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Objective Distribution of take-home naloxone (THN) by emergency services may increase access to THN and reduce deaths and morbidity from opioid overdose. As part of a feasibility study for a randomised controlled trial (RCT) of distribution of THN kits and education within ambulance services and Emergency Departments (EDs), we used qualitative methods to explore key stakeholders’ perceptions of feasibility and acceptability of delivering the trial. Methods We undertook semi-structured interviews and focus groups with 26 people who use opioids and with 20 paramedics and ED staff from two intervention sites between 2019 and 2021. Interviews and focus groups were recorded, transcribed verbatim and analysed using Framework Analysis. Results People using opioids reported high awareness of overdose management, including personal experience of THN use. Staff perceived emergency service provision of THN as a low-cost, low-risk intervention with potential to reduce mortality, morbidity and health service use. Staff understood the trial aims and considered it compatible with their work. All participants supported widening access to THN but reported limited trial recruitment opportunities partly due to difficulties in consenting patients during overdose. Procedural problems, restrictive recruitment protocols, limited staff buy-in and patients already owning THN limited trial recruitment. Determining trial effectiveness was challenging due to high levels of alternative community provision of THN. Conclusions Distribution of THN in emergency settings was considered feasible and acceptable for stakeholders but an RCT to establish the effectiveness of THN delivery is unlikely to generate further useful evidence due to difficulties in recruiting patients and assessing benefits.

Objectives. To determine whether the Communities That HEAL (CTH) intervention is effective in increasing naloxone distribution compared with usual care. Methods. The HEALing (Helping to End Addiction Long-Term) Communities Study (HCS) is a cluster-randomized, parallel-arm, wait-list controlled implementation science trial testing the impact of the CTH intervention on increasing the use of evidence-based practices to lower opioid-related overdose deaths. Communities (n = 67) highly impacted by opioid overdose in Kentucky, Massachusetts, New York, and Ohio were allocated to CTH intervention (n = 34) or wait-list comparison (usual care; n = 33) arms. The primary outcome for this study was the number of naloxone units distributed in HCS communities during the comparison period (July 1, 2021‒June 30, 2022), examined using an intent-to-treat negative binomial regression model. Results. Naloxone distribution was 79% higher in the CTH intervention versus usual care arm (adjusted relative rate = 1.79; 95% confidence interval = 1.28, 2.51; P = .001; adjusted rates of naloxone distribution 3378 vs 1884 naloxone units per 100 000 residents), when controlling for urban‒rural status, state, baseline opioid-related overdose death rate, and baseline naloxone distribution rate. Conclusions. The CTH intervention increased naloxone distribution compared with usual care in communities highly impacted by the opioid crisis. Trial Registration. ClinicalTrials.gov identifier: NCT04111939. ( Am J Public Health. 2025;115(1):83–94. https://doi.org/10.2105/AJPH.2024.307845 )

How to mitigate the dramatic increase in the number of self-inflicted deaths from suicide, alcohol-related liver disease, and drug overdose among young adults has become a critical public health question. A promising area of study looks at interventions designed to address risk factors for the behaviors that precede these —often denoted—“deaths of despair.” This paper examines whether a childhood intervention can have persistent positive effects by reducing adolescent and young adulthood (age 25) behaviors that precede these deaths, including suicidal ideation, suicide attempts, hazardous drinking, and opioid use. These analyses test the impact and mechanisms of action of Fast Track (FT), a comprehensive childhood intervention designed to decrease aggression and delinquency in at-risk kindergarteners. We find that random assignment to FT significantly decreases the probability of exhibiting any behavior of despair in adolescence and young adulthood. In addition, the intervention decreases the probability of suicidal ideation and hazardous drinking in adolescence and young adulthood as well as opioid use in young adulthood. Additional analyses indicate that FT’s improvements to children’s interpersonal (e.g., prosocial behavior, authority acceptance), intrapersonal (e.g., emotional recognition and regulation, social problem solving), and academic skills in elementary and middle school partially mediate the intervention effect on adolescent and young adult behaviors of despair and self-destruction. FT’s improvements to interpersonal skills emerge as the strongest indirect pathway to reduce these harmful behaviors. This study provides evidence that childhood interventions designed to improve these skills can decrease the behaviors associated with premature mortality.

