Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

描述（申请人提供）：本研究将获得80名阿片类药物依赖患者每日观察Suboxone和美沙酮12周疗程的可接受性的初步数据，随后进行剂量递减或转诊至当地治疗计划（40/组）在过去30天内注射Subutex或其他丁丙诺啡制剂10天或以上，以及每种药物对艾滋病毒风险的影响以及治疗期间Subutex和阿片类药物的使用以及第20周的随访。它将在第比利斯的格鲁吉亚联盟替代方案成瘾研究中心附属的Uranti美沙酮方案进行。与注射吸毒者中艾滋病毒流行率为40- 50%的乌克兰和俄罗斯不同，格鲁吉亚注射吸毒者中的流行率为10-15%，尽管丙型肝炎的流行率为50%或更多。除非扩大包括药物滥用治疗在内的艾滋病毒预防工作，否则艾滋病毒的低流行率不太可能持续下去。在格鲁吉亚和其他几个国家发现的一个问题是，大约一半的类阿片成瘾者正在注射丁丙诺啡，主要是从西欧走私到该国的Subutex。目前还没有关于如何治疗这些患者或如何最好地降低其艾滋病毒风险的数据，这是该提案的重点。这项研究建立在与格鲁吉亚P.I.医学博士大卫奥蒂亚什维利和医学博士Gvantsa Piralishvili，博士，谁与奥蒂阿什维利博士，目前是一个NIDA/CTN投资研究员由伍迪博士和同事在宾夕法尼亚州和特拉华州谷节点的CTN指导，因为她在4/08抵达。她的奖学金的重点是学习如何研究美沙酮和Suboxone治疗的结果及其对艾滋病毒风险行为的影响，当她在4/09返回第比利斯时。虽然丁丙诺啡注射并不是格鲁吉亚独有的，但格鲁吉亚是获得如何治疗它的试点数据的独特环境，因为丁丙诺啡注射剂的浓度很高，激动剂治疗有等待名单，患者招募应该不是问题。因此，这项试点研究的主要目的是：1）获得为期12周的每日观察Suboxone和美沙酮治疗对艾滋病毒注射风险行为影响的试点数据，特别是与注射使用Subutex相关的行为2）获得关于目标人群接受每日观察Suboxone和美沙酮治疗的程度的试点数据 公共卫生相关性：本研究将获得在过去30年中注射Subutex或其他丁丙诺啡制剂15天或以上的80名阿片类药物依赖患者（40名/组）中每日观察Suboxone和美沙酮12周疗程的可接受性以及每种药物对治疗期间和随访期间艾滋病毒风险和阿片类药物使用的影响的初步数据。这项工作将在Uranti美沙酮方案进行，该方案隶属于格鲁吉亚共和国第比利斯的格鲁吉亚联盟替代方案成瘾研究中心，该方案的艾滋病毒流行率相对较低，但大约一半的阿片类药物依赖患者注射Subutex和其他丁丙诺啡制剂后，艾滋病毒风险较高。

DESCRIPTION (provided by applicant): This study will obtain pilot data on the acceptability of a 12-week course of daily observed Suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40/group) who have been injecting Subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on Subutex and opioid use during treatment and a followup at week 20. It will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative Georgia in Tbilisi. Unlike Ukraine and Russia where the prevalence of HIV among IDUs is 40-50%, the prevalence among IDUs in Georgia is 10-15% even though hepatitis C is found in 50% or more. This low prevalence of HIV is not likely to continue unless there is an expansion in HIV prevention that includes substance abuse treatment. A problem found in Georgia and a few other countries is that approximately half the persons addicted to opioids are injecting buprenorphine, mostly Subutex that is smuggled into the country from Western Europe. There are no data on how to treat these patients or how to best reduce their HIV risk, which is the focus of this proposal. This study builds on a relationship established with the Georgian P.I. David Otiashvili, MD, and with Gvantsa Piralishvili, M.D., PhD, who works with Dr. Otiashvili and is currently a NIDA/CTN Invest fellow mentored by Dr. Woody and colleagues at Penn and the Delaware Valley Node of the CTN since her arrival in 4/08. The focus of her fellowship is learning how to study outcome from methadone and Suboxone treatment and their impact on HIV risk behavior for when she returns to Tbilisi in 4/09. Though buprenorphine injecting is not unique to Georgia, Georgia is a unique setting to obtain pilot data on how to treat it because the concentration of buprenorphine injectors is high, there are waiting lists for agonist treatment, and patient recruitment should not be a problem. The primary aims of this pilot study are thus to: 1) Obtain pilot data on the impact of a 12-week course of daily, observed Suboxone and methadone treatment on HIV injecting risk behavior, particularly that associated with injecting use of Subutex 2) Obtain pilot data on the degree to which the target population accepts treatment with daily observed Suboxone and methadone PUBLIC HEALTH RELEVANCE: This study will obtain pilot data on the acceptability of a 12-week course of daily observed Suboxone and methadone on 80 opioid dependent patients (40/group) who have been injecting Subutex or other buprenorphine preparations for 15 or more days in the past 30, and of the impact of each medication on HIV risk and opioid use during treatment and at followup. It will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative Georgia in Tbilisi, Republic of Georgia where the prevalence of HIV is relatively low, but where HIV risk is high in association with injecting Subutex and other buprenorphine preparations by approximately half of the opioid dependent patients.