Irvine, California 92697


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.


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.).


Study is Available At:


Original ID:

HS#2004-4019


NCT ID:

NCT00581282


Secondary ID:


Study Acronym:


Brief Title:

Brain Imaging Studies of the Effects of Cocaine Abstinence


Official Title:

Brain Imaging Studies of the Effects of Cocaine Abstinence


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Joseph C Wu, M.D.
Principal Investigator
University of California, Irvine
Primary Contact:Joseph C Wu, M.D.
949-824-7867
jcwu@uci.edu

Study Dates

Start Date:October 2006
Completion Date:January 2018
Completion Type:Anticipated
Primary Completion Date:January 2018
Primary Completion Type:Anticipated
Verification Date:October 2010
Last Changed Date:October 14, 2010
First Received Date:December 21, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:PET scans, fMRI scans
Time Frame:The beginning and three to six months after a treatment program
Safety Issues:False

Study Interventions

Intervention Type:Radiation
Name:PET scan
Description:positron emission tomography PET scan
Arm Name:1
Intervention Type:Other
Name:fMRI
Description:functional magnetic resonance imaging fMRI
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Cocaine abstinent group
Study Arm Type:Other
Arm Name:2
Description:Normal healthy control group

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Department of Veterans Affairs

Samples and Retentions

Study Population: Participants in cocaine dependency treatment program Normal Healthy Control Subjects
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.