NCT06746831

Methamphetamine Isomer Pharmacology in Humans

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Methamphetamine

Interventions

Type	Name	Description
DRUG	S-(+)-methamphetamine	15 mg
DRUG	R-(-)-methamphetamine	15 mg
DRUG	1:1 racemic mixture of two isomers	15 mg R-Meth + 15 mg S-Meth

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2024-12-24
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study