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Alcohol Response and Genetics for Alcohol Consumption

Phase 1

Recruiting

Led By Vijay A Ramchandani, Ph.D.

Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female participants between 21-60 years of age

Non-smokers with no history of smoking in the past year and less than 20 uses of nicotinic products lifetime

Must not have

Regular use of drugs known to affect hemodynamic response

Inability to lie comfortably on back for up to 2 hours in the MRI scanner

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how different people react to alcohol, and how genes affect this. They will focus on a nicotine receptor gene that may increase a person's AUD risk.

Who is the study for?

Adults aged 21-60, both smokers (with at least a year of daily smoking and certain cotinine levels) and non-smokers (with no recent smoking history), can join this study. Women must use effective birth control if they're sexually active. People with alcohol or substance disorders, seeking treatment for such issues, or with significant withdrawal symptoms are excluded.

What is being tested?

The trial is testing how genetic variations in a nicotine receptor gene affect the way people consume alcohol and their brain's response to it. Participants will undergo two sessions involving alcohol consumption via different methods and monitoring through breath tests, blood samples, questionnaires, and MRI scans.

What are the potential side effects?

Potential side effects from participating in this trial may include the common effects of alcohol consumption such as dizziness, nausea, mood changes, coordination problems, and altered judgment. The MRI scan could cause discomfort for those who have claustrophobia or fear enclosed spaces.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 60 years old.

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I have not smoked or used nicotine products more than 20 times in my life.

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I am using effective birth control or do not need it due to my or my partner's sterilization.

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I am using effective birth control or do not need it due to my or my partner's sterilization.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use medication that affects my blood flow.

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I cannot lie on my back comfortably for 2 hours.

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I regularly take medications that interact with alcohol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To examine the effect of CHRNA5 (rs16969968) genetic variation on IV alcohol self-administration, as measured by BrAC exposure (peak BrAC, number of infusions, time to binge-level) in non-smoking, non-dependent drinkers.

To examine the effect of CHRNA5 (rs16969968) genetic variation on neural correlates of incentive salience for alcohol, as measured by BOLD response during the Alcohol-Food Incentive Delay (AFID) task using fMRI.