GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
Status: | Active, not recruiting |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 21 - 27 |
Updated: | 8/25/2018 |
Start Date: | May 2008 |
End Date: | May 2020 |
This study will assess whether the presence of a particular form of a gene, GABRA2, affects
the functional responses of the human brain to alcohol administration and will evaluate that
relationship in the context of factors known to increase the risk for future alcoholism.
the functional responses of the human brain to alcohol administration and will evaluate that
relationship in the context of factors known to increase the risk for future alcoholism.
Each subject completed a total of 2 2.8 hr-long clamping sessions.Within each session,
procedures differed only by the content of the infusate. In one session, 6% ethanol was
infused. In the other session, only vehicle was infused, quantifying the placebo response for
every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were
blind to which session was which; sessions were scheduled to occur approximately 2 weeks
apart. Measures were collected before, and at beginning and end of infusion, and included
subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory
responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol
and acute tolerance to alcohol.
procedures differed only by the content of the infusate. In one session, 6% ethanol was
infused. In the other session, only vehicle was infused, quantifying the placebo response for
every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were
blind to which session was which; sessions were scheduled to occur approximately 2 weeks
apart. Measures were collected before, and at beginning and end of infusion, and included
subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory
responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol
and acute tolerance to alcohol.
Inclusion Criteria:
- European American male and females between 21-27 years of age.
- Good health as determined by medical history, physical exam, and laboratory tests.
- Females must have a negative urine pregnancy (hCG) test at the start of each study
session.
- People who consume 0.10 standard drinks per week (12 g-ethanol) per liter of total
body water when averaged over the preceding month, or more, OR who have consumed more
than 0.10 standard drinks per liter of total body water on any one occasion in the
last month.
Exclusion Criteria:
- Inability to read or comprehend eighth grade English.
- Inability to hear or comprehend verbal instructions, or inability or unwillingness to
cooperate with the procedures required for the study.
- Inability to resolve 2 dots, each 2 mm in diameter with centers placed 5 mm apart on a
card placed 20 inches from the bridge of the nose, or the need to wear eyeglasses to
do so.
- Current or prior history of any serious disease, including head trauma causing loss of
consciousness, cancer, CNS, cardiovascular, respiratory, gastrointestinal, hepatic,
renal, endocrine, or alcohol or drug dependence, but not alcohol abuse or nicotine
dependence.
- Positive hepatitis or HIV test at screening, provided subject consented to these
tests.
- Current or prior history of alcohol-induced flushing reactions.
- Current diagnosis of Axis-I psychiatric illness.
- Positive result on urine drug screen obtained at the face-to-face interview.
- Pregnancy, as determined by urine HcG on each day of laboratory testing, or intention
to become pregnant for women.
- Use of medications known to interact with alcohol within 2 weeks of the study.
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