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NCT00401999 · ClinicalTrials.gov registry record
OPRM1 A118G SNP, Alcohol Response, and Striatal Dopamine
A clinical trial, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- 35
- Enrollment target
NCT00401999: Completed study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT00401999 is a clinical trial that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00401999 has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
Study Summary
This study will examine the relationship between variations in a gene called OPRM1 and the response to alcohol. The OPRM1 (Mu-opioid Receptor-1) gene helps regulate brain pathways involved in experiencing pleasure. Brain pathways use a chemical called dopamine. Different forms of the OPRM1 gene may lead to differences in how dopamine is released and subsequently to differences in a person's response to alcohol. Healthy non-smokers between 21 and 45 years of age may be eligible for this study. Candidates are screened with a medical and psychiatric history and physical examination, blood and urine tests, and breathalyzer (breath alcohol test). A blood test is also done to determine the variant of OPRM1 gene. Participants undergo the following procedures in three study sessions: Session 1 " Breathalyzer test, urine test for illicit drugs and pregnancy test for women who can become pregnant. " Insertion of catheters (plastic tubes) into a vein in one arm for infusing alcohol and into the other arm for drawing blood samples. " Completion of questionnaires on how intoxicated the subject feels. " Blood draw for research studies. " Eye movement test (a visor with a digital camera tracks the subject's eye movements while he or she watches lights on a computer screen). " 45-minute alcohol infusion (up to 0,08 grams per deciliter - a level considered in most states as driving under the influence of alcohol). " Repeat breathalyzer, questionnaires, eye movement test and blood draw every 15 minutes during the infusion and again after the infusion is complete. " Subjects remain in the clinic until their blood alcohol content falls below 0.02 g/dL, determined by a breathalyzer test done every 15 minutes. Subjects can usually return home about 3 to 4 hours after the alcohol infusion stops. Sessions 2 and 3 The procedure is the same as for session 1, except subjects receive an infusion of alcohol one session and an infusion of saline (salt water) the other. Also, subject
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2006-11-16 |
| Est. Completion | 2011-01-28 |
What the finished NCT00401999 record still lists
NCT00401999 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00401999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00401999 about?
NCT00401999 is a clinical study titled "OPRM1 A118G SNP, Alcohol Response, and Striatal Dopamine". This study will examine the relationship between variations in a gene called OPRM1 and the response to alcohol. The OPRM1 (Mu-opioid Receptor-1) gene helps regulate brain pathways involved in experiencing pleasure. Brain pathways use a chemical called dopamine. Different forms of the OPRM1 gene may ...
What is the current status of trial NCT00401999?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2006-11-16. Estimated completion is 2011-01-28.
Who is sponsoring clinical trial NCT00401999?
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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