Faculty Bibliography

Importance/UNASSIGNED:Extended-release buprenorphine (XRB), a monthly injectable long-acting opioid use disorder (OUD) treatment, has not been studied for use in corrections facilities. Objective/UNASSIGNED:To compare treatment retention following release from jail among adults receiving daily sublingual buprenorphine-naloxone (SLB) vs those receiving XRB. Design, Setting, and Participants/UNASSIGNED:This open-label, randomized comparative effectiveness study included 52 incarcerated adults in New York City observed for 8 weeks postrelease between June 2019 and May 2020. Participants were soon-to-be-released volunteers from 1 men's and 1 women's jail facility who had OUDs already treated with SLB. Follow-up treatment was received at a primary care clinic in Manhattan. Data were analyzed between June 2020 and December 2020. Interventions/UNASSIGNED:XRB treatment was offered prior to release and continued monthly through 8 weeks after release. SLB participants continued to receive daily directly observed in-jail SLB administration, were provided a 7-day SLB supply at jail release, and followed up at a designated clinic (or other preferred clinics). Main Outcomes and Measures/UNASSIGNED:Buprenorphine treatment retention at 8 weeks postrelease. Results/UNASSIGNED:A total of 52 participants were randomized 1:1 to XRB (26 participants) and SLB (26 participants). Participants had a mean (SD) age of 42.6 (10.0) years; 45 participants (87%) were men; and 40 (77%) primarily used heroin prior to incarceration. Most participants (30 [58%]) reported prior buprenorphine use; 18 (35%) reported active community buprenorphine treatment prior to jail admission. Twenty-one of 26 assigned to XRB received 1 or more XRB injection prior to release; 3 initiated XRB postrelease; and 2 did not receive XRB. Patients in the XRB arm had fewer jail medical visits compared with daily SLB medication administration (mean [SD] visits per day: XRB, 0.11 [0.03] vs SLB, 1.06 [0.08]). Community buprenorphine treatment retention at week 8 postrelease was 18 participants in the XRB group (69.2%) vs 9 in the SLB group (34.6%), and rates of opioid-negative urine tests were 72 of 130 tests in the XRB group (55.3%) and 50 of 130 tests in the SLB group (38.4%). There were no differences in rates of serious adverse events, no overdoses, and no deaths. Conclusions and Relevance/UNASSIGNED:XRB was acceptable among patients currently receiving SLB, and patients had fewer in-jail clinic visits and increased community buprenorphine treatment retention when compared with standard daily SLB treatment. These results support wider use and further study of XRB as correctional and reentry OUD treatment. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03604159.

BACKGROUND:Few studies have documented patient attitudes and experiences with extended-release naltrexone (XR-NTX) opioid relapse prevention in criminal justice settings. This study assessed barriers and facilitators of jail-to-community reentry among adults with opioid use disorder (OUD) treated with XR-NTX, buprenorphine, methadone, and no medications. METHODS:This qualitative study conducted individual interviews with a purposeful and convenience sample of adults with OUD who were recently released from NYC jails. XR-NTX, no medication, and methadone participants were concurrently enrolled in a large randomized controlled trial evaluating XR-NTX vs. a no medication Enhanced Treatment As Usual (ETAU) condition, or enrolled in a non-randomized quasi-experimental methadone maintenance cohort. Buprenorphine participants were referred from NYC jails to a public hospital office-based buprenorphine program and not enrolled in the parent trial. Interviews were audio recorded, transcribed, independently coded by two researchers, and analyzed per a grounded theory approach adapted to the Social Cognitive Theory framework. The research team reviewed transcripts and coding to reach consensus on emergent themes. RESULTS:N = 33 adults with OUD (28 male, 5 female) completed a single individual interview. Purposeful sampling recruited persons leaving jail on XR-NTX (n = 11), no active medication treatment (n = 9), methadone (n = 9), and buprenorphine (n = 4). Emergent themes were: (1) general satisfaction with XR-NTX's long-acting antagonist effects and control of cravings; (2) "testing" XR-NTX's blockade with heroin upon reentry was common; (3) early discontinuation of XR-NTX treatment was most common among persons with high self-efficacy and/or heavy exposure to drug use environments and peers; (4) similar satisfaction regarding effects of methadone and buprenorphine maintenance among retained-in-treatment individuals, alongside general dissatisfaction with daily observed dosing requirements and misinformation and stigmas regarding methadone adverse effects; (5) unstable housing, economic insecurity, and exposure to actively using peers were attributed to early termination of treatment and relapse; (6) individual motivation and willpower as central to long-term opioid abstinence and reentry success. CONCLUSIONS:In the context of more familiar agonist maintenance treatments, XR-NTX relapse prevention during jail-to-community reentry was viewed as a helpful and unique intervention though with important limitations. Commonly described barriers to treatment retention and heroin abstinence included homelessness, economic insecurity, and drug-using peers. Trial registration ClinicalTrials.gov, NCT01999946 (XOR), Registered 03 December 2013, https://clinicaltrials.gov/ct2/show/NCT01999946 .

Aim: Naltrexone is first-line pharmacotherapy for alcohol use disorders (AUD). Oral naltrexone (ONTX) is under-prescribed in primary care and possibly limited by poor adherence. Monthly injectable extended-release naltrexone (XR-NTX) may improve adherence and good clinical outcomes.
Method(s): This is a randomized, open-label, comparative effectiveness trial of 24 weeks of XR-NTX vs. O-NTX as AUD treatment in primary care at a public hospital in New York City. Adults (>18 yo) with AUD randomized to XR-NTX (380 mg/month) vs. O-NTX (50 mg/day) with Medical Management. Self-reported daily drinking recall informed the primary outcome, a Good Clinical Outcome (GCO) across weeks 5-24, defined as abstinence or moderate drinking and 0-2 days of heavy drinking per month. Data & Results: N = 237 adults randomized (n = 117 XR-NTX; n = 120 O-NTX); mean age 48.5 (SD 10.6); 71%male; 54%AA, 21% Hispanic; 41%employed. At baseline mean drinks/day were 9.6 (SD 11.6); 29% abstinent days; 61%heavy drinking days; mean Obsessive Compulsive Drinking Scale (OCDS) scores were 17.6 (SD 7.1) and mean AUDIT scores were 24.2 (SD 8.0). 64%of monthly XR-NTX injections were received and 67%ofmonthly O-NTX refills were provided. The primary GCO across weeks 5-24 was reported by 29%XR-NTX and 23%O-NTX (p = 0.29). Mean months with a GCO was 2.9 XR-NTX, 2.5 O-NTX (p = 0.21). Rates of%days abstinent (70%XRNTX vs. 71%O-NTX; p = 0.77) and %heavy drinking days (20%XR-NTX vs. 16%O-NTX; p = 0.28) were similar weeks 1-24. Mean blood pressure decreased from 127/86 mmHg at baseline to 124/83 mmHg at week 25; there was no change in mean weight (180 lb) pre/post, and there were no differences in BP or weight changes by arm. Declines in OCDS scores (17.6 to 7.6) were similar by arm.
Conclusion(s): Initiation and retention on both forms of naltrexone was robust. Overall, participants reported improved longitudinal drinking outcomes. There was insufficient evidence of any differences in primary and secondary self-reported drinking outcomes between monthly XR-NTX and daily ONTX. Additional analysis will examine CDT and LFT levels during treatment, and interactions with OPMR1 genotype status

Statement of Problem Or Question (One Sentence): How do we provide effective, dignified primary care for medically complex patients with homelessness in a safety-net health system? Objectives of Program/Intervention (No More Than Three Objectives): To effectively engage homeless patients with complex barriers to primary care To provide dignified, trauma-informed care focused on patient-oriented care goals while addressing addiction, mental health, and chronic disease To implement an interdisciplinary care team model in a safety-net health care system combining primary care, social work, care coordination, and nursing Description of Program/Intervention, Including Organizational Context (E.G. Inpatient Vs. Outpatient, Practice or Community Characteristics): Unstably housed people with complex chronic disease often receive fragmented care from various emergency departments and inpatient settings, accruing high rates of acute care utilization without improvements in health. Recently, intensive outpatient models have emerged to better manage high need patients. Here we describe our efforts to create a complex care clinic for medically, socially, and behaviorally complex patients with unstable housing at the largest safety-net health system in the United States. Launched in August 2018, the clinic aims to engage patients in a trusting healthcare environment and break the cycle of disease, addiction, and housing instability. Our team includes four buprenorphine-waivered internal medicine physicians, a social worker, care coordinator, and home care nurse provided by our system's Medicaid Health Home. Patients are referred from the ED, inpatient service, other clinics, street outreach organizations, shelters, and jails. They receive extensive care coordination; on-site addiction, medical, and social services; home nursing visits; and collaboration with shelters and community based organizations. Measures of Success (Discuss Qualitative And/Or Quantitative Metrics Which Will Be Used To Evaluate Program/Intervention): A quantitative analysis will be used to determine program impact on clinical outcomes and utilization, patient experience, and provider satisfaction. Both quantitative and qualitative measures will be used to evaluate clinic capacity, services provided, patient engagement, and progress towards patient-oriented care goals. Findings To Date (It Is Not Sufficient To State Findings Will Be Discussed): From August through December 2018, 156 referrals were given appointments and 83 patients completed at least one appointment. Of those, at least 44 patients (53%) returned for a second visit. On average patients completed 2.1 visits. We had a 16% cancellation rate and 38% no show rate. Patients are mostly male, middle-aged and street or shelter dwelling with common diagnosis of substance use disorder, lower extremity wounds, and hypertension. Our most engaged patients (> 3 visits, n=15) have seen an average reduction in ED visits by 68% and inpatient admissions by 58% within our system compared to pre-clinic intervention. Key Lessons For Dissemination (What Can Others Take Away For Implementation To Their Practice Or Community?): Relationships have been a core element of patient care, building an interdisciplinary team, and developing referral and collaborative resources internally and in the community. Our focus on a patient-directed care plan, warm hand-offs, continuity of care, and community outreach has also allowed this model to succeed

Aim: Naltrexone is first-line pharmacotherapy for alcohol use disorders (AUD). Oral naltrexone (ONTX) is under-prescribed in primary care and possibly limited by poor adherence. Monthly injectable extended-release naltrexone (XR-NTX) may improve rates of medication adherence, retention, good clinical outcomes (Aim 1), and cost savings (Aim 2). Methods: This is an on-going randomized, open-label, comparative effectiveness trial of 24 weeks of XR-NTX vs. O-NTX as AUD treatment in primary care at a public hospital in New York City. Adults (>18 yo) with a DSM-V diagnosis of AUD randomized to XR-NTX (380 mg/month) vs. O-NTX (50-100 mg/day).Medical Management visits occur biweekly (weeks 1-8), then monthly.Major research assessments occur at baseline, weeks 13, 25, 48. The primary outcome is a Good Clinical Outcome (GCO) across weeks 5-24: abstinence or moderate drinking and 0-2 days of heavy drinking per month. This preliminary, descriptive analysis presentsWeek 0-5 results among all participants. Results: N = 237 participants were randomized from 6/14-9/17: mean age 48.5 (SD = 10.6); 71% male; 54% AA, 21%Hispanic; 41% employed, 81%reported other lifetime substance use. Mean AUDIT scores (instrument range 0-40) at baseline: 24.2 (SD = 8.0); mean OCDS (range 0-40) scores 17.1 (SD = 8.1); mean drinks/day 9.6 (SD = 11.6) with 29%abstinent vs. 61% heavy drinking days. Medication induction was robust, 115 of 117 (98.2%) initiating XR-NTX and 120 (100%) filled or received an initial O-NTX prescription. The GCO was reported by 41%XR-NTX and 47%ONTX atWeek 5. DuringWeek 1-5, mean drinks/day were 3.1 (SD = 6.1), 63% abstinent/22%heavy drinking days for XR-NTX; 2.4 (SD = 4.03), 61%abstinent/22%heavy drinking days for O-NTX. 62%received XR-NTX injection #2 and 67%received O-NTXmonthly refill #2. Adherence self-report for O-NTX at Week 5 indicated moderate average daily adherence,MMAS-8 mean (range <6 low, 6 to <8 moderate, =8 high) score 6.13 (SD = 3.02). Conclusion: This on-going XR vs. oral naltrexone alcohol primary care treatment trial recruited a primarily male, unemployed, ethnic minority adult population. Initial acceptance of both XR and ONTX was high. Primary outcomes will focus on drinking reductions and cost and value comparisons during weeks 5-24

BACKGROUND: Buprenorphine maintenance for opioid dependence remains of limited availability among underserved populations, despite increases in US opioid misuse and overdose deaths. Low threshold primary care treatment models including the use of unobserved, "home," buprenorphine induction may simplify initiation of care and improve access. Unobserved induction and long-term treatment outcomes have not been reported recently among large, naturalistic cohorts treated in low threshold safety net primary care settings. METHODS: This prospective clinical registry cohort design estimated rates of induction-related adverse events, treatment retention, and urine opioid results for opioid dependent adults offered buprenorphine maintenance in a New York City public hospital primary care office-based practice from 2006 to 2013. This clinic relied on typical ambulatory care individual provider-patient visits, prescribed unobserved induction exclusively, saw patients no more than weekly, and did not require additional psychosocial treatment. Unobserved induction consisted of an in-person screening and diagnostic visit followed by a 1-week buprenorphine written prescription, with pamphlet, and telephone support. Primary outcomes analyzed were rates of induction-related adverse events (AE), week 1 drop-out, and long-term treatment retention. Factors associated with treatment retention were examined using a Cox proportional hazard model among inductions and all patients. Secondary outcomes included overall clinic retention, buprenorphine dosages, and urine sample results. RESULTS: Of the 485 total patients in our registry, 306 were inducted, and 179 were transfers already on buprenorphine. Post-induction (n = 306), week 1 drop-out was 17%. Rates of any induction-related AE were 12%; serious adverse events, 0%; precipitated withdrawal, 3%; prolonged withdrawal, 4%. Treatment retention was a median 38 weeks (range 0-320) for inductions, compared to 110 (0-354) weeks for transfers and 57 for the entire clinic population. Older age, later years of first clinic visit (vs. 2006-2007), and baseline heroin abstinence were associated with increased treatment retention overall. CONCLUSIONS: Unobserved "home" buprenorphine induction in a public sector primary care setting appeared a feasible and safe clinical practice. Post-induction treatment retention of a median 38 weeks was in line with previous naturalistic studies of real-world office-based opioid treatment. Low threshold treatment protocols, as compared to national guidelines, may compliment recently increased prescriber patient limits and expand access to buprenorphine among public sector opioid use disorder patients.