The impact of the implementation of medication for opioid use disorder and COVID-19 in a statewide correctional system on treatment engagement, postrelease continuation of care, and overdose.

BACKGROUND: People with opioid use disorder (OUD) are overrepresented in US correctional facilities and experience disproportionately high risk for overdose after release. Medications for OUD (MOUD) are highly efficacious but not available to most incarcerated individuals. In 2018, Vermont began providing MOUD for all incarcerated individuals with OUD statewide. In 2020, the COVID-19 state of emergency began. We assessed the impact of both events on MOUD utilization and treatment outcomes. METHODOLOGY: Analyses linked Vermont Department of Corrections administrative data and Medicaid claims data between 07/01/2017 and 03/31/2021. The study used logistic regression to analyze treatment engagement among all incarcerated individuals in Vermont. Multilevel modeling assessed change in clinical outcomes among release episodes that occurred among individuals with an OUD diagnosis Medicaid claim. RESULTS: Prescriptions for MOUD while incarcerated increased from 0.8% to 33.9% of the incarcerated population after MOUD implementation (OR = 67.4) and subsequently decreased with the onset of COVID-19 to 26.6% (OR = 0.7). After MOUD implementation, most prescriptions (63.1%) were to individuals who had not been receiving MOUD prior to incarceration, but this figure decreased to 53.9% with the onset of COVID-19 (OR = 0.7). Prescriptions for MOUD within 30 days after release increased from 33.9% of those with OUD before to 41.0% after MOUD implementation (OR = 1.4) but decreased to 35.6% with the onset of COVID-19 (OR = 0.8). Simultaneously, opioid-related nonfatal overdoses within 30 days after release decreased from 1.2% before to 0.8% after statewide MOUD implementation (OR = 0.3) but increased to 1.9% during COVID-19 (OR = 3.4). Fatal overdoses within 1 year after release decreased from 27 deaths before to ≤10 after statewide MOUD implementation and remained ≤10 during COVID-19. CONCLUSIONS: This longitudinal evaluation demonstrated increased treatment engagement and a decrease in opioid-related overdose following implementation of MOUD in a statewide correctional system. In contrast, these improvements were somewhat attenuated with the onset of COVID-19, which was associated with decreased treatment engagement and an increase in nonfatal overdoses. Considered together, these findings demonstrate the benefits of statewide MOUD for incarcerated individuals as well as the need to identify and address barriers to continuation of care following release from incarceration in the context of COVID-19.

Simple, Rapid Spectrophotometric Assay of Dispensed Methadone for Diversion Control.

OBJECTIVES: Treatment of opioid use disorder with methadone is highly effective. Methadone is dispensed from opioid treatment programs under regulated circumstances. However, diversion of take-home doses can occur and is difficult to detect. We wanted to test the application of a handheld ultraviolet light absorption spectrometer to detect the concentration of methadone in take-home bottles that were suspected of being altered by the patient. METHODS: Standardized dilutions of methadone hydrochloride oral concentrate were used to calibrate absorption wavelengths and then compared to take homes from suspected and unsuspected bottles to see if measured concentrations differed from expected doses. RESULTS: Ten standardized "control" doses were analyzed to determine 99% confidence intervals. These were compared to 104 samples "not-of-concern" obtained randomly over a 10-month period. An additional 103 methadone bottles of concern from 27 patients showed 15 bottles with <25 % and 8 with <75 % of expected concentrations. CONCLUSIONS: A handheld, low-cost ultraviolet light spectrometer detected altered take-home doses of methadone. This assay presents a simple and effective method for methadone clinics to perform inhouse analysis on "call back" methadone doses. It allows individual clinics to define diversion rates of their patient body, while allowing state and federal agencies to better understand how much prescribed methadone is diverted for illicit uses.

Characterizing the Clinical use of a Novel Video-assisted Dosing Protocol With Secure Medication Dispensers to Reduce Barriers to Opioid Treatment.

OBJECTIVES: Distance and travel costs to opioid treatment programs (OTPs), especially in rural communities, are barriers to treatment for opioid use disorder. Retention rates at 12 months in our OTP are 55% (range 53%-61%).We piloted a novel treatment platform utilizing a video directly observed therapy (VDOT) smartphone app and a secure medication dispenser to support adherence with take-home doses of methadone or buprenorphine while enabling patients to maintain prosocial activities, reduce time and cost of travel, and increase retention. METHODS: Participants (n»58) were adults in a Vermont OTP. Inclusion criteria included travel hardship, access to Wi-Fi or cellular network, and having an iPhone 4S or Android 4.0 or greater. Patients received a dispenser, VDOT app, clinic dispensed medication, counseling, and urine drug testing. Chart reviews assessed VDOT compliance, engagement in prosocial activities, travel costs and time savings, and treatment disposition/retention. Project-associated costs were examined. RESULTS: Of the 15,831 expected videos, 15,581 (98.4%) were received and only 10 (0.063%) showed signs of medication noncompliance with 1 (0.0064%) showing an overt attempt at diversion. About 93% of participants engaged in prosocial activities, travel time and costs were reduced 86%, median cost saved $72 weekly, median travel time saved 5.5 hours weekly and 98% of participants were in treatment 12 months later. CONCLUSIONS: VDOT participants using dispensers showed high levels of medication ingestion integrity, had favorable clinical stability, and lower travel time and costs. These findings suggest that using VDOT with dispensers may hold promise as an innovative platform for supporting medication adherence.

Influence of Opioid Prescription Policy on Overdoses and Related Adverse Effects in a Primary Care Population.

BACKGROUND: In response to the opioid epidemic, many states have enacted policies limiting opioid prescriptions. There is a paucity of evidence of the impact of opioid prescribing interventions in primary care populations, including whether unintended consequences arise from limiting the availability of prescribed opioids. OBJECTIVE: Our aim was to compare changes in opioid overdose and related adverse effects rate among primary care patients following the implementation of state-level prescribing policies. DESIGN: A cohort of primary care patients within an interrupted time series model. PARTICIPANTS: Electronic medical record data for 62,776 adult (18+ years) primary care patients from a major medical center in Vermont from January 1, 2016, to June 30, 2018. INTERVENTIONS: State-level opioid prescription policy changes limiting dose and duration. MAIN MEASURES: Changes in (1) opioid overdose rate and (2) opioid-related adverse effects rate per 100,000 person-months following the July 1, 2017, prescription policy change. KEY RESULTS: Among primary care patients, there was no change in opioid overdose rate following implementation of the prescribing policy (incidence rate ratio; IRR: 0.64, 95% confidence interval; CI: 0.22-1.88). There was a 78% decrease in the opioid-related adverse effects rate following the prescribing policy (IRR: 0.22, 95%CI: 0.09-0.51). This association was moderated by opioid prescription history, with decreases observed among opioid-naïve patients (IRR: 0.18, 95%CI: 0.06-0.59) and among patients receiving chronic opioid prescriptions (IRR: 0.17, 95%CI: 0.03-0.99), but not among those with intermittent opioid prescriptions (IRR: 0.51, 95%CI: 0.09-2.82). CONCLUSIONS: Limiting prescription opioids did not change the opioid overdose rate among primary care patients, but it reduced the rate of opioid-related adverse effects in the year following the state-level policy change, particularly among patients with chronic opioid prescription history and opioid-naïve patients. Limiting the quantity and duration of opioid prescriptions may have beneficial effects among primary care patients.

Integrating DATA 2000 waiver training into undergraduate medical education: The time is now.

Background: Medications for opioid use disorder (MOUD) significantly reduce morbidity and mortality from opioid use disorder (OUD). To prescribe MOUD, physicians must obtain a DEA waiver through requirements outlined in the Drug Addiction Treatment Act of 2000 (DATA 2000). We developed an Addiction Medicine curriculum that features DATA 2000 waiver training at the Robert Larner, MD College of Medicine (LCOM). Methods: All third-year medical students completed a virtual DATA 2000 waiver training at the commencement of clinical clerkships. We conducted a curriculum needs assessment followed by pre- and post-training surveys to evaluate MOUD pharmacology knowledge and best prescribing practices. Results: Of LCOM students surveyed, 77.6% reported interest in being waivered to prescribed MOUD for OUD treatment. Third-year medical students demonstrated increases in both MOUD Pharmacology Knowledge from 64.2% to 84.8% (chi-squared = 40.8; p < .001) and MOUD Best Prescribing Practices from 55.9% to 75.2% (chi-squared = 29.9; p < .001). Discussion: Surveys showed the majority of students felt waiver training was relevant to their future practice. An online DATA 2000 waiver training format effectively improved student knowledge of MOUD. Conclusion: This curriculum exposed medical students to DATA 2000 waiver training, MOUD pharmacology and best practices, and increased the number of future physicians eligible to treat OUD using MOUD.

Vermont Hub-and-Spoke Model of Care for Opioid Use Disorder: Development, Implementation, and Impact.

