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

NCT ID: NCT00829634

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nasal Congestion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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l-methamphetamine

Group Type OTHER

l-methamphetamine

Intervention Type DRUG

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

d-methamphetamine

Intervention Type DRUG

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

Interventions

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l-methamphetamine

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

Intervention Type DRUG

d-methamphetamine

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

Intervention Type DRUG

Other Intervention Names

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l-MA d-MA

Eligibility Criteria

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Inclusion Criteria

* Healthy Males and Females Between the Ages of 18 and 50
* Must have some experience with methamphetamine
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Francisco General Hospital

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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John Mendelson, MD

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CPMC Addiction & Pharmacology Research Laboratory (APRL)

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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27.092

Identifier Type: -

Identifier Source: org_study_id

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