Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00829634|
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Nasal Congestion||Drug: l-methamphetamine Drug: d-methamphetamine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
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
- Serum samples [ Time Frame: Predose and Multiple Timepoints Post Doses ]
- Urine Samples [ Time Frame: 24 Hour Inpatient Collection ]
- Questionnaries [ Time Frame: Predose and Multiple Timepoints Post Doses ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829634
|United States, California|
|CPMC Addiction & Pharmacology Research Laboratory (APRL)|
|San Francisco, California, United States, 94110|