Methamfetamine-isomeerfarmacologie bij mensen
De low-down over methamfetamine-isomeren: prevalentie en farmacologie bij mensen
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Heather Barkholtz, PhD
- Telefoonnummer: 608-890-1967
- E-mail: hbarkholtz@wisc.edu
Studie Locaties
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53705
- University of Wisconsin
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
15 mg
Andere namen:
15 mg
Andere namen:
15 mg R-Meth + 15 mg S-Meth |
|
Experimenteel: 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 |
15 mg
Andere namen:
15 mg
Andere namen:
15 mg R-Meth + 15 mg S-Meth |
|
Experimenteel: 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 |
15 mg
Andere namen:
15 mg
Andere namen:
15 mg R-Meth + 15 mg S-Meth |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Peak concentration (Cmax)
Tijdsspanne: 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. |
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)
Tijdsspanne: 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. |
pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cognitive Effects: Divided Attention Task (DAT)
Tijdsspanne: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
The DAT requires participants track a moving stimulus on a computer screen while simultaneously monitoring numbers located in the corners of the screen. Participants must respond to target numbers as they appear, and the task quantifies mean distance of the mouse cursor from the center of the target stimulus. |
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
|
Cognitive Effects: Digital Symbol Substitution Task (DSST)
Tijdsspanne: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
The DSST asks participants to recreate patterns of various shapes presented on a computer screen using the keyboard. The total number of correct patterns are recorded within 90 seconds. |
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
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Cognitive Effects: Paced Serial Addition Task (PASAT)
Tijdsspanne: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
The PASAT has participants view a string of single-digit numbers and calculate the sum of the two most recently presented numbers. The total number of correct trials out of 90 will be recorded. |
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
|
Subjective Effects: Drug Effect Questionnaire (DEQ)
Tijdsspanne: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
Subjective current general effects will be measured by asking the participant to rate if they feel the drug effect, if they like/dislike the drug effect, if they feel high, and if they would like more of the drug. Effects will be measured on a scale from "not at all" anchored at 0 to "extremely" at 100. |
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
|
Subjective Effects: Number of Participants Who Answer 'True' for Amphetamine-specific questions
Tijdsspanne: Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
Participants will be asked 11 amphetamine-specific questions including feelings of pleasantness, excitability, memory, emptiness, body tingling, weird feeling, patience, and mental sharpness. Results are measured as either "true" (experiencing the specific state) or "false" (not experiencing the specific state). Number of participants who answered 'True' is reported here |
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Heather K Barkholtz, PhD, University of Wisconsin, Madison
- Hoofdonderzoeker: David Leinweber, MD, University of Wisconsin, Madison
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2024-1164
- A523000 (Andere identificatie: UW Madison)
- Protocol Version 2/12/25 (Andere identificatie: UW Madison)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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