Accidental opioid-involved overdose (OD) mortalities in the U.S. have escalated at an alarming pace, with 81,000 OD deaths recorded in 2019-2020, the highest number ever recorded in a 12-month period. Deaths due to synthetic opioids, primarily illicitly manufactured fentanyl, increased by 38.4%. OD deaths have continued to accelerate as a result of disruptions caused by the pandemic [1,2]. According to provisional data for 2020 from the Centers for Disease Control and Prevention (CDC), US drug OD deaths increased by almost 30% to a record 93,331 deaths during the pandemic year of 2020 [3], with the highest number of deaths occurring amongst those aged 35-44 years [4]. Interventions involving OD response training, including use of the opioid antagonist naloxone, have been a critical part of the national response to the crisis. Several Food and Drug Administration (FDA)-approved products (eg, Narcan Nasal Spray) have made the administration of naloxone easier for laypeople and professional first responders by reducing the risk of needle stick injuries (NSIs) [5-11]. Recent large-scale strategies to address the opioid crisis have invoked a greater role for law enforcement, including being trained in OD response and naloxone administration. For example, researchers [12-14], health advocacy organizations, and government agencies, including the US Department of Justice [15], emphasize the need to implement programs that address the role of law enforcement in shaping health risks among people who use drugs (PWUD) [16-18].

Despite the widely perceived benefits of engaging law enforcement in OD response, considerable barriers limit the uptake of policing practices that could further public health goals [19,20]. Past research has demonstrated that police officers experience an elevated risk of NSIs emanating from routine contact with people who inject drugs (PWID), which, in turn, can lead to infectious disease acquisition. Although the risk of acquiring HIV from NSIs is low [21,22], the perceived risk is high. Concern about NSIs and broader risks related to infectious disease exposure contribute to already elevated levels of stress and burnout among the police. For instance, Strathdee et al [13] noted that of 803 officers working in Tijuana, Mexico, 666 (83%) felt that NSIs carry a level of risk analogous to a gunshot wound. Additionally, widespread sensational and misleading information in news media about incidental fentanyl exposure may reduce the likelihood an officer would intervene in an OD situation [23,24].

Good Samaritan laws providing legal immunity to OD responders who administer naloxone vary across US states. However, these laws are often not well understood, including by police officers. For example, police officers are not always aware of their protection from liability and the protection offered to bystanders [25]. Finally, persistent accounts of police unions filing “unfair labor complaints” because officers have been told to carry naloxone can be an additional barrier, even for police officers who want to carry the life-saving medication [26].

The choices that the police make also have serious implications for the relative harm and safety of the PWID whom they confront. Several studies indicate that policing strategies related to arrests for drug possession and decisions made therein about the confiscation of syringes can influence where, with whom, when, and how PWID consume drugs [27-33]. This aggravates the drug use risk environment by pushing use further to the social and geographical margins (eg, back alleys and shooting galleries). In these settings, risky consumption practices, such as syringe sharing and rushed injection, are more likely, while ODs are less likely to be witnessed [34-37]. Law enforcement may also serve as a barrier to the uptake of syringe exchange services or drug treatment, as the police have frequently been observed to obstruct the transport of syringes, harass treatment program patients, interfere in program operations, and aggressively surveil these programs, which deters people who use opioids (PWUO) from accessing them [38-44]. Racial gradients in police encounters among PWID also suggest that policing practices can be a structural driver in injection-related risk and disease acquisition [45]. Stigma against PWUO and PWID has also been common in press reports citing police chiefs and sheriffs for refusing to allow their officers to carry and administer naloxone [46,47]. A recent survey revealed that some police officers, particularly those who responded to the most OD emergencies, expressed negative attitudes about naloxone administration, drug treatment, and their role in handling drug-related OD emergencies [48].

Despite the barriers described, engaging law enforcement in opioid OD prevention and response initiatives is critical to minimizing some of the secondary harms related to commonplace policing practices [49-51]. Although some overdose education and naloxone distribution (OEND) training initiatives with law enforcement have had mixed results [48,52,53], police education programs, including our own online curricula [54,55], have shown promise in precipitating procedural and attitudinal changes related to substance use. Previous research using the Safety and Health Integration in the Enforcement of Laws on Drugs (SHIELD) model developed by another member of our team (author LB) demonstrated that police officers are especially receptive to education on working with at-risk groups when bundled with occupational safety messages that highlight their own risk of acquiring HIV, hepatitis C virus (HCV), and hepatitis B virus (HBV) from a needle stick and other harms [14,22,30,56]. Police education programs also can address pervasive misconceptions about addiction, and medication for the treatment of opioid use disorder (OUD), as well as the efficacy of harm reduction programming [57] and accurate information about the risks of fentanyl exposure [57,58]. Finally, police education can disseminate promising policing protocols to divert and deflect PWUD to lifesaving health and supportive services in lieu of arrest. Reducing the confrontational nature and frequency of contact with law enforcement is especially salient in the context of racial disparities in US drug law enforcement, although the footprint of the police’s role in treatment and other service navigation remains controversial [18,59].

