Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT00829634
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2009-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
Sponsor:
California Pacific Medical Center Research Institute
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: