Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.

BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

Characterizing Multisystem Barriers to Women's Residential SUD Treatment: A Multisite Qualitative Analysis in Los Angeles.

Residential substance use disorder (SUD) treatment programs are challenged by the differing values of the problem-solving court (PSC) and child welfare (CW) systems, along with communication barriers between staff. This study aimed to understand, from the viewpoints of SUD treatment providers, how divergent values and communication barriers adversely affect women's residential SUD treatment. We conducted qualitative semistructured interviews with 18 SUD treatment clinicians and six directors from four women's residential SUD treatment programs. Using a thematic analysis framework, we identified salient themes across specified codes. Analysis revealed six main themes, suggesting differing values and communication barriers across the SUD, PSC, and CW systems adversely affect the provision of SUD treatment. For differing values, three main themes emerged: (a) unaddressed trauma and fear of mental health treatment seeking; (b) perceptions of mothers with a SUD; and (c) the Adoption and Safe Families Act (ASFA) timeline as a barrier to SUD treatment provision. For communication barriers, three themes emerged: (a) inadequate communication and responsiveness with PSC and CW systems adversely affect treatment coordination, induce patient stress, and treatment disengagement; (b) lack of PSC and CW communication regarding child visitation planning adversely affects treatment motivation and retention; and (c) competing ASFA, PSC, and CW priorities and inadequate cross-system communication adversely affect treatment planning. Treatment providers face significant barriers in providing effective treatment to women simultaneously involved in the CW and PSC systems. Aligning values and addressing communication barriers, changes in policy, and enhanced cross-system training are crucial. Additionally, it is essential to reevaluate the ASFA timeline to align with the long-term treatment needs of mothers with a SUD. Further research should explore the viewpoints of patients, CW, and PSC staff to gain deeper insights into these SUD treatment barriers.

Experiences of and recommendations for LGBTQ+-affirming substance use services: an exploratory qualitative descriptive study with LGBTQ+ people who use opioids and other drugs.

BACKGROUND: Lesbian, gay, bisexual, transgender, queer, and other LGBTQ populations (LGBTQ+; e.g., asexual individuals) have higher rates of substance use (SU) and disorders (SUD) compared to heterosexual and cisgender populations. Such disparities can be attributed to minority stress, including stigma and discrimination in healthcare settings. LGBTQ+-affirming SU treatment and related services remain limited. The purpose of this exploratory qualitative descriptive study was to characterize LGBTQ+ people's experiences in SU services and recommendations for LGBTQ+- affirming care. METHODS: We conducted demographic surveys (characterized using descriptive statistics) and individual qualitative interviews with N = 23 LGBTQ+ people. We employed flexible coding and a thematic analysis approach to describe participants' experiences with stigma, discrimination, and support within SU services at the patient-, staff-, and organizational-level; and participant recommendations for how to make such services LGBTQ+-affirming. We highlighted components of minority stress and mitigators of adverse stress responses throughout our thematic analysis. RESULTS: Patient-level experiences included bullying, name-calling, sexual harassment, and physical distancing from peers; and support via community-building with LGBTQ+ peers. Staff-level experiences included name-calling, denial of services, misgendering, lack of intervention in peer bullying, and assumptions about participants' sexuality; and support via staff advocacy for LGBTQ+ patients, holistic treatment models, and openly LGBTQ+ staff. Organizational-level experiences included stigma in binary gendered program structures; and support from programs with gender-affirming groups and housing, and in visual cues (e.g., rainbow flags) of affirming care. Stigma and discrimination led to minority stress processes like identity concealment and stress coping responses like SU relapse; support facilitated SU treatment engagement and retention. Recommendations for LGBTQ+-affirming care included non-discrimination policies, LGBTQ+-specific programming, hiring LGBTQ+ staff, routine staff sensitivity training, and gender-inclusive program structures. CONCLUSIONS: LGBTQ+ people experience stigma and discrimination within SU services; supportive and affirming care is vital to reducing treatment barriers and promoting positive health outcomes. The current study offers concrete recommendations for how to deliver LGBTQ+-affirming care, which could reduce SU disparities and drug overdose mortality overall.

An Approach to Enhancing Medication Treatment for Opioid Use Disorder in the HEALing Communities Study.

The HEALing (Helping to End Addiction Long-term) Communities Study (HCS) aims to test the effectiveness of the Communities That HEAL intervention in decreasing opioid overdose deaths in 67 communities across four U.S. states. This intervention enlists a collaborative team of researchers, academic experts, and community coalitions to select and implement interventions from a menu of evidence-based practices, including medications for opioid use disorder (MOUD). The HCS's New York team developed an integrated network systems (INS) approach with a mapping tool to coach coalitions in the selection of strategies to enhance medication treatment. With the INS approach, community coalitions develop a map of service delivery venues in their local county to better engage people with medication treatment wherever this need arises. The map is structured around core services that can provide maintenance MOUD and satellite services, which include all settings where people with opioid use disorder are encountered and can be identified, possibly given medication, and referred to core programs for ongoing MOUD care. This article describes the rationale for the INS mapping tool, with a discussion framed by the consolidated framework for implementation research, and provides a case example of its application.

Predictors of urine toxicology and other biologic specimen missingness in randomized trials of substance use disorders.

BACKGROUND: High levels of missing outcome data for biologically confirmed substance use (BCSU) threaten the validity of substance use disorder (SUD) clinical trials. Underlying attributes of clinical trials could explain BCSU missingness and identify targets for improved trial design. METHODS: We reviewed 21 clinical trials funded by the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) and published from 2005 to 2018 that examined pharmacologic and psychosocial interventions for SUD. We used configurational analysis-a Boolean algebra approach that identifies an attribute or combination of attributes predictive of an outcome-to identify trial design features and participant characteristics associated with high levels of BCSU missingness. Associations were identified by configuration complexity, consistency, coverage, and robustness. We limited results using a consistency threshold of 0.75 and summarized model fit using the product of consistency and coverage. RESULTS: For trial design features, the final solution consisted of two pathways: psychosocial treatment as a trial intervention OR larger trial arm size (complexity=2, consistency=0.79, coverage=0.93, robustness score=0.71). For participant characteristics, the final solution consisted of two pathways: interventions targeting individuals with poly- or nonspecific substance use OR younger age (complexity=2, consistency=0.75, coverage=0.86, robustness score=1.00). CONCLUSIONS: Psychosocial treatments, larger trial arm size, interventions targeting individuals with poly- or nonspecific substance use, and younger age among trial participants were predictive of missing BCSU data in SUD clinical trials. Interventions to mitigate missing data that focus on these attributes may reduce threats to validity and improve utility of SUD clinical trials.

Provider perspectives on the impact of COVID-19 on treatment of substance use and opioid use disorders among American Indian and Alaska Native adults.

Introduction: American Indian/Alaska Native (AI/AN) communities are more likely to suffer negative consequences related to substance misuse. The COVID-19 pandemic exacerbated the opioid poisoning crisis, in combination with ongoing treatment barriers resulting from settler-colonialism, systemic oppression and racial discrimination. AI/AN adults are at greatest risk of COVID-19 related serious illness and death. In collaboration with an Indigenous community advisory board and Tribal leadership, this study explored AI/AN treatment provider perceptions of client-relatives' (i.e., SUD treatment recipients) experiences during the pandemic from 2020 to 2022. Methods: Providers who underwent screening and were eligible to participate (N = 25) represented 6 programs and organizations serving rural and urban areas in Washington, Utah, and Minnesota. Participants engaged in audio-recorded 60-90 min semi-structured individual interviews conducted virtually via Zoom. The interview guide included 15 questions covering regulatory changes, guidance for telemedicine, policy and procedures, staff communication, and client-relatives' reactions to implemented changes, service utilization, changes in treatment modality, and perceptions of impact on their roles and practice. Interview recordings were transcribed and de-identified. Members of the research team independently reviewed transcripts before reaching consensus. Coding was completed in Dedoose, followed by analyses informed by a qualitative descriptive approach. Results: Five main domains were identified related to client-relative experiences during the COVID-19 pandemic, as observed by providers: (1) accessibility, (2) co-occurring mental health, (3) social determinants of health, (4) substance use, coping, and harm reduction strategies, and (5) community strengths. Providers reported the distinctive experiences of AI/AN communities, highlighting the impact on client-relatives, who faced challenges such as reduced income, heightened grief and loss, and elevated rates of substance use and opioid-related poisonings. Community and culturally informed programming promoting resilience and healing are outlined. Conclusion: Findings underscore the impact on SUD among AI/AN communities during the COVID-19 pandemic. Identifying treatment barriers and mental health impacts on client-relatives during a global pandemic can inform ongoing and future culturally responsive SUD prevention and treatment strategies. Elevating collective voice to strengthen Indigenous informed systems of care to address the gap in culturally-and community-based services, can bolster holistic approaches and long-term service needs to promote SUD prevention efforts beyond emergency response efforts.

Wiidookaage'win: Beta-test of a Facebook group intervention for Native women to support opioid use recovery.

INTRODUCTION: The ongoing opioid misuse epidemic has had a marked impact on American Indian/Alaska Native (AI/AN) communities. Culture- and gender-specific barriers to medically assisted recovery from opioid use disorder (OUD) have been identified, exacerbating its impact for AI/AN women. Wiidookaage'win is a community-based participatory research study that aims to develop a culturally tailored, moderated, private Facebook group intervention to support Minnesotan AI/AN women in medically assisted recovery from OUD. The current study assessed the preliminary feasibility and acceptability of the intervention in a beta-test to inform refinements before conducting a pilot randomized controlled trial (RCT). METHODS: The intervention was beta-tested for 30 days. Moderators were trained prior to delivering the intervention. Study assessments were conducted at baseline and post-intervention. The post-intervention assessments included substance use (self-report and urine drug screen), treatment acceptability, mental health, and spirituality outcomes. We examined intervention engagement patterns using Facebook metrics and qualitatively explored common topics that emerged in participant posts and comments. RESULTS: Ten AI/AN women taking medication for OUD (MOUD) were accrued (age range 25-62 years). Participants had been in opioid recovery a mean of 15.2 months (SD = 16.1; range = 3-60). The study participation rate (accrued/eligible) was 91 %. Nine participants completed the post-intervention survey assessment and eight completed a UDS. Acceptability was high based on the mean treatment satisfaction score (M = 4.8, SD = 0.2 out of a possible 5.0), Facebook group engagement, and positive qualitative feedback. All participants retained at post-intervention continued their MOUD treatment, and none had returned to opioid use. CONCLUSIONS: The beta-test indicated that the Facebook platform and study procedures generally worked as intended and that the intervention was largely acceptable to study participants. The results of this study phase provided valuable insights to inform refinements prior to conducting a pilot RCT to further assess the feasibility, acceptability, and potential efficacy of the intervention.

Effect of the Communities that HEAL intervention on receipt of behavioral therapies for opioid use disorder: A cluster randomized wait-list controlled trial.

BACKGROUND: The U.S. opioid overdose crisis persists. Outpatient behavioral health services (BHS) are essential components of a comprehensive response to opioid use disorder and overdose fatalities. The Helping to End Addiction Long-Term® (HEALing) Communities Study developed the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in 67 communities in Kentucky, Ohio, New York, and Massachusetts through the implementation of evidence-based practices (EBPs), including BHS. This paper compares the rate of individuals receiving outpatient BHS in Wave 1 intervention communities (n = 34) to waitlisted Wave 2 communities (n = 33). METHODS: Medicaid data included individuals ≥18 years of age receiving any of five BHS categories: intensive outpatient, outpatient, case management, peer support, and case management or peer support. Negative binomial regression models estimated the rate of receiving each BHS for Wave 1 and Wave 2. Effect modification analyses evaluated changes in the effect of the CTH intervention between Wave 1 and Wave 2 by research site, rurality, age, sex, and race/ethnicity. RESULTS: No significant differences were detected between intervention and waitlisted communities in the rate of individuals receiving any of the five BHS categories. None of the interaction effects used to test the effect modification were significant. CONCLUSIONS: Several factors should be considered when interpreting results-no significant intervention effects were observed through Medicaid claims data, the best available data source but limited in terms of capturing individuals reached by the intervention. Also, the 12-month evaluation window may have been too brief to see improved outcomes considering the time required to stand-up BHS. TRIAL REGISTRATION: Clinical Trials.gov http://www. CLINICALTRIALS: gov: Identifier: NCT04111939.

Post-Dobbs Challenges in Research and Patient Protections.

This Viewpoint describes the challenges for clinical research and participant protections following the US Supreme Court ruling in Dobbs v Jackson Women's Health Organization.