Substance Abuse DisorderNCT00581282
Brain Imaging Studies of the Effects of Cocaine Abstinence
An observational study of Substance Abuse Disorder, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Disorder
- What is being tested?
- PET scan and fMRI
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants in cocaine dependency treatment program Normal Healthy Control Subjects
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine, Brain Imaging Center
Irvine, California, 92697
About this study
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.
- Conditions
- Substance Abuse Disorder
- Being tested
- PET scan, fMRI
- Keywords
- Cocaine abstinence, PET scan
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanRadiation
positron emission tomography PET scan
fMRIOther
functional magnetic resonance imaging fMRI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cocaine abstinent group Receives: Radiation: PET scan; Other: fMRI | |
| 2 | Normal healthy control group Receives: Radiation: PET scan; Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET scans, fMRI scans
Measured: The beginning and three to six months after a treatment program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startDec 2005
- Primary completionDec 2005
- Study completionDec 2005
Why it stopped: Nonapplicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse DisorderStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Joseph C Wu, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581282
- Sponsor's protocol ID
- HS#2004-4019
- Status last verified
- Jan 2021
- First submitted
- 21 Dec 2007
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging Studies of the Effects of Cocaine Abstinence
- ClinicalTrials.gov ID
- NCT00581282
- Acronym / sponsor ID
- HS#2004-4019
- Conditions
- Substance Abuse Disorder
- Keywords
- Cocaine abstinence, PET scan
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Nonapplicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Dec 2005 (actual)
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Radiation: PET scan, Other: fMRICocaine abstinent group |
| 2 | – | Radiation: PET scan, Other: fMRINormal healthy control group |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in cocaine dependency treatment program Normal Healthy Control Subjects
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scanpositron emission tomography PET scan | Radiation | 1, 2 |
| fMRIfunctional magnetic resonance imaging fMRI | Other | 1, 2 |
Primary outcome
PET scans, fMRI scans
Time frame: The beginning and three to six months after a treatment program
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph C Wu, M.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse Disorder, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET scans, fMRI scans (time frame: The beginning and three to six months after a treatment program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.