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Central Nervous System Stimulant

Methamphetamine for Methamphetamine Use

Madison, WI

Phase 1

Waitlist Available

Led By Heather K Barkholtz, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate how the body processes and the effects of methamphetamine. Meth can occur in two different forms: R-meth and S-meth. S-meth is a powerful stimulant

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Who is the study for?

This trial is for healthy individuals who want to help understand how different forms of methamphetamine work in the body. Participants will be involved in three study visits over a maximum of 12 weeks.Check my eligibility

What is being tested?

The study is testing two mirror-image chemical structures of methamphetamine: R-meth, found in nasal decongestants, and S-meth, used to treat ADD. It aims to compare their effects on metabolism and impairment.See study design

What are the potential side effects?

Potential side effects may include those commonly associated with central nervous system stimulants such as increased heart rate, insomnia, anxiety, appetite loss, and possible psychological effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't have major heart, brain, mental health, cancer, hormone, metabolism, kidney, or liver diseases.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the concentration versus time curve (AUC)

Peak concentration (Cmax)

Secondary study objectives

Cognitive Effects: Digital Symbol Substitution Task (DSST)

Cognitive Effects: Divided Attention Task (DAT)

Cognitive Effects: Paced Serial Addition Task (PASAT)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: S-Meth, R-Meth, Racemic IsomerExperimental Treatment3 Interventions

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

Group II: Racemic Isomer, S-Meth, R-MethExperimental Treatment3 Interventions

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

Group III: R-Meth, Racemic Isomer, S-MethExperimental Treatment3 Interventions

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

0 / 1Eligibility criteria met