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NCT00074360 · ClinicalTrials.gov registry record
The Effect of Ethanol on Brain Activity
A clinical trial, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- 107
- Enrollment target
NCT00074360 is a clinical trial that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 107 participants.
The verdict
NCT00074360 has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- 107 participants
- Enrollment target
Study Summary
This study is divided into two parts; each designed to answer a separate but related question: Which brain regions are activated in humans by the rewarding properties of ethanol administration? Is it possible to demonstrate a conditioned response to a stimulus paired with rising blood alcohol concentrations (BAC) in humans and can this response be observed in the brain using functional magnetic resonance images (fMRI) techniques? Part 1. In order to determine which brain regions are activated by the rewarding properties of ethanol administration, we propose to use Blood Oxygenation Level Dependent (BOLD) fMRI techniques to test the hypothesis that during the time of rising and peak BAC, mesolimbic, mesocortical, and nigrostriatal dopamine (DA) terminal areas of the brain will show significant increases in cerebral blood flow. Healthy, non-alcoholic subjects will be given intravenous (IV) ethanol or placebo infusions on separate days. The infusions will have three phases. On each day, during the first phase a saline infusion will be used to measure basal brain blood flow. The second phase will be an ethanol infusion delivered at rates calculated to produce a BAC of 0.08 plus or minus 0.005 g/dl at 10 minutes. The rate of the infusion for the next 10 minutes (third phase) will be calculated to maintain BAC at the target level of 0.08 plus or minus 0.005 g/dl for the duration of the infusion. On the placebo day, subjects will receive a saline infusion at the same set of rates for phases two and three as used during their ethanol infusion. Continuous multi-slice fMRI data will be collected during each infusion. Part 2. In order to investigate conditioned response to ethanol, three groups of healthy, non-alcoholic subjects will be given a series of IV infusions on separate days. The experimental group will receive ethanol infusion paired with a conditioned stimulus (CS) which will be presented while the BAC is rising. One control group (I) of healthy, non-alcoholic s
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2003-12-09 |
| Est. Completion | 2012-12-17 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00074360
The ClinicalTrials.gov registry entry for NCT00074360 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00074360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00074360 about?
NCT00074360 is a clinical study titled "The Effect of Ethanol on Brain Activity". This study is divided into two parts; each designed to answer a separate but related question: Which brain regions are activated in humans by the rewarding properties of ethanol administration? Is it possible to demonstrate a conditioned response to a stimulus paired with rising blood alcohol conc...
What is the current status of trial NCT00074360?
This trial is currently completed. The enrollment target is 107 participants. The study started on 2003-12-09. Estimated completion is 2012-12-17.
Who is sponsoring clinical trial NCT00074360?
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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