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

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ClinicalTrials.gov Identifier: NCT00829634
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : May 31, 2013
Sponsor:
Collaborators:
San Francisco General Hospital
University of California, San Francisco
National Institutes of Health (NIH)
Information provided by (Responsible Party):
John Mendelson, MD, 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.

Condition or disease Intervention/treatment Phase
Nasal Congestion Drug: l-methamphetamine Drug: d-methamphetamine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : October 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Serum samples [ Time Frame: Predose and Multiple Timepoints Post Doses ]
  2. Urine Samples [ Time Frame: 24 Hour Inpatient Collection ]

Secondary Outcome Measures :
  1. Questionnaries [ Time Frame: Predose and Multiple Timepoints Post Doses ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829634


Locations
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
National Institutes of Health (NIH)

Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00829634     History of Changes
Other Study ID Numbers: 27.092
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by John Mendelson, MD, California Pacific Medical Center Research Institute:
methamphetamine
inpatient
d-MA
l-MA
APRL
San Francisco
metabolism
Metabolism of methamphetamine

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors