Faculty Bibliography

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.

BACKGROUND: An Audio Computer-assisted Self Interview (ACASI) version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) could reduce barriers to substance use screening and assessment in primary care settings. This study evaluated the diagnostic accuracy of an ACASI ASSIST for identification of unhealthy substance use and substance use disorders (SUD). METHODS: 399 adult patients were consecutively recruited from an urban safety-net primary care clinic. ACASI ASSIST scores for tobacco, alcohol, marijuana, and cocaine were compared against reference standard measures to assess the instrument's diagnostic accuracy for identifying unhealthy use and SUD, first using empirically-derived optimal cutoffs, and second using the currently recommended ASSIST cutoffs. RESULTS: For identifying any unhealthy use, at the empirically-derived cutoffs the ACASI ASSIST had 93.6% sensitivity and 85.8% specificity (AUC=0.90) for tobacco, 85.9% sensitivity and 60.3% specificity (AUC=0.73), for alcohol in men, 100% sensitivity and 62.4% specificity (AUC=0.81) for alcohol in women, 94.6% sensitivity and 81.6% specificity (AUC=0.88) for marijuana, and 86.1% sensitivity, 84.0% specificity (AUC=0.85) for cocaine. For SUD, sensitivity ranged from 79% (for alcohol in males), to 100% (for tobacco), and specificity was 83% or higher (AUCs ranged 0.83-0.91). For substances other than tobacco, empirically-derived cutoff scores were lower than the standard cutoffs, and resulted in higher sensitivity and lower specificity for identifying unhealthy substance use. CONCLUSIONS: The ACASI ASSIST is a valid measure of unhealthy use and SUD for substances that are commonly used by primary care patients, and could facilitate effective and efficient screening for substance use in medical settings.

BACKGROUND: Extended-release naltrexone (XR-NTX) is an injectable monthly sustained-release mu opioid receptor antagonist, which blocks the typical effects of heroin and other opioid agonists. Use of XR-NTX among opioid dependent persons leaving jails and prisons is increasing despite scant high-quality evidence regarding XR-NTX's effectiveness at re-entry. METHODS: This 24-week, open-label randomized controlled trial examines the effectiveness of XR-NTX as opioid relapse prevention at release from jail (N=85) compared to enhanced treatment as usual (ETAU, N=85). A third, non-randomized, quasi-experimental naturalistic arm of participants who have newly initiated a jail-to-community methadone treatment program (MTP, N=85) allows for comparisons to a methadone standard-of-care. RESULTS: We describe the rationale, design, and primary and secondary outcomes of the study. The primary outcome is an opioid relapse event; the primary contrast is a time-to-relapse comparison of XR-NTX and ETAU over a 24-week treatment phase. Secondary outcomes are rates of: (a) post-release opioid treatment participation, (b) opioid, alcohol, and cocaine use, (c) injection drug use and HIV sexual risk behaviors, (d) overdose (fatal and non-fatal) and all-cause mortality, and, (e) re-incarceration. CONCLUSIONS: XR-NTX is a potentially important, effective treatment and relapse prevention option for a large US population of persons with opioid use disorders leaving jails. This study will estimate XR-NTX's effectiveness relative to existing standards of care, including counseling-only treatment-as-usual and methadone maintenance.

BACKGROUND: Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS: In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. RESULTS: A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures--self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration--were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02). CONCLUSIONS: In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).

BACKGROUND AND AIMS: To address barriers to implementing the "Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)" in medical settings, we adapted the traditional interviewer-administered (IA) ASSIST to an audio-guided computer assisted self-interview (ACASI) format. This study sought to validate the ACASI ASSIST by estimating the concordance, correlation, and agreement of scores generated using the ACASI versus the reference standard IA ASSIST. Secondary aims were to assess feasibility and compare ASSIST self-report to drug testing results. DESIGN: Participants completed the ACASI and IA ASSIST in a randomly assigned order, followed by drug testing. SETTING: Urban safety-net primary care clinic in New York City, USA. PARTICIPANTS: A total of 393 adult patients. MEASUREMENTS: Scores generated by the ACASI and IA ASSIST; drug testing results from saliva and hair samples. FINDINGS: Concordance between the ACASI and IA ASSIST in identifying moderate-high risk use was 92-99% for each substance class. Correlation was excellent for global scores (ICC = 0.94, CI 0.92-0.95) and for substance-specific scores for tobacco (ICC = 0.93, CI 0.91-0.94), alcohol (ICC = 0.91, CI 0.89-0.93) and illicit drugs (ICC = 0.85, CI 0.85-0.90), and good for prescription drugs (ICC = 0.68, CI 0.61-0.73). Ninety-four percent of differences in global scores fell within anticipated limits of agreement. Among participants with a positive saliva test, 74% self-reported use on the ACASI ASSIST. The ACASI ASSIST required a median time of 3.7 minutes (range 0.7-15.4), and 21 (5.3%) participants requested assistance. CONCLUSIONS: The computer self-administered Alcohol, Smoking and Substance Involvement Screening Test appears to be a valid alternative to the interviewer-administered approach for identifying substance use in primary care patients.

BACKGROUND: Hospital care on weekends has been associated with delays in care, reduced quality, and poor clinical outcomes. OBJECTIVE: The purpose of this study was to evaluate the impact of a weekend hospital intervention on processes of care and clinical outcomes. The multifaceted intervention included expanded weekend diagnostic services, improved weekend discharge processes, and increased physician and care management services on weekends. DESIGN AND PATIENTS: This was an interrupted time series observational study of adult non-obstetric patients hospitalized at a single academic medical center between January 2011 and January 2014. The study included 18 months prior to and 19 months following the implementation of the intervention. Data were analyzed using segmented regression analysis with adjustment for confounders. MAIN MEASURES: The primary outcome was average length of stay. Secondary outcomes included percent of patients discharged on weekends, 30-day readmission rate, and in-hospital mortality rate. KEY RESULTS: The study included 57,163 hospitalizations. Following implementation of the intervention, average length of stay decreased by 13 % (95 % CI 10-15 %) and continued to decrease by 1 % (95 % CI 1-2 %) per month as compared to the underlying time trend. The proportion of weekend discharges increased by 12 % (95 % CI 2-22 %) at the time of the intervention and continued to increase by 2 % (95 % CI 1-3 %) per month thereafter. The intervention had no impact on readmissions or mortality. During the post-implementation period, the hospital was evacuated and closed for 2 months due to damage from Hurricane Sandy, and a new hospital-wide electronic health record was introduced. The contributions of these events to our findings are not known. We observed a lower inpatient census and found differences in patient characteristics, including higher rates of Medicaid insurance and comorbidities, in the post-Hurricane Sandy period as compared to the pre-Sandy period. CONCLUSIONS: The intervention was associated with a reduction in length of stay and an increase in weekend discharges. Our longitudinal study also illuminated the challenges of evaluating the effectiveness of a large-scale intervention in a real-world hospital setting.