AlcoholismGPRANCT00681655
GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
A study testing Alcohol in people with Alcoholism, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- Alcohol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 14 Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcoholism
- Being tested
- Alcohol, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholOther
Alcohol (6% in saline vehicle) infused for 2.8 hour long clamping session (Breath alcohol level maintained at 60 mg/dL throughout).
PlaceboOther
Placebo (saline vehicle) infused for 2.8 hour long session.
| Study group | Role | What they receive |
|---|---|---|
| Responses to alcohol | Experimental | 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. Receives: Other: Alcohol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Both session responses and lifetime traits will be included in analysis
Secondary outcomes (3)
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.
Measured: Within 3 hour session
Initial response to alcohol
Comparison of measures taken during baseline with the same measures taken during the initial hour of the alcohol clamp.
Measured: Within 3 hour session
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
Measured: Within 3 hour session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2008
- Primary completion14 Apr 2012
- Study completion14 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two session, within subjects, single blind
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sean O'Connor, Indiana University
- Investigators
- Martin H Plawecki, M.D., Study director, Indiana UniversitySean J. O'Connor, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681655
- Sponsor's protocol ID
- O'CONNOR_AA007611-18
- Other IDs
- P60AA007611
- Acronym
- GPRA
- Status last verified
- Mar 2022
- First submitted
- 19 May 2008
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for data sharing will be considered on a case by case basis. No sharing of HIPPA sensitive data will be allowed.
Publications
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.
PubMed 26087834Plawecki 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.
PubMed 29705707
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
- ClinicalTrials.gov ID
- NCT00681655
- Acronym / sponsor ID
- GPRA / O'CONNOR_AA007611-18
- Conditions
- Alcoholism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2008
- Primary completion
- 14 Apr 2012 (actual)
- Study completion
- 14 Apr 2012 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two session, within subjects, single blind
| Arm | Type | Receives |
|---|---|---|
| Responses to alcohol | Experimental | Other: Alcohol, Other: PlaceboEach 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. |
Who may qualify
- Ages
- 21 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholAlcohol (6% in saline vehicle) infused for 2.8 hour long clamping session (Breath alcohol level maintained at 60 mg/dL throughout). | Other | Responses to alcohol |
| PlaceboPlacebo (saline vehicle) infused for 2.8 hour long session. | Other | Responses to alcohol |
Primary outcome
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
3 secondary outcomes
Acute tolerance to alcohol
Time frame: Within 3 hour session
Initial response to alcohol
Time frame: Within 3 hour session
Responses to alcohol vs placebo
Time frame: Within 3 hour session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Results publication: PubMed 26087834Kosobud 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 publication: PubMed 29705707Plawecki 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.
- Individual participant dataSharing planned: Yes. Requests for data sharing will be considered on a case by case basis. No sharing of HIPPA sensitive data will be allowed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin H Plawecki, M.D. study director
Indiana University
Sean J. O'Connor, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol in people with Alcoholism, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of GABRA2 SNP status on AUD risk (time frame: Both session responses and lifetime traits will be included in analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.