Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

描述(由申请人提供):本研究将获得试验数据的可接受性日常观察到的12周的课程目前美沙酮,紧随其后的是一剂锥度或推荐当地的治疗项目80阿片类药物依赖患者(40 /组)被注入Subutex或其他丁丙诺啡准备10个或更多天过去30,和每一个药物对艾滋病风险的影响和Subutex和阿片类药物使用和后续治疗一周20。它将在乌兰蒂美沙酮项目中进行，该项目隶属于成瘾研究中心，位于第比利斯的格鲁吉亚联合替代方案。乌克兰和俄罗斯的注射吸毒者中艾滋病毒的患病率为40-50%，而格鲁吉亚的注射吸毒者的患病率为10-15%，尽管丙型肝炎的患病率为50%或更多。除非扩大艾滋病毒预防工作，包括药物滥用治疗，否则艾滋病毒的低流行率不太可能继续下去。在格鲁吉亚和其他一些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，其中大部分是从西欧走私到该国的亚丁酮。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，这是本提案的重点。本研究建立在与格鲁吉亚P.I. David Otiashvili医学博士和Gvantsa Piralishvili医学博士建立的关系之上，Gvantsa医学博士与Otiashvili博士一起工作，目前是NIDA/CTN投资研究员，自2008年4月来到宾夕法尼亚大学和CTN特拉华谷节点的伍迪博士及其同事的指导下。她的研究重点是学习如何研究美沙酮和苏博松治疗的结果及其对艾滋病毒风险行为的影响，以便于2009年4月返回第比利斯。虽然注射丁丙诺啡并不是格鲁吉亚独有的，但由于丁丙诺啡注射者的浓度很高，有等待激动剂治疗的名单，并且患者招募不应该是一个问题，因此格鲁吉亚是一个独特的环境，可以获得如何治疗的试点数据。因此，本试点研究的主要目的是：1)获得为期12周的每日观察苏博松和美沙酮治疗对HIV注射风险行为的影响的试点数据，特别是与注射使用Subutex有关的数据；2)获得目标人群接受每日观察苏博松和美沙酮治疗的程度的试点数据

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.