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Risk Reduction with Buprenorphine– Naloxone And LETTERS TO THE EDITOR Risk Reduction With The protocol was thus the antithesis of this study was to evaluate if buprenor- what prevails in the “real world,” where phine–naloxone causes hepatotoxicity. Buprenorphine– patients can receive prescriptions for as Several previous case reports suggested much as a month’s supply of buprenor- that it does, and the FDA asked NIDA Naloxone and phine from the outset, to be dispensed by to conduct a trial to explore this question. Methadone: a community pharmacy. The request was that the trial includes at The bottom line would seem to be least 300 patients who were treated with Patient’s Choice that this study underscores the rationale each medication for 6 or more months and for allowing those who need and seek had 4 or more postbaseline blood draws to care for opioid dependence to “vote with test for liver enzyme changes. A random- To the Editors: their feet,” and for researchers and clini- ized trial, as the gold standard for compar- A recent study by Woody et al1 cians to respect that vote. ing interventions, was judged to be the demonstrated “. marked and approxi- best way to explore this question. It was mately equal reductions in injection necessary to do the study in methadone related risk” among subjects who applied Robert G. Newman, MD, MPH programs since both medications would for methadone maintenance but agreed to available and the daily dosing minimized Department of Preventive Medicine, be randomized to receive either buprenor- the risk of medication nonadherence due Icahn School of Medicine at Mount Sinai, phine or methadone, and who remained in to diversion. All potential participants New York, NY their assigned treatment condition for 24 received thorough informed consent including the fact that they could drop weeks. It is respectfully suggested that REFERENCES this trial raises serious ethical issues while out of the study at any time, agreed to contributing little if anything to guide 1. Woody G, Bruce D, Korthuis P, et al. HIV risk be randomized before entering the study, reduction with buprenorphine-naloxone or meth- and were not asked for their preferred either clinicians or prospective patients. adone: findings from a randomized trial. J Acquir Although the outcome of the 2 Immune DeficSyndr.2014;66:288–293. treatment. The protocol was written at groups with regard to virtually all of the 2. Federal opioid treatment standards. Fed Regist. a time that patient requests for buprenor- – fi – parameters measured was remarkably sim- 2002;1(42):65 68. To be codi ed at 42 CFR 2.1 phine naloxone treatment in primary care §8.12. were expanding and before publication of ilar, a major distinction was observed with 2 regard to retention: at the end of 24 weeks, the Cochran review showing better reten- 74% of methadone recipients were still tion with methadone than buprenorphine. enrolled compared with only 46% of those Thus, the magnitude of the differential assigned to the buprenorphine arm. This Authors’ Reply: “Risk dropout that occurred was unexpected. fi finding is not unexpected when research Study ndings showed no evidence of bu- Reduction With prenorphine–naloxone induced transami- protocol rather than applicant preference 3 determines the treatment regimen to be Buprenorphine– nase elevations thus addressing concerns provided. It is of particular concern given Naloxone and that led the FDA to request the study, and the clear risk of both morbidity and methadone maintenance and other local mortality associated with opioid depen- Methadone: Patient’s treatment options were available to pa- dence, and the very strong and consistent tients who dropped out of their assigned evidence of the favorable outcomes asso- Choice“ medication condition. HIV risk was one of ciated with methadone, which was the several measures included for secondary fi treatment of choice of all these subjects. analyses. We hope that these clari cations Furthermore, in this trial, buprenor- To the Editors: are responsive to the comments raised by phine recipients were subject to the same We agree with the observation1 that this letter. inflexible demands for observed “dosing” this trial did not represent the way patients as are required by federal regulation of all are treated with buprenorphine–naloxone George Woody, MD*† those who receive methadone. Thus, for in clinical practice; however, it is impor- Douglas Bruce, MD‡ roughly half the 24 weeks of this trial, tant to point out that the main purpose of P. Todd Korthuis, MD§ they were obliged to make visits to the † OTP (not to a primary care provider) at Sumedha Chhatre, PhD* k least 6 days per week, and for the balance Supported by NIDA grants: U10-DA013714 Maureen Hillhouse, PhD of the investigation could receive no (D. Donovan); U10 DA-13043, KO5 Petra Jacobs, MD† 2 DA-17009 (G.E.W.). more than 2 “take-home” doses weekly. The authors have no conflicts of interest to James Sorensen, MD¶ disclose. Andrew J. Saxon, MD# These HIV data have not been presented; however, Sabrina Poole, PsyD* they will be presented at AMERSA, November † The author has no funding or conflicts of interest to 8, 2014, San Francisco, CA, and at the ACNP, David Metzger, PhD* disclose. December 2014. Walter Ling, MDk e142 | www.jaids.com J Acquir Immune Defic Syndr Volume 67, Number 5, December 15, 2014 J Acquir Immune Defic Syndr Volume 67, Number 5, December 15, 2014 Letters to the Editor *Perelman School of Medicine at the become widespread, with 89% of a social and sexual network question- University of Pennsylvania, Americans aged 18–29 years reporting naire and received risk-reduction coun- Philadelphia, PA that they use social networking sites.1 seling and a rapid HIV antibody test.17 †Treatment Research Institute, Men who have sex with men (MSM) Eligibility criteria for NYCM2M were Philadelphia, PA use social networking sites at high rates male at birth, at least 18 years old, hav- ‡Yale University School of Medicine, in part because they are able to form ing anal sex with a man in the past 3 New Haven, CT private, anonymous, and relatively safe months, and communicating in English §Oregon Health and Science University, communities on these sites.2,3 A variety or Spanish. Participants received $50 for Portland, OR of niche sites like Grindr, Manhunt, an NYCM2M visit. kUniversity of California, Los Angeles, Adam4Adam, and Scruff have web HVTN 505 was a phase 2B Los Angeles, CA pages and mobile phone-based applica- vaccine efficacy trial in 21 sites in the ¶University of California, San Francisco, tions for use by MSM, with a large United States that enrolled 2504 MSM San Francisco, CA proportion of MSM using such applica- and transgender women who had sex #Veterans Affairs Puget Sound Health Care tions to find sex partners.2–8 Several with men from June 2009 to March System, Seattle, WA studies have documented the success of 2013.18 Participants were randomized using social networking for HIV preven- to receive 4 injections of vaccine or REFERENCES tion9–11 and recruitment for HIV preven- placebo over 6 months and were fol- – – 1. Newman RG. Risk reduction with buprenorphine tion research.12 14 Recently, researchers lowed every 3 months for 2 years to naloxone and methadone: patient’schoice.JAc- quir Immune DeficSyndr. 2014;67:e142. have reported the use of mobile phone complete a medical history, physical 15 2. Mattick RP, Kimber J, Breen C, et al. Buprenor- applications for education and as a tool examinations, risk-reduction counsel- phine maintenance versus placebo or methadone to recruit MSM for research studies.16 ing, and HIV testing and to provide maintenance for opioid dependence. The Cochrane Here, we describe our experience blood specimens. Men and transgender Collaboration. John Wiley and Sons, Ltd; 2008. – 3. Saxon AJ, Ling W, Hillhouse M, et al. Buprenor- using a geospatial social networking women were eligible if they were 18 50 phine/naloxone and methadone effects on labora- application (Grindr) for recruitment into years, HIV-uninfected, circumcised, and tory indices of liver health: a randomized trial. 3 different HIV prevention projects, met behavioral risk criteria indicating Drug Alcohol Depend. 2013;128:71–76. including an HIV testing program, a social risk for HIV acquisition. Compensation epidemiologic survey (NYCM2M), and for HVTN 505 ranged from $25 to Recruitment by an HIV vaccine trial [HIV Vaccine Trials $75 per visit, depending on the type Network 505 (HVTN 505)]. of visit. aGeospatial The HIV testing program was part Before placement of the advertise- of a national testing initiative with the ments on the geospatial social network- Networking Application goal of identifying undiagnosed HIV- ing application, the 3 projects used for Research and infected MSM, with a specific focus a variety of recruitment methods. For on Latino and black men. Community- the HIV testing program, a mobile van Practice: The New York based organizations in approximately 20 was taken to various community and City Experience cities across the United States participate public settings to recruit MSM. For the in the testing initiative under a contrac- social epidemiologic study, venue- tual relationship with Abt Associates. based time-space sampling was con- The testing program in New York City ducted.17 Recruitment for the HIV To the Editors: was implemented in 2012. Participants vaccine trial was conducted by local Social networking using mobile received a one-time risk-reduction coun- print advertising, street, venue, and “ ” phone-based applications ( apps ) has seling session and a rapid HIV antibody event outreach, participant referrals, test at 1 of our 2 clinic sites or in our and centralized national web recruit- Supported by the National Institute of Allergy and mobile van at various locations. MSM ment, predominantly on sites such as Infectious Disease (NIAID) UM1 AI069470 to 19 Columbia University; UM1 AI068614 to Fred were eligible to participate if they were Facebook and Adam4Adam.
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