The Low-Down on Methamphetamine Isomers: Prevalence and Pharmacology in Humans
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Peak concentration (Cmax)
研究概览
简要总结
This study is being done to understand the metabolism and impairment profile of methamphetamine (meth). Meth exists as two chemical structures that are mirror images of each other: R-meth and S-meth. S-meth is a strong central nervous system stimulant and used to treat attention deficit disorder (ADD). R-meth is not a strong central nervous system stimulant and is available over-the-counter in nasal decongestant sprays.17 healthy participants will be enrolled for 3 study visits and on study for up to 12 weeks.
详细描述
Double-blind crossover study design. Healthy volunteers will attend three study drug administration visits, at least 7 days apart, in which methamphetamine isomer pharmacology will be assessed following intravenous administration of (1) S-(+)-methamphetamine, (2) R(-)-methamphetamine, or (3) a (1:1) racemic mixture of R-(-)- and S-(+)-methamphetamine. The order of these interventions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick, oral fluid collections, and pooled urine specimens.
Primary Objective
- Characterize the pharmacokinetics of acute S-(+)-methamphetamine administration.
- Characterize the pharmacokinetics of acute R-(-)-methamphetamine administration.
- Characterize the pharmacokinetics of acute racemic (1:1) R-(-)- and S-(+)-methamphetamine administration.
Secondary Objectives
- Assess for evidence of stereo-selective metabolic pathways.
- Assess for evidence of subjective, cognitive, or physiological effects from acute R-(-)-methamphetamine administration.
- Assess for evidence of more than additive effects when administering racemic methamphetamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good mental health as determined by self-reported responses to the Psychopathology Screener
- •Absence of any major cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal, or hepatic disease as determined by self-reported responses to the Medical History Screener
- •English-speaking (able to provide consent and complete questionnaires)
- •Written Informed Consent
排除标准
- •Any serious prior adverse response to sympathomimetic agents or amphetamine analogs
- •History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener
- •Pregnancy or lactation (pregnancy test, if needed)
- •Use of medications that may impact cognition or metabolism (e.g., mood stabilizers, sedatives)
- •Dependent on prohibited concomitant therapy that cannot be withheld for 48 hours prior to and during study visits.
研究组 & 干预措施
S-Meth, R-Meth, Racemic Isomer
First visit: Administer S-Meth, then at least 7 days later Second visit: Administer R-Meth, then at least 7 days later Third visit: Administer (1:1) racemic methamphetamine
干预措施: R-(-)-methamphetamine (Drug)
R-Meth, Racemic Isomer, S-Meth
First visit: Administer R-Meth, then at least 7 days later Second visit: Administer (1:1) racemic methamphetamine, then at least 7 days later Third visit: Administer S-Meth
干预措施: S-(+)-methamphetamine (Drug)
S-Meth, R-Meth, Racemic Isomer
First visit: Administer S-Meth, then at least 7 days later Second visit: Administer R-Meth, then at least 7 days later Third visit: Administer (1:1) racemic methamphetamine
干预措施: S-(+)-methamphetamine (Drug)
Racemic Isomer, S-Meth, R-Meth
First visit: Administer (1:1) racemic methamphetamine, then at least 7 days later Second visit: Administer S-Meth, then at least 7 days later Third visit: Administer R-Meth
干预措施: S-(+)-methamphetamine (Drug)
Racemic Isomer, S-Meth, R-Meth
First visit: Administer (1:1) racemic methamphetamine, then at least 7 days later Second visit: Administer S-Meth, then at least 7 days later Third visit: Administer R-Meth
干预措施: R-(-)-methamphetamine (Drug)
S-Meth, R-Meth, Racemic Isomer
First visit: Administer S-Meth, then at least 7 days later Second visit: Administer R-Meth, then at least 7 days later Third visit: Administer (1:1) racemic methamphetamine
干预措施: 1:1 racemic mixture of two isomers (Drug)
R-Meth, Racemic Isomer, S-Meth
First visit: Administer R-Meth, then at least 7 days later Second visit: Administer (1:1) racemic methamphetamine, then at least 7 days later Third visit: Administer S-Meth
干预措施: 1:1 racemic mixture of two isomers (Drug)
R-Meth, Racemic Isomer, S-Meth
First visit: Administer R-Meth, then at least 7 days later Second visit: Administer (1:1) racemic methamphetamine, then at least 7 days later Third visit: Administer S-Meth
干预措施: R-(-)-methamphetamine (Drug)
Racemic Isomer, S-Meth, R-Meth
First visit: Administer (1:1) racemic methamphetamine, then at least 7 days later Second visit: Administer S-Meth, then at least 7 days later Third visit: Administer R-Meth
干预措施: 1:1 racemic mixture of two isomers (Drug)
结局指标
主要结局
Peak concentration (Cmax)
时间窗: pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours
The pharmacokinetic analysis relies on observed drug and metabolite concentration measurements over time and across biological matrices (plasma, whole blood, dried capillary spots, oral fluid, urine) included in this study.
Area under the concentration versus time curve (AUC)
时间窗: pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours
The pharmacokinetic analysis relies on observed drug and metabolite concentration measurements over time and across biological matrices (plasma, whole blood, dried capillary spots, oral fluid, urine) included in this study.
次要结局
- Cognitive Effects: Divided Attention Task (DAT)(Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2))
- Cognitive Effects: Digital Symbol Substitution Task (DSST)(Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2))
- Cognitive Effects: Paced Serial Addition Task (PASAT)(Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2))
- Subjective Effects: Drug Effect Questionnaire (DEQ)(Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2))
- Subjective Effects: Number of Participants Who Answer 'True' for Amphetamine-specific questions(Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2))