Clinical trial NCT00581282: Brain Imaging Studies of the Effects of Cocaine Abstinence
Official title: Brain Imaging Studies of the Effects of Cocaine Abstinence
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Substance Abuse Disorder
Keywords: Cocaine abstinence
PET scan
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2007-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in cocaine dependency treatment program Normal Healthy Control Subjects

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.


Eligibility 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.).

Primary outcomes:
measure: PET scans, fMRI scans
timeFrame: The beginning and three to six months after a treatment program
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine, Brain Imaging Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Joseph C Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: