Brain Imaging Studies of the Effects of Cocaine Abstinence

NCT ID: NCT00581282

Last Updated: 2021-01-25

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2005-12-31

Brief Summary

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This study evaluates theories regarding cocaine abstinence which propose that increased presynaptic and postsynaptic dopamine activity and increased serotonin activity are associated with abstinence in cocaine dependent subjects at the beginning and three to six months after a treatment program. We are using positron emission tomography (PET), Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI) in cortical and subcortical areas in a series of brain imaging studies testing these theories of abnormalities in the dopamine and serotonin system for cocaine addiction by examining the distribution of 18F-fallypride, 18F-altanserin, and FDG. We are evaluating genetic theories associated with cocaine addiction through the examination of genetic markers and functional genomics.

Detailed Description

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Conditions

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Substance Abuse Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Cocaine abstinent group

PET scan

Intervention Type RADIATION

positron emission tomography PET scan

fMRI

Intervention Type OTHER

functional magnetic resonance imaging fMRI

2

Normal healthy control group

PET scan

Intervention Type RADIATION

positron emission tomography PET scan

fMRI

Intervention Type OTHER

functional magnetic resonance imaging fMRI

Interventions

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PET scan

positron emission tomography PET scan

Intervention Type RADIATION

fMRI

functional magnetic resonance imaging fMRI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be male or female and English speaking.
2. Subjects must be adults with a history of diagnosis of cocaine dependence disorder (n=20) who are under supervised treatment for dependence or normal control (n=10).
3. Subjects must be between 21 to 65 years of age.

Exclusion Criteria

1. Suicidality or psychosis.
2. Head injury, kidney or bladder disease or any unstable or serious medical conditions.
3. Prior exposure to radiation (including diagnostic or treatment x-rays), which might cause subjects to exceed standard guidelines.
4. Unwillingness or inability to adhere to the requirements of the study.
5. Donation or large loss of blood (\>400 ml) within the past month.
6. Current or very recent illnesses, painful conditions or other disorders, which in the judgment of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for subjects.
7. Pregnancy or breast feeding.
8. Individuals who would be unable to undergo a magnetic resonance imaging (MRI) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body, metallic prostheses (i.e., replacement body parts, such as a hip joint), a pacemaker, or other pieces of metal in their body (shrapnel, metal filings, etc.).
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph C Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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University of California, Irvine, Brain Imaging Center

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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HS#2004-4019

Identifier Type: -

Identifier Source: org_study_id

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