Jenna's Project: Preventing Overdose and Improving Recovery Outcomes for Women Leaving Incarcerated Settings during Pregnancy and Postpartum Periods.

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

The effects of prenatal exposure to opioids on early childhood development: context matters most.

INTRODUCTION: The opioid crisis has brought an increasing focus on the long-term outcomes of children following prenatal opioid exposure. Evidence to date has been conflicting, which has caused confusion and concern amongst parents, caregivers, social service providers, medical providers and policy makers. METHODS: This review systematically evaluated the highest quality studies relating prenatal exposure to opioids with early childhood developmental outcomes. It focused on developmental outcomes as measured by the Bayley Scales of Infant and Toddler Development, encompassing cognitive, motor, and psychosocial domains of child development. RESULTS: Although several articles reported correlations between prenatal opioid exposure and poor early childhood developmental outcomes, these relationships were no longer statistically significant after adjusting for socio-environmental factors. CONCLUSION: Additional research is needed to determine the extent of any relationship of socio-environmental factors with early childhood development in children prenatally exposed to opioids. This review suggests that socio-environmental factors may be significantly related to poor early childhood outcomes in the presence of prenatal opioid exposure.

Hospital admissions among patients with Comorbid Substance Use disorders: a secondary analysis of predictors from the NavSTAR Trial.

BACKGROUND: Individuals with substance use disorders (SUDs) frequently use acute hospital services. The Navigation Services to Avoid Rehospitalization (NavSTAR) trial found that a patient navigation intervention for hospitalized patients with comorbid SUDs reduced subsequent inpatient admissions compared to treatment-as-usual (TAU). METHODS: This secondary analysis extends previous findings from the NavSTAR trial by examining whether selected patient characteristics independently predicted hospital service utilization and moderated the effect of the NavSTAR intervention. Participants were 400 medical/surgical hospital patients with comorbid SUDs. We analyzed 30- and 90-day inpatient readmissions (one or more readmissions) and cumulative incidence of inpatient admissions through 12 months using multivariable logistic and negative binomial regression, respectively. RESULTS: Consistent with primary findings and controlling for patient factors, NavSTAR participants were less likely than TAU participants to be readmitted within 30 (P = 0.001) and 90 (P = 0.03) days and had fewer total readmissions over 12 months (P = 0.008). Hospitalization in the previous year (P < 0.001) was associated with cumulative readmissions over 12 months, whereas Medicaid insurance (P = 0.03) and index diagnoses of infection (P = 0.001) and injuries, poisonings, or procedural complications (P = 0.004) were associated with fewer readmissions. None of the selected covariates moderated the effect of the NavSTAR intervention. CONCLUSIONS: Previous findings showed that patient navigation could reduce repeat hospital admissions among patients with comorbid SUDs. Several patient factors were independently associated with readmission. Future research should investigate risk factors for hospital readmission among patients with comorbid SUDs to optimize interventions. TRIAL REGISTRATION: NIH ClinicalTrials.gov NCT02599818, Registered November 9, 2015 https://classic. CLINICALTRIALS: gov/ct2/show/NCT02599818 .

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.

The Relationship between Vaping Cannabis and Frequency of Cannabis Use and Cannabis-Related Problems among Urban High School Students.

Background: Vaping, including vaping cannabis, is increasing among adolescents. In this longitudinal study, we examined the relationship between vaping cannabis and frequency of cannabis use and related problems over 6 months among adolescents. Material and Methods: Data were from 233 participants (46.8% male, 93.1% African American, mean age = 16.4 years) reporting cannabis use. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) assessed frequency of past 30-day cannabis use and cannabis-related problems at baseline, 3- and 6-months post-baseline. We used latent growth curve modeling to compare vaping to non-vaping adolescents on trends in cannabis use frequency and ASSIST cannabis scores. Results: Adolescents who vaped cannabis (11.7%) had higher past 30-day frequency (mean = 17.89 days, SD = 10.49) of cannabis use at baseline compared to adolescents who had not vaped (mean = 12.1 days, SD = 10.93), but reported a significantly sharper decline in frequency of cannabis use (b = -0.34, p = 0.017). A significantly steeper decrease existed in the mean cannabis ASSIST scores for the vaping group than for the non-vaping group (b = -0.34, p = 0.014). Mean ASSIST scores on the cannabis subscale between the two groups were significantly different at 6-month follow-up (Vape mean = 6.00, SD = 8.12 vs. Non-vape mean = 9.6, SD = 9.39; p < 0.021). Conclusions: In a sample of cannabis-using adolescents, adolescents with experience vaping cannabis, compared to adolescents without vaping experience, on average reported sharper decreases in frequency of cannabis use and cannabis-related problems such as health or social problems.

Distributions of easy axes and reversal processes in patterned MRAM arrays.

The distribution of the easy-axes in an array of MRAM cells is a vital parameter to understand the switching and characteristics of the devices. By measuring the coercivity as a function of applied-field angle, and remaining close to the perpendicular orientation, a classic Stoner-Wohlfarth approximation has been applied to the resulting variation to determine the standard deviation, [Formula: see text], of a Gaussian distribution of the orientation of the easy-magnetisation directions. In this work we have compared MRAM arrays with nominal cells sizes of 20 nm and 60 nm and a range of free layer thicknesses. We have found that a smaller diameter cell will have a wider switching-field distribution with a standard deviation [Formula: see text]. The MRAM arrays consist of pillars produced by etching a multilayer thin film. This value of [Formula: see text] is dominated by pillar uniformity and edge effects controlling the reversal, reinforcing the need for ever-improving etch processes. This is compared to larger pillars, with distributions as low as [Formula: see text]. Furthermore we found that the distribution broadens from [Formula: see text] to [Formula: see text] with free layer thickness in larger pillars and that thinner films had a more uniform easy-axis orientation. For the 20 nm pillars the non-uniform size distribution of the pillars, with a large and unknown error in the free-layer volume, was highlighted as it was found that the activation volume for the reversal of the free layer 930 nm[Formula: see text] was larger than the nominal physical volume of the free layer. However for the 60 nm pillars, the activation volume was measured to be equal to one fifth of their physical volume. This implies that the smaller pillars effectively reverse as one entity while the larger pillars reverse via an incoherent mechanism of nucleation and propagation.

Comparing outcomes of extended-release naltrexone in adolescents and young adults with opioid use disorder.

INTRODUCTION: Opioid use among youth is a public health concern in the United States, with >3300 overdose deaths occurring nationally each year. Unfortunately, youth in the United States are still prescribed medication for opioid use disorder (OUD) at a lower rate than their adult counterparts. METHODS: From 10/2013 to 01/2018, adolescents (ages 15-17; n = 25) and young adults (ages 18-21; n = 263) with moderate to severe OUD enrolled in the parent trial of extended-release naltrexone (XR-NTX; n = 82) versus treatment-as-usual (TAU; either buprenorphine maintenance [n = 94] or counseling without buprenorphine maintenance [n = 112]). The study assessed opioid use outcomes for adolescents vs. young adults using timeline follow-back self-report procedures at baseline and 3-/6-month follow-up assessments. Mixed-effects longitudinal and clustered panel regression models compared treatment effects over time of XR-NTX and TAU on opioid use outcomes in this secondary analysis. RESULTS: Though adolescent participants reported significantly less opioid use at baseline relative to their young adult counterparts (p < 0.05), the two age groups reported similar rates of opioid use throughout the intervention period. Additionally, both adolescents and young adults receiving XR-NTX evidenced lower rates of opioid use than those receiving TAU at all time points, and adolescents on XR-NTX were the only group who reduced their opioid use at all time points. Mixed-effects models indicated adolescents receiving XR-NTX demonstrated a 48 % lower rate of opioid use days [Incidence Rate Ratio (IRR) = 0.52; p = 0.020], while young adults receiving XR-NTX reported an estimated 26 % lower rate (IRR = 0.74; p = 0.009). CONCLUSIONS: Results indicate that adolescents respond favorably to XR-NTX relative to TAU for treatment of OUD, demonstrating similar outcomes to young adults.

Health care use and cost of treatment for adolescents and young adults with opioid use disorder.

BACKGROUND: Few studies have examined the cost of medication for opioid use disorder (MOUD) with counseling for the adolescent and young adult population. This study calculated the health care utilization and cost of MOUD treatment, other substance use disorder treatment, and general health care for adolescents and young adults receiving treatment for opioid use disorder. METHODS: The study randomized youth ages 15 to 21 (N = 288) equally into the two study conditions: extended-release naltrexone (XR-NTX) or treatment as usual (TAU). While participants committed to treatment based on randomization the study observed considerable nonadherence to both randomized conditions. Instead of using the randomly assigned study conditions, we present descriptive costs by the type of MOUD treatment received: XR-NTX only, buprenorphine only, any other combination of MOUD treatments, and no MOUD. Health care use was aggregated over the 6-month period for each participant, and we calculated average/participant utilization for each treatment group. To determine participant costs, we multiplied the unit costs of health care services obtained from the literature by the reported amount of health care utilization for each participant. We then calculated the mean, standard error, median and IQR for MOUD costs, other substance use disorder treatment costs and general healthcare cost from the health care sector perspective. RESULTS: On average, participants in the XR-NTX only group received 2.6 doses of XR-NTX (equivalent to approximately 78 days of treatment). The buprenorphine only group had an average of 97 days of buprenorphine treatment. The XR-NTX only group had higher/patient costs compared to participants in the buprenorphine only group ($10,491 vs. $8765) and higher XR-NTX utilization would further increase costs. Participants in the any other MOUD combination group had the highest total costs ($14,627) while participants in the no MOUD group at the lowest ($3453). DISCUSSION: Our cost analysis calculates the real-world cost of MOUD treatment and, while not generalizable, provides policy makers an estimate of costs for adolescents and young adults. We found that participants in the XR-NTX only group received fewer days of medication compared to the buprenorphine only group, but their medication costs were higher due to the cost of XR-NTX injections. While the buprenorphine only group had the highest number of days of medication utilization of all the groups, the average number of days of medication utilization was considerably shorter than the six-month treatment period.

Sustainability of Adolescent Screening and Brief Intervention Services in Primary Care After Removal of Implementation Supports.

OBJECTIVE: Although many health care organizations have sought to increase the integration of substance use services into clinical practice, such practice changes can prove difficult to sustain. METHOD: Seven primary care clinics participated in an implementation study of screening and brief intervention (BI) services for adolescent patients (ages 12-17). All sites delivered screening and brief advice (BA) for low-risk use using a uniform protocol. Clinics were randomized to deliver BI using generalist (provider-delivered) or specialist (behavioral health clinician-delivered) models. Implementation was facilitated by multiple supporting activities (e.g., trainings, local "champion," electronic health record [EHR] integration of screening and documentation, individualized feedback, project-specific materials, etc.). Data on the penetration of screening, BA, and BI delivery (N = 14,486 adolescent patient visits) were abstracted from the EHR for the 20-month implementation phase and a 12-month sustainability phase (during which implementation supports were removed). RESULTS: Penetration of screening continued to slowly increase across the implementation-to-sustainability phases (62% vs. 70%; p = .04). Although uptake during implementation was low for BA (29%) and BI (22%), there was no significant decrease in service provision during the sustainability phase. Although overall delivery of BI was significantly higher in generalist compared with specialist sites (p < .001), sustainability did not differ by generalist versus specialist conditions. There were considerable differences in penetration across clinic sites. CONCLUSIONS: Clinics sustained a high level of substance use screening. Uptake of intervention services was low but did not decrease further following the cessation of implementation supports. This study illustrates the challenges of successfully implementing and sustaining substance use services in adolescent primary care.

Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention.

PURPOSE: The Facilitating Change for Excellence in SBIRT (FaCES) is a service package for adolescent primary care that was developed based on best practices and evidence, but was empirically untested. The aim of this study is to compare the FaCES intervention to treatment as usual (TAU) for rural adolescent primary care patients. METHODS: In this modified cluster-randomized stepped wedge design, providers who completed at least 20 adolescent TAU visits received training in the FaCES package in random order. Adolescent patients (N = 1,226) waiting for appointments were continuously recruited into the study and completed a baseline assessment before their scheduled appointment and an on-line 3-month follow-up. Participants received either FaCES or TAU, depending on whether their provider had been trained in FaCES. Due to COVID-19 disruptions, only 14 of the 29 providers were trained before study recruitment activities ceased. RESULTS: More than 80% of the sample indicated no prior use of tobacco, alcohol, or marijuana at study entry. The Arm × Time interaction failed to reach significance for the substance use outcomes considered. In the FaCES condition, the group with no prior use had an increased probability of substance use at 3-month follow-up, while the group reporting prior use had a decreased probability of use at follow-up. Participants who reported no use at baseline had an increased probability of use at follow-up, whether they received the FaCES intervention or TAU. DISCUSSION: This study was unable to demonstrate the effectiveness of FaCES. Findings suggest some natural movement in substance use risk over time.

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population.

BACKGROUND: A randomized clinical trial found that patient navigation for hospital patients with comorbid substance use disorders (SUDs) reduced emergency department (ED) and inpatient hospital utilization compared with treatment-as-usual. OBJECTIVE: To compare the cost and calculate any cost savings from the Navigation Services to Avoid Rehospitalization (NavSTAR) intervention over treatment-as-usual. RESEARCH DESIGN: This study calculates activity-based costs from the health care providers and uses a net benefits approach to calculate the cost savings generated from NavSTAR. NavSTAR provided patient navigation focused on engagement in SUD treatment, starting before hospital discharge and continuing for up to 3 months postdischarge. SUBJECTS: Adult hospitalized medical/surgical patients with comorbid SUD for opioids, cocaine, and/or alcohol. COST MEASURES: Cost of the 3-month NavSTAR patient navigation intervention and the cost of all inpatient days and ED visits over a 12-month period. RESULTS OF BASE CASE ANALYSIS: NavSTAR generated $17,780 per participant in cost savings. Ninety-seven percent of bootstrapped samples generated positive cost savings, and our sensitivity analyses did not change our results. LIMITATIONS: Participants were recruited at one hospital in Baltimore, MD through the hospital's addiction consultation service. Findings may not generalize to the broader population. Outpatient health care cost data was not available through administrative records. CONCLUSION: Our findings show that patient navigation interventions should be considered by payors and policy makers to reduce the high hospital costs associated with comorbid SUD patients.

Costs and Implementation Effectiveness of Generalist Versus Specialist Models for Adolescent Screening and Brief Intervention in Primary Care.

OBJECTIVE: This study analyzed the marginal service and program costs, and conducted a cost-effectiveness analysis (CEA) of two models of implementation of adolescent substance screening, brief intervention, and referral to treatment (SBIRT). METHOD: SBIRT was implemented at seven clinics in a multisite, cluster-randomized trial, through a Specialist model (behavioral health counselor-delivered brief intervention), and a Generalist model (primary care provider-delivered brief intervention). The CEA calculated marginal costs using an activity-based costing methodology for direct SBIRT services, and effectiveness was measured by the proportion of brief interventions delivered among patients who screened positive for alcohol, tobacco, or other drugs. Site-level program costs comprised start-up and maintenance (training and technical assistance). Costs were estimated in 2017 U.S. dollars. RESULTS: The marginal cost of SBIRT per patient with a positive screen for brief intervention was $6.72 in the Specialist model and $6.05 in the Generalist model. Implementation effectiveness was 7.2% (SE = 2.9%) in the Specialist model and 37.7% (SE = 5.6%) in the Generalist model. The program costs to provide SBIRT for 1 year per site were $13,548 for the Specialist site and $12,081 for the Generalist. CONCLUSIONS: The Generalist model was more effective in implementing brief intervention and less expensive than the Specialist model. Results were robust to sensitivity analysis. Brief intervention delivered by primary care providers rather than by handoff to a behavioral health counselor may ensure greater penetration and a lower cost of these services in primary care settings.

Increasing knowledge about recovery-related life domains among pregnant and parenting women in comprehensive substance use disorder treatment: The Art of Addiction Recovery Program.

BACKGROUND: Group treatments designed specifically for pregnant and parenting women with substance use disorders are lacking. This study provides a preliminary assessment of the Art of Addiction Recovery Program, a manualized group treatment imbedded within a comprehensive substance use disorder treatment program for pregnant and parenting women. METHODS: The Program consists of 14 sessions, each focusing on a different topic, including health, social relationships, the recovery process, well-being, and introspection. Each session includes both the presentation of information by a facilitator, group discussions guided by the facilitator, and a creative project. A single-group pretest-posttest design provides an initial evaluation of the Art of Addiction Recovery Program. RESULTS: Participants were 51 women with an average age of 28.7 (SD = 5.0) with most (69%) having a primary opioid use disorder and 82% reporting tobacco use. Significant (ps < 0.001) pre- to post-session increases in session-specific knowledge occurred for all 14 sessions with a measure of multivariate association indicating that these changes were substantial. Ratings of learning and effectiveness were generally high, with 19/28 means at 3.7 or above (maximum score = 4). CONCLUSIONS: Findings suggest that The Art of Addiction Recovery Program was effective in conveying knowledge about substance use and recovery, and that participants increased their knowledge and generally strongly agreed that the sessions provided high levels of learning and were highly effective. The Art of Addiction Recovery Program provides an option for those seeking a manual-based group treatment program as an aid in the treatment process for this subpopulation.

Sexually Transmitted Infection Testing After Brief Intervention for Risk Behaviors in School-Based Health Centers.

PURPOSE: The initiation and escalation of substance use and sex behaviors is prevalent during adolescence. School-based health centers (SBHCs) are well-equipped to provide interventions for risky behaviors and offer sexually transmitted infection (STI) testing services. This study examined receipt of STI testing following brief intervention (BI) among sexually active adolescents. METHODS: This is a secondary analysis of data from a randomized trial comparing computer versus nurse practitioner-delivered BI approaches among adolescents (ages 14-18) with risky alcohol and/or cannabis use at two SBHCs within two urban high schools. Associations were examined among receipt of STI testing and participant characteristics, BI format, site, and frequency of substance use/sexual behaviors. RESULTS: Among sexually active participants (N = 254), 64.2% received STI testing at their SBHC within 6 months of receiving a BI. Participants receiving nurse practitioner-delivered BI had higher odds of getting STI testing than participants receiving computer-delivered BI (adjusted odds ratio 2.51, 95% confidence interval 1.41-4.47, p = .002). Other variables associated with STI testing in multivariable logistic regression included female sex (p = .001), being in a serious relationship (p = .018), and SBHC site (p < .001). Frequency of substance use and sexual risk behaviors were not independently associated with receipt of STI testing services. CONCLUSION: Sexually active adolescents who received in-person BI from a nurse practitioner were more likely to get STI testing than adolescents who received BI via computer. Nurse practitioners working in SBHCs can successfully engage adolescents in additional sexual health services subsequent to BI for risky behaviors.

Opioid agonist treatment initiation and linkage for hospitalized patients seen by a substance use disorder consultation service.

Background: Facilitating opioid agonist treatment (OAT) for opioid use disorder (OUD) is an important role of hospital substance use disorder (SUD) consultation services. In the NavSTAR trial, hospital patients receiving SUD consultation who were randomly assigned to patient navigation services for 3 months post-discharge had fewer readmissions compared to usual care. Methods: This secondary analysis examined hospital-based OAT initiation (pre-randomization) and community-based OAT linkage (post-discharge) among NavSTAR trial participants with OUD (N=314). Associations between OAT initiation and linkage, and patient demographics, housing status, comorbid SUD diagnoses, recent substance use, and study condition were examined using multinomial and dichotomous logistic regression. Results: Overall, 57.6% initiated OAT during hospitalization (36.3% methadone, 21.3% buprenorphine). Compared to participants not initiating OAT, participants who received methadone were more likely to be female (Relative Risk Ratio [RRR]=2.05, 95% CI=1.11, 3.82, p=0.02), while participants who received buprenorphine were more likely to report homelessness (RRR=2.57, 95% CI=1.24, 5.32, p=0.01). Compared to participants initiating methadone, participants initiating buprenorphine were more likely to be non-White (RRR=3.89; 95% CI=1.55, 9.70; p=0.004) and to report prior buprenorphine treatment (RRR=2.57; 95% CI=1.27, 5.20; p=0.009). OAT linkage within 30-days post-discharge was associated with hospital-based buprenorphine initiation (Adjusted Odds Ratio [AOR]=3.86, 95% CI=1.73, 8.61, p=0.001) and patient navigation intervention (AOR=2.97, 95% CI=1.60, 5.52, p=0.001). Conclusions: OAT initiation differed by sex, race, and housing status. Hospital-based OAT initiation and patient navigation were independently associated with linkage to community-based OAT. Hospitalization is a reachable moment to begin OAT to alleviate withdrawal and facilitate treatment continuity post-discharge.

Extended-release naltrexone for youth with opioid use disorder.

BACKGROUND: Few published research studies have examined the effectiveness of extended-release naltrexone (XR-NTX) for the treatment of opioid use disorder (OUD) among adolescents and young adults. METHODS: This two-group randomized controlled trial recruited 288 youth, ages 15-21, with moderate/severe OUD from a residential addiction treatment program in Baltimore, Maryland. The study randomized the youth within the first week of treatment entry to receive either XR-NTX or treatment-as-usual (TAU; either buprenorphine maintenance treatment or treatment without OUD medication following medically managed withdrawal) prior to discharge, with continued treatment in the community for 6 months. However, due to various reasons spanning patients' and caregivers' preferences and constraints, considerable participant nonadherence to randomized condition occurred (i.e., only 30% of the participants randomized to XR-NTX received an initial injection, while 27% of participants randomized to TAU received an XR-NTX injection at treatment discharge, instead of their assigned treatment). The study used generalized linear mixed modeling (GLiMM) to examine self-reported 90-day opioid, cocaine, marijuana, and alcohol use as well as DSM-5 OUD criteria on "intention-to-treat" (as randomized), "as-received" (XR-NTX vs. not XR-NTX), and "as-medicated" (XR-NTX vs. buprenorphine vs. no medication) bases. RESULTS: The condition x time interactions in the intention-to-treat analyses failed to reach significance for past-90-day self-reported use of illicit opioids, cocaine, marijuana, or alcohol, or in meeting DSM-5 OUD criteria at 3 or 6 months [all ps > 0.05]. However, these findings are of limited interpretive value due to participant nonadherence to their randomized condition. When the study analyzed results by the treatment received at discharge, the "as-received" group x time interaction for illicit opioid use was significant [p = .003], with the XR-NTX group reporting less opioid use in the past 90 days at 3 and 6 months. Participants who received their first XR-NTX dose at inpatient discharge (n = 82) received, on average, 1.3 subsequent injections in the community over the 6-month study follow-up period. Only 2 of the 82 study participants received XR-NTX continuously through the 6-month postdischarge follow-up period. Twelve serious adverse events (SAEs) occurred during the study, but the study determined that only 1 was possibly study related (hepatitis C/elevated liver function test results). CONCLUSION: None of the condition x time interactions in the intention-to-treat analyses reached significance. Participants' nonadherence may have contributed to the failure to reject the null hypothesis. Irrespective of randomized condition, participants who received XR-NTX for OUD demonstrated low retention in treatment, receiving an average of only 1.3 subsequent injections, yet reported less opioid use at follow-up than participants who did not received XR-NTX. Treatment programs should consider XR-NTX as a treatment option for youth motivated to receive it. Future research should focus on building developmentally informed strategies to improve uptake of and adherence to relapse prevention medication in this population.

Preventing Hospital Readmission for Patients With Comorbid Substance Use Disorder : A Randomized Trial.

BACKGROUND: Hospitalized patients with comorbid substance use disorders (SUDs) are at high risk for poor outcomes, including readmission and emergency department (ED) use. OBJECTIVE: To determine whether patient navigation services reduce hospital readmissions. DESIGN: Randomized controlled trial comparing Navigation Services to Avoid Rehospitalization (NavSTAR) versus treatment as usual (TAU). (ClinicalTrials.gov: NCT02599818). SETTING: Urban academic hospital in Baltimore, Maryland, with an SUD consultation service. PARTICIPANTS: 400 hospitalized adults with comorbid SUD (opioid, cocaine, or alcohol). INTERVENTION: NavSTAR used proactive case management, advocacy, service linkage, and motivational support to resolve internal and external barriers to care and address SUD, medical, and basic needs for 3 months after discharge. MEASUREMENTS: Data on inpatient readmissions (primary outcome) and ED visits for 12 months were obtained for all participants via the regional health information exchange. Entry into SUD treatment, substance use, and related outcomes were assessed at 3-, 6-, and 12-month follow-up. RESULTS: Participants had high levels of acute care use: 69% had an inpatient readmission and 79% visited the ED over the 12-month observation period. Event rates per 1000 person-days were 6.05 (NavSTAR) versus 8.13 (TAU) for inpatient admissions (hazard ratio, 0.74 [95% CI, 0.58 to 0.96]; P = 0.020) and 17.66 (NavSTAR) versus 27.85 (TAU) for ED visits (hazard ratio, 0.66 [CI, 0.49 to 0.89]; P = 0.006). Participants in the NavSTAR group were less likely to have an inpatient readmission within 30 days than those receiving TAU (15.5% vs. 30.0%; P < 0.001) and were more likely to enter community SUD treatment after discharge (P = 0.014; treatment entry within 3 months, 50.3% NavSTAR vs. 35.3% TAU). LIMITATION: Single-site trial, which limits generalizability. CONCLUSION: Patient navigation reduced inpatient readmissions and ED visits in this clinically challenging sample of hospitalized patients with comorbid SUDs. PRIMARY FUNDING SOURCE: National Institute on Drug Abuse.

Sex and female empowerment (SAFE): A randomized trial comparing sexual health interventions for women in treatment for opioid use disorder.

BACKGROUND: Unintended pregnancies are prevalent among women with opioid use disorder (OUD). The Sex and Female Empowerment (SAFE) project developed a social-cognitive, theory-driven intervention to increase acceptance of and adherence to contraceptive practices among women receiving medication for OUD (MOUD). This study evaluated the feasibility and acceptability of two SAFE interventions (Face-to-face and Computer-adapted) compared to usual care as well as their efficacy to improve contraception utilization. METHODS: This pilot randomized trial enrolled 90 heterosexual, non-pregnant, reproductive-age women receiving MOUD. Participants were randomized into either a: SAFE Face-to-face intervention, SAFE Computer-adapted intervention, or usual care (UC) condition (n = 30 each) and followed for 6 months. Outcome measures included intervention completion, intervention satisfaction, attendance at a contraception consultation appointment, and long-acting reversible contraceptive (LARC) method receipt. A generalized linear model was used for inferential testing and to estimate least squares means (predicted probabilities for binary outcomes) and their standard errors. RESULTS: Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) = 0.97 (.03) and 0.97 (.03), respectively, vs. 0.53 (.09); ps<.001], higher intervention satisfaction [Ms (SEs) = 3.7 (.11) and 3.8 (.11), respectively, vs. 3.1 (.11); ps<0.001), higher contraception consultation visit attendance [Ms(SEs) = 0.80 (.07) and 0.73 (.08) vs. 0.33 (.09); p < .001], and greater LARC receipt [Ms(SEs) = 0.77 (.08) and 0.73 (.08) vs. 0.23 (.08); p < .001). CONCLUSIONS: SAFE appears feasible and efficacious for supporting women in contraception decision-making. Integrating SAFE into women's comprehensive OUD treatment services holds promise to increase contraceptive decision-making and initiation of a chosen method.

An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: A per-protocol and completers analysis.

BACKGROUND: The distinct pharmacological properties and clinical uses of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) present challenges in analyzing patient outcomes. METHODS: We conducted a secondary analysis of a multi-site randomized trial comparing XR-NTX with sublingual BUP-NX treatment for opioid use disorder initiated during inpatient detoxification and continued in outpatient treatment. Urine testing data for non-study opioids from the last 22 weeks of the 24-week trial were analyzed in both a per-protocol sample (n = 474 participants who received at least one dose of medication) and a completers sample (n = 211 participants who received all XR-NTX doses or all BUP-NX prescriptions). The present analyses sought to identify differences in the weekly percentages of opioid-positive urine tests between participants treated with the two medications. RESULTS: The proportion of opioid-positive tests in both conditions was less than 20 % for 21 of the 22 weeks in the per-protocol sample and all 22 weeks in the completers sample. Generalized linear mixed model analyses revealed a significant treatment (XR-NTX vs. BUP-NX) X week (weeks 3-24) interaction in the per-protocol sample but not the completers sample. In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks. CONCLUSIONS: Longitudinal modeling approaches that utilize flexible procedures for handling missing data can offer a different perspective on study findings. Results from the present analyses suggest that XR-NTX appeared to be somewhat more effective than BUP-NX in reducing illicit opioid use in the per-protocol sample.