Faculty Bibliography

BACKGROUND: Extended-release naltrexone (XR-NTX, Vivitrol(R); Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS: This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of >/=10days of opioid use in a 28-day (4week) period, with a positive or missing urine test counted as 5days of opioid use. RESULTS: We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed. CONCLUSIONS: XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898.

Aims: We conducted a descriptive, cross-sectional survey exploring mobile phone and TM use patterns and preferences pertaining to their substance treatment in a public sector, office-based buprenorphine program. Methods: A 28-item, quantitative and qualitative semistructured survey was administered to 71 patients enrolled in a public sector, office-based buprenorphine program between June and September 2013. Survey domains included: demographic characteristics, mobile phone and TM use patterns, and mobile phone and TM use patterns and preferences pertaining to their substance treatment. Results: Mobile phone ownership was common (93%) with no significant differences in ownership among self-reported homeless, recently incarcerated, and unemployed respondents. Most reported sending or receiving TM (93%) and reporting 'very much' or 'somewhat' comfort sending TM (79%). Contacting buprenorphine providers by phone (30%) or TM (17%) was uncommon, however most preferred to use either form of communication to reach their provider (67%). Older patients received less TM (25) compared to younger age groups (128) yet were as interested as the rest of the clinic population to have their provider's mobile phone number (96%) and send TM if at risk of relapse (78%). Conclusions: Our findings highlight the acceptability of enhancing patient-provider mobile phone and TM communications in a public sector, office-based buprenorphine clinic, even among respondents that were not comfortable in using TM. Although mobile phone ownership was very common, frequent turnover in phone ownership and changing phone numbers highlights challenges in feasibility for any future m health interventions in this clinical setting

BACKGROUND: On October 2012, Hurricane Sandy struck New York City, resulting in unprecedented damages, including the temporary closure of Bellevue Hospital Center and its primary care office-based buprenorphine program. OBJECTIVES: At 6 months, we assessed factors associated with higher rates of substance use in buprenorphine program participants that completed a baseline survey one month post-Sandy (i.e. shorter length of time in treatment, exposure to storm losses, a pre-storm history of positive opiate urine drug screens, and post-disaster psychiatric symptoms). METHODOLOGY: Risk factors of interest extracted from the electronic medical records included pre-disaster diagnosis of Axis I and/or II disorders and length of treatment up to the disaster. Factors collected from the baseline survey conducted approximately one month post-Sandy included self-reported buprenorphine supply disruption, health insurance status, disaster exposure, and post-Sandy screenings for PTSD and depression. Outcome variables reviewed 6 months post-Sandy included missed appointments, urine drug results for opioids, cocaine, and benzodiazepines. RESULTS: 129 (98%) patients remained in treatment at 6 months, and had no sustained increases in opioid-, cocaine-, and benzodiazepine-positive urine drug tests in any sub-groups with elevated substance use in the baseline survey. Contrary to our initial hypothesis, diagnosis of Axis I and/or II disorders pre-Sandy were associated with significantly less opioid-positive urine drug findings in the 6 months following Sandy compared to the rest of the clinic population. CONCLUSION: These findings demonstrate the adaptability of a safety net buprenorphine program to ensure positive treatment outcomes despite disaster-related factors.

Aims: (1) Assess feasibility of a text message appointment reminder (TMR) intervention (2) Determine the clinical impact of the TMR on appointment adherence Methods: A 52-item survey was administered to 100 patients in an urban, public sector, office-based buprenorphine program between June 2013 and March 2014. Survey domains included: demographic characteristics, communication patterns, and content preferences for supportive, informational, and relapse prevention TM interventions. A TMR was then sent 7, 4, 1 day prior to the patients' upcoming appointment followed by a 16 item survey that assessed satisfaction and feedback for the TM reminders (n = 72). Results: Respondents were predominately African-American (42%), unemployed or reliant on public assistance (68%), and lacked permanent housing (52%). MP ownership was common (93%) with the caveat of a high turnover of phones (2) and phone numbers (2) in the past year. Most reported TM use (93%) and comfort with sending TM (79%). The feasibility survey demonstrated satisfaction with the TMR (100%) and most preferred receiving text reminders (88%) in place of telephone reminders at 6 months. There was no significant difference between participants receiving the TMR compared to patients that did not receive the reminders. Conclusions: TM based interventions are an acceptable and feasible strategy for enhancing the delivery of care in a safety net, office-based buprenorphine program

BACKGROUND: Unobserved, or "home" buprenorphine induction is common in some clinical practices. Patients take the initial and subsequent doses of buprenorphine after, rather than during, an office visit. This review summarizes the literature on the feasibility and acceptability, safety, effectiveness, and prevalence of unobserved induction. METHODS: We searched the English language literature for studies describing unobserved buprenorphine induction and associated outcomes. Clinical studies were assessed by strength of design, bias, and internal and external validity. Surveys of provider practices and unobserved induction adoption were reviewed for prevalence data and key findings. We also examined previous review papers and international buprenorphine treatment guidelines. RESULTS: N = 10 clinical studies describing unobserved induction were identified: 1 randomized controlled trial, 3 prospective cohort studies, and 6 retrospective cohort studies. The evidence supports the feasibility of unobserved induction, particularly in office-based primary care practices. Evidence is weak to moderate in support of no differences in adverse event rates between unobserved and observed inductions. There is insufficient or weak evidence in terms of any or no differences in overall effectiveness (treatment retention, medication adherence, illicit opioid abstinence, other drug use). N = 9 provider surveys assessed unobserved induction: observed induction logistics are seen as barriers to buprenorphine prescribing; unobserved induction appears widespread in specific locations. International guidelines reviewed emphasize clinician or pharmacist observed induction (the United States, the United Kingdom, France, Australia); only one (Denmark) explicitly endorses unobserved induction. CONCLUSIONS: There is insufficient evidence supporting unobserved induction as more, less, or as effective as observed induction. However, the predominantly observational and naturalistic studies of unobserved induction reviewed, all of which have significant sources of bias and limited external validity, document feasibility and low rates of adverse events. Unobserved induction seems to be widely adopted in US and French regional provider surveys. Prescribers, policy makers, and patients should balance the benefits of observed induction such as maximum clinical supervision with the ease-of-use and comparable safety profile of unobserved induction.

Unobserved or "home" buprenorphine induction has become a common clinical practice. Patients take the initial and subsequent doses of buprenorphine after, rather than during, an office visit. This clinical case summarizes an unobserved induction onto buprenorphine in a typical new patient. We review the core issues surrounding patient selection, feasibility, logistics, safety, and effectiveness of unobserved buprenorphine induction. Prescribers, treatment providers, policy makers, and patients should weigh the benefits of observed induction (maximum clinical supervision) with the reduced resource burden, flexibility, and comparable safety of unobserved induction.

The time required to conduct drug and alcohol screening has been a major barrier to its implementation in mainstream healthcare settings. Because patient self-administered tools are potentially more efficient, we translated the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) into an audio guided computer assisted self interview (ACASI) format. This study reports on the test-retest reliability of the ACASI ASSIST in an adult primary care population. Adult primary care patients completed the ACASI ASSIST, in English or Spanish, twice within a 1-4week period. Among the 101 participants, there were no significant differences between test administrations in detecting moderate to high risk use for tobacco, alcohol, or any other drug class. Substance risk scores from the two administrations had excellent concordance (90-98%) and high correlation (ICC 0.90-0.97) for tobacco, alcohol, and drugs. The ACASI ASSIST has good test-retest reliability, and warrants additional study to evaluate its validity for detecting unhealthy substance use.

BACKGROUND AND OBJECTIVES: This analysis aims to: (1) compare induction experiences among participants who self-reported using one of the four most commonly reported POs, and (2) examine factors associated with difficult bup-nx induction. Our hypothesis, based on previous research and current guidelines, is that those on longer-acting opioids will have experienced more difficult inductions. METHODS: The Prescription Opioid Addiction Treatment Study (POATS) was a multi-site, randomized clinical trial, using a two-phase adaptive treatment research design. This analysis examines bup-nx induction of participants who self-reported primary PO use of methadone, ER-oxycodone, IR-oxycodone, and hydrocodone (n = 569). Analyses examined characteristics associated with difficult induction, defined as increased withdrawal symptoms measured by the Clinical Opiate Withdrawal Scale (COWS) after the first bup-nx dose with higher scores denoting greater withdrawal symptoms/severity. RESULTS: Contrary to our hypothesis, difficult induction experiences did not differ by primary PO type. Those who experienced a post-induction increase in COWS score had lower pre-dose COWS scores compared to those who did not experience a post-induction increase in COWS score (10.09 vs. 12.77, t(624) = -13.56, p < .001). Demographics characteristics, depression, and pain history did not predict a difficult induction. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Difficult bup-nx inductions were not associated with participants' primary PO. Severity of withdrawal, measured with the COWS, was an important variable, reminding clinicians that bup-nx should not be commenced prior to evidence of moderate opioid withdrawal. These findings add to the evidence that with careful procedures, bup-nx can used with few difficulties in PO-dependent patients. (Am J Addict 2013;XX:000-000).

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.

BACKGROUND: The 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. METHODS: A 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. RESULTS: There 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. CONCLUSIONS: The 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.