Loading search results
Sponsor study identifier
Secondary identifiers
observational
35
1 country
1
Study Start
November 16, 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 28, 2011
Date type not reportedThis date has not been verified as actual or estimated.
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, subjects undergo positron emission tomography (PET) scanning during the infusions. For this test, the subject lies on a bed that slides in and out of a doughnut-shaped scanner. A custom-molded mask is used to support the head and prevent it from moving during the scanning. A small amount of radioactive substance called C-11 raclopride is injected through one of the catheters to trace brain dopamine activity. ...
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 28, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 18, 2006
Actual (reported)November 22, 2006
Actual (reported)January 28, 2011
Date type not reportedThis date has not been verified as actual or estimated.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Kreek MJ, LaForge KS, Butelman E. Pharmacotherapy of addictions. Nat Rev Drug Discov. 2002 Sep;1(9):710-26. doi: 10.1038/nrd897.
Contet C, Kieffer BL, Befort K. Mu opioid receptor: a gateway to drug addiction. Curr Opin Neurobiol. 2004 Jun;14(3):370-8. doi: 10.1016/j.conb.2004.05.005.
Roberts AJ, McDonald JS, Heyser CJ, Kieffer BL, Matthes HW, Koob GF, Gold LH. mu-Opioid receptor knockout mice do not self-administer alcohol. J Pharmacol Exp Ther. 2000 Jun;293(3):1002-8.
35 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2006
First Posted
November 22, 2006
Study Start
November 16, 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
January 28, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
July 2, 2017
Record last verified: 2011-01-28
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: