AFA-281 for Alