Faculty Bibliography

OBJECTIVE:To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients. METHODS:We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes. RESULTS:We identified two subpopulations: HRQoL "pharmacotherapy responsive" (82.3 %) and HRQoL "characteristic sensitive" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics. CONCLUSION/CONCLUSIONS:Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.

OBJECTIVES/OBJECTIVE:The effectiveness of treatment incorporating relapse prevention medications for opioid use disorder (OUD) is typically examined in research using rigidly predefined endpoints of success versus failure, usually over a single episode of care. But this perspective may not adequately portray the nonlinear trajectories typical of real-world treatment courses in this chronic, remitting, and relapsing disorder. METHODS:This descriptive study examined 12-month treatment trajectories of n = 60 patients enrolled at a single site of a larger multisite randomized controlled trial examining the comparative effectiveness of buprenorphine versus extended-release naltrexone. While the parent study provided medication treatment through the research protocol for 6 months, this study documents treatment up to 12 months, including medications, provided through standard community resources (treatment as usual) outside of the protocol. RESULTS:Some patients continued medications past the end of the study intervention, whereas others did not. Some patients initiated medications other than the one assigned by the study. Some patients switched from 1 medication to the other. Many patients returned to treatment after 1 or more periods of dropout and/or relapse. Patients utilized multiple episodes of bed-based care, including short-term acute residential and long-term residential treatment, and also recovery housing supports. Described trajectories are also depicted graphically. At 12 months, while rates of continuous treatment retention were low (8%), rates of cross-sectional treatment engagement including return to treatment after drop out were higher (35%). CONCLUSIONS:This description of nonlinear treatment trajectories highlights the potential benefits of flexibility and optimism in the promotion of re-engagement, despite interim outcomes that might traditionally be considered "failure" endpoints.

Objectives: To study the health-related quality of life (HRQoL) of persons with opioid use disorder (OUD) initiating medication treatment.
Method(s): We conducted a secondary analysis of data collected from a clinical trial funded by the National Drug Abuse Treatment Clinical Trials Network, where participants (N=570) in residential treatment were randomized to initiating extended-release naltrexone (XR-NTX) or buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse. A generalized structural equation latent-class model was used to identify associations and describe HRQoL trajectories over the 24-week trial and subsequent 28- and 36-week follow-ups for all participants regardless of success initiating treatment.
Result(s): Two latent classes were identified and defined: HRQoL "pharmacotherapy responsive" (82.3%), and HRQoL "baseline sensitive" (17.7%). The pharmacotherapy responsive class was characterized by HRQoL that tended to increase over time and a significant positive association between HRQoL and whether BUP-NX or XR-NTX was received in the past 30 days. The baseline sensitive class was characterized by lower average receipt of pharmacotherapy, initial increase in HRQoL with gradual decrease over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time among patients in this class were sensitive to age, race, marital status, and motivation at baseline. Compared to the pharmacotherapy responsive class, the baseline sensitive class included higher proportions of participants who were female, white, married, less educated, and less motivated at baseline. The pharmacotherapy responsive class participants had, on average, less severe medical, drug, legal, and psychiatric problems at baseline.
Conclusion(s): The majority of persons with OUD enrolled in this trial experienced improvements in HRQoL that were associated with pharmacotherapy, while a smaller sub-group with lower average receipt of pharmacotherapy had HRQoL changes that were associated with baseline characteristics but not pharmacotherapy. Our analysis provides insights for improved person-centered care for OUD patients receiving pharmacotherapy who are not adherent to treatment.
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Despite high rates of Hepatitis C virus (HCV) infection among people who use drugs (PWUDs), access to the HCV care continuum combined with the receipt of medications for addiction treatment in primary care settings remains suboptimal. A qualitative study was conducted among adults admitted for inpatient detoxification for opioid use disorder (OUD) in New York City (n=23) to assess barriers and facilitators with HCV prevention, screening, treatment, interactions with primary care providers, and experiences with integrated care approaches. Study findings yielded six major themes related to HCV care. Major gaps persist in knowledge regarding HCV harm reduction strategies, voluntary HCV testing services, and eligibility for HCV treatment. Treatment coordination challenges reinforce the importance of enhancing linkages to HCV care in key access-points utilized by PWUDs (e.g., emergency rooms, specialty addiction treatment settings). Peer networks combined with frequent patient-physician communication were elicited as important factors in facilitating linkage to HCV care. Additional care coordination needs in primary care settings included access to integrated treatment of HCV and OUD, and administrative support for enrollment in Medicaid, subsidized housing, and access to transportation vouchers.

Project Extension for Community Healthcare Outcomes (Project ECHO) offers an innovative and low-cost approach to enhancing the management of complex conditions among primary care providers. The NYC Health + Hospitals Buprenorphine ECHO (H + H ECHO) program offers primary care providers (PCPs) training and support in managing opioid use disorder (OUD). This exploratory study assessed the feasibility of a 16-session video conferencing platform led by Addiction Medicine experts in improving addiction knowledge, perceived self-efficacy, and buprenorphine prescribing among PCPs located in 17 publicly-funded ambulatory care clinics. A pre- and post-training survey assessed changes in knowledge and self-efficacy. Buprenorphine prescribing patterns were also captured pre-post training. Training sessions consisted of a review of the agenda by the H + H ECHO hub team, 15-30 min didactic lectures led by specialists, followed by a patient case presentation. Participants attended an average of 9 lectures (range, 1-15 sessions) and 53% of trainees attended at least 10 of the 16 sessions. Perceived self-efficacy improved post-H + H ECHO (73.2%) versus pre-training survey results (58.1%). There were minimal increases in knowledge post-training (58.4%) versus pre-training (51.4%). Only three additional providers reported prescribing Buprenorphine post-training (n = 10) versus pre-training (n = 7). Suggestions for improving H + H ECHO included trainings addressing stigma, administrative support, improved referrals to office-based opioid treatment (OBOT), integration of non-physician staff (i.e., case management, social work), and combining multimodal learning strategies (i.e., podcasts, web-based modules) with videoconferencing. This study demonstrates the feasibility of H + H ECHO among PCPs in publicly-funded clinics and improvements in self-efficacy. Studies are needed to identify alternative strategies to improve knowledge and prescribing of buprenorphine post-H + H ECHO.

BACKGROUND:Engagement in the HIV care continuum combined with office-based opioid treatment remains a cornerstone in addressing the intertwined epidemics of opioid use disorder (OUD) and HIV/AIDS. Factors influencing patient engagement with OUD and HIV care are complex and require further study. METHODS:In this qualitative study, in-depth interviews were conducted among 23 adult patients who use drugs (PWUD) in an inpatient detoxification program in New York City. The semi-structured interview guide elicited participant experiences with various phases of the HIV care continuum, including factors influencing access to HIV care, interactions with HIV and primary care providers, preferences around integrated care approaches for OUD and HIV, and barriers experienced beyond clinical settings which affected access to HIV care (e.g., insurance issues, transportation, cost, retrieving prescriptions from their pharmacy). Data collection and thematic analysis took place concurrently using an iterative process-based established qualitative research method. RESULTS:Respondents elicited high acceptability for integrated or co-located care for HIV and OUD in primary care. Factors influencing engagement in HIV care included (1) access to rapid point-of-care HIV testing and counseling services, (2) insurance coverage and costs related to HIV testing and receipt of antiretroviral therapy (ART), (3) primary care providers offering HIV care and buprenorphine, (4) illicit ART sales to pharmacies, (5) disruption in supplies of ART following admissions to inpatient detoxification or residential treatment programs, (6) in-person and telephone contact with peer support networks and clinic staff, (7) stigma, and (8) access to administrative support in primary care to facilitate reengagement with care following relapse, behavioral health services, transportation vouchers, and relocation from subsidized housing exposing patients to actively using peers. CONCLUSION/CONCLUSIONS:These findings suggest expanding clinical and administrative support in primary care for PWUDs with patient navigators, case managers, mobile health interventions, and peer support networks to promote linkage and retention in care.

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 .

Introduction: This study explored factors influencing patient access to medications for opioid use disorder (OUD), particularly for individuals eligible but historically suboptimal follow-up with in-house referrals to office-based opioid treatment (OBOT). Objectives: In-depth qualitative interviews among a mostly underserved sample of adults with OUD elicited: 1) knowledge and experiences across the OUD treatment cascade; and 2) more nuanced elements of patient-centered care, including shared decision making with providers, experiences in OBOT versus specialty addiction treatment, transitioning from methadone to buprenorphine or extended-release naltrexone (XR-NTX), and voluntary discontinuation of medications for OUD. Methods: We conducted semi-structured qualitative interviews between January and February of 2018 among adult inpatient detoxification program patients with OUD (n = 23). Preliminary analysis of interviews yielded key themes and ideas that were coded from a grounded theory approach. Results: Willingness to engage with OBOT was influenced by a complex array of practical considerations, including access to patient-centered care in OBOT settings, positive experiences with illicitly obtained buprenorphine, and differential experiences pertaining to OBOT versus specialty addiction treatment. Responses were generally favorable towards OBOT with buprenorphine, yet knowledge regarding extended-release naltrexone was limited. Respondents were often frustrated by clinicians when requesting to transition from methadone to buprenorphine or XR-NTX. Lastly, participants elucidated limited access to OBOT programs in underserved neighborhoods and suburban settings. Conclusion: Limited access to patient-centered care in OBOT with buprenorphine and extended-release naltrexone may exacerbate challenges to retention and/or reengagement with OUD care.

We examined technology use patterns (e.g., mobile phone and computer ownership, text messaging, internet access) and preferences for adopting health information technologies to optimize office-based treatment for substance use disorders, HIV, and Hepatitis C virus (HCV) infection. Surveys were administered to patients enrolled in inpatient detoxification program in a publicly-funded tertiary referral center. Most reported mobile phone ownership (86%) and described high rates of mobile phone (3.3) and phone number (2.6) turnover in the preceding year. Internet access was reported on a daily (52%) or weekly basis (22%). Most participants were amenable to receiving text message-based informational content (i.e., medications, support groups, treatment programs) pertaining to substance use disorders (79%), HIV (50%), and HCV care (58%). Respondents reporting less than high school education and past year incarcerated elicited higher favorability in adopting smartphone apps to facilitate peer sharing of HIV-HCV related content. Results suggest high favorability for adopting health information technologies to enhance office-based treatment for substance use disorders, HIV, and HCV, particularly among vulnerable patient sub-groups.

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