AN ACE INHIBITOR AS A TREATMENT FOR METHAMPHETAMINE DEPENDENCE
AN ACE INHIBITOR AS A TREATMENT FOR METHAMPHETAMINE DEPENDENCE
批准号:
8356772
负责人:
Thomas Frederick Newton
金额:
$4.39万
依托单位国家:
美国
项目类别:
财政年份:
2010
资助国家:
美国
项目状态:
已结题
起止时间:
2010-12-01 至 2011-11-30
关键词:
AbstinenceAdmission activityAdverse eventAngiotensin-Converting Enzyme InhibitorsClinical ResearchDiscipline of NursingDoseDouble-Blind MethodEnsureFundingGrantHourInpatientsMedical centerMethamphetamineMethamphetamine dependenceMonitorNational Center for Research ResourcesOutpatientsParticipantPerindoprilPlacebo ControlPlacebosPrincipal InvestigatorProtocols documentationRandomizedResearchResearch InfrastructureResourcesSecureSelf AdministrationSourceStudy SubjectTestingUnited States National Institutes of HealthUrinecostcue reactivityhospital bedpayment
中文摘要
这个子项目是利用资源的许多研究子项目之一。
由NIH/NCRR资助的中心拨款提供。对子项目的主要支持
子项目的首席调查员可能是由其他来源提供的,
包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能
表示该子项目使用的中心基础设施的估计数量,
不是由NCRR赠款提供给次级项目或次级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、受试者之间的研究。它将在80名寻求甲基苯丙胺(MA)依赖的非治疗受试者中进行,他们将在Michael de Bakey VA医学中心(MEDVAC)住院8天。
在进入研究和稳定状态并进行初步监测后,参与者将接受间隔至少4小时的15 mg和30 mg MA。在接下来的几天里,他们将接受线索反应性测试,然后参加MA自我管理,在这个过程中,他们将有机会在3 mg MA或Money替代品中进行选择。然后,参与者将被随机分配到安慰剂(n=20)或培哚普利4 mg、8 mg或16 mg(每组n=20)进行剩下的研究。然后,将像以前一样重复15和30 mg MA剂量、线索反应性测试和MA自我给药活动。然后,参与者将从研究中出院,并将每隔一段时间返回,以支付费用并评估后期出现的不良事件。
如果难以获得足够的医院床位,或者如果周末护理覆盖变得有问题,部分协议可能会以门诊患者的身份进行。将通过每日尿液检测和连续稀释尿液来确保戒除非法使用MA的行为,这些尿液用于将非法使用MA与作为本研究一部分实施的MA区分开来。参与者将获得每天50美元的报酬,只要他们不非法使用MA,无论他们是以住院患者还是门诊患者的身份参加。
英文摘要
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.
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