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NCT00011752 · ClinicalTrials.gov registry record
Serotonin in Alcoholism
A clinical trial, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- 75
- Enrollment target
NCT00011752: Completed study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT00011752 is a clinical trial that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00011752 has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
Study Summary
This study uses positron emission tomography (PET) scanning to study how serotonin works in alcoholics. Serotonin is a chemical that allows brain cells to communicate. There is evidence that people with alcoholism have altered serotonin; their brains begin to make and break down serotonin more slowly than people who do not drink. PET scans use radioactive substances injected into the body. A special camera detects the radiation emitted by the radioactive fluid and a computer processes the radioactivity into images of the brain, which show the activity of brain chemicals like serotonin. People with alcohol dependency may participate in this study. Candidates are screened with a medical history, including questions about alcohol and drug use, physical examination, blood tests, breath alcohol tests, electrocardiogram (ECG), urine test for illicit drugs and, for women, a pregnancy test, and a stool test for hidden blood. They also undergo magnetic resonance imaging (MRI) scan of the brain and complete questionnaires on their alcohol and drug history. Participants undergo the following tests and procedures: * Diet low in tryptophan. Tryptophan is an amino acid from which serotonin is made. * Brain MRI before starting the study to make sure brain structure is normal. * Lumbar puncture (spinal tap) to collect a small sample of cerebrospinal fluid (CSF). A local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle. * Arterial catheter (plastic tube) placed in an artery in the wrist area for drawing blood samples. The skin is numbed with a local anesthetic for placement of the catheter. * Intravenous (IV) catheter placed in a vein for injecting the radioactive isotope used in the PET scan. * Two PET scans - baseline and active. * Amino acid drink (orange flavored) before the active PET scan. The drink lowers tryptophan levels. * Amino acid capsules - 23 amino
Interventions
- DRUG FCWAY
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2001-02 |
| Est. Completion | 2005-09 |
What the finished NCT00011752 record still lists
NCT00011752 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which FCWAY is the first listed.
NCT00011752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00011752 about?
NCT00011752 is a clinical study titled "Serotonin in Alcoholism". This study uses positron emission tomography (PET) scanning to study how serotonin works in alcoholics. Serotonin is a chemical that allows brain cells to communicate. There is evidence that people with alcoholism have altered serotonin; their brains begin to make and break down serotonin more slowl...
What is the current status of trial NCT00011752?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2001-02. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00011752?
The interventions under investigation include: FCWAY (DRUG).
Who is sponsoring clinical trial NCT00011752?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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