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The Impact of Genetic Variation in CYP2D6 on the Pharmacokinetics and Pharmacodynamics of Methamphetamine

NCT01529892 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-05-31

No results posted yet for this study

Summary

Methamphetamine abuse and addiction are widespread and is causing increasing pressures on social, public health and criminal justice systems worldwide. Some of the risk for developing addiction may be genetic. Identifying specific genotypes and understanding their interactions with the environment may help predict who is at risk for developing a disease. In this study the investigators are evaluating the contribution of differences in one genotype - called CYP2D6 to the removal of methamphetamine from the body. Methamphetamine is removed from the body by special enzymes in the liver. One of these enzymes is called Cytochrome P450 2D6. The activity of 2D6 is genetically determined. Some people have no active 2D6 whereas in others 2D6 is very active. One group of scientists found that people with low 2D6 activity were less likely to become methamphetamine addicts. In this study the investigators will determine the activity of your 2D6 by looking at the CYP2D6 genotype. If low levels of 2D6 decrease the risk of methamphetamine addiction it may be because there is less of the chemicals (called metabolites) made by 2D6. The first step in the metabolism (the process of removal of drugs from the body) of methamphetamine by 2D6 is conversion of methamphetamine to amphetamine and para-hydroxymethamphetamine. 2D6 then converts these to inactive chemicals. In addition to determining your genotype, the investigators are interested in the relationship of genotype with the methamphetamine metabolism. Thus, as part of this study, you will be given a modest oral dose of 5 milligrams of methamphetamine. After receiving the methamphetamine you will need to collect your urine for 24 hours.

The purpose of this study is to investigate the impact of genetic variation in CYP2D6 on the disposition of methamphetamine in the human body as well as its pharmacologic effects to humans.

Conditions

  • Methamphetamine Metabolism, CYP2D6 Genotype

Interventions

DRUG

A single oral 5 mg of duterium labeled methamphetamine

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • John Mendelson, MD · California Pacific Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01529892 on ClinicalTrials.gov