Alcohol Consumption Clinical Trial
Official title:
Striatal Dopamine and Alcohol Risk
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Subjects who are included: 1. will be between the ages of 21 and 25. 2. 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. 3. 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. 4. will be willing to undergo a complete medical and psychiatric evaluation, as described in NIAAA protocol 98-AA-0009. 5. will be willing to undergo indicated laboratory and EKG examination, as described in NIAAA protocol 98-AA-0009. 6. 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. 7. will be willing to submit a urine sample for the purpose of drug screening and, in the case of females, for pregnancy testing. 8. will be willing to submit blood samples for the genetic testing described herein. 9. must be essentially physically and emotionally healthy, as determined by the screening procedures in Criteria 4& 5. 10. 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. EXCLUSION CRITERIA: A subject will be excluded from the study if they: 1. have an intermediate score on the telephone administered SRE (within one standard deviation of the mean). 2. have an abnormal physical exam or laboratory values outside the normal ranges. 3. are pregnant. 4. have a positive drug screen. 5. have fulfilled DSM-IV criteria for ethanol or other substance dependency at any time within the past 5 years. 6. have a history of stimulant use or abuse. 7. have a history of smoking within the last year, or a lifetime history of smoking more than 100 cigarettes. 8. have fulfilled DSM-IV criteria for any major (non substance-related) Axis I psychiatric disorder. 9. 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). 10. have a history of claustrophobia. 11. have a history of facial flushing syndrome in response to alcohol exposure. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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