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Methamphetamine Isomer Pharmacology in Humans

Phase I Interventional Methamphetamine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: S-(+)-methamphetamine, R-(-)-methamphetamine, 1:1 racemic mixture of two isomers.
Who it may be relevant to
Registry conditions: Methamphetamine. Basic parameters: 21 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Peak concentration (Cmax) [Time frame: 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) [Time frame: pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours]
Secondary outcome measures (5)
  • Cognitive Effects: Divided Attention Task (DAT) [Time frame: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
  • Cognitive Effects: Digital Symbol Substitution Task (DSST) [Time frame: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
  • Cognitive Effects: Paced Serial Addition Task (PASAT) [Time frame: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
  • Subjective Effects: Drug Effect Questionnaire (DEQ) [Time frame: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]
  • Subjective Effects: Number of Participants Who Answer 'True' for Amphetamine-specific questions [Time frame: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Wisconsin — Madison

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