PHARMACOTHERAPY DOSING REGIMEN

药物治疗剂量方案

• 批准号: 7626825
• 负责人: JOY Marie SCHMITZ
• 金额: $ 41.1万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7626825
• 关键词: Address; Adverse effects; Agonist; Amphetamines; Behavioral; Budgets; Clinical; Cocaine; Cocaine Dependence; Cognitive; Combination Medication; Consent; Data; Dependence; Dextroamphetamine; Diagnosis; Dose; Economics; Elements; Evaluation; Functional Magnetic Resonance Imaging; Grant; Heroin Dependence; Individual; Measurement; Measures; Medical; Mental Depression; Methadone; Methods; Modafinil; Monitor; Opiate Addiction; Opioid; Personal Communication; Pharmaceutical Preparations; Pharmacotherapy; Placebos; Population; Published Comment; Range; Recommendation; Reporting; Research; Research Ethics Committees; Research Personnel; Review Literature; Sampling; Standards of Weights and Measures; TNFRSF5 gene; Time; Treatment Protocols; Urine; Work; analog; aripiprazole; base; day; disorder later incidence prevention; novel; pre-clinical; programs; response; social; stimulant abuse; success

Cocaine dependence alone or co-occurring with opioid dependence is difficult to treat. We have reported reduced cocaine use in both populations using a potent agonist. Single dependence results have been confirmed by Australian colleagues. The proposed work follows from earlier studies. The theme is delineation of representative medications, doses and combinations for these difficult populations. Year I: We will continue preliminary small N evaluations to further evaluate dosing parameters. These will include combinations of d-amphetamine and modafinil, methadone and modafinil, and methadone and aripiprazole. Years II-V: We will conduct large RCT's, with continuing related small trials. Study I will include 200 consenting cocaine using subjects distributed across 4 groups: 1) 30 mg d-amphetamine+ 200 mg (estimate) modafinil; 2) 200 mg (est) modafinil; 3) 400 mg (est) modafinil; 4) placebo. Study II will include 200 consenting cocaine+opioid dependent subjects distributed across 5 groups all receiving up to1.2 mg/kg methadone/day. Groups will be: 1) 200 mg (est) modafinil; 2) 400 mg (est) modafinil; 3) 5 mg (est) aripiprazole; 4) 10 mg (est) aripiprazole; 5) placebo. Following consent, subjects will have complete medical and psychiatric evaluations, provide thrice weekly urine screens, weekly cognitive behavioral / relapse prevention based therapy, and regular monitoring with a standard measurement battery. Also, per Project 2, all consenting subjects will have fMRI at study entry and end.

可卡因依赖性单独或与阿片类药物依赖性共同发生很难治疗。我们有 据报道，使用有效的激动剂在两个种群中可卡因的使用降低。澳大利亚同事证实了单一依赖结果。拟议的工作遵循早期研究。主题是描述这些困难人群的代表性药物，剂量和组合。第一年：我们将继续初步的小N评估，以进一步评估给药参数。这些将包括D-苯丙胺和莫达非尼，美沙酮和莫达非尼的组合，以及美沙酮和阿立哌唑。 II-V年：我们将进行大型RCT，并继续进行相关的小型试验。研究I将使用分布在4个组中的受试者包括200个同意可卡因：1）30 mg D-苯丙胺+ 200 mg（估计）莫达非尼； 2）200 mg（EST）莫达非尼； 3）400 mg（EST）莫达非尼； 4）安慰剂。研究II将包括200名可卡因+阿片类药物依赖性受试者，分布在5组中，均收到1.2 mg/kg美沙酮/天。组将是：1）200 mg（EST）莫达非尼； 2）400 mg（EST）莫达非尼； 3）5 mg（EST）阿立哌唑； 4）10 mg（EST）阿立哌唑； 5）安慰剂。同意后，受试者将进行完整的医学和精神病学评估，提供三次每周的尿液筛查，每周的认知行为 /基于预防的治疗，并通过标准测量电池进行定期监测。同样，根据项目2，所有同意受试者将在研究入门和结束时拥有fMRI。