Methamphetamine Isomer Pharmacology in Humans

Официальное название

The Low-Down on Methamphetamine Isomers: Prevalence and Pharmacology in Humans

Обзор

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.

Подробное описание

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.

Correlative Objectives

* Compare biological methamphetamine and metabolite concentrations in surveyed biological matrices (i.e., plasma, whole blood, oral fluid, dried capillary blood spots, and urine) over time. * Compare cognitive and subjective effects of acute S-(+)-methamphetamine, R-(-)-methamphetamine, and racemic methamphetamine administration.

Вмешательства

• Препарат S-(+)-methamphetamine
  15 mg
• Препарат R-(-)-methamphetamine
  15 mg
• Препарат 1:1 racemic mixture of two isomers
  15 mg R-Meth + 15 mg S-Meth

Первичные конечные точки

• Peak concentration (Cmax) [Срок оценки: pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours]
• Area under the concentration versus time curve (AUC) [Срок оценки: pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours]

Вторичные конечные точки (5)

• Cognitive Effects: Divided Attention Task (DAT) [Срок оценки: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
• Cognitive Effects: Digital Symbol Substitution Task (DSST) [Срок оценки: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
• Cognitive Effects: Paced Serial Addition Task (PASAT) [Срок оценки: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
• Subjective Effects: Drug Effect Questionnaire (DEQ) [Срок оценки: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
• Subjective Effects: Number of Participants Who Answer 'True' for Amphetamine-specific questions [Срок оценки: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Идентификаторы

NCT: NCT06746831 · 2024-1164 · Protocol Version 2/12/25 · A523000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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