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Brain Imaging Studies of the Effects of Cocaine Abstinence

This study is currently recruiting participants.
Verified October 2010 by University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581282
First Posted: December 27, 2007
Last Update Posted: October 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
VA Office of Research and Development
Information provided by:
University of California, Irvine
  Purpose
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.

Condition Intervention
Substance Abuse Disorder Radiation: PET scan Other: fMRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Imaging Studies of the Effects of Cocaine Abstinence

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • PET scans, fMRI scans [ Time Frame: The beginning and three to six months after a treatment program ]

Estimated Enrollment: 30
Study Start Date: October 2006
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Cocaine abstinent group
Radiation: PET scan
positron emission tomography PET scan
Other: fMRI
functional magnetic resonance imaging fMRI
2
Normal healthy control group
Radiation: PET scan
positron emission tomography PET scan
Other: fMRI
functional magnetic resonance imaging fMRI

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants in cocaine dependency treatment program Normal Healthy Control Subjects
Criteria

Inclusion Criteria:

Inclusion criteria include:

  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:

Exclusion criteria include:

  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.).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581282


Contacts
Contact: Joseph C Wu, M.D. 949-824-7867 jcwu@uci.edu

Locations
United States, California
University of California, Irvine, Brain Imaging Center Recruiting
Irvine, California, United States, 92697
Contact: Joseph C Wu, M.D.    949-824-7867    jcwu@uci.edu   
Sub-Investigator: Mark L Katz, M.D.         
Sub-Investigator: Steven Potkin, MD.         
Sub-Investigator: Jogesh Mukherjee, Ph.D., CV         
Sub-Investigator: Orhan Nalcioglu, Ph.D.         
Sub-Investigator: Tugan Muftuler, Ph.D.         
Sub-Investigator: Marquis Vawter, Ph.D.         
Sub-Investigator: Paul Rodriguez         
Sub-Investigator: Nikunj Shah, B.A.         
Sub-Investigator: David Keator         
Sub-Investigator: Carol Schachat, M.A.         
Sponsors and Collaborators
University of California, Irvine
VA Office of Research and Development
Investigators
Principal Investigator: Joseph C Wu, M.D. University of California, Irvine
  More Information

Responsible Party: Joseph C. Wu, M. D. ,Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581282     History of Changes
Other Study ID Numbers: HS#2004-4019
First Submitted: December 21, 2007
First Posted: December 27, 2007
Last Update Posted: October 15, 2010
Last Verified: October 2010

Keywords provided by University of California, Irvine:
Cocaine abstinence
PET scan

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents