Faculty Bibliography

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.).

Introduction: Online drug markets and social media are facilitating the spread of information and sale of illicit substances. Online sites, such as Craigslist and Bluelight, underscore an emerging shift in contemporary drug consumerism. Case Descriptions: We report on two cases. Case 1 is a 42-year-old male with a history of heroin-use disorder, presented for an initial visit to an office-based buprenorphine program, and reported having acquired heroin from Craigslist. Despite several harrowing experiences, Craigslist remained Patient 1's primary method of purchasing heroin during a 14-month period. Craigslist ads also redirected the patient to the web site Bluelight, which facilitated access to updated information on open-air drug markets in New York City. Case 2 is a 23-year-old male, who was admitted to inpatient detoxification and utilized the site for the sale of heroin in order to fund his own use of heroin. He sold heroin via Craigslist for 1 year until his arrest, noting undeterred advertising and largely uncomplicated transactions. He secured largely professionals buyers that purchased a steady quantity of heroin over extended periods of time. Discussion: Online drug marketplaces offer platforms to extend public health surveillance, harm reduction, and treatment entry strategies for internet users with substance-use disorders.

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((R)) ; 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.

BACKGROUND: Integrating mobile phone technologies in addiction treatment is of increasing importance and may optimize patient engagement with their care and enhance the delivery of existing treatment strategies. Few studies have evaluated mobile phone and text message (TM) use patterns in persons enrolled in addiction treatment, and none have assessed the use in safety net, office-based buprenorphine practices. METHODS: A 28-item, quantitative and qualitative semistructured survey was administered to opiate-dependent adults in an urban, publicly funded, office-based buprenorphine program. Survey domains included demographic characteristics, mobile phone and TM use patterns, and preferences pertaining to their recovery. RESULTS: Surveyors approached 73 of the 155 eligible subjects (47%); 71 respondents completed the survey. Nearly all participants reported mobile phone ownership (93%) and TM use (93%), and most reported "very much" or "somewhat" comfort sending TM (79%). Text message contact with 12-step group sponsors, friends, family members, and counselors was also described (32%). Nearly all preferred having their providers' mobile phone number (94%), and alerting the clinic via TM in the event of a potential relapse to receive both supportive TM and a phone call from their buprenorphine provider was also well received (62%). CONCLUSIONS: Mobile phone and TM use patterns and preferences among this sample of office-based buprenorphine participants highlight the potential of adopting patient-centered mobile phone-based interventions in this treatment setting.

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.