BackgroundAlthough naloxone prevents opioid overdose deaths, few patients prescribed opioids receive naloxone, limiting its effectiveness in real-world settings. Barriers to naloxone prescribing include concerns that naloxone could increase risk behavior and limited time to provide necessary patient education.ObjectiveTo determine whether pharmacy-based naloxone co-dispensing affected opioid risk behavior. Secondary objectives were to assess if co-dispensing increased naloxone acquisition, increased patient knowledge about naloxone administration, and affected opioid dose and other substance use.DesignCluster randomized pragmatic trial of naloxone co-dispensing.SettingSafety-net health system in Denver, Colorado, between 2017 and 2020.ParticipantsSeven pharmacies were randomized. Pharmacy patients (N=768) receiving opioids were followed using automated data for 10 months. Pharmacy patients were also invited to complete surveys at baseline, 4 months, and 8 months; 325 survey participants were enrolled from November 15, 2017, to January 8, 2019.InterventionIntervention pharmacies implemented workflows to co-dispense naloxone while usual care pharmacies provided usual services.Main MeasuresSurvey instruments assessed opioid risk behavior; hazardous drinking; tobacco, cannabis, and other drug use; and knowledge. Naloxone dispensings and opioid dose were evaluated using pharmacy data among pharmacy patients and survey participants. Intention-to-treat analyses were conducted using generalized linear mixed models accounting for clustering at the pharmacy level.Key ResultsOpioid risk behavior did not differ by trial group (P=0.52; 8-month vs. baseline adjusted risk ratio [ARR] 1.07; 95% CI 0.78, 1.47). Compared with usual care pharmacies, naloxone dispensings were higher in intervention pharmacies (ARR 3.38; 95% CI 2.21, 5.15) and participant knowledge increased (P=0.02; 8-month vs. baseline adjusted mean difference 1.05; 95% CI 0.06, 2.04). There was no difference in other substance use by the trial group.ConclusionCo-dispensing naloxone with opioids effectively increased naloxone receipt and knowledge but did not increase self-reported risk behavior.Trial RegistrationRegistered at ClinicalTrials.gov; Identifier: NCT03337100

Objectives. To determine the Connect intervention’s effectiveness in reducing substance use among rural and tribal adolescents in northeastern Oklahoma. Methods. We conducted a 2-arm cluster randomized trial from 2021 to 2024, with 10 high schools per condition. Results. At baseline, 919 students were enrolled (mean age = 15 years), and the majority were American Indian or White. Alcohol-use days during the past 30 days was reduced by 18% per survey wave in the intervention compared with the control condition (rate ratio [RR] = 0.82; 95% confidence interval [CI] = 0.72, 0.93; t = −3.02; P = .003), binge drinking was reduced by 26% (RR = 0.74; 95% CI = 0.64, 0.86; t = −3.90; P < .001), cannabis use was reduced by 11% (RR = 0.89; 95% CI = 0.80, 1.00; t = −2.03; P = .04), and prescription opioid misuse was reduced by 40% (RR = 0.60; 95% CI = 0.43, 0.85; t = −2.86; P = .004). Model-predicted means revealed the control condition followed the expected developmental trajectory of increased substance use and the intervention condition showed a flat or decreasing use pattern. Conclusions. The Connect intervention prevented the typical escalation of substance use during adolescence. Trial Registration. ClinicalTrials.gov NCT04839978. Registered on April 9, 2021. Version 10, April 30, 2025. ( Am J Public Health. 2025;115(9):1508–1517. https://doi.org/10.2105/AJPH.2025.308205 )

Background The United States (US) continues to face decades-long increases in opioid overdose fatalities. As an opioid overdose reversal medication, naloxone can dramatically reduce opioid overdose mortality rates when distributed to people likely to experience or witness an opioid overdose and packaged with education on its use, known as overdose education and naloxone distribution (OEND). Syringe services programs (SSPs) are ideal venues for OEND with staff who are culturally competent in providing services for people who are at risk of experiencing or observing an opioid overdose. We carried out a randomized controlled trial of SSPs to understand the effectiveness of the organize and mobilize for implementation effectiveness (OMIE) approach at improving OEND implementation effectiveness within SSPs. Methods Using simple randomization, 105 SSPs were enrolled into the trial and assigned to one of two study arms — (1) dissemination of OEND best practice recommendations (Control SSPs) or the OMIE approach along with dissemination of the OEND best practice recommendations (i.e., OMIE SSPs). OMIE SSPs could participate in 60-min OMIE sessions once a month for up to 12 months. At 12-month post-baseline, 102 of 105 SSPs (97%) responded to the follow-up survey. Results The median number of sessions completed by OMIE SSPs was 10. Comparing OMIE SSPs to control SSPs, we observed significant increases in the number of participants receiving naloxone (incidence rate ratio: 2.15; 95% CI : 1.42, 3.25; p  < 0.01) and the rate of naloxone doses distributed per SSP participant (adjusted incidence rate ratio: 1.97; 95% CI : 1.18, 3.30; p  = 0.01). We observed no statistically significant difference in the number of adopted best practices between conditions (difference in means 0.2, 95% CI : − 0.7, 1.0; p  = 0.68). We also observed a threshold effect where SSPs receiving a higher OMIE dose had greater effect sizes with regard to the number of people given naloxone and the number of naloxone doses distributed. Conclusions In conclusion, the multifaceted OMIE approach was effective at increasing naloxone distribution from SSPs, despite substantial external shocks during the trial. These findings have major implications for addressing the overdose crisis, which has continued unabated for decades. Trial registration ClinicalTrials.gov, NCT03924505 . Registered 19 April 2019.

Background Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips can identify fentanyl and some fentanyl analogs in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. Fentanyl test strips are a promising harm reduction strategy; however, little is known about the real-world acceptability and impact of fentanyl test strip use. This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs. Methods The research team will recruit 2400 individuals ≥ 18 years with self-reported use of illicit drugs or drugs purchased on the street within the past 6 months. Recruitment will occur at opioid overdose education and naloxone distribution programs in 16 urban and 12 rural Ohio counties. Participating sites will be randomized at the county level to the intervention or non-intervention study arm. A brief fentanyl test strip educational intervention and fentanyl test strips will be provided to participants recruited from sites in the intervention arm. These participants will be eligible to receive additional fentanyl test strips for 2 years post-enrollment. Participants recruited from sites in the non-intervention arm will not receive fentanyl test strip education or fentanyl test strips. All participants will be followed for 2 years post-enrollment using biweekly, quarterly, and 6-month surveys. Primary outcomes include (1) identification of perceived barriers and facilitating factors associated with incorporating fentanyl test strip education and distribution into opioid overdose education and naloxone distribution programs; (2) differences in knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for reducing overdose risk between the intervention and non-intervention groups; and (3) differences in non-fatal and fatal overdose rates between the intervention and non-intervention groups. Discussion Findings from this cluster randomized controlled trial will contribute valuable information about the feasibility, acceptability, and impact of integrating fentanyl test strip drug checking in rural and urban communities in Ohio and help guide future overdose prevention interventions. Trial registration ClinicalTrials.gov NCT05463341. Registered on July 19, 2022. https://clinicaltrials.gov/study/NCT05463341

Background Overdoses have surged in rural areas in the U.S. and globally for years, but harm reduction interventions have lagged. Overdose education and naloxone distribution (OEND) programs reduce overdose mortality, but little is known about people who use drugs’ (PWUD) experience with these interventions in rural areas. Here, we analyze qualitative data with rural PWUD to learn about participants’ experiences with an OEND intervention, and about how participants’ perceptions of their rural risk environments influenced the interventions’ effects. Methods Twenty-nine one-on-one, semi-structured qualitative interviews were conducted with rural PWUD engaged in the CARE2HOPE OEND intervention in Appalachian Kentucky. Interviews were conducted via Zoom, audio-recorded, and transcribed verbatim. Thematic analysis was conducted, guided by the Rural Risk Environment Framework. Results Participants’ naloxone experiences were shaped by all domains of their rural risk environments. The OEND intervention transformed participants’ roles locally, so they became an essential component of the local rural healthcare environment. The intervention provided access to naloxone and information, thereby increasing PWUDs’ confidence in naloxone administration. Through the intervention, over half of participants gained knowledge on naloxone (access points, administration technique) and on the criminal-legal environment as it pertained to naloxone. Most participants opted to accept and carry naloxone, citing factors related to the social environment (responsibility to their community) and physical/healthcare environments (overdose prevalence, suboptimal emergency response systems). Over half of participants described recent experiences administering intervention-provided naloxone. These experiences were shaped by features of the local rural social environment (anticipated negative reaction from recipients, prior naloxone conversations). Conclusions By providing naloxone paired with non-stigmatizing health and policy information, the OEND intervention offered support that allowed participants to become a part of the healthcare environment. Findings highlight need for more OEND interventions; outreach to rural PWUD on local policy that impacts them; tailored strategies to help rural PWUD engage in productive dialogue with peers about naloxone and navigate interpersonal conflict associated with overdose reversal; and opportunities for rural PWUD to formally participate in emergency response systems as peer overdose responders. Trial registration The ClinicalTrials.gov ID for the CARE2HOPE intervention is NCT04134767. The registration date was October 19th, 2019.

Background The HEALing Communities Study was a multi-site cluster randomized waitlist-controlled trial evaluating a community-engaged, data-driven intervention to select and deploy evidence-based practices (EBPs) including overdose education and naloxone distribution (OEND), medication for opioid use disorder (MOUD), and safer opioid prescribing. The trial was conducted in 67 highly impacted communities in 4 states, including 8 Rural and 8 urban communities in New York State (NYS). To inform future community-level decision making, we estimated the implementation costs of the EBPs selected by NYS communities. Methods The study was implemented between January 2020-June 2022 (Wave 1, 30 months duration including the peak COVID-19 emergency period) and July 2022-December 2023 (Wave 2, 18 months); each wave included 4 Rural and 4 urban NYS communities. We collected cost data prospectively using invoices, administrative records, and interviews with program staff and stakeholders. We then conducted a micro-costing analysis from the community perspective and compared costs from Waves 1 and 2. Results In both Waves, each community deployed on average 15 EBPs (range 8–25). EBP costs averaged $705,000 (range $320,000-$1.3 million) and $312,000 (range $39,200-$686,300) in Waves 1 and 2, respectively. In Wave 1, 25% of costs were allocated for OEND, 71% for MOUD, and 4% for safer prescribing, compared to 38% for OEND, 60% for MOUD, and 2% for safer prescribing in Wave 2. Average EBP costs per community were $147,600 (range $20,900-$374,000) for those in the OEND category, $345,400 (range $4,100-$1.1 million) for MOUD, and $16,400 (range $360-$105,500) for safer prescribing. Total EBP cost per capita in urban communities was $0.32 compared to $2.65 in Rural communities in Wave 1, and $0.41 urban communities compared to $0.65 in Rural communities in Wave 2. Conclusions The lower EBP costs in Wave 2 resulted from differences in EBP categories and specific EBPs selected and may also reflect differences in the duration of the intervention and the impact of the COVID-19 pandemic over time. Higher per capita costs in rural communities indicate that many costs were not directly related to the number of individuals served.