Brain Imaging Studies of the Effects of Cocaine Abstinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by University of California, Irvine
Sponsor:
Collaborator:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581282
First received: December 21, 2007
Last updated: October 14, 2010
Last verified: October 2010
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Joseph C Wu, M.D. University of California, Irvine
  More Information

No publications provided

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
Study First Received: December 21, 2007
Last Updated: October 14, 2010
Health Authority: United States: Institutional Review Board

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
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 21, 2014