Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail.

Importance: Extended-release buprenorphine (XRB), a monthly injectable long-acting opioid use disorder (OUD) treatment, has not been studied for use in corrections facilities. Objective: To compare treatment retention following release from jail among adults receiving daily sublingual buprenorphine-naloxone (SLB) vs those receiving XRB. Design, Setting, and Participants: 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: 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: Buprenorphine treatment retention at 8 weeks postrelease. Results: 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: 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: ClinicalTrials.gov Identifier: NCT03604159.

Perceptions of extended-release naltrexone, methadone, and buprenorphine treatments following release from jail.

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 .

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON).

BACKGROUND: Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders. METHODS: This pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. O-NTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120). RESULTS: We describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported. CONCLUSIONS: XR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX's treatment and cost effectiveness relative to oral naltrexone.

Public sector low threshold office-based buprenorphine treatment: outcomes at year 7.

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.

Development of a structured year-end sign-out program in an outpatient continuity practice.

BACKGROUND: In an effort to prevent medical errors, it has been recommended that all healthcare organizations implement a standardized approach to communicating patient information during transitions of care between providers. Most research on these transitions has been conducted in the inpatient setting, with relatively few studies conducted in the outpatient setting. OBJECTIVES: To develop a structured transfer of care program in an academic outpatient continuity practice and evaluate whether this program improved patient safety as measured by the documented completion of patient care tasks at 3 months post-transition. DESIGN: Graduating residents and the corresponding incoming interns inheriting their continuity patient panels were randomized to the pilot structured transfer group or the standard transfer group. The structured transfer group residents were asked to complete written and verbal sign-outs with their interns; the standard transfer group residents continued the current standard of care. PARTICIPANTS: Thirty-two resident-intern pairs in an academic internal medicine residency program in New York City. MAIN MEASURES: Three months after the transition, study investigators evaluated whether patient care tasks assigned by the graduating residents had been successfully completed by the interns in both groups. In addition, follow-up appointments, continuity of care and house officer satisfaction with the sign-out process were evaluated. KEY RESULTS: Among patients seen during the first 3 months, the clinical care tasks were more likely to be completed by interns in the structured group (73 %, n = 49) versus the standard group (46 %, n = 28) (adjusted OR 3.21; 95 % CI 1.55-6.62; p = 0.002). This was further enhanced if the intern who saw the patient was also the assigned primary care provider (adjusted OR 4.26; 95 % CI 1.7-10.63; p = 0.002). CONCLUSIONS: A structured outpatient sign-out improved the odds of follow-up of important clinical care tasks after the year-end resident clinic transition. Further efforts should be made to improve residents' competency with regard to sign-outs in the ambulatory setting.

Foreign body-induced abscess resembling pancreatic neoplasia.

We report the case of a 44-year-old man presenting with abdominal pain and leukocytosis. His initial computed tomography demonstrated a pancreatic head mass concerning for pancreatic adenocarcinoma. However, on further review of the patient's imaging, the mass was determined to be an abscess caused by foreign body ingestion and gastric perforation rather than cancer. This report describes the clinical and radiographic distinctions between pancreatic neoplasia and abscess. It also reviews the pertinent medical literature on how such viscus perforations affect subsequent prognostication and clinical management.

Let the dead teach the living: the rise of body bequeathal in 20th-century America.

America's medical schools have long used human cadavers to teach anatomy, but acquiring adequate numbers of bodies for dissection has always been a challenge. Physicians and medical students of the 18th and 19th centuries often resorted to robbing graves, and this history has been extensively examined. Less studied, however, is the history of body acquisition in the 20th century, and this article evaluates the factors that coalesced to transition American society from body theft to body donation. First, it describes the legislation that released the unclaimed bodies of those dying in public institutions to medical schools for dissection, thereby effectively ending grave robbery. Then it discusses midcentury journalistic exposés of excesses in the funeral industry-works that were instrumental in bringing alternatives, including the previously unpopular option of body donation, to public consciousness. Finally, it examines the rise of body transplantation, the Uniform Anatomical Gifts Act of 1968, and the subsequent state of willed-body programs at the turn of the 21st century. Body-donation programs have gradually stabilized since and currently provide most of the bodies used for dissection in American medical schools. Relying as they do on public trust, however, these programs remain potentially precarious and threatened by public scandals. Whether American medical schools will receive enough bodies to properly educate students in the future remains to be seen.