BACKGROUND: Opioid use disorders (OUDs) are reaching epidemic proportions in the United States, and many geographic areas struggle with a persistent shortage in availability of opioid agonist treatment. Over the past 5 years, Vermont addiction medicine physicians and public health leaders have responded to these challenges by developing an integrated hub-and-spoke opioid treatment network. METHODS: In the present report, we review the development, implementation, and impact of this novel hub-and-spoke model for expanding OUD treatment in Vermont. RESULTS: Vermont's hub-and-spoke system has been implemented state-wide and well-received by providers and patients alike. Adoption of this model has been associated with substantial increases in the state's OUD treatment capacity, with Vermont now having the highest capacity for treating OUD in the United States with 10.56 people in treatment per 1000. There has been a 64% increase in physicians waivered to prescribe buprenorphine, a 50% increase in patients served per waivered physician, and a robust bidirectional transfer of patients between hubs and spokes based upon clinical need. Challenges to system implementation and important future directions are discussed. CONCLUSIONS: Development and implementation of a hub-and-spoke system of care has contributed substantially to improvements in opioid agonist treatment capacity in Vermont. This system may serve as a model for other states grappling with the current opioid use epidemic.

Bridging waitlist delays with interim buprenorphine treatment: initial feasibility.

Despite the effectiveness of agonist maintenance for opioid dependence, individuals can remain on waitlists for months, during which they are at significant risk for morbidity and mortality. Interim dosing, consisting of daily medication without counseling, can reduce these risks. In this pilot study, we examined the initial feasibility of a novel technology-assisted interim buprenorphine treatment for waitlisted opioid-dependent adults. Following buprenorphine induction during Week 1, participants (n=10) visited the clinic at Weeks 2, 4, 6, 8, 10 and 12 to ingest their medication under staff observation, provide a urine specimen and receive their remaining doses via a computerized Med-O-Wheel Secure device. They also received daily monitoring via an Interactive Voice Response (IVR) platform, as well as random call-backs for urinalysis and medication adherence checks. The primary outcome was percent of participants negative for illicit opioids at each 2-week visit, with secondary outcomes of past-month drug use, adherence and acceptability. Participants achieved high levels of illicit opioid abstinence, with 90% abstinent at the Week 2 and 4 visits and 60% at Week 12. Significant reductions were observed in self-reported past-month illicit opioid use (p<.001), opioid withdrawal (p<.001), opioid craving (p<.001) and ASI Drug composite score (p=.008). Finally, adherence with buprenorphine administration (99%), daily IVR calls (97%) and random call-backs (82%) was high. Interim buprenorphine treatment shows promise for reducing patient and societal risks during delays to conventional treatment. A larger-scale, randomized clinical trial is underway to more rigorously examine the efficacy of this treatment approach.

A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers.

IMPORTANCE: Although abuse of prescription opioids (POs) is a significant public health problem, few experimental studies have investigated the treatment needs of this growing population. OBJECTIVE: To evaluate, following brief stabilization with a combination of buprenorphine hydrochloride and naloxone hydrochloride dihydrate, the relative efficacy of 1-, 2-, and 4-week buprenorphine tapering regimens and subsequent naltrexone hydrochloride therapy in PO-dependent outpatients. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, 12-week randomized clinical trial was conducted in an outpatient research clinic. Following a brief period of buprenorphine stabilization, 70 PO-dependent adults were randomized to receive 1-, 2-, or 4-week tapers followed by naltrexone therapy. INTERVENTION: During phase 1 (weeks 1-5 after randomization), participants visited the clinic daily; during phase 2 (weeks 6-12), visits were reduced to thrice weekly. Participants received behavioral therapy and urine toxicology testing throughout the trial. MAIN OUTCOMES AND MEASURES: The percentage of participants negative for illicit opioid use, retention, naltrexone ingestion, and favorable treatment response (ie, retained in treatment, opioid abstinent, and receiving naltrexone at the end of the study). RESULTS: Opioid abstinence at the end of phase 1 was greater in the 4-week compared with the 2- and 1-week taper conditions (P = .02), with 63% (n = 14), 29% (n = 7), and 29% (n = 7) of participants abstinent in the 4-, 2-, and 1-week conditions, respectively. Abstinence at the end of phase 2 was also greater in the 4-week compared with the 2- and 1-week conditions (P = .03), with 50% (n = 11), 16% (n = 4), and 20% (n = 5) of participants abstinent in the 4-, 2-, and 1-week conditions, respectively. There were more treatment responders in the 4-week condition (P = .03), with 50% (n = 11), 17% (n = 4), and 21% (n = 5) of participants in the 4-, 2-, and 1-week groups considered responders at the end of treatment, respectively. Retention and naltrexone ingestion also were superior in the 4-week vs briefer tapers (both P = .04). Experimental condition (ie, taper duration) was the strongest predictor of treatment response, followed by buprenorphine stabilization dose. CONCLUSIONS AND RELEVANCE: This study represents a rigorous experimental evaluation of outpatient buprenorphine stabilization, brief taper, and naltrexone maintenance for treatment of PO dependence. Results suggest that a meaningful subset of PO-dependent outpatients may respond positively to a 4-week taper plus naltrexone maintenance intervention.