Methamphetamin-Isomer-Pharmakologie beim Menschen
Die Fakten zu Methamphetamin-Isomeren: Prävalenz und Pharmakologie beim Menschen
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Heather Barkholtz, PhD
- Telefonnummer: 608-890-1967
- E-Mail: hbarkholtz@wisc.edu
Studienorte
-
-
Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53705
- University of Wisconsin
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Peak concentration (Cmax)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cognitive Effects: Divided Attention Task (DAT)
Zeitfenster: 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)
Zeitfenster: 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)
|
|
Cognitive Effects: Paced Serial Addition Task (PASAT)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Heather K Barkholtz, PhD, University of Wisconsin, Madison
- Hauptermittler: David Leinweber, MD, University of Wisconsin, Madison
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2024-1164
- A523000 (Andere Kennung: UW Madison)
- Protocol Version 2/12/25 (Andere Kennung: UW Madison)
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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