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

May 29, 2013 updated by: John Mendelson, MD, California Pacific Medical Center Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • CPMC Addiction & Pharmacology Research Laboratory (APRL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: l-methamphetamine
Drug: l-methamphetamine
5mg of l-methamphetamine per day throughout the 2 week study
Other Names:
  • l-MA
Drug: d-methamphetamine
15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13
Other Names:
  • d-MA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum samples
Time Frame: Predose and Multiple Timepoints Post Doses
Predose and Multiple Timepoints Post Doses
Urine Samples
Time Frame: 24 Hour Inpatient Collection
24 Hour Inpatient Collection

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionnaries
Time Frame: Predose and Multiple Timepoints Post Doses
Predose and Multiple Timepoints Post Doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27.092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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