Brain Imaging Studies of the Effects of Cocaine Abstinence

NCT00581282 | Withdrawn

• 1 other identifier: HS#2004-4019
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Abuse Disorder

Keywords

Cocaine abstinence; PET scan

Outcome Measures

Primary Outcomes (1)

• PET scans, fMRI scans

  The beginning and three to six months after a treatment program

Study Arms (2)

1

Cocaine abstinent group

Radiation: PET scan; Other: fMRI

2

Normal healthy control group

Radiation: PET scan; Other: fMRI

Interventions

PET scan RADIATION

positron emission tomography PET scan

1; 2

fMRI OTHER

functional magnetic resonance imaging fMRI

1; 2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in cocaine dependency treatment program Normal Healthy Control Subjects

You may qualify if:

• Subjects must be male or female and English speaking.
• 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).
• Subjects must be between 21 to 65 years of age.

You may not qualify if:

• Suicidality or psychosis.
• Head injury, kidney or bladder disease or any unstable or serious medical conditions.
• Prior exposure to radiation (including diagnostic or treatment x-rays), which might cause subjects to exceed standard guidelines.
• Unwillingness or inability to adhere to the requirements of the study.
• Donation or large loss of blood (\>400 ml) within the past month.
• 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.
• Pregnancy or breast feeding.
• 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.).

Sponsors & Collaborators

• University of California, Irvine: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

University of California, Irvine, Brain Imaging Center

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Joseph C Wu, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: December 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (1)