Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
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.
|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 ]
|Study Start Date:||October 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
5mg of l-methamphetamine per day throughout the 2 week study
Other Name: l-MADrug: d-methamphetamine
15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13
Other Name: d-MA
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829634
|United States, California|
|CPMC Addiction & Pharmacology Research Laboratory (APRL)|
|San Francisco, California, United States, 94110|