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GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA) (GPRA)

Primary Purpose

Alcoholism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alcohol

Placebo

About this trial

This is an interventional other trial for Alcoholism

Eligibility Criteria

21 Years - 27 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Responses to alcohol

Arm 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 about 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Initial response to alcohol

Comparison of measures taken during baseline with the same measures taken during the initial hour of the alcohol clamp.

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

Full Information

NCT ID

NCT00681655

First Posted

May 19, 2008

Last Updated

March 29, 2022

Sponsor

Indiana University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00681655

Brief Title

GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

Acronym

GPRA

Official Title

GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

April 14, 2012 (Actual)

Study Completion Date

April 14, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Two session, within subjects, single blind

Masking

None (Open Label)

Allocation

N/A

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Responses to alcohol

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Alcohol

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo (saline vehicle) infused for 2.8 hour long session.

Primary Outcome Measure Information:

Title

Effect of GABRA2 SNP status on AUD risk

Description

Results will assess the effect of GABRA2 SNPs on responses to alcohol and traits related to alcoholism risk

Time Frame

Both session responses and lifetime traits will be included in analysis

Secondary Outcome Measure Information:

Title

Acute tolerance to alcohol

Description

Comparison of measures taken during the initial hour of the clamp with the same measures taken during the 3rd hour of the alcohol clamp.

Time Frame

Within 3 hour session

Title

Initial response to alcohol

Description

Comparison of measures taken during baseline with the same measures taken during the initial hour of the alcohol clamp.

Time Frame

Within 3 hour session

Title

Responses to alcohol vs placebo

Description

Time Frame

Within 3 hour session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

27 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin H Plawecki, M.D.

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sean J. O'Connor, M.D.

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Requests for data sharing will be considered on a case by case basis. No sharing of HIPPA sensitive data will be allowed.

IPD Sharing Time Frame

While lab analyses are ongoing, data is available on request

IPD Sharing Access Criteria

Data access requests will be reviewed by the investigators. Requestors will be required to sign a data access agreement.

Citations:

PubMed Identifier

26087834

Citation

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 Clin Exp Res. 2015 Jul;39(7):1148-57. doi: 10.1111/acer.12749. Epub 2015 Jun 19.

Results Reference

result

PubMed Identifier

29705707

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.

Results Reference

result

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GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)

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