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Completed

NCT Number: NCT00829634

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

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.

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Key information

Conditions

Nasal Congestion Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CPMC Addiction & Pharmacology Research Laboratory (APRL)

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

l-methamphetamine

Drug

5mg of l-methamphetamine per day throughout the 2 week study

Other names: l-MA

d-methamphetamine

Drug

15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13

Other names: d-MA

Primary outcomes

  1. Serum samples

    Time frame: Predose and Multiple Timepoints Post Doses

  2. Urine Samples

    Time frame: 24 Hour Inpatient Collection

Secondary outcomes

  1. Questionnaries

    Time frame: Predose and Multiple Timepoints Post Doses

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Collaborators

  • National Institutes of Health (NIH)
  • San Francisco General Hospital
  • University of California, San Francisco

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2009
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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