Despite the promise of police education programs to reduce risky—and encourage protective—behavior, no previous study has longitudinally assessed the impact of such an intervention in the U.S. The Opioids and Police Safety Study (OPS) closes this gap with a focus on Pennsylvania (PA), Vermont (VT), and New Hampshire (NH)—3 states with some of the highest rates of OD in the U.S. (PA, 39.9/100,000; VT, 22.8/100,000; and NH, 31.1/100,000) [60,61]. Since the early years of the current opioid crisis in the U.S., PA, VT, and NH have experienced OD mortality at rates far exceeding national averages and those rates continue to rise alarmingly [62,63].

Delivering easily accessible web-based educational interventions to overcome barriers to OD response among law enforcement is particularly important in rural areas and states experiencing the highest opioid-related mortality rates. The study team has demonstrated the effectiveness of their online computer-assisted instructional course on GetNaloxoneNow.org (GNN) [54,55], which promotes learning by presenting information that requires active responding to queries or situational scenarios [64,65]. Use of feedback and remediation functions as a computer-based coach, allowing users to evaluate progress [66]. All 50 states have utilized the module, either formally when approved by state officials or informally when individuals within the state take it on their own. Accordingly, the protocol leverages existing capacity within the states while investigating potential differences between major metropolitan areas and more rural and geographically isolated areas.

Using a mixed methods design, organized around a pragmatic trial design, this study will achieve the following objectives: (1) adapt a web-based occupational risk reduction (ORR) curriculum to add to a web-based OD response and naloxone training platform, the GNN First Responder Training; (2) describe naloxone use patterns, OD response experiences, and attitudes related to illicit opioid use among a sample (N=300) of police officers in PA, VT, and NH, trained via the GNN platform; (3) evaluate the relative effectiveness of GNN + ORR compared with GNN + COVID-19 (with respect to the rates of carrying naloxone while on/off duty, rates of OD response in which naloxone is/is not administered, number of referrals to treatment, number of syringes confiscated, and rates of information sharing with OD survivors and others), as well as analyze mediators and moderators of efficacy; and (4) document the range of psychosocial mechanisms underlying participant OD response engagement postintervention.

Accordingly, our hypotheses include the following: Officers enrolled in the experimental arm will carry naloxone both while on duty and while off duty at greater rates than officers in the control arm of the study. In addition, officers in the experimental arm will also have higher rates of OD response in which naloxone is administered, a lower rate of confiscating syringes, and a higher rate of information sharing with OD survivors and others.

The study is guided by an integrated conceptual framework comprising risk environment theory (RET) and the elaboration likelihood model of persuasion (ELM). Together, these models are ideally suited to identifying and contextualizing the barriers to and facilitators of OD response (see Figure 1) and presenting strong arguments in terms of police safety about the value in promoting risk reduction practices and treatment among PWID [67].

RET defines a risk environment as “the space, whether social or physical, in which a variety of factors exogenous to the individual interact to increase vulnerability” [68]. RET specifically guides our understanding of how policing practices at the “micro” environment or community level have direct influences over the behavior, perceptions, and health outcomes of PWUO and of PWID. These practices may also increase occupational health risks for police officers. Similarly, “meso” level policy and legal statutes influence the attitudes and practices of police officers, as do “macro” level forces, such as the US war on drugs via the criminalization of drug use and the arrest and incarceration of drug users who suffer from addiction [26,69,70].

The ELM guides the adaptation of the ORR curricula. This model emphasizes the importance of intrinsic motivation in modifying attitudes or shaping behavior through interventions grounded in persuasion and argumentation. Guided by this theory, the ORR intervention will seek to appeal to law enforcement personnel through appeals to their own self-protection, while also highlighting the agency and utility of the police in combating the opioid crisis. These approaches take the form of strong arguments within the ELM, as they are far more likely to create favorable thoughts than what might be considered weak arguments [71,72] grounded in moral assertions about the value of PWID to society, the importance of compassionate community policing, or the disease model of addiction, for example. Within the ELM, the influence carried by an argument is also dependent upon the extent of personal involvement that the audience assumes with regard to the topic [72,73]. The proposed ORR intervention will therefore feature the voices and experiences of active police personnel and will highlight the ways in which policing practices more aligned with public health agendas are fundamentally safer for the police and the communities they serve.

The protocol proposed here is a pragmatic trial design [74,75]. Pragmatic trials, unlike more conventional randomized controlled trials, are ideally suited to scenarios in which it is inefficient or unethical to isolate intervention components and compare their efficacy in an explanatory trial involving a placebo control [76].

The GNN First Responder Training (both experimental and control; 45 minutes) (1) explains why first responders need education and tools to reverse opioid ODs, (2) teaches and demonstrates (using animated scenarios, graphic sequences, and narration provided by professional voice actors) how to effectively respond to an opioid OD in accordance with the American Heart Association, and (3) describes barriers to calling 911 and the purpose and content of Good Samaritan laws. A detailed question-and-answer session and a posttest reinforce learning.

The OPS (experimental only; 50 minutes) provides web-based ORR training for police in 49 slides, including 8 filmed videos (police officers, physicians, syringe service program staff, and a person in recovery). The training is delivered online, with secure access only for enrolled study participants.

The COVID-19 and Police Safety Training (control only) takes approximately 25 minutes to complete and includes 22 slides, also narrated by a professional voice narrator.

The study was approved by the New York University Institutional Review Board (IRB-FY2019-3315). The study was registered on ClinicalTrials.gov (NCT05008523) and approved on June 21, 2021. Enrollment began on January 22, 2021, prior to the approval date due to technical difficulties we experienced with the clinical trial registration website. Delays due to the COVID-19 pandemic and the national spotlight on policing practices in the U.S. posed numerous challenges to recruitment, including minimal enrollment prior to the approval of our clinical trial on ClinicalTrial.gov. To address these challenges, we added 2 sites (VT and NH) after commencing enrollment. Additional changes to our methodology—all of which were approved by the New York University Institutional Review Board (Washington Square Campus)—included the addition of a short qualitative interview (15 minutes) with a subset of approximately 20 (6.7%) of the 300 study participants to better understand and address recruitment challenges and the addition of referral incentives for study participants. There were no changes to our attitudinal and behavioral outcome measures once enrollment commenced in January 2021.

As depicted in Figure 3, the study will join qualitative and quantitative data sources at a number of key intersections throughout. Mixed methods studies in public health conventionally focus on multiple (and potentially interacting) determinants of health-related outcomes by locating points of articulation between different theoretical and methodological approaches [91-98]. Our mixed methods strategy has multiple “points of interface” [99] designed to yield a dialogue between data sources [100]. The National Institutes of Health (NIH) Best Practices for Mixed Methods Research [101] distinguishes 3 primary mechanisms for integration: merging, connecting, and embedding.

The OPS will be the first study to longitudinally assess the impact of a web-based opioid-related ORR intervention for law enforcement in the U.S. Findings from our randomized pragmatic clinical trial will provide evidence as to whether our experimental training actually removes barriers to life-saving police engagement with PWUO/PWID by focusing both on the safety of law enforcement and on evidence-based and best practices for working with persons at risk of an opioid OD. In sum, we expect our simultaneous embedded mixed methods approach will provide empirical evaluation of the diffusion of a naloxone-based response among law enforcement.

Despite the fact that COVID-19-related precautions and the national spotlight on policing practices hindered study participation, we expected our baseline data collection to be complete (with a sample of 300 police officers) by the end of 2021, with a 1-year follow-up for each study participant, ending in December 2022.

OD deaths are currently the largest cause of accidental deaths in the U.S., and opioid-related OD deaths constitute the overwhelming majority of these deaths. To address the epidemic, a knowledge base for effective law enforcement interventions is both necessary and urgent. This proposed study is designed to provide a knowledge base regarding key obstacles to and facilitators of the willingness and preparedness of the police to administer naloxone and the related risk reduction practices, and evaluate the efficacy of a web-based opioid-related occupational safety and risk reduction curriculum.

The OPS is the first study to longitudinally assess the impact of an opioid-related ORR intervention for law enforcement in the U.S.

Our randomized pragmatic clinical trial aims to remove barriers to life-saving police engagement with PWUO/PWID by focusing both on the safety of law enforcement and evidence-based and best practices for working with persons at risk of an opioid OD.

Our simultaneous embedded mixed methods approach will provide empirical evaluation of the diffusion of the naloxone-based response among law enforcement.

However, COVID-19-related precautions and the national spotlight on policing practices may hinder study participation.

Findings from this study will be applied to the development and implementation of effective interventions for police officers aimed at harmonizing law enforcement practices with public health goals. Study products (training curricula) will also be disseminated nationally.