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.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 抽象的 这将是一项双盲，安慰剂对照，受试者之间的研究。 这将在80个寻求甲基苯丙胺（MA）的非治疗中进行，他们将在研究的8天期间居住在Michael de Bakey VA医疗中心（MEDVAC）。 在接受研究和稳定和初步监测后，参与者将获得15mg和30mg的MA，至少分别为4小时。 在接下来的几天中，他们将经过提示反应性的测试，然后参加MA自我管理，其中他们将有机会在3mg MA或货币替代方案之间进行选择。 然后，参与者将在其余的研究中随机分配到安慰剂（n = 20）或perindopril 4mg，8mg或16mg（每组n = 20）。 然后将像以前一样重复15和30mg的MA剂量，提示反应性测试以及MA自我管理活动。 然后，参与者将退出研究，并将以付款和评估后期新兴不良事件的付款和评估。 如果难以确保获得足够的医院病床，或者如果周末护理覆盖范围有问题，则可以将协议的一部分与参与者一起作为门诊病人进行。 通过每日尿液测试，将通过对尿液进行连续稀释来确保非法使用MA使用的禁欲，用于将非法使用的发作与本研究的一部分分开的MA施用。 参与者将每天获得50美元的付款，只要他们弃用住院患者还是门诊病人，他们都不会使用非法MA使用。