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Substance use can be a coping mechanism during stressful times. The United States opioid crisis worsened during the COVID-19 pandemic. This study looks at the effects of the pandemic on self-reported change in drug and alcohol use and medications for opioid use disorder (MOUD) and naloxone interest in a population and region hit hard by the opioid crisis—people who use illicit opioids (PWUO) and other drugs in the Southern United States. Cross-sectional data came from the National Institute on Drug Abuse Clinical Trials Network survey study CTN-0082. During the pandemic, participants (N=381) completed a survey about their pandemic-attributed increase, decrease, or no change in use of opioids, non-opioid drugs, or alcohol and interest in MOUD and naloxone. Data were analyzed using multinomial logistic regressions; regression models included potential contributing factors like sociodemographics, substance use frequency, and psychological distress. Results showed that most participants reported no change in: use of opioids (54%), non-opioid drugs (59%), or alcohol (64%) and interest in MOUD (60%) or naloxone (72%). Factors related to no change in relation to change in substance use and/or service interest included past 12-month substance use frequency, race, ethnicity, age, sex, and education.

Conclusions: We conclude that the lack of change in drug use and interest in MOUD and naloxone suggests stability amidst challenging times in our sample of PWUO in the Southern United States. Differences in outcomes based on sociodemographics and substance use frequency indicate the need for tailored services during future public health emergencies.

Related protocols: CTN-0082

Objectives: Despite drug overdose deaths increasing among peripartum persons, little is known about how to increase naloxone acceptance in this population. This study evaluated the effect of a brief 15-min computer facilitated personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Educational intervention (TOME) on naloxone uptake and compared participant characteristics based on naloxone acceptance.

Methods: This secondary analysis of data is from an outpatient randomized multisite trial with peripartum individuals receiving MOUD treatment (CTN-0150). Participants were randomized to TOME or control. TOME participants met 1:1 with research staff to review a printout of missed pre-test opioid overdose and MOUD knowledge questions that explained the correct answer. Control participants received educational materials from the Substance Abuse and Mental Health Services Administration. Baseline demographics, treatment characteristics, opioid overdose and MOUD knowledge, and self-report MOUD stigma ratings were compared between participants who accepted versus declined free study-provided naloxone because they already had it or for other reasons. The intervention’s effect on naloxone acceptance was evaluated after delivery of TOME or control among those accepting versus those declining naloxone for other reasons.

Results: Of 111 participants, 90 accepted naloxone, 14 declined due to already having naloxone, and seven declined for other reasons (e.g., not affiliating with people who would need it, not wanting it in their house, allergy), These three groups significantly differed on past stigma from family (p = 0.007) and employers (p = 0.013) whereby participants declining naloxone due to already having it had the lowest stigma. Those accepting naloxone (n = 90) were nearly evenly split between TOME (n = 48) and control (n = 42). Six of the seven declining naloxone for other reasons were control participants. Among the 97 accepting naloxone or declining it for other reasons, TOME trended toward increasing naloxone acceptance (OR: 6.857, CI: 0.793, 59.291, Fisher Exact test p = 0.0592). There was a higher percentage of correct MOUD answers in the 90 accepting naloxone (66.8 %) vs. the 7 declining for other reasons (55.7 %; p = 0.0471).

Conclusions: These preliminary results suggest the need for further work to determine if educational interventions can enhance naloxone acceptance and suggest that stigma and medication treatment knowledge may be important factors influencing naloxone acceptance.

Related protocols: CTN-0150

This is the primary outcomes article for CTN-0095.

Nearly 727,000 individuals in the US died of opioid overdoses between 1999 and 2022. The current workforce of addiction medicine specialists is inadequate to address the scale of this crisis, and primary care clinicians (PCCs) do not feel sufficiently supported to treat opioid use disorder (OUD).

Objective: To evaluate whether an electronic health record–integrated clinical decision support system (CDSS) increases OUD diagnosis and treatment in primary care.

Design, Setting, and Participants: This pragmatic cluster randomized clinical trial was conducted from April 2021 to December 2023. Primary care clinics in 3 health systems in 4 US states were randomized to receive or not receive an electronic health record–integrated CDSS aimed at improving OUD diagnosis and treatment. Eligible patients were aged 18 to 75 years, visited a randomized clinic, and had an OUD diagnosis in the last 2 years, opioid overdose in the last 6 months, or risk score indicating high risk of OUD or opioid overdose. Data were analyzed from September 2023 to October 2024.

Interventions: The OUD CDSS provided personalized treatment recommendations to patients and PCCs in intervention clinics.

Main Outcomes and Measures: Primary outcomes were likelihood to receive (1) an OUD diagnosis (among high-risk patients without a baseline OUD diagnosis), (2) a naloxone prescription, or (3) a prescription of a medication for OUD (MOUD) or specialty referral, all within 30 days of first eligible (index) visit, and (4) days covered by a MOUD prescription in the 90 days after index.

Results: Among 10,891 patients meeting eligibility criteria, 5918 (54.3%) were female, and the mean (SD) age was 48.0 (13.9) years. There was no difference in OUD diagnoses within 30 days between groups. Patients in the intervention group had more naloxone orders (80 of 5538 [1.4%] vs 40 of 5353 [0.7%]; odds ratio, 1.76; 95% CI, 1.14-2.72) and orders for MOUDs or treatment referral (775 of 5538 [14.0%] vs 503 of 5353 [9.4%]; odds ratio, 1.48; 95% CI, 1.05-2.08) within 30 days. There were no differences in median (IQR) days covered by MOUD over 90 days postindex between intervention (84 [55-90] days) and usual care (83 [55-90] days; rate ratio, 1.00; 95% CI, 0.93-1.08) or in overdose or death rates during the intervention period.

Conclusions and Relevance: In this cluster randomized clinical trial, the intervention improved rates of naloxone orders and OUD treatment in primary care but did not affect days covered by a MOUD over 90 days postindex or overdose or death rates. These findings demonstrate an OUD CDSS can help increase access to OUD treatment in primary care.

Related protocols: CTN-0095

Background: The opioid epidemic presses on as a significant public health issue in the U.S., with particularly high overdose death rates in the Southeast. Naloxone is the standard of care for reversing opioid overdose; however, many people who use drugs (PWUD) experience barriers to naloxone use. This cross-sectional survey study aims to describe awareness of, experience with, willingness, barriers, and distribution strategies for naloxone among PWUD in the Southeast.

Methods: Data were obtained from a larger implementation survey study (CTN-0082). Descriptive analyses focused on N = 381 people in substance use treatment programs, syringe services programs, and sexually transmitted infection clinics who reported non-prescription opioid use in the past 12 months and completed a naloxone-related questionnaire.

Results: Most PWUD reported using opioids daily (60–62 %). 82 % had previously heard of naloxone, but only 43 % reported having received any type of training to use it. On a 5-point scale, PWUD without prior training (n = 219) reported being very willing to be trained to use naloxone on someone who overdoses (Mdn=5.00, IQR=2.00). Among all PWUD, not knowing where to go for naloxone training was the only barrier to using naloxone that was endorsed with certainty (Mdn=4.00, IQR=2.00). PWUD endorsed three strategies to improve naloxone distribution, including wanting their site to offer naloxone training (Mdn=4.00, IQR=1.00), increased access to naloxone education (Mdn=4.00, IQR=1.00), and connecting people to training programs (Mdn=4.00, IQR=1.00).

Conclusion: This study suggests that improvements are still needed in the saturation of naloxone training and distribution among PWUD, including in settings that provide non-opioid related services.

Related protocols: CTN-0082

Emergency departments (ED) are incorporating Peer Support Specialists (PSSs) to help with patient care for substance use disorders (SUDs). Despite rapid growth in this area, little is published regarding workflow, expectations of the peer role, and core components of the PSS intervention. This study describes these elements in a national sample of ED-based peer support intervention programs.

A survey was conducted to assess PSS site characteristics as part of site selection process for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study evaluating PSS effectiveness (CTN-0107). Surveys were distributed to clinical sites affiliated with the 16 CTN nodes. Surveys were completed by a representative(s) of the site and collected data on the PSS role in the ED including details regarding funding and certification, services rendered, role in medications for opioid use disorder (MOUD) and naloxone distribution, and factors impacting implementation and maintenance of ED PSS programs. Quantitative data was summarized with descriptive statistics. Free-text fields were analyzed using qualitative content analysis.

A total of 11 surveys were completed, collected from 9 different states. ED PSS funding was from grants (55%), hospital funds (46%), peer recovery organizations (27%) or other (18%). Funding was anticipated to continue for a mean of 16 months (range 12 to 36 months). The majority of programs provided “general recovery support (81%) Screening, Brief Intervention, and Referral to Treatment (SBIRT) services (55%), and assisted with naloxone distribution to ED patients (64%). A minority assisted with ED-initiated buprenorphine (EDIB) programs (27%). Most (91%) provided services to patients after they were discharged from the ED. Barriers to implementation included lack of outpatient referral sources, barriers to initiating MOUD, stigma at the clinician and system level, and lack of ongoing PSS availability due to short-term grant funding.

Conclusions: The majority of ED-based PSSs were funded through time-limited grants, and short-term grant funding was identified as a barrier for ED PSS programs. There was consistency among sites in the involvement of PSSs in facilitation of transitions of SUD care, coordination of follow-up after ED discharge, and PSS involvement in naloxone distribution.

Related protocols: CTN-0107

Pharmacists are on the frontline caring for patients at risk of an opioid overdose and for patients with an opioid use disorder (OUD). Dispensing naloxone and medications for OUD and counseling patients about these medications are way pharmacists can provide care. Key to pharmacists’ involvement is their willingness to take on these practice responsibilities.

As part of NIDA Clinical Trials Network protocol CTN-0075, Physician-Pharmacist Collaboration in the Management of Patients with Opioid Use Disorder, this scoping review aimed to identify, evaluate, and summarize published literature describing pharmacists’ attitudes toward naloxone and medications for OUD, i.e., methadone, buprenorphine, and naltrexone. All searches were performed on December 7, 2015, in 5 databases: Embase.com, PubMed.gov, Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCOhost, Cochrane Central Register of Controlled Trials via Wiley, and Clarivate Web of Science. Articles included original research conducted in the United States, described attitude-related language toward naloxone and medications for OUD, and pharmacists.

A total of 1323 articles were retrieved, 7 were included. Five studies reported on pharmacists’ attitudes toward naloxone dispensing; 1 study reported on attitudes toward naloxone, buprenorphine, and buprenorphine/naloxone; and 1 reported on attitudes toward buprenorphine/naloxone. Respondents were diverse, including pharmacists from different practice specialties.

Studies found that pharmacists agreed with a naloxone standing order, believed that naloxone should be dispensed to individuals at risk of an opioid overdose, and were supportive of dispensing buprenorphine. A minority of pharmacists expressed negative attitudes. Barriers cited to implementation included education and training, workflow, and management support.

Conclusions: Pharmacists were positive in their attitudes toward increased practice responsibilities for patients at risk of an opioid overdose or with an OUD. Pharmacists must receive education and training to be current in their understanding of OUD medications, and they must be supported in order to provide effective care to this patient population.

Related protocols: CTN-0075

To date, the National Drug Abuse Clinical Trials Network Starting Treatment with Agonist Replacement Treatment Study (START) includes the largest database of patients (n=1269) entering opioid agonist treatment programs at community methadone centers around the United States (U.S.). Participants in the study were randomized to either Methadone (MET) treatment or Buprenorphine/Naloxone (BUP/Nx) treatment, and closely monitored during induction as well as throughout active treatment and follow-up. Pharmacotherapy was provided for 24 weeks with taper or continuation possible through week 32. Primary outcomes showed low rates of liver injury and no differences in liver functions between MET and BUP/Nx groups. Secondary findings present a multitude of interesting and clinically relevant outcomes. This Blending Initiative workshop presented several of those secondary outcomes from both a U.S. and international perspective.

Session One: United States Perspective

This segment of the session presented several important secondary outcomes from the START study including: From a comparison of the impact of MET vs. BUP/Nx treatment on HIV risk behaviors; a description of six different BUP/Nx and three different MET induction trajectories and their outcomes; and an association between genotype and treatment outcome in African-American participants receiving BUP/Nx or MET.

Session Two: International Perspective

To complement the findings and dissemination strategies from the U.S. perspective, a panel of international collaborators presented findings from studies conducted abroad and implementation strategies that have been successful. Presentations included outcomes from a collaborative project between NIDA and treatment providers in Indonesia, data from epidemiological studies showing the association between the length of MET treatment and mortality rates and dissemination and implementation strategies, and the use of incentive-based interventions in reducing drug use and associated consequences. The session also described the N-ALIVE (NALoxone InVEstigation) study–a large, prison-based, trial that assesses the number of lives that could be saved by providing Naloxone-on-release to adult prisoners with a history of heroin injection. The discussion after session two focused on on how the knowledge gained from these analyses and findings can be translated for the implementation of relevant MET or BUP/Nx treatment in clinical settings treating opioid dependent patients in the U.S. as well as internationally

Related protocols: CTN-0027

This dissemination conference, co-sponsored by the CTN Ohio Valley Node, aimed to build partnerships across systems to improve access to evidence-based treatments to prevent overdose, deaths, and relapse to opioid use. Featuring community members and professionals from Ohio, Kentucky, and Indiana impacted by the prescription drug epidemic, the conference featured a variety of presentations addressing the significant toll prescription drug misuse is having on communities in the region, the types of prevention and treatment programs already available, community-based strategies, and cross-systems perspectives. Available slides include:

Understanding the Impact of Opioid Use, Misuse & Abuse in the Region — Erin L. Winstanley, PhD and Mike Kroeger

Overdose Education and Naloxone Rescue in Massachusetts — Alexander Walley, MD, MSc

Project Lazarus: Community Perspective on Pain Management and Prescription Opioid Overdose Prevention — Fred Wells Brason II and Mike Lancaster

Law as Barrier to and Facilitator of Opioid Overdose Prevention — Corey Davis, JD, MSPH

Syringe Exchange in Cincinnati — Judith Feinberg, MD

Ohio “Project DAWN”: Deaths Avoided with Naloxone — Lisa Roberts, RN

Buprenorphine and Related Dynamics in a Clinical Setting — Dean Babcock, MSW, LCSW, LCAC

2012 Student Drug Use Survey Regional Data Release on Non-Medical Use of Prescription Drugs and Over-the-Counter Medications — Mary Haag, RN

Surviving Our Loss and Continuing Everyday (SOLACE) — Jo Anna Krohn