy that engaged local champions, developed protocols, and provided learning collaboratives and performance feedback. Main Outcomes and Measures: The primary outcomes were the rate of patients in the observational cohorts who received ED-initiated buprenorphine with referral for OUD treatment (primary implementation outcome) and the rate of patients engaged in OUD treatment at 30 days after enrollment (effectiveness outcome). Additional implementation outcomes included the numbers of ED clinicians with an X-waiver to prescribe buprenorphine and ED visits with buprenorphine administered or prescribed and naloxone dispensed or prescribed. Results: A total of 394 patients were enrolled during the baseline evaluation period and 362 patients were enrolled during the IF evaluation period across all sites, for a total of 756 patients (540 [71.4%] male; mean [SD] age, 39.3 [11.7] years), with 223 Black patients (29.5%) and 394 White patients (52.1%). The cohort included 420 patients (55.6%) who were unemployed, and 431 patients (57.0%) reported unstable housing. Two patients (0.5%) received ED-initiated buprenorphine during the baseline period, compared with 53 patients (14.6%) during the IF evaluation period (P < .001). Forty patients (10.2%) were engaged with OUD treatment during the baseline period, compared with 59 patients (16.3%) during the IF evaluation period (P = .01). Patients in the IF evaluation period who received ED-initiated buprenorphine were more likely to be in treatment at 30 days (19 of 53 patients [35.8%]) than those who did not 40 of 309 patients (12.9%; P < .001). Additionally, there were increases in the numbers of ED clinicians with an X-waiver (from 11 to 196 clinicians) and ED visits with provision of buprenorphine (from 259 to 1256 visits) and naloxone (from 535 to 1091 visits). Conclusions and Relevance: In this multicenter effectiveness-implementation nonrandomized trial, rates of ED-initiated buprenorphine and engagement in OUD treatment were higher in the IF period, especially among patients who received ED-initiated buprenorphine. Trial Registration: ClinicalTrials.gov Identifier: NCT03023930.

What to Expect With Pregnant or Postpartum Prescribing of Extended-Release Buprenorphine (CAM2038).

Weekly and monthly CAM2038 (Brixadi®) extended-release subcutaneous buprenorphine (XR bup) has been available in Europe and Australia for several years and was approved by the Food and Drug Administration in May 2023. Little is known about the clinical experience of patients and providers using this new medication during prenatal care. Two cases of pregnant persons with opioid use disorder receiving weekly XR bup in an ongoing randomized multi-site outpatient clinical trial are presented along with a brief review of the pharmacology and literature on XR bup formulations. The cases in pregnancy illustrate how treatment with the weekly formulation is initiated including how to make dose adjustments, which may be necessary given the longer half-life; it takes 1 month to achieve steady state. Injection site pain with medication administration was time limited and managed readily. Other injection site reactions experienced included subcutaneous erythema and induration that was delayed in onset and typically mild, resolving with minimal intervention. Delivery management and breastfeeding recommendations while on weekly XR bup were not different compared to sublingual buprenorphine (SL bup). Weekly XR bup is a new treatment for opioid use disorder that may be used in the obstetric population. Obstetric and addiction medicine clinicians should be aware of this new formulation as its use is expected to increase.

Racial Inequities in Breastfeeding Counseling Among Pregnant People Who Use Cannabis.

We examined how breastfeeding advice in the context of cannabis use differed by race and ethnicity. Data from the 2017-2018 PRAMS (Pregnancy Risk Assessment Monitoring System) survey were used to assess differences in breastfeeding guidance related to cannabis use among 1,213 individuals who self-reported cannabis use 3 months before or during pregnancy. A multivariable logistic regression model was specified to examine the extent to which the odds of receiving prenatal advice against breastfeeding if using cannabis differed by self-reported race and ethnicity. We found that non-Hispanic Black people were four times more likely than non-Hispanic White people to be advised against breastfeeding if using cannabis (adjusted odds ratio 4.1, 95% CI 2.1-8.2). Pregnant non-Hispanic Black people were disproportionately advised not to breastfeed if using cannabis.

Breastfeeding Initiation and Continuation Among Women with Substance and Tobacco Use During Pregnancy: Findings from the Pregnancy Risk Assessment Monitoring System 2016-2018.

