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Alcohol Effects on Impulsivity in Alcoholism

Phase < 1

Recruiting

Led By Jessica Weafer, PhD

Research Sponsored by Jessica Weafer

Eligibility Criteria Checklist

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

Must have

21-25 years old

Be between 18 and 65 years old

Must not have

Body weight < 110 or > 210 pounds

Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 70 minutes

Summary

This trial will investigate how impulsivity and how someone's body responds to alcohol are related to Alcohol Use Disorder in young adults. The goal is to find new ways to prevent and treat AUD by targeting both

Who is the study for?

This trial is for young adults aged 21-25 who drink alcohol frequently, reaching a blood alcohol concentration (BAC) of over .08% at least once in the past month. Participants must have been drinking at least twice weekly in the last month and be fluent in English.

What is being tested?

The study is examining how impulsivity and personal reactions to alcohol may contribute to Alcohol Use Disorder (AUD). It involves giving participants either actual alcohol or a placebo to compare their responses.

What are the potential side effects?

Since this trial involves consuming alcohol, potential side effects include typical reactions such as dizziness, nausea, impaired coordination, and mood changes. The placebo should not cause any side effects.

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 25 years old.

Exclusion Criteria

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

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My weight is either below 110 pounds or above 210 pounds.

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I do not have serious medical issues like liver disease or diabetes.

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I am currently using or have used psychotropic medication in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 70 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~70 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 70 minutes for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Breath Alcohol Concentration (BrAC)

Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR)

Lab Subjective Response to Alcohol (SR)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, Then Alcohol, then Free-access sessionExperimental Treatment2 Interventions

participants will complete two intravenous administration sessions in the lab during which they will receive placebo (saline) then alcohol, followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min

Group II: Alcohol, Then Placebo, then Free-access sessionExperimental Treatment2 Interventions

participants will complete two intravenous administration sessions in the lab during which they will receive alcohol then placebo (saline), followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alcohol

2008

Completed Phase 3

~1360

Placebo

1995

Completed Phase 3

~2670