Brain Imaging Studies of the Effects of Cocaine Abstinence

Substance Abuse Disorder Clinical Trial

Official title:

Brain Imaging Studies of the Effects of Cocaine Abstinence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00581282
• Other study ID #: HS#2004-4019
• Status: Withdrawn
• Start date: December 2005
• Est. completion date: December 2005

Study information

• Verified date: January 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Substance Abuse Disorder
• Substance-Related Disorders

Intervention

Radiation:
• PET scan
positron emission tomography PET scan

Other:
• fMRI
functional magnetic resonance imaging fMRI

Locations

Country	Name	City	State
United States	University of California, Irvine, Brain Imaging Center	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET scans, fMRI scans		The beginning and three to six months after a treatment program