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

This study has been completed.
San Francisco General Hospital
University of California, San Francisco
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute Identifier:
First received: January 23, 2009
Last updated: May 29, 2013
Last verified: May 2013

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 Intervention
Nasal Congestion
Drug: l-methamphetamine
Drug: d-methamphetamine

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

Resource links provided by NLM:

Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Serum samples [ Time Frame: Predose and Multiple Timepoints Post Doses ] [ Designated as safety issue: No ]
  • Urine Samples [ Time Frame: 24 Hour Inpatient Collection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaries [ Time Frame: Predose and Multiple Timepoints Post Doses ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
l-methamphetamine Drug: l-methamphetamine
5mg of l-methamphetamine per day throughout the 2 week study
Other Name: l-MA
Drug: d-methamphetamine
15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13
Other Name: d-MA

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.


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00829634

United States, California
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
  More Information

No publications provided

Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute Identifier: NCT00829634     History of Changes
Other Study ID Numbers: 27.092
Study First Received: January 23, 2009
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by California Pacific Medical Center Research Institute:
San Francisco
Metabolism of methamphetamine

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on August 27, 2015