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Methadone is an essential tool for addressing opioid use disorder, especially with the prevalence of high-potency synthetic opioids in the drug supply. The current care delivery model in the United States with siloed methadone clinics has many limitations. Legislation has been proposed to expand access to methadone to office-based settings with pharmacy dispensing. Even with legal and regulatory changes, there are many practical barriers to implementation which include insurance coverage and patient cost, prior authorizations, and stocking of methadone.

Practical steps for clinicians and policymakers to take to overcome these barriers include ensuring insurance coverage for methadone, removing methadone from the algorithms that limit the amount of controlled substances pharmacies can order, and obtaining concentrated methadone formulations.

Related protocols: CTN-0131

This is the primary outcomes paper for CTN-0105.

Background: Pharmacists play a key role in combating the opioid-related overdose epidemic in the United States (US), but little is known about their experience and willingness to deliver preventive services for opioid use disorder (OUD).

Aims: This study seeks to identify correlates of pharmacists’ concerns about drug use problems (prescription drug misuse/use disorder and illicit drug use/use disorder) as well as their practice experience delivering preventive services for OUD (e.g., asked about opioid use, provided advice, made a referral) and willingness to provide services to patients with drug use problems.

Design: An online survey of licensed US pharmacists was conducted. Participants were recruited from Community Pharmacy Enhanced Services Networks (CPESN) and state pharmacist associations (N=1146).

Findings: Overall, 75% of surveyed pharmacists indicated having concerns about opioid use problems, and 62% had concerns about non-opioid drug use problems at their pharmacies. Pharmacists who were White, practiced at a rural location, worked at a chain pharmacy, had not received opioid-related training in the past year, or practiced screening patients for opioid use had elevated odds of perceiving concerns about opioid use problems in their practice settings. Pharmacists who were White, practiced at a rural location, or had not received opioid-related training in the past year had elevated odds of perceiving concerns about non-opioid (illicit) drug use problems. Being male, being White, or having received opioid-related training were associated with increased odds of screening patients for opioid use problems. Being White, having practiced at a rural location (vs. an urban location), being a pharmacy owner/manager, or having received opioid-related training were associated with increased odds of delivering opioid-related advice/intervention. Being male or having received opioid-related training were associated with increased odds of making a referral to OUD treatment. Finally, being male, being White, having practiced pharmacy services for under 6 years, having received opioid-related training for 2 h in the past year, or having performed OUD-related preventive services (asked about opioid use, provided advice, or made a referral) were associated with increased levels of commitment/readiness for providing care to patients with drug use problems.

Conclusions: The overall findings highlight pharmacists’ involvement with OUD preventive services. It is critical to promote opioid-related preventive service training for pharmacists and provide incentives/tools to help initiate a structured practice of delivering such preventive services.

Related protocols: CTN-0105

As the opioid epidemic continues to have a major negative impact across the US, community pharmacies have come under scrutiny from legal systems attempting to hold them accountable for their role in over-dispensing and lack of patient intervention. While the most available tool for monitoring patients’ opioid use is Prescription Drug Monitoring Programs (PDMP), these do not provide pharmacists with actionable information and decision support. Our study addresses this gap through three objectives: [1] incorporate validated opioid risk metric thresholds into a PDMP platform to create the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool; [2] assess ORRCDS’ ability to reduce patient opioid risk; [3] assess ORRCDS’ sustainability and viability for broader dissemination in community pharmacy.

For objective 1, our team is partnering with leadership from the largest US PDMP organization and a top-five pharmacy chain to implement ORRCDS into the pharmacy chain’s workflow following the Guideline Implementation with Decision Support (GUIDES) framework. For objective 2, our team will conduct a type-1 implementation mixed methods study using a 2-arm parallel group clustered randomized design. We anticipate enrolling ~6,600 patients with moderate and high opioid use risk during the 6-month enrollment phase across 80 pharmacies. This sample size will provide 96.3% power to detect a 5% or greater difference in responder rate between the intervention and control arm. Responders are patients with moderate-risk at baseline who reduce to low-risk or those with high-risk at baseline who reduce to moderate or low-risk at 180 days post last intervention. To accomplish objective 3, we will use the Consolidated Framework for Implementation Research (CFIR) to develop and execute cross-sectional qualitative interviews with pharmacists (n=15), pharmacy leaders (n=15), and PDMP leaders (n=15) regarding long term adoption and sustainability of the ORRCDS tool.

Conclusions: A PDMP tool that addresses moderate- and high-risk opioid use is not available in community pharmacy. This study will implement ORRCDS in a large retail pharmacy chain that will include additional screening and guidance to pharmacy staff to address risky opioid medication use. Our results will make critical advancements for protecting patient health and addressing the opioid epidemic.

Related protocols: CTN-0138

This is the primary outcomes paper for CTN-0124.

This paper aims to address the challenges in providing adequate access to Medications for Opioid Use Disorder (MOUDs) within underserved areas by examining the potential role of pharmacies and proposing actionable strategies for improvement. The health system faces increasing criticism for failure to provide adequate access to MOUDs. Pharmacies are being promoted as an asset to increase MOUD access in rural and underserved areas.

Method: An engineering systems analysis approach was employed to investigate ways to enhance pharmacy roles in delivering MOUDs in underserved regions. Interviews were conducted with community pharmacists, pharmacy associations, and addiction treatment experts. Innovation development techniques with experts from inside and outside the field were used to create recommendations.

Results: The findings underscore the importance of embracing technological advancements to overcome resource limitations and expand MOUD access in underserved areas. When our project began, we believed pharmacy roles related to MOUD distribution could expand through traditional means. We now feel that expansion is practical only through adoption of recent developments in information and communication technology. Our recommendations offer actionable strategies to expand MOUD availability in underserved areas. Technological changes can address stigma and mindsets, workflow simplification, family engagement, integration with other parts of the health system, reimbursement practice, and regulation.

Conclusions: Implementing pertinent technological innovations could augment MOUD availability within the pharmacy sector, thus addressing the pressing need for improved access to treatment in underserved communities. These technological changes would expand MOUD access within a field constrained by limited and diminishing resources.

Related protocols: CTN-0124

Pharmacists remain an underutilized resource in the treatment of opioid use disorder (OUD). Although studies have engaged pharmacists in dispensing medications for OUD (MOUD), few studies have evaluated collaborative care models in which pharmacists are an active, integrated part of a primary care team offering OUD care.

This study, protocol CTN-0116 (Pharmacist-Integrated Model of Medication Treatment for Opioid Use Disorder), seeks to implement a pharmacist integrated MOUD clinical model (called PrIMO) and evaluate its feasibility, acceptability, and impact across four diverse primary care sites. The Consolidated Framework for Implementation Research is used as an organizing framework for study development and interpretation of findings. Implementation Facilitation is used to support PrIMO adoption. We assess the primary outcome, the feasibility of implementing PrIMO, using the Stages of Implementation Completion (SIC). We evaluate the acceptability and impact of the PrIMO model at the sites using mixed-methods and combine survey and interview data from providers, pharmacists, pharmacy technicians, administrators, and patients receiving MOUD at the primary care sites with patient electronic health record data. We hypothesize that it is feasible to launch delivery of the PrIMO model (reach SIC Stage 6), and that it is acceptable, will positively impact patient outcomes 1 year post model launch (e.g., increased MOUD treatment retention, medication regimen adherence, service utilization for co-morbid conditions, and decreased substance use), and will increase each site’s capacity to care for patients with MOUD (e.g., increased number of patients, number of prescribers, and rate of patients per prescriber).

Conclusions: This study will provide data on a pharmacist-integrated collaborative model of care for the treatment of OUD that may be feasible, acceptable to both site staff and patients and may favorably impact patients’ access to MOUD and treatment outcomes.

Related protocols: CTN-0116

In the last decade, the U.S. opioid overdose crisis has magnified, particularly since the introduction of synthetic opioids, including fentanyl. Despite the benefits of medications for opioid use disorder (MOUD), only about a fifth of people with opioid use disorder (OUD) in the U.S. receive MOUD.

The ubiquity of pharmacists, along with their extensive education and training, represents great potential for expansion of MOUD services, particularly in community pharmacies. The National Institute on Drug Abuse’s National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) convened a working group to develop a research agenda to expand OUD treatment in the community pharmacy sector to support improved access to MOUD and patient outcomes.

Identified settings for research include independent and chain pharmacies and co-located pharmacies within primary care settings. Specific topics for research included adaptation of pharmacy infrastructure for clinical service provision, strategies for interprofessional collaboration including health service models, drug policy and regulation, pharmacist education about OUD and OUD treatment, including didactic, experiential, and interprofessional curricula, and educational interventions to reduce stigma towards this patient population. Together, expanding these research areas can bring effective MOUD to where it is most needed.

