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Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00829634
Enrollment
12
Registered
2009-01-27
Start date
2008-10-31
Completion date
2009-09-30
Last updated
2013-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Congestion

Keywords

methamphetamine, inpatient, d-MA, l-MA, APRL, San Francisco, metabolism, Metabolism of methamphetamine

Brief summary

The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.

Detailed description

Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility. Once enrolled the study will take two weeks. During the first week subjects attend daily, hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and receive a blood draw. During the second week of the study subjects are admitted to San Francisco General Hospital for a week long inpatient stay. During this stay the subject continues to receive l-methamphetamine but also receives three doses of d-methamphetamine on three separate days. In addition the subject receives blood draws, has their urine collected, and answers questionnaires.

Interventions

DRUGl-methamphetamine

5mg of l-methamphetamine per day throughout the 2 week study

DRUGd-methamphetamine

15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13

Sponsors

San Francisco General Hospital
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
California Pacific Medical Center Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy Males and Females Between the Ages of 18 and 50 * Must have some experience with methamphetamine

Design outcomes

Primary

MeasureTime frame
Serum samplesPredose and Multiple Timepoints Post Doses
Urine Samples24 Hour Inpatient Collection

Secondary

MeasureTime frame
QuestionnariesPredose and Multiple Timepoints Post Doses

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026