GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA) (GPRA)
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|ClinicalTrials.gov Identifier: NCT00681655|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2008
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: Alcohol Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Two session, within subjects, single blind|
|Masking:||None (Open Label)|
|Official Title:||GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Responses to alcohol
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 about 2 weeks apart. Measures were collected before, and at beginning and end of infusion, and included subjective perceptions, 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.
Alcohol (6% in saline vehicle) infused for 2.8 hour long clamping session (Breath alcohol level maintained at 60 mg/dL throughout).Drug: Placebo
Placebo (saline vehicle) infused for 2.8 hour long session.
- Effect of GABRA2 SNP status on AUD risk [ Time Frame: Both session responses and lifetime traits will be included in analysis ]Results will assess the effect of GABRA2 SNPs on responses to alcohol and traits related to alcoholism risk
- Acute tolerance to alcohol [ Time Frame: Within 3 hour session ]Comparison of measures taken during the initial hour of the clamp with the same measures taken during the 3rd hour of the alcohol clamp.
- Initial response to alcohol [ Time Frame: Within 3 hour session ]Comparison of measures taken during baseline with the same measures taken during the initial hour of the alcohol clamp.
- Responses to alcohol vs placebo [ Time Frame: Within 3 hour session ]Measures taken during the alcohol session will either be compared to those taken during placebo, or in some cases measures taken during the alcohol session will be corrected for placebo effects by subtracting placebo responses from alcohol responses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681655
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Study Director:||Martin H Plawecki, M.D.||Indiana University School of Medicine|
|Principal Investigator:||Sean J. O'Connor, M.D.||Indiana University School of Medicine|