Opioid and other substance related deaths continue to rise in the U.S. (CDC, May 2022). A treatment model that includes professionals working across disciplines and settings, especially primary care – which is the most common point of healthcare contact – could help address the opioid and substance use crisis by increasing access to evidence based screening and interventions. The National Institute on Drug Abuse (NIDA) Drug Treatment Clinical Trials Network (CTN) has conducted several trials in these settings and this session will provide insights from investigators on successful models for substance and opioid use disorders (SUD/OUD) screening, prevention, and treatment in primary care.

This session will provide an overview and rationale of establishing primary care models for screening and interventions for SUD, and the main objectives are to learn about (1) approaches for incorporating alcohol and drug screening into primary care practices, integrated with the electronic health record (EHR); (2) lessons learned from SUD collaborative care trials in primary care settings; and (3) establishing collaborative care models in Federally Qualified Health Centers (FQHC), including pharmacists, in SUD/OUD treatment and management.

Presentation Slides:

• CTN and the expansion of SUD treatment delivery in primary care settings – C. Rosa, M.S.
• Primary care provider role in SUD screening, prevention, and treatment – G. Bart, M.D.
• Feasibility of implementing alcohol and drug screening in primary care – J. McNeely, MD, MS
• Lessons learned and unanswered questions from trials of collaborative care for alcohol and substance use disorders – K. Bradley, M.D.
• Pharmacist-Integrated Collaborative Care in OUD Treatment – L. Marsch, PhD

This is the primary outcomes paper for CTN-0093.

Prescription drug monitoring programs (PDMPs) are critical for pharmacists to identify risky opioid medication use. This study, an independent evaluation of the PDMP-based Narcotic Score (NS) metric, was a one-time, cross-sectional health assessment within 19 pharmacies from a national chain among adults picking up opioid medications. The NS metric is a 3-digit composite indicators. The WHO Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) was the gold-standard to which the NS metric was compared. Machine learning determined optimal risk thresholds; Receiver Operating Characteristic curves an Spearman (P) and Kappa (K) coefficients analyzed concurrent validity. Regression analyses evaluated participant characteristics associated with misclassification.

The NS metric showed fair concurrent validity (area under the curve=0.70; K=0.35; P = 0.37, p < 0.001). The ASSIST and NS metric categorized 37% of participants as low-risk (i.e., not needing screening/intervention). Further, 17.2% were categorized as low ASSIST risk but moderate/high NS metric risk, termed false positives. These reported disability (OR=3.2), poor general health (OR=0.66), and/or greater pain severity/interference (OR=1.12/1.09; all p < 0.05; i.e., needing unmanaged-pain screening/intervention). A total of 13.4% were categorized as moderate/high ASSIST risk but low NS metric risk, termed false negatives. These reported greater overdose history (OR=1.24) and/or substance use (OR=1.81-12.66; all p < 0.05).

Conclusions: The NS metric could serve as a useful initial universal prescription opioid-risk screener given its: 1) low burden (i.e., no direct assessment); 2) high accuracy (86.5%) of actionable data identifying low-risk patients and those needing opioid use/unmanaged pain screening/intervention; and 3) broad availability.

Related protocols: CTN-0093

Cannabis use is common among individuals with pain who are prescribed opioids, occurring in approximately 10% of this population. This study aimed to explore the relationship between non-medical cannabis use and other health risks among individuals filling opioids at community pharmacies.

This study was an exploratory secondary data analysis of a National Drug Abuse Treatment Clinical Trials Network (CTN)-sponsored study, Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening (CTN-0093), examining the relationship between risky cannabis use and depressive symptoms, pain, overdose, and other substance misuse among individuals filling opioid prescriptions in community pharmacies (N = 1440).

Participants reporting moderate- to high-risk compared to low-risk cannabis use were more likely to report depressive symptoms (adjusted OR = 1.67, 95% CI = 1.11–2.56), history of overdose (adjusted OR = 2.15, 95% CI = 1.34–3.44), and moderate- to high-risk use of alcohol (adjusted OR = 2.10, 95% CI = 1.28–3.45), opioids (adjusted OR = 2.50, 95% CI = 1.67–3.76), sedatives (adjusted OR = 2.58, 95% CI = 1.72–3.86), stimulants (adjusted OR = 4.79, 95% CI = 2.83–8.01), and tobacco (adjusted OR = 3.60, 95% CI = 2.47–5.24).

