Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Nasal Congestion |
Drug: l-methamphetamine Drug: d-methamphetamine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
- Serum samples [ Time Frame: Predose and Multiple Timepoints Post Doses ] [ Designated as safety issue: No ]
- Urine Samples [ Time Frame: 24 Hour Inpatient Collection ] [ Designated as safety issue: No ]
- Questionnaries [ Time Frame: Predose and Multiple Timepoints Post Doses ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
-
Drug: l-methamphetamine
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy Males and Females Between the Ages of 18 and 50
- Must have some experience with methamphetamine
Contacts and Locations| United States, California | |
| CPMC Addiction & Pharmacology Research Laboratory (APRL) | |
| San Francisco, California, United States, 94110 | |
More Information
No publications provided
| Responsible Party: | John Mendelson, MD, California Pacific Medical Center |
| ClinicalTrials.gov Identifier: | NCT00829634 History of Changes |
| Other Study ID Numbers: | 27.092 |
| Study First Received: | January 23, 2009 |
| Last Updated: | September 14, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by California Pacific Medical Center Research Institute:
|
methamphetamine inpatient d-MA l-MA |
APRL San Francisco metabolism Metabolism of methamphetamine |
Additional relevant MeSH terms:
|
Methamphetamine Amphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013