Brain Imaging Studies of the Effects of Cocaine Abstinence
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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 |
- 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 |
Participants in cocaine dependency treatment program Normal Healthy Control Subjects
Inclusion Criteria:
Inclusion criteria include:
- 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.
Exclusion Criteria:
Exclusion criteria include:
- 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.).
Contacts and Locations| Contact: Joseph C Wu, M.D. | 949-824-7867 | jcwu@uci.edu |
| 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. | |
| 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 Mental Disorders Cocaine Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013