Faculty Bibliography

Background/UNASSIGNED:Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder. Objective/UNASSIGNED:To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone. Design/UNASSIGNED:Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs. Data Sources/UNASSIGNED:Study instruments. Target Population/UNASSIGNED:Adults with opioid use disorder. Time Horizon/UNASSIGNED:24-week intervention with an additional 12 weeks of observation. Perspective/UNASSIGNED:Health care sector and societal. Interventions/UNASSIGNED:Buprenorphine-naloxone and extended-release naltrexone. Outcome Measures/UNASSIGNED:Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids. Results of Base-Case Analysis/UNASSIGNED:Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective. Results of Sensitivity Analysis/UNASSIGNED:The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation. Limitation/UNASSIGNED:Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs. Conclusion/UNASSIGNED:Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone. Primary Funding Source/UNASSIGNED:National Institute on Drug Abuse, National Institutes of Health.

BACKGROUND:Federal regulations (42 CFR Part 2) provide special privacy protections for persons seeking treatment for substance use disorders. Primary care providers, hospitals, and health care organizations have struggled to balance best practices for medical care with adherence to 42 CFR Part 2, but little formal research has examined this issue. The aim of this study was to explore institutional variability in the interpretation and implementation of 42 CFR Part 2 regulations related to health systems data privacy practices, policies, and information technology architecture. METHODS:This was a cross-sectional qualitative study using purposive sampling to conduct interviews with privacy/legal officers (n = 17) and information technology specialists (n = 10) from 15 integrated healthcare organizations affiliated with three research nodes of the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN). Trained staff completed a short survey and digitally recorded semi-structured qualitative interview with each participant. Interviews were transcribed and coded within Atlas.ti. Framework analysis was used to identify and organize key themes across selected codes. RESULTS:Participants voiced concern over balancing patient safety with 42 CFR Part 2 privacy protections. Although similar standards of protection regarding release of information outside of the health system was described, numerous workarounds were used to manage intra-institutional communication and care coordination. To align 42 CFR Part 2 restrictions with electronic health records, health systems used sensitive note designation, "break the glass" technology, limited role-based access for providers, and ad hoc solutions (e.g., provider messaging). CONCLUSIONS:In contemporary integrated care systems, substance-related EHR records (e.g., patient visit history, medication logs) are often accessible internally without specific consent for sharing despite the intent of 42 CFR Part 2. Recent amendments to 42 CFR Part 2 have not addressed information sharing needs within integrated care settings.

OBJECTIVES:To estimate the costs of providing extended-release injectable naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX) following inpatient detoxification using data derived from a multisite randomized controlled trial at 8 US community-based treatment programs. STUDY DESIGN:Cost data were collected for 3 intervention phases: program start-up, inpatient detoxification, and up to 24 weeks of medication induction and management visits (post detoxification). Cost analyses were from the healthcare sector perspective (2015 US$); patient costs are also reported. METHODS:We conducted site visits, administered a cost survey to treatment programs, and analyzed study data on medication and services utilization. Nationally representative sources were used to estimate unit costs. Uncertainty was evaluated in sensitivity analyses. RESULTS:Mean start-up costs were $1071 per program for XR-NTX and $828 per program for BUP-NX. Mean costs per participant were $5416 for XR-NTX (57% detoxification, 37% medication, 3% provider, 3% patient) and $4148 for BUP-NX (64% detoxification, 12% medication, 10% provider, 14% patient). Total cost per participant ranged by site from $2979 to $8963 for XR-NTX and from $2521 to $6486 for BUP-NX. CONCLUSIONS:For treatment providers, offering XR-NTX and/or BUP-NX as part of existing detoxification treatment modalities generates modest costs in addition to the costs of detoxification, which vary substantially among the 8 sites. From the patient's perspective, the costs associated with medication management visits may be a barrier for some individuals considering these treatments.

BACKGROUND & OBJECTIVES/OBJECTIVE:We investigated gender differences in individuals with opioid use disorder (OUD) receiving inpatient services and entering a randomized controlled trial comparing extended-release naltrexone to buprenorphine. METHODS:Participants (N = 570) provided demographic, substance use, and psychiatric information. RESULTS:Women were significantly younger, more likely to identify as bisexual, live with a sexual partner, be financially dependent, and less likely employed. Women reported significantly greater psychiatric comorbidity and risk behaviors, shorter duration but similar age of onset of opioid use. DISCUSSION/CONCLUSIONS/CONCLUSIONS:Findings underscore economic, psychiatric, and infection vulnerability among women with OUD. SCIENTIFIC SIGNIFICANCE/CONCLUSIONS:Interventions targeting these disparities should be explored, as women may face complicated treatment initiation, retention, and recovery. (Am J Addict 2018;XX:1-6).

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

Dysregulation of the stress response is implicated in drug addiction; therefore, polymorphisms in stress-related genes may be involved in this disease. An analysis was performed to identify associations between variants in 11 stress-related genes, selected a priori, and heroin addiction. Two discovery samples of American subjects of European descent (EA, n = 601) and of African Americans (AA, n = 400) were analyzed separately. Ancestry was verified by principal component analysis. Final sets of 414 (EA) and 562 (AA) variants were analyzed after filtering of 846 high-quality variants. The main result was an association of a non-coding SNP rs255105 in the CRH (CRF) receptor 2 gene (CRHR2), in the discovery EA sample (Pnominal = .00006; OR = 2.1; 95% CI 1.4-3.1). The association signal remained significant after permutation-based multiple testing correction. The result was corroborated by an independent EA case sample (n = 364). Bioinformatics analysis revealed that SNP rs255105 is associated with the expression of a downstream long intergenic non-coding RNA (lincRNA) gene AC005154.6. AC005154.6 is highly expressed in the pituitary but its functions are unknown. LincRNAs have been previously associated with adaptive behavior, PTSD, and alcohol addiction. Further studies are warranted to corroborate the association results and to assess the potential relevance of this lincRNA to addiction and other stress-related disorders.

Background: Substance use (SU) is common among ED patients, with 1 in 10 ED users having an alcohol or drug use disorder. ED patients also have high levels of social needs such as homelessness and food insecurity. Yet, little research has examined how such social determinants of health (SDOH) intersect with SU among ED patients. In this study, we compared the prevalence of several SDOH among ED patients who did and did not screen positive for unhealthy alcohol and drug use. Methods: We surveyed a random sample of ED patients at a NYC public hospital from Nov 2016-Sept 2017. Eligible patients were >=18 years old, medically/psychiatrically stable, not in prison/police custody, and spoke English or Spanish. RA shifts occurred during all days of the week and hours of the day. RAs administered a 20-40 minute survey with validated single-item screeners for unhealthy alcohol and drug use and questions on self-reported past year social needs from national surveys or prior studies. We compared prevalence of SDOH by SU screening status in bivariate analyses with chisquare tests. Results: About half of patients (52.0%) approached were ineligible, primarily because they were medically unfit, intoxicated, or in prison/police custody. 2,396 of 2,925 eligible patients participated (81.9%); 76 duplicate patient records were removed, leaving a final sample size of 2,321 patients. Nearly one-third (32.3%) screened positive for unhealthy alcohol use and 21.8% for any drug use. Regarding SDOH, rates among patients overall vs. those with unhealthy alcohol use vs. those with drug use were: 1) homelessness 13.8%, 18.7% (X2 p<0.01 for difference between those who did vs. did not screen positive), 25.8% (p<0.01); 2) housing instability 25.2%, 29.5% (p<0.01), 35.9% (p<0.01); 3) food insecurity 50.9%, 56.3% (p<0.01), 63.4% (p<0.01); 4) inability to meet essential expenses 40.8%, 45.9% (p<0.01), 52.7% (p<0.01); and 5) unemployment 43.3%, 45.1% (p=0.23), 55.1% (p<0.01). Conclusion: Rates of homelessness and other social needs were high among ED patients in this study, suggesting the importance of considering SDOH in emergency medicine practice. We add to prior literature by showing that these needs were even higher among patients who screened positive for SU. These findings are important, as patients' significant comorbid social needs may affect the success of ED-based efforts to address substance use

BACKGROUND:Homelessness and substance use often coexist, resulting in high morbidity. Emergency department (ED) patients have disproportionate rates of both homelessness and substance use, yet little research has examined the overlap of these issues in the ED setting. We aimed to characterize alcohol and drug use in a sample of homeless vs. non-homeless ED patients. METHODS:A random sample of urban hospital ED patients were invited to complete an interview regarding housing, substance use, and other health and social factors. We compared substance use characteristics among patients who did vs. did not report current literal (streets/shelter) homelessness. Additional analyses were performed using a broader definition of homelessness in the past 12-months. RESULTS:Patients who were currently homeless (n = 316, 13.7%) versus non-homeless (n = 1,993, 86.3%) had higher rates of past year unhealthy alcohol use (44.4% vs. 30.5%, p < .0001), any drug use (40.8% vs. 18.8%, p < .0001), heroin use (16.7% vs. 3.8%, p < .0001), prescription opioid use (12.5% vs. 4.4%, p < .0001), and lifetime opioid overdose (15.8% vs. 3.7%, p < .0001). In multivariable analyses, current homelessness remained significantly associated with unhealthy alcohol use, AUDIT scores among unhealthy alcohol users, any drug use, heroin use, and opioid overdose; past 12-month homelessness was additionally associated with DAST-10 scores among drug users and prescription opioid use. CONCLUSIONS:Patients experiencing homelessness have higher rates and greater severity of alcohol and drug use than other ED patients across a range of measures. These findings have implications for planning services for patients with concurrent substance use and housing problems.