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

This study has been completed.
Sponsor:
Collaborators:
San Francisco General Hospital
University of California, San Francisco
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00829634
First received: January 23, 2009
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Males and Females Between the Ages of 18 and 50
  • Must have some experience with methamphetamine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
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:
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014