Brain Imaging Studies of the Effects of Cocaine Abstinence

Withdrawn

• Conditions: Substance Abuse Disorder
• Interventions: Radiation: PET scan; Other: fMRI

• Registration Number: NCT00581282
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	PET scan	Normal healthy control group
2	fMRI	Normal healthy control group
1	PET scan	Cocaine abstinent group
1	fMRI	Cocaine abstinent group

Primary Outcome Measures

Name	Time	Method
PET scans, fMRI scans	The beginning and three to six months after a treatment program

Trial Locations

Locations (1)

University of California, Irvine, Brain Imaging Center; 🇺🇸 Irvine, California, United States