Background and Aims: Substance and tobacco use is associated with poor maternal and child health outcomes. Although these have each been linked to lower breastfeeding rates when examined separately, studies have yet to examine how the combination of tobacco and other substance use influences breastfeeding initiation and continuation. The aim of this study was to examine how the combination of smoking tobacco and use of illicit substances influences the odds of breastfeeding initiation and continuation. Materials and Methods: This retrospective cohort study (n = 15,634) used survey data from the 2016-2018 Centers for Disease Control and Prevention (CDC) Pregnancy Risk Assessment Monitoring System from eight US states to examine the association of tobacco and illicit substance use with breastfeeding initiation and continuation (≥6 weeks). The odds of breastfeeding initiation and continuation for individuals with and without prenatal tobacco and illicit substance use, adjusting for maternal and infant characteristics, were estimated using weighted, multivariable logistic regression models. Results: The combination of prenatal tobacco and illicit substance use was associated with a 42% reduction in the odds of initiating breastfeeding (adjusted odds ratio [aOR] 0.58 [95% confidence interval, CI 0.39-0.87]) and a 39% reduction in the odds of breastfeeding for at least 6 weeks (aOR 0.61 [95% CI 0.41-0.92]) when compared with those without tobacco and substance use. Conclusion: The odds of breastfeeding initiation and continuation are significantly lower among individuals with both prenatal tobacco and illicit substance use. Future studies are needed to identify barriers to breastfeeding within this population, to inform patient-centered interventions aimed at overcoming these barriers.

Substance Use and Utilization of Prenatal and Postpartum Care.

OBJECTIVES: Prenatal and postpartum care for women with substance use is important due to increased risk of poor health outcomes. The influence of substance use on perinatal care utilization is not well characterized, especially postpartum care. The objective of this study was to examine the effect of substance use during pregnancy on prenatal and postpartum care utilization in a nationally representative sample and to identify maternal characteristics associated with inadequate prenatal and postpartum care among women with substance use. METHODS: Pregnancy Risk Assessment Monitoring System data (2016-2018) from 8 states were used for this study. Logistic regression models adjusted for complex survey weights and confounder variables were used to estimate the odds of not receiving adequate prenatal care and postpartum care. Weighted Rao-Scott chi-square tests were used to examine maternal characteristics associated with care utilization among women who reported substance use during pregnancy. RESULTS: The study included 15,131 women, with 5.3% who reported illicit substance use during pregnancy. In multivariable models, substance use was associated with an increase in the odds of not receiving adequate prenatal care (OR 1.69, CI 1.32, 2.17) and not receiving postpartum care (OR: 1.47, CI 1.10, 1.95). Among women who reported substance use, depression and smoking status were associated with not receiving adequate prenatal or postpartum care. CONCLUSIONS: Substance use during pregnancy is independently associated with disparities in prenatal and postpartum care access. Future studies are needed to identify how barriers lead to care inequalities and importantly, to identify strategies to improve care utilization.

The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists.

Background: The use of peer interventionists may be helpful in addressing problems associated with substance use disorders. However, implementation issues such as training, supervision, and the impact of delivering the intervention on the interventionists themselves require additional examination. This report describes the training methods and peer interventionist outcomes in a pilot study of a single-session Peer Recovery Support Services (PRSS) telephone intervention to facilitate enrollment in medication for opioid use disorder (MOUD) treatment. Methods: This was a secondary analysis of a pilot study testing a PRSS intervention in adults using illicit opioids who reported a recent non-fatal opioid overdose (N = 80, with 40 PRSS participants). Candidates recruited from MOUD treatment programs were trained to deliver the PRSS intervention. Assessments of adverse events, global health, and peer satisfaction were used to evaluate the effects of serving as an interventionist. Fidelity and proportion of cases enrolling in MOUD were calculated for each interventionist. Results: Four consented candidates were trained to deliver the PRSS intervention to thirty-six study participants (90% PRSS arm). All interventionists successfully maintained fidelity to the PRSS intervention and reported no negative effects. Interventionists experienced differential success in encouraging treatment enrollment ranging from 16%-60% of their cases. Conclusions: This pilot study demonstrates promise in utilizing peer interventionists to deliver a brief PRSS intervention with limited training and no reported negative effects on the interventionists themselves. Factors contributing to the differential success of the interventionists are unclear. Future research on the variable efficacy of peer interventionists is warranted to identify, quantify, and evaluate specific interactional elements associated with peer efficacy. Additionally, further evaluation of training, supervision practices, and the effects of serving as a PRSS interventionist, is needed. Trial Registration: Clinical Trials.gov http://www.clinicaltrials.gov; Identifier: NCT02922959.

Pandemic-Related Disruptions in Nursing Education: Zooming Out for an Innovative Interprofessional Simulation.

When the COVID-19 global pandemic began, many higher education systems had to restructure their educational delivery system and transition to online learning. This posed a challenge for students in health professions education programs as it impacted their ability to participate in hands-on learning regarding patient care. As a result, the University of Cincinnati College of Nursing developed and implemented simulation-based learning experiences to allow graduate-level social worker, counselor, and psychiatric-mental health nurse practitioner students the opportunity to learn as an interdisciplinary team in a virtual format. The Opioid Use Disorder Simulation Case Study discussed in this article was developed as part of the Serving At-risk Youth Fellowship Experience Training program with the overarching aim to prepare culturally competent providers to deliver direct patient care and education around prevention and recovery services to individuals with substance use disorders.

A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.

BACKGROUND: Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs. METHOD: This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS. RESULTS: Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X2 = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants. CONCLUSIONS: The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.

Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.

BACKGROUND: Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD). METHOD: A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect. RESULTS: PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization. CONCLUSIONS: PTOEND may be effective for promoting harm reduction and treatment readiness.

Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.

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.

Association of methadone dose with substance use and treatment retention in pregnant and postpartum women with opioid use disorder.

BACKGROUND: In non-pregnant individuals being treated for opioid use disorder (OUD) with methadone, doses ≥60mg per day are associated with improved treatment retention and decreased illicit opioid use. Although methadone remains the first line treatment for OUD in pregnant women, there are no studies replicating this finding in pregnancy. METHODS: We conducted a retrospective cohort study of 189 pregnant women treated with methadone for OUD from 2006 to 2013. Chart data collected included demographics, pregnancy dates, methadone doses, and urine drug screen (UDS) results. RESULTS: Treatment retention at delivery was significantly higher for subjects taking ≥60mg of methadone (90.1% v. 74.1% p<0.005), as was treatment retention at 60days postpartum (71.6% v. 37.0%, p<0.0001). Percent of UDS results negative for illicit substances during pregnancy was also significantly higher for subjects taking ≥60mg (71.5% v. 58.0%, p<0.04). There was no significant difference in UDS results in the first 60days postpartum (63.9% v. 68.1%). Generalized linear models showed a significant positive relationship between methadone dose and treatment retention at delivery (p<0.02) and at 60days postpartum (p<0.004) as well as a significant positive relationship between length of time in treatment and treatment retention at delivery (p<0.04) and at 60days postpartum (p<0.007). Maternal age and percent of negative UDS results were not predictive of treatment retention in either model and there was no significant interaction effect between methadone dose and percent negative UDS results. CONCLUSIONS: In this cohort, women taking ≥60mg of methadone during pregnancy were more likely to remain in treatment and to provide urine samples negative for illicit drugs. Multivariate modeling suggested a dose dependent response across the entire dose range, rather than a threshold effect at 60mg.

Patient perspectives on an opioid overdose education and naloxone distribution program in the U.S. Department of Veterans Affairs.

BACKGROUND: In an effort to prevent opioid overdose mortality among Veterans, Department of Veterans Affairs (VA) facilities began implementing opioid overdose education and naloxone distribution (OEND) in 2013 and a national program began in 2014. VA is the first national health care system to implement OEND. The goal of this study is to examine patient perceptions of OEND training and naloxone kits. METHODS: Four focus groups were conducted between December 2014 and February 2015 with 21 patients trained in OEND. Participants were recruited from a VA residential facility in California with a substance use disorder treatment program (mandatory OEND training) and a homeless program (optional OEND training). Data were analyzed using matrices and open and closed coding approaches to identify participants' perspectives on OEND training including benefits, concerns, differing opinions, and suggestions for improvement. RESULTS: Veterans thought OEND training was interesting, novel, and empowering, and that naloxone kits will save lives. Some veterans expressed concern about using syringes in the kits. A few patients who never used opioids were not interested in receiving kits. Veterans had differing opinions about legal and liability issues, whether naloxone kits might contribute to relapse, and whether and how to involve family in training. Some veterans expressed uncertainty about the effects of naloxone. Suggested improvements included active learning approaches, enhanced training materials, and increased advertisement. CONCLUSIONS: OEND training was generally well received among study participants, including those with no indication for a naloxone kit. Patients described a need for OEND and believed it could save lives. Patient feedback on OEND training benefits, concerns, opinions, and suggestions provides important insights to inform future OEND training programs both within VA and in other health care settings. Training is critical to maximizing the potential for OEND to save lives, and this study includes specific suggestions for improving the effectiveness and acceptability of training.

Risk factors for opioid overdose and awareness of overdose risk among veterans prescribed chronic opioids for addiction or pain.

Rising overdose fatalities among U.S. veterans suggest veterans taking prescription opioids may be at risk for overdose. However, it is unclear whether veterans prescribed chronic opioids are aware of this risk. The objective of this study was to identify risk factors and determine awareness of risk for opioid overdose in veterans treated with opioids for chronic pain, using veterans treated with methadone or buprenorphine for opioid use disorder as a high-risk comparator group. In the current study, 90 veterans on chronic opioid medication, for either opioid use disorder or pain management, completed a questionnaire assessing risk factors, knowledge, and self-estimate of risk for overdose. Nearly all veterans in both groups had multiple overdose risk factors, although individuals in the pain management group had on average a significantly lower total number of risk factors than did individuals in the opioid use disorder group (5.9 versus 8.5, p < .0001). On average, participants treated for pain management scored slightly but significantly lower on knowledge of opioid overdose risk factors (12.1 versus 13.5, p < .01). About 70% of participants, regardless of group, believed their overdose risk was below that of the average American adult. There was no significant relationship between self-estimate of overdose risk and either number or knowledge of opioid overdose risk factors. Our results suggest that veterans in both groups underestimated their risk for opioid overdose. Expansion of overdose education to include individuals on chronic opioids for pain management and a shift in educational approaches to overdose prevention may be indicated.

Barriers to implementation of opioid overdose prevention programs in Ohio.

BACKGROUND: Nationally, overdose fatalities have reached epidemic proportions. Ohio has one of the highest overdose death rates in the country, as well as high rates of prescription opioid trafficking. METHODS: A cross-sectional self-report survey of opioid overdose prevention programs (OOPPs) in Ohio was conducted between August and October 2014 to characterize programs and ascertain barriers to successful implementation. A 91% response rate was achieved with 18 programs participating in the study. RESULTS: The first Ohio OOPP opened in August 2012, a second program opened in 2013, and the remaining programs began in 2014. All of the programs distribute nasal naloxone and provide overdose prevention education, and 89% (n = 16) provide overdose kits for free. Six OOPPs are funded by the Ohio Department of Health, 3 programs are funded by a local health foundation, and several other public and private funding sources were reported. The OOPPs have funding to distribute a combined total of 8,670 overdose kits and had distributed 1998 kits by October 2014. The OOPPs reported 149 overdose reversals. Fifteen programs (83%) reported implementation barriers that were categorized as stigma-, cost-, staffing-, legal, regulatory, and client-related problems. Legislative changes aimed at removing some of the obstacles to distribution and lay administration of naloxone have recently been enacted in Ohio. CONCLUSIONS: OOPPs have rapidly expanded in Ohio during the past 3 years. Although recent legislative changes have addressed some of the reported implementation barriers, stigma and the cost of naloxone remain significant problems.

Pharmacological Management of Opioid Use Disorder in Pregnant Women.

Opioid misuse during pregnancy is associated with negative outcomes for both mother and fetus due not only to the physiological effects of the drug but also to the associated social, medical and mental health problems that accompany illicit drug use. An interdisciplinary approach to the treatment of opioid use disorder during pregnancy is most effective. Ideally, obstetric and substance use treatment are co-located and ancillary support services are readily available. Medication-assisted treatment with methadone or buprenorphine is intrinsic to evidence-based care for the opioid-using pregnant woman. Women who are not stabilized on an opioid maintenance medication experience high rates of relapse and worse outcomes. Methadone has been the mainstay of maintenance treatment for nearly 50 years, but recent research has found that both methadone and buprenorphine maintenance treatments significantly improve maternal, fetal and neonatal outcomes. Although methadone remains the current standard of care, the field is beginning to move towards buprenorphine maintenance as a first-line treatment for pregnant women with opioid use disorder, because of its greater availability and evidence of better neonatal outcomes than methadone. However, there is some evidence that treatment dropout may be greater with buprenorphine relative to methadone.

Medication assisted treatment discontinuation in pregnant and postpartum women with opioid use disorder.

BACKGROUND: Increasing use of opioids has led to an increase in the number of pregnant and postpartum women in medication assisted treatment (MAT) for opioid use disorder. METHODS: We (1) conducted a systematic review of published literature on MAT discontinuation (methadone and buprenorphine) in pregnant and postpartum women and (2) determined methadone discontinuation rates in a retrospective cohort (2006-2013) of pregnant and postpartum women in a university affiliated methadone clinic. RESULTS: We found limited generalizable literature reports of discontinuation rates, with a range of prenatal discontinuation rates from 0 to 33% and rates which spanned various prenatal and postnatal periods from 26 to 64%. In our cohort of 229 women, 251 pregnancies were reported, with a prenatal methadone discontinuation rate of 11.0%. Based on a Cox proportional hazards model controlling for age, pregnancy outcome, and duration of treatment prior to delivery, the probability of methadone discontinuation at or before 6 months postpartum was 56.0%. Duration of methadone treatment prior to delivery was inversely associated with risk for postpartum discontinuation of treatment (HR = 0.98, 95% CI (0.96, 0.99)). CONCLUSIONS: We conclude that the postpartum period is a time of increased risk for discontinuation of MAT. More accurate assessment of rates of pre- and postpartum MAT discontinuation, as well as further investigation of factors affecting these rates, is warranted. Development and testing of interventions to encourage early prenatal enrollment in MAT and improve postnatal retention in MAT would benefit pregnant women and new mothers with opioid use disorder.

Design considerations for point-of-care clinical trials comparing methadone and buprenorphine treatment for opioid dependence in pregnancy and for neonatal abstinence syndrome.

RATIONALE: In recent years, the U.S. has experienced a significant increase in the prevalence of pregnant opioid-dependent women and of neonatal abstinence syndrome (NAS), which is caused by withdrawal from in-utero drug exposure. While methadone-maintenance currently is the standard of care for opioid dependence during pregnancy, research suggests that buprenorphine-maintenance may be associated with shorter infant hospital lengths of stay (LOS) relative to methadone-maintenance. There is no "gold standard" treatment for NAS but there is evidence that buprenorphine, relative to morphine or methadone, treatment may reduce LOS and length of treatment. DESIGN: Point-of-care clinical trial (POCCT) designs, maximizing external validity while reducing cost and complexity associated with classic randomized clinical trials, were selected for two planned trials to compare methadone to buprenorphine treatment for opioid dependence during pregnancy and for NAS. This paper describes design considerations for the Medication-assisted treatment for Opioid-dependent expecting Mothers (MOMs; estimated N = 370) and Investigation of Narcotics for Ameliorating Neonatal abstinence syndrome on Time in hospital (INFANTs; estimated N = 284) POCCTs, both of which are randomized, intent-to-treat, two-group trials. Outcomes would be obtained from participants' electronic health record at three participating hospitals. Additionally, a subset of infants in the INFANTs POCCT would be from mothers in the MOMs POCCT and, thus, potential interaction between medication treatment of mother and infant could be evaluated. CONCLUSION: This pair of planned POCCTs would evaluate the comparative effectiveness of treatments for opioid dependence during pregnancy and for NAS. The results could have a significant impact on practice.