BUPRENORPHINE NALOXONE TREATMENT FOR OPIOID DEPENDENCE

阿片依赖是一个严重的公共卫生问题，其严重性是 由于它与静脉注射毒品和艾滋病有关而被放大。美联队 各州正在积极寻求批准承诺的新疗法 丁丙诺啡等替代药物用于对抗阿片类药物依赖。在这 申请，我们建议延长丁丙诺啡之前的成功 到大型城市环境，有大量未经处理的 瘾君子。具体地说，我们将研究一种有前景的新组合 丁丙诺啡-纳洛酮片五项临床药理研究及临床应用 一项维护研究。我们建议回答三个问题中的六个 三年多的实验。实验一将我们的研究扩展到 丁丙诺啡替代给药方案证明 受试者可以每隔一天或每三天安全地接受丁丙诺啡治疗 将丁丙诺啡剂量增加一倍或三倍。这些配药计划 可能会使患者不再需要带回家的药物 从诊所放假几天。实验一解决了两个问题。研究1 确定丁丙诺啡-纳洛酮片是否可以 每隔一天安全有效地给药一次，无论倍数 每日剂量的多少是必不可少的。研究2检查治疗结果 丁丙诺啡-纳洛酮片每日与3日比较 包括带回家剂量和不带带回家剂量的剂量计划。实验二考察了 丁丙诺啡-纳洛酮片联合用药的滥用倾向 三组阿片类药物滥用者的联合试验 减少丁丙诺啡的非肠道滥用。实验二涉及三个问题 问题。研究1确定了组合的滥用责任 丁丙诺啡-纳洛酮片在丁丙诺啡维持治疗中的应用 研究2确定丁丙诺啡联合用药的滥用责任- 纳洛酮片用于未寻求治疗的阿片依赖患者。 研究3确定丁丙诺啡联合用药的滥用责任- 非依赖阿片类药物滥用者的纳洛酮片。实验三 确定丁丙诺啡联合用药的临床疗效- 纳洛酮片短期维持治疗的两种方法比较 丁丙诺啡-纳洛酮片的剂量和两种剂量的纳洛酮 美沙酮在为期16周的随机试验中。总体而言，这项研究 为从业者和科学家提供基本的实用指导 丁丙诺啡-纳洛酮片的临床应用 从而允许片剂以最大的功效在 临床环境。此外，这些研究将扩展先前的发现和 通过提供有关以下方面的重要信息来改善药物滥用治疗 新研制的丁丙诺啡-纳洛酮广谱配伍片 个人，包括那些没有接触美沙酮的人 和/或其他治疗阿片依赖问题的方法。

Opioid dependence is a serious public health problem whose severity is magnified due to its association with IV drug use and AIDS. The United States is actively pursuing approval of promising new treatment alternatives such as buprenorphine to combat opioid dependence. In this application, we propose to extend previous successes with buprenorphine to a large urban environment with significant numbers of untreated addicts. Specifically, we will examine a promising new combination buprenorphine-naloxone tablet in five clinical pharmacology studies and one maintenance study. We propose to answer six questions across three experiments over three years. Experiment I extends our research on alternative buprenorphine dosing schedules which demonstrated that subjects can safely receive buprenorphine every other day or every three days by doubling or tripling buprenorphine doses. These dosing schedules may eliminate the need for take-home medication for patients who need days off from the clinic. Experiment I addresses two questions. Study 1 determines whether a combination buprenorphine-naloxone tablet can be administered safely and effectively every other day and whether multiples of the daily dose are essential. Study 2 examines treatment outcome with a combination buprenorphine-naloxone tablet by comparing daily to 3-day dosing schedules with and without take-home doses. Experiment II examines the abuse liability of combination buprenorphine-naloxone tablets in three populations of opioid abusers to determine if the combination reduces parenteral abuse of buprenorphine. Experiment II addresses three questions. Study 1 determines the abuse liability of the combination buprenorphine-naloxone tablet in buprenorphine-maintained patients. Study 2 determines the abuse liability of the combination buprenorphine- naloxone tablet in opioid-dependent individuals not seeking treatment. Study 3 determines the abuse liability of the combination buprenorphine- naloxone tablet in non-dependent opioid abusers. Experiment III determines the clinical efficacy of the combination buprenorphine- naloxone tablet for short-term maintenance treatment by comparing two doses of the combination buprenorphine-naloxone tablet and two doses of methadone during a 16-week randomized trial. Overall, this research provides essential pragmatic guidance for practitioners and scientists about the clinical use of the combination buprenorphine-naloxone tablet thereby permitting the tablet to be used with the greatest efficacy in clinical settings. Moreover, these studies will extend prior findings and improve drug abuse treatment by providing important information about a newly-developed combination buprenorphine-naloxone tablet in a wide range of individuals, including those who have not been exposed to methadone and/or other treatments for opioid dependence problems.