Ellie Grossman

Home Buprenorphine/Naloxone Induction in Primary Care

Buprenorphine can be used for the treatment of opioid dependence in primary care settings. National guidelines recommend directly observed initial dosing followed by multiple in-clinic visits during the induction week. We offered buprenorphine treatment at a public hospital primary care clinic using a home, unobserved induction protocol. Participants were opioid-dependent adults eligible for office-based buprenorphine treatment. The initial physician visit included assessment, education, induction telephone support instructions, an illustrated home induction pamphlet, and a 1-week buprenorphine/naloxone prescription. Patients initiated dosing off-site at a later time. Follow-up with urine toxicology testing occurred at day 7 and thereafter at varying intervals. Primary outcomes were treatment status at week 1 and induction-related events: severe precipitated withdrawal, other buprenorphine-prompted withdrawal symptoms, prolonged unrelieved withdrawal, and serious adverse events (SAEs). Patients (N = 103) were predominantly heroin users (68%), but also prescription opioid misusers (18%) and methadone maintenance patients (14%). At the end of week 1, 73% were retained, 17% provided induction data but did not return to the clinic, and 11% were lost to follow-up with no induction data available. No cases of severe precipitated withdrawal and no SAEs were observed. Five cases (5%) of mild-to-moderate buprenorphine-prompted withdrawal and eight cases of prolonged unrelieved withdrawal symptoms (8% overall, 21% of methadone-to-buprenorphine inductions) were reported. Buprenorphine-prompted withdrawal and prolonged unrelieved withdrawal symptoms were not associated with treatment status at week 1. Home buprenorphine induction was feasible and appeared safe. Induction complications occurred at expected rates and were not associated with short-term treatment drop-out.ABSTRACTBACKGROUNDBuprenorphine can be used for the treatment of opioid dependence in primary care settings. National guidelines recommend directly observed initial dosing followed by multiple in-clinic visits during the induction week. We offered buprenorphine treatment at a public hospital primary care clinic using a home, unobserved induction protocol.METHODSParticipants were opioid-dependent adults eligible for office-based buprenorphine treatment. The initial physician visit included assessment, education, induction telephone support instructions, an illustrated home induction pamphlet, and a 1-week buprenorphine/naloxone prescription. Patients initiated dosing off-site at a later time. Follow-up with urine toxicology testing occurred at day 7 and thereafter at varying intervals. Primary outcomes were treatment status at week 1 and induction-related events: severe precipitated withdrawal, other buprenorphine-prompted withdrawal symptoms, prolonged unrelieved withdrawal, and serious adverse events (SAEs).RESULTSPatients (N = 103) were predominantly heroin users (68%), but also prescription opioid misusers (18%) and methadone maintenance patients (14%). At the end of week 1, 73% were retained, 17% provided induction data but did not return to the clinic, and 11% were lost to follow-up with no induction data available. No cases of severe precipitated withdrawal and no SAEs were observed. Five cases (5%) of mild-to-moderate buprenorphine-prompted withdrawal and eight cases of prolonged unrelieved withdrawal symptoms (8% overall, 21% of methadone-to-buprenorphine inductions) were reported. Buprenorphine-prompted withdrawal and prolonged unrelieved withdrawal symptoms were not associated with treatment status at week 1.CONCLUSIONSHome buprenorphine induction was feasible and appeared safe. Induction complications occurred at expected rates and were not associated with short-term treatment drop-out.

Buprenorphine-Naloxone Maintenance Following Release from Jail

Primary care is understudied as a reentry drug and alcohol treatment setting. This study compared treatment retention and opioid misuse among opioid-dependent adults seeking buprenorphine/naloxone maintenance in an urban primary care clinic following release from jail versus community referrals. Postrelease patients were either (a) induced to buprenorphine in-jail as part of a clinical trial, or (b) seeking buprenorphine induction post release. From 2007 to 2008, N = 142 patients were new to primary care buprenorphine: n = 32 postrelease; n = 110 induced after community referral and without recent incarceration. Jail-released patients were more likely African American or Hispanic and uninsured. Treatment retention rates for postrelease (37%) versus community (30%) referrals were similar at 48 weeks. Rates of opioid positive urines and self-reported opioid misuse were also similar between groups. Postrelease patients in primary care buprenorphine treatment had equal treatment retention and rates of opioid abstinence versus community-referred patients.

Extended-release naltrexone for treatment of alcohol dependence in primary care

The feasibility of using extended-release injectable naltrexone (XR-NTX) to treat alcohol dependence in routine primary care settings is unknown. An open-label, observational cohort study evaluated 3-month treatment retention, patient satisfaction, and alcohol use among alcohol-dependent patients in two urban public hospital medical clinics. Adults seeking treatment were offered monthly medical management (MM) and three XR-NTX injections (380 mg, intramuscular). Physician-delivered MM emphasized alcohol abstinence, medication effects, and accessing mutual help and counseling resources. Seventy-two alcohol-dependent patients were enrolled; 90% (65 of 72) of eligible subjects received the first XR-NTX injection; 75% (49 of 65) initiating treatment received the second XR-NTX injection; 62% (40 of 65), the third. Among the 56% (n = 40) receiving three injections, median drinks per day decreased from 4.1 (95% confidence interval = 2.9-6) at baseline to 0.5 (0-1.7) during Month 3. Extended-release naltrexone delivered in a primary care MM model appears a feasible and acceptable treatment for alcohol dependence.

Opioid treatment at release from jail using extended-release naltrexone: A pilot proof-of-concept randomized effectiveness trial

BACKGROUND AND AIMS Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid-dependent male adults leaving a large urban jail. DESIGN Eight-week, proof-of-concept, open-label, non-blinded randomized effectiveness trial. SETTING New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA. PARTICIPANTS From January 2010 to July 2013, 34 opioid-dependent adult males with no stated interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR-NTX (n = 17) versus no medication (n = 17) within one week prior to jail release. INTERVENTION XR-NTX (Vivitrol(®) ; Alkermes Inc.), a long-acting injectable mu opioid receptor antagonist. MEASURES The primary intent-to-treat outcome was post-release opioid relapse at week 4, defined as ≥10 days of opioid misuse by self-report and urine toxicologies. Secondary outcomes were proportion of urine samples negative for opioids and rates of opioid abstinence, intravenous drug use (IVDU), cocaine use, community treatment participation, re-incarceration and overdose. FINDINGS Acceptance of XR-NTX was high; 15 of 17 initiated treatment. Rates of the primary outcome of week 4 opioid relapse were lower among XR-NTX participants: 38 versus 88% [P<0.004; odds ratio (OR) = 0.08, 95% confidence interval (CI) = 0.01-0.48]; more XR-NTX urine samples were negative for opioids, 59 versus 29% (P<0.009; OR = 3.5, 95% CI = 1.4-8.5). There were no significant differences in the remaining secondary outcomes, including rates of IVDU, cocaine use, re-incarceration and overdose. CONCLUSION Extended-release naltrexone is associated with significantly lower rates of opioid relapse among men in the United States following release from jail when compared with a no medication treatment-as-usual condition.

Undergraduate medical education in substance abuse: a review of the quality of the literature.

Purpose To prepare to develop a medical school curriculum on substance abuse disorders (SADs), the authors conducted a review of the quality of the sparse published literature. Method The authors searched MEDLINE (1950 through December 2008) using OVID, PsycINFO, and PubMed to identify all studies of SAD interventions targeted toward undergraduate medical students. Of the 1,084 studies identified initially, 31 reported sufficient data to allow the authors to evaluate quality using Medical Education Research Study Quality Instrument (MERSQI) scores. The authors also determined the impact of the studies by considering three-year citation rate and journal impact factor. A detailed review of the literature provided data on contact hours and intervention content. Results The three-rater intraclass correlation coefficient for total MERSQI score was 0.82 (95% confidence interval: 0.70–0.90). The mean MERSQI score was 10.42 of a possible 18 (SD 2.59; range: 6.33–14.83). MERSQI scores were higher for more recently published studies and correlated with three-year citation rate but not impact factor. The mean contact time for 26 studies was 29.25 hours (range: 0.83–200 hours). Conclusions The literature provides a variety of educational methods to train medical students in SAD detection and intervention skills. This literature is of variable quality and provides limited guidance for development of curricula and medical education policy. Better methods of curriculum evaluation and publication guidelines would help ensure that this literature has a positive impact on educational practice and public health.

Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months

The feasibility of long-term extended-release naltrexone (XR-NTX) alcohol treatment is unknown. Following an initial 12-week, single-arm, observational trial of XR-NTX plus medical management (MM) in primary care, we offered 48 additional weeks of XR-NTX treatment (12 additional monthly injections) in two public primary care clinics as a naturalistic extension study. Of 65 alcohol dependent adults initiating XR-NTX treatment, 40 (62%) completed the initial 12-week XR-NTX observational trial, and 19 (29%) continued treatment for a median of 38 weeks total (range, 16-72 weeks; median 8 total XR-NTX injections). Among active extension phase participants, self-reported rates of drinking days (vs. last 30 days pre-treatment baseline) were low: median 0.2 vs. 6.0 drinks per day; 82 vs. 38% days abstinent; 11 vs. 61% heavy drinking days. Long-term XR-NTX treatment in a primary care MM model was feasible and may promote lasting drinking reductions or alcohol abstinence (clinical trial: NCT00620750).

Outcomes among buprenorphine-naloxone primary care patients after Hurricane Sandy

BackgroundThe extent of damage in New York City following Hurricane Sandy in October 2012 was unprecedented. Bellevue Hospital Center (BHC), a tertiary public hospital, was evacuated and temporarily closed as a result of hurricane-related damages. BHC’s large primary care office-based buprenorphine clinic was relocated to an affiliate public hospital for three weeks. The extent of environmental damage and ensuing service disruption effects on rates of illicit drug, tobacco, and alcohol misuse, buprenorphine medication supply disruptions, or direct resource losses among office-based buprenorphine patients is to date unknown.MethodsA quantitative and qualitative semi-structured survey was administered to patients in BHC’s primary care buprenorphine program starting one month after the hurricane. Survey domains included: housing and employment disruptions; social and economic support; treatment outcomes (buprenorphine adherence and ability to get care), and tobacco, alcohol, and drug use. Open-ended questions probed general patient experiences related to the storm, coping strategies, and associated disruptions.ResultsThere were 132 patients enrolled in the clinic at the time of the storm; of those, 91 patients were recruited to the survey, and 89 completed (98% of those invited). Illicit opioid misuse was rare, with 7 respondents reporting increased heroin or illicit prescription opioid use following Sandy. Roughly half of respondents reported disruption of their buprenorphine-naloxone medication supply post-event, and self-lowering of daily doses to prolong supply was common. Additional buprenorphine was obtained through unscheduled telephone or written refills from relocated Bellevue providers, informally from friends and family, and, more rarely, from drug dealers.ConclusionsThe findings highlight the relative adaptability of public sector office-based buprenorphine treatment during and after a significant natural disaster. Only minimal increases in self-reported substance use were reported despite many disruptions to regular buprenorphine supplies and previous daily doses. Informal supplies of substitute buprenorphine from family and friends was common. Remote telephone refill support and a temporary back-up location that provided written prescription refills and medication dispensing for uninsured patients enabled some patients to maintain an adequate medication supply. Such adaptive strategies to ensure medication maintenance continuity pre/post natural disasters likely minimize poor treatment outcomes.

Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial

BackgroundHospitalization may be a particularly important time to promote smoking cessation, especially in the immediate post-discharge period. However, there are few studies to date that shed light on the most effective or cost-effective methods to provide post-discharge cessation treatment, especially among low-income populations and those with a heavy burden of mental illness and substance use disorders.Methods/designThis randomized trial will compare the effectiveness and cost-effectiveness of two approaches to smoking cessation treatment among patients discharged from two urban public hospitals in New York City. During hospitalization, staff will be prompted to ask about smoking and to offer nicotine replacement therapy (NRT) on admission and at discharge. Subjects will be randomized on discharge to one of two arms: one arm will be proactive multi-session telephone counseling with motivational enhancement delivered by study staff, and the other will be a faxed or online referral to the New York State Quitline. The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost-effectiveness from a societal and a payer perspective, as well as explore subgroup analyses related to patient location of hospitalization, race/ethnicity, immigrant status, and inpatient diagnosis.DiscussionThis study will explore issues of implementation feasibility in a post-hospitalization patient population, as well as add information about the effectiveness and cost-effectiveness of different strategies for designing smoking cessation programs for hospitalized patients.Trial registrationClinicaltrials.gov ID# NCT01363245

Primary care for low-income populations: comparing health care delivery systems.

Amidst recent policy discussions about the health care safety net there has been relatively little information about whether the actual site of care affects care quality. We therefore used National Health Interview Survey data to describe low-income adults seeking primary care at different types of sites and the quality of access and preventive care at these sites. After adjusting for sociodemographic characteristics and illness burden, hospital-outpatient- department patients were more likely to receive vaccinations for influenza (adjusted odds ratio [AOR] 1.3, 95% confidence interval [CI] 1.0–1.6) and pneumococcus (AOR 1.4, 95% CI 1.1–1.8) than were those at clinics or health centers. Hospital-clinic patients were more likely to report delays in care due to office administrative difficulties (AOR 1.3, 95% CI 1.1–1.7) and more likely to have more than one emergency room visit (AOR 1.9, 95% CI 1.5–2.3). Physicians’ office or HMO patients were less likely to report administrative delays in care than those at clinics or health centers, but there were no other differences in quality between these two site types. Policymakers and health care services analysts and providers must monitor quality as they decide how best to deliver care to vulnerable populations.

Psychiatric Comorbidity, Red Flag Behaviors, and Associated Outcomes among Office-Based Buprenorphine Patients Following Hurricane Sandy

In October 2012, Bellevue Hospital Center (Bellevue) in New York City was temporarily closed as a result of Hurricane Sandy, the largest hurricane in US history. Bellevue’s primary care office-based buprenorphine program was temporarily closed and later relocated to an affiliate public hospital. Previous research indicates that the relationships between disaster exposure, substance use patterns, psychiatric symptoms, and mental health services utilization is complex, with often conflicting findings regarding post-event outcomes (on the individual and community level) and antecedent risk factors. In general, increased use of tobacco, alcohol, and illicit drugs is associated with both greater disaster exposure and the development or exacerbation of other psychiatric symptoms and need for treatment. To date, there is limited published information regarding post-disaster outcomes among patients enrolled in office-based buprenorphine treatment, as the treatment modality has only been relatively approved recently. Patients enrolled in the buprenorphine program at the time of the storm were surveyed for self-reported buprenorphine adherence and illicit substance and alcohol use, as well as disaster-related personal consequences and psychiatric sequelae post-storm. Baseline demographic characteristics and insurance status were available from the medical record. Analysis was descriptive (counts and proportions) and qualitative, coding open-ended responses for emergent themes. There were 132 patients enrolled in the program at the time of the storm; of those, 91 were contacted and 89 completed the survey. Almost half of respondents reported disruption of their buprenorphine supply. Unexpectedly, patients with psychiatric comorbidity were no more likely to report increased use/relapse as a result. Rather, major risk factors associated with increased use or relapse post-storm were: (1) shorter length of time in treatment, (2) exposure to storm losses such as buprenorphine supply disruption, (3) a pre-storm history of red flag behaviors (in particular, repeat opioid-positive urines), and (4) new-onset post-storm psychiatric symptoms. Our findings highlight the relative resilience of buprenorphine as an office-based treatment modality for patients encountering a disaster with associated unanticipated service disruption. In responding to future disasters, triaging patient contact and priority based on a history of red-flag behaviors, rather than a history of psychiatric comorbidity, will likely optimize resource allocation, especially among recently enrolled patients. Additionally, patients endorsing new-onset psychiatric manifestations following disasters may be an especially high-risk group for poor outcomes, warranting further study.