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

• Sponsor: California Pacific Medical Center Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00829634
• Collaborator: San Francisco General Hospital (Other), University of California, San Francisco (Other), National Institutes of Health (NIH) (NIH)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Congestion	Drug: l-methamphetamine; Drug: d-methamphetamine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: l-methamphetamine	Drug: l-methamphetamine; 5mg of l-methamphetamine per day throughout the 2 week study; Other Names: l-MA ; Drug: d-methamphetamine; 15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13; Other Names: d-MA

Outcome Measures

Primary Outcome Measures

1. Serum samples [Predose and Multiple Timepoints Post Doses]

2. Urine Samples [24 Hour Inpatient Collection]

Secondary Outcome Measures

1. Questionnaries [Predose and Multiple Timepoints Post Doses]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	CPMC Addiction & Pharmacology Research Laboratory (APRL)	San Francisco	California	United States	94110

Sponsors and Collaborators

• California Pacific Medical Center Research Institute
• San Francisco General Hospital
• University of California, San Francisco
• National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
• ClinicalTrials.gov Identifier: NCT00829634
• Other Study ID Numbers: 27.092
• First Posted: Jan 27, 2009
• Last Update Posted: May 31, 2013
• Last Verified: May 1, 2013

• Keywords provided by John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute: methamphetamine; inpatient; d-MA; l-MA; APRL; San Francisco; metabolism; Metabolism of methamphetamine
• Additional relevant MeSH terms: Methamphetamine

Study Results

No Results Posted as of May 31, 2013