Health TrialsbyHealthPanel

Methamphetamine Isomer Pharmacology in Humans

ConditionMethamphetamine
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-64
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • S-(+)-methamphetamine

    Drug

    15 mg

  • R-(-)-methamphetamine

    Drug

    15 mg

  • 1:1 racemic mixture of two isomers

    Drug

    15 mg R-Meth + 15 mg S-Meth

Treatment groups

17 Participants
are divided into 3 treatment groups
Group A: S-Meth, R-Meth, Racemic IsomerExperimental treatment 3 interventions
Group B: R-Meth, Racemic Isomer, S-MethExperimental treatment 3 interventions
Group C: Racemic Isomer, S-Meth, R-MethExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Peak concentration (Cmax)

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.

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
2

Area under the concentration versus time curve (AUC)

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.

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 outcomes

1

Cognitive Effects: Divided Attention Task (DAT)

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.

Time frame
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
2

Cognitive Effects: Digital Symbol Substitution Task (DSST)

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.

Time frame
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
3

Cognitive Effects: Paced Serial Addition Task (PASAT)

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.

Time frame
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)
4

Subjective Effects: Drug Effect Questionnaire (DEQ)

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.

Time frame
Visit 1 (baseline), Visit 2 (week 1), Visit 3 (week 2)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

U.S. Department of Justice

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: