Faculty Bibliography

This chapter describes recent clinical trials for opioid use disorder (OUD), an area that has rapidly accelerated in response to the opioid overdose crisis in the USA and newly appropriated funding. Trials involve a wide range of compounds including cannabinoids and psychedelics, new and existing compounds targeting domains emerging from addiction neuroscience, agents repurposed from other indications, and novel strategies including vaccines, enzymes, and other biologicals. In parallel, new formulations of existing compounds offer immediate promise, as do a variety of web-based interventions and smartphone-delivered apps. Trials focused on implementing existing effective interventions in mainstream healthcare settings, and others focused on special populations, e.g., adolescents, criminal justice, pregnant women, native Americans, etc., have the potential to vastly expand treatment in the near term. Given the range of ongoing and recent trials, this chapter is not intended to be an exhaustive review but rather to present an overview of approaches within the framework of the opioid treatment cascade and the context of current OUD pharmacotherapies.

BACKGROUND:Substance use frequently goes undetected in primary care. Though barriers to implementing systematic screening for alcohol and drug use have been examined in urban settings, less is known about screening in rural primary care. OBJECTIVE:To identify current screening practices, barriers, facilitators, and recommendations for the implementation of substance use screening in rural federally qualified health centers (FQHCs). DESIGN/METHODS:As part of a multi-phase study implementing electronic health record-integrated screening, focus groups (n = 60: all stakeholder groups) and individual interviews (n = 10 primary care providers (PCPs)) were conducted. PARTICIPANTS/METHODS:Three stakeholder groups (PCPs, medical assistants (MAs), and patients) at three rural FQHCs in Maine. APPROACH/METHODS:Focus groups and interviews were recorded, transcribed, and content analyzed. Themes surrounding current substance use screening practices, barriers to screening, and recommendations for implementation were identified and organized by the Knowledge to Action (KTA) Framework. KEY RESULTS/RESULTS:Identifying the problem: Stakeholders unanimously agreed that screening is important, and that universal screening is preferred to targeted approaches. Adapting to the local context: PCPs and MAs agreed that screening should be done annually. Views were mixed regarding the delivery of screening; patients preferred self-administered, tablet-based screening, while MAs and PCPs were divided between self-administered and face-to-face approaches. Assessing barriers: For patients, barriers to screening centered around a perceived lack of rapport with providers, which contributed to concerns about trust, judgment, and privacy. For PCPs and MAs, barriers included lack of comfort, training, and preparedness to address screening results and offer treatment. CONCLUSIONS:Though stakeholders agree on the importance of implementing universal screening, concerns about the patient-provider relationship, the consequences of disclosure, and privacy appear heightened by the rural context. Findings highlight that strong relationships with providers are critical for patients, while in-clinic resources and training are needed to increase provider comfort and preparedness to address substance use.

Objectives: In a US randomized clinical trial testing the effectiveness of preventing opioid relapse among individuals initiating extended-release naltrexone (XR-NTX) compared to buprenorphine-naloxone (BUP-NX) in an inpatient detoxification setting, the additional time required to detoxify from opioids prior to initiating XR-NTX resulted in fewer persons initiating XR-NTX, leading to a higher opioid relapse rate, and higher detoxification costs compared to BUP-NX. The objective of this study was to use trial data to estimate whether an efficient model of inpatient opioid detoxification would improve the economic value of XR-NTX compared to BUP-NX.
Method(s): We identified efficient models of inpatient detoxification for trial participants assigned to XR-NTX using 1) latent class analysis to identify detoxification pharmacotherapy use patterns, 2) a multivariable generalized structural equation model to explore determinants of XR-NTX initiation and detoxification duration, while controlling for endogeneity, and 3) data from the trial on detoxification daily cost by site. We then estimated trial cost-effectiveness outcomes from the healthcare sector perspective assuming alternative detoxification models for trial participants.
Result(s): Five latent pharmacotherapy classes were identified and included in the multivariable model. Site effects were the largest determinants of both XRT-NTX initiation and detoxification duration. The predicted probabilities of successful initiation per detoxification-day ranged from 0.13-0.15 at the four sites with significant effects, and the predicted durations ranged from 5.5 to 6.9 days. The predicted cost/detoxification-day varied from $115-$348, largely due to different staffing models. We estimated that the most efficient site model would result in non-significant cost and effectiveness differences between initiating XR-NTX or BUP-NX.
Conclusion(s): Adopting an efficient model of XR-NTX initiation could result in XR-NTX and BUP-NX having similar economic value from the healthcare sector perspective for the average patient requiring residential detoxification before initiating XR-NTX. The feasibility of implementing more efficient detoxification models needs to be explored.
Copyright

OBJECTIVES/OBJECTIVE:To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory. METHODS:Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254). RESULTS:Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes. CONCLUSIONS:Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.

Background: Emergency department (ED) visits related to substance use are common. ED patients also have high levels of health-related material needs (HRMNs), such as homelessness and food insecurity. However, little research has examined the intersection between ED patient HRMNs and substance use. Methods: We surveyed a random sample of public hospital ED patients. Surveys included validated single-item screeners for unhealthy alcohol and any drug use and questions on self-reported past-year material needs. We compared individual HRMNs and cumulative number of HRMNs by substance use screening status using bivariate and multivariable analyses. Results: A total of 2312 surveys were completed. Nearly one third of patients (32.3%, n = 747) screened positive for unhealthy alcohol use, and 21.8% (n = 503) screened positive for drug use. Prevalence of HRMNs for all patients-including food insecurity (50.8%), inability to meet essential expenses (40.8%), cost barriers to medical care (24.6%), employment issues (23.8%), and homelessness (21.4%)-was high and was significantly higher for patients with unhealthy alcohol use or drug use. In multivariable analyses, homelessness was independently associated with unhealthy alcohol use (adjusted odds ratio [aOR]: 1.61, 95% confidence interval [CI]: 1.24-2.09) and drug use (aOR: 2.30, 95% CI: 1.74-3.05). There was a significant stepwise increase in the odds of patient unhealthy alcohol or drug use as number of HRMNs increased. Conclusions: ED patients with unhealthy alcohol or drug use have higher prevalence of HRMNs than those without. Our findings suggest that HRMNs may act additively and that homelessness is particularly salient. Patients' comorbid HRMNs may affect the success of ED-based substance use interventions.