Conclusion: Community pharmacies may be valuable sites for identifying, studying, and intervening with substance use problems.

Related protocols: CTN-0093

This is the primary outcomes article for CTN-0075.

Physician and pharmacist collaboration may help address the shortage of buprenorphine-waivered physicians and improve care for patients with opioid use disorder (OUD). This study, CTN-0075, investigated the feasibility and acceptability of a new collaborative care model involving buprenorphine-waivered physicians and community pharmacists.

The study was a nonrandomized, single-arm, open-label feasibility trial held in three office-based buprenorphine treatment (OBBT) clinics and three community pharmacies in the United States. Participants were six physicians, six pharmacists, and 71 patients aged 18 or older with DMS-5 OUD on buprenorphine maintenance. After screening, eligible patients’ buprenorphine care was transferred from their OBBT physician to a community pharmacist for 6 months. Primary outcomes included recruitment, treatment retention and adherence, and opioid use. Secondary outcomes were intervention fidelity, pharmacists’ use of prescription drug monitoring program (PDMP), participant safety, and satisfaction with treatment delivery.

A high proportion (93.4%) of eligible participants enrolled into the study. There were high rates of treatment retention (88.7%) and adherence (95.3%) at the end of the study. The proportion of opioid-positive urine drug screenings (UDSs) among complete cases (i.e., those with all six UDSs collected during 6 months) at month 6 was 4.9%. Intervention fidelity was excellent. Pharmacists used PDMP at 96.8% of visits, and there were no opioid-related safety events. Over 90% of patients endorsed that they were “very satisfied with their experience and the quality of treatment offered,” that “treatment transfer from physician’s office to the pharmacy was not difficult at all,” and that “holding buprenorphine visits at the same place the medication is dispensed was very or extremely useful/convenient.” Similarly, positive ratings of satisfaction were found among physicians/pharmacists.

Conclusions: Overall success of this pilot trial offers strong support for a physician-pharmacist collaborative care model to help improve buprenorphine treatment access for OUD. Future randomized trials are needed to test the efficacy, effectiveness, and implementation of physician-pharmacist collaborative care models for management and treatment of patients with OUD as part of real-world practice.

Related protocols: CTN-0075

The U.S. has been experiencing a devastating opioid epidemic with enormous negative impacts on public health across the country. While efforts to reduce opioid prescribing have been successful, rates of opioid use disorder (OUD) continue to surge, with 300-400% increases among some populations.

Medications for opioid use disorder (MOUD), like methadone and buprenorphine, are effective strategies for treatment of OUD and reducing overdose risk. However, medication treatment rates continue to be low across the U.S., and the COVID-19 pandemic is making it even more difficult than usual for people to connect with care.

Given the challenges of getting and keeping people in treatment, expanding the role of community pharmacies may be one solution. Pharmacists have specialized training, high levels of consumer trust, and are often widely available in communities. Canadian, Australian, and European pharmacists have made important contributions to the treatment and care of those with OUD in the past decades, but U.S. pharmacists have continued to be blocked from prescribing medications for OUD and are only currently allowed to dispense methadone for pain.

Two NIDA Clinical Trials Network trials are investigating the use of pharmacies in this role:

• CTN-0093, Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool, is working in community pharmacies to validate a national prescription drug monitoring program-based metric that will allow pharmacists to triage and understand care needed by patients with prescription opioid-related risk, including OUD.
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• CTN-0105, Integrating Pharmacy-Based Prevention and Treatment of Opioid and Other Substance Use Disorders: A Survey of Pharmacists and Stakeholders, is working to understand the current status, knowledge, and attitudes of pharmacists in the U.S. toward identification, brief intervention, referral, and MOUD provision.

U.S. policymakers, regulators, and practitioners must work to facilitate this advancement of community pharmacy-based MOUD care, through research, education, practice, and industry changes.

Conclusions: Advancing community pharmacy-based MOUD services could make a critical difference in addressing the opioid epidemic in the United States, helping to mitigate the fallout from COVID-19 on people seeking help with their opioid use, and getting individuals the life-saving care they need.

Related protocols: CTN-0093, CTN-0105

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