GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

Alcoholism Clinical Trial

— GPRA  

Official title:

GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681655
• Other study ID #: O'CONNOR_AA007611-18
• Secondary ID: P60AA007611
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Est. completion date: April 14, 2012

Study information

• Verified date: March 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 14, 2012
• Est. primary completion date: April 14, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 27 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism

Intervention

Other:
• Alcohol
Alcohol (6% in saline vehicle) infused for 2.8 hour long clamping session (Breath alcohol level maintained at 60 mg/dL throughout).
• Placebo
Placebo (saline vehicle) infused for 2.8 hour long session.

Locations

Country	Name	City	State
United States	University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kosobud AE, Wetherill L, Plawecki MH, Kareken DA, Liang T, Nurnberger JL, Windisch K, Xuei X, Edenberg HJ, Foroud TM, O'Connor SJ. Adaptation of Subjective Responses to Alcohol is Affected by an Interaction of GABRA2 Genotype and Recent Drinking. Alcohol — View Citation

Plawecki MH, Windisch KA, Wetherill L, Kosobud AEK, Dzemidzic M, Kareken DA, O'Connor SJ. Alcohol affects the P3 component of an adaptive stop signal task ERP. Alcohol. 2018 Aug;70:1-10. doi: 10.1016/j.alcohol.2017.08.012. Epub 2017 Aug 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of GABRA2 SNP status on AUD risk	Results will assess the effect of GABRA2 SNPs on responses to alcohol and traits related to alcoholism risk	Both session responses and lifetime traits will be included in analysis
Secondary	Acute tolerance to alcohol	Comparison of measures taken during the initial hour of the clamp with the same measures taken during the 3rd hour of the alcohol clamp.	Within 3 hour session
Secondary	Initial response to alcohol	Comparison of measures taken during baseline with the same measures taken during the initial hour of the alcohol clamp.	Within 3 hour session
Secondary	Responses to alcohol vs placebo	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	Within 3 hour session