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

Not Applicable

Completed

• Conditions: Nasal Congestion
• Interventions: Drug: l-methamphetamine; Drug: d-methamphetamine

• Registration Number: NCT00829634
• Lead Sponsor: California Pacific Medical Center Research Institute

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
l-methamphetamine	l-methamphetamine	-
l-methamphetamine	d-methamphetamine	-

Primary Outcome Measures

Name	Time	Method
Serum samples	Predose and Multiple Timepoints Post Doses
Urine Samples	24 Hour Inpatient Collection

Secondary Outcome Measures

Name	Time	Method
Questionnaries	Predose and Multiple Timepoints Post Doses

Trial Locations

Locations (1)

CPMC Addiction & Pharmacology Research Laboratory (APRL); 🇺🇸 San Francisco, California, United States