Role of Dopamine in Response to Alcohol
Striatal Dopamine and Alcohol Risk
2 other identifiers
observational
60
1 country
1
Brief Summary
This study will examine the role of the brain chemical dopamine in people's response to alcohol consumption. Dopamine is thought to influence whether people have a strong or weak response to alcohol and how pleasurable that response is. The findings of this study may shed light on why some people are at higher risk of developing problem drinking behaviors. Healthy normal volunteers between 21 and 25 years of age who have never had a serious problem with alcohol abuse or drug abuse may be eligible for this study. Candidates will be screened with a medical history and physical examination, and will be interviewed about their smoking and drinking behaviors. Participants will undergo test procedures on two separate days, as follows: Test Day 1 Upon arrival at the Clinical Center, participants will take a breathalyzer test for alcohol and provide a urine sample for a drug screen. Women will also have a urine pregnancy test. They will then lie on a hospital bed and two intravenous catheters (IV lines) will be placed, one into each arm. One line will be used to collect blood samples during the test session; the other will be used to infuse alcohol into the bloodstream. The alcohol will rapidly increase the blood alcohol level to between 0.06 and 0.08 grams per deciliter. (0.08 g/dL is the level at which a person is charge with driving under the influence of alcohol in all States.) Before, during, and after the infusion, subjects will be asked about their feelings in response to the alcohol, such as confusion, elation, level of discomfort or dizziness, ability to concentrate, and so forth. At 35 and 60 minutes after the infusion begins, subjects will take a body sway test. This involves standing on a machine to determine how the alcohol has affected the sense of balance. Subjects will then relax in the clinic for a few hours. During this time, a blood sample will be collected and a questionnaire will be given hourly until the blood alcohol level has gone down to 0.02 g/dL. When the alcohol level has declined to 0.02 g/dL (usually 3 to 4 hours after the infusion), the subject will be sent home in a taxi. Test Day 2 Participants will again take a breathalyzer test for alcohol and provide a urine sample for drug screen and, for women, a pregnancy test. Subjects will lie on a hospital bed and three IV lines will be inserted, one to draw blood samples, one to infuse alcohol, and one to give raclopride, a radioactive substance used for positron emission tomography (PET) scanning. For PET, the subject lies on a table in the scanner with a mask placed over his or her head to help hold the head still during the scan. After a brief scan to adjust the machine, a small amount of radioactive water (O-15 water) is injected through the IV line and a series of pictures is taken over a period of about 1 minute. These images show how the radioactive water distributes in the brain, indicating blood flow. After the water scan, raclopride is given through the IV line and more pictures of the brain are taken over the next 2 hours. Blood samples are collected during and after the raclopride scan. During this procedure, subjects are asked the same questions about their feelings in response to the alcohol as they did during the earlier session. After he scans, they will be monitored in the clinic with hourly blood tests and questionnaires until the blood alcohol concentration decreases to 0.02 g/dL and will then be sent home in a taxi.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 29, 2002
CompletedFirst Posted
Study publicly available on registry
December 2, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedMarch 4, 2008
September 1, 2004
November 29, 2002
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Subjects who are included:
- will be between the ages of 21 and 25.
- will have a score on the telephone administered SRE at least one standard deviation above the mean, in the case of subjects to be evaluated further as potential Low-Response group participants.
- will have a score on the telephone administered SRE at least one standard deviation below the mean, in the case of persons to be evaluated further as potential High Responders.
- will be willing to undergo a complete medical and psychiatric evaluation, as described in NIAAA protocol 98-AA-0009.
- will be willing to undergo indicated laboratory and EKG examination, as described in NIAAA protocol 98-AA-0009.
- will be willing to have the results of their intake evaluation become part of their record at NIH, as described in NIAAA protocol 98-AA-0009.
- will be willing to submit a urine sample for the purpose of drug screening and, in the case of females, for pregnancy testing.
- will be willing to submit blood samples for the genetic testing described herein.
- must be essentially physically and emotionally healthy, as determined by the screening procedures in Criteria 4\& 5.
- must be willing to be contacted at five year intervals for purpose of interview about their drinking behavior in the interim, and provide identification and contact information which would facilitate such follow-up.
You may not qualify if:
- A subject will be excluded from the study if they:
- have an intermediate score on the telephone administered SRE (within one standard deviation of the mean).
- have an abnormal physical exam or laboratory values outside the normal ranges.
- are pregnant.
- have a positive drug screen.
- have fulfilled DSM-IV criteria for ethanol or other substance dependency at any time within the past 5 years.
- have a history of stimulant use or abuse.
- have a history of smoking within the last year, or a lifetime history of smoking more than 100 cigarettes.
- have fulfilled DSM-IV criteria for any major (non substance-related) Axis I psychiatric disorder.
- have taken any prescribed, non-prescribed, or over-the-counter medications or drugs within 14 days prior to the study days (excluding oral contraceptive agents, aspirin, or acetaminophen).
- have a history of claustrophobia.
- have a history of facial flushing syndrome in response to alcohol exposure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Bethesda, Maryland, 20892, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 29, 2002
First Posted
December 2, 2002
Study Start
November 1, 2002
Study Completion
September 1, 2004
Last Updated
March 4, 2008
Record last verified: 2004-09