NCT01529892|WithdrawnPhase 4DMC

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

An Open-Label Study to Evaluate the Impact of Genetic Variation in CYP2D6 on the Pharmacokinetics and Pharmacodynamics of Methamphetamine in Healthy Adults

California Pacific Medical Center Research Institute ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 7, 2012
Actual (reported)
First Posted
February 9, 2012
Actual (reported)

Last Updated: May 31, 2013
Status Verified: May 2013
Last Update Submitted: May 29, 2013

Conditions

Methamphetamine Metabolism, CYP2D6 Genotype

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

The subject is healthy, as judged by a responsible physician, with no clinically significant abnormality identified on the laboratory or medical evaluation, including 12-lead ECG, at screening. A subject with a clinical laboratory or laboratory parameter outside the reference range (adjusted for age, if appropriate), may be included only if the Investigator considers that the abnormal finding does not pose additional risk and will not interfere with the study procedures.
Male or female, aged 18-55 years inclusive
Body weight over 50kg (110 lbs) and body mass index (BMI) of 18.5 to 30 kg/m2 inclusive.
Have normal cardiac function including normal blood pressure and heart rate.
Have normal renal function as evident by a creatinine clearance \>70 ml/min and normal serum creatinine levels
The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

A positive urine test for drugs of abuse or alcohol at screening or prior to the start of dosing.
Subjects with a clinical history of current alcohol or illicit drug use which, in the opinion of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
Active Psychiatric disease: DSM-IV diagnosis of a current alcohol, opiate, or sedative hypnotic dependence disorder requiring medical detoxification, history of decompensated schizophrenia, schizophreniform, or schizoaffective disorder; Severe mania, hypomania, agitated behaviour, bipolar disorder or post-traumatic stress disorder within the past 90 days; presence of suicidal behavior two years prior to enrolment or suicidal intent within the past 30 days.
The subject has received an investigational drug or participated in any other research trial within 30 days, 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.

Contact the study team to confirm eligibility.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

methamphetamine EM

methamphetamine PM

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

methamphetamine EM

methamphetamine PM

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations