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

Nasal Congestion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829634
• Other study ID #: 27.092
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: May 29, 2013
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: May 2013
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy Males and Females Between the Ages of 18 and 50

• Must have some experience with methamphetamine

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

Drug:
• l-methamphetamine
5mg of l-methamphetamine per day throughout the 2 week study
• d-methamphetamine
15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13

Locations

Country	Name	City	State
United States	CPMC Addiction & Pharmacology Research Laboratory (APRL)	San Francisco	California

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum samples		Predose and Multiple Timepoints Post Doses	No
Primary	Urine Samples		24 Hour Inpatient Collection	No
Secondary	Questionnaries		Predose and Multiple Timepoints Post Doses	No