Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06746831 | NOT YET RECRUITING | Methamphetamine

Methamphetamine Isomer Pharmacology in Humans
Sponsor:

University of Wisconsin, Madison

Brief 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.

Condition or disease

Methamphetamine

Intervention/treatment

S-(+)-methamphetamine

R-(-)-methamphetamine

1:1 racemic mixture of two isomers

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 17 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : The Low-Down on Methamphetamine Isomers: Prevalence and Pharmacology in Humans
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2027-08
Estimated Study Completion Date : 2027-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 64 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Methamphetamine Isomer Pharmacology in Humans

Location Details

NCT06746831

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53705