AN ACE INHIBITOR AS A TREATMENT FOR METHAMPHETAMINE DEPENDENCE

ACE 抑制剂治疗甲基苯丙胺依赖

• 批准号: 8356772
• 负责人: Thomas Frederick Newton
• 金额: $ 4.39万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356772
• 关键词: Abstinence; Admission activity; Adverse event; Angiotensin-Converting Enzyme Inhibitors; Clinical Research; Discipline of Nursing; Dose; Double-Blind Method; Ensure; Funding; Grant; Hour; Inpatients; Medical center; Methamphetamine; Methamphetamine dependence; Monitor; National Center for Research Resources; Outpatients; Participant; Perindopril; Placebo Control; Placebos; Principal Investigator; Protocols documentation; Randomized; Research; Research Infrastructure; Resources; Secure; Self Administration; Source; Study Subject; Testing; United States National Institutes of Health; Urine; cost; cue reactivity; hospital bed; payment

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT This will be a double-blind, placebo-controlled, between- subjects study. It will be conducted in 80 non-treatment seeking methamphetamine (MA) dependent subjects who will be resident at the Michael De Bakey VA Medical Center (MEDVAC) for the 8-day duration of the study. After admission to the study and stabilization and initial monitoring, participants will receive 15mg and 30mg MA separated by at least 4 hours. Over the next several days they will undergo testing of cue reactivity and then participate in MA self-administration in which they will have the opportunity to choose between 3mg MA or money alternatives. Participants will then be randomly assigned to placebo (n=20) or perindopril 4mg, 8mg, or 16mg (n=20 for each group) for the remainder of the study. The 15 and 30mg MA dosing, cue reactivity testing, and MA self-administration activities will then be repeated as before. Participants will then be discharged from the study and will return at intervals for payment and assessment of late emerging adverse events. Should there be difficulties securing access to sufficient hospital beds or if weekend nursing coverage becomes problematic, parts of the protocol may be conducted with participants as outpatients. Abstinence from illicit MA use will be ensured by daily urine testing with serial dilution of urine used to separate episodes of illicit use from MA administered as part of this study. Participants will receive payments of $50 per day provided they abstain from illicit MA use regardless of whether they participate as inpatients or outpatients.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 摘要 这将是一项双盲、安慰剂对照、受试者间研究。 将在80名非寻求治疗的甲基苯丙胺（MA）依赖受试者中进行，这些受试者将在研究的8天期间居住在Michael De Bakey VA Medical Center（MEDVAC）。 在进入研究并稳定和初始监测后，受试者将接受15 mg和30 mg MA，间隔至少4小时。 在接下来的几天里，他们将接受线索反应性测试，然后参与MA自我管理，他们将有机会在3 mg MA或金钱替代品之间进行选择。 然后，受试者将被随机分配到安慰剂组（n=20）或培哚普利4 mg、8 mg或16 mg组（每组n=20），以完成剩余的研究。 然后将如前所述重复15和30 mg MA给药、线索反应性检测和MA自我给药活动。 然后，受试者将从研究中出院，并将定期返回进行付款和评估晚期出现的不良事件。 如果难以确保获得足够的医院床位，或者如果周末护理覆盖率成为问题，则可以将参与者作为门诊患者进行部分方案。 将通过每日尿液检测（使用连续稀释尿液将非法使用事件与作为本研究一部分给药的MA分开）来确保禁止非法使用MA。 参与者将获得每天50美元的报酬，前提是他们放弃非法使用MA，无论他们是作为住院患者还是门诊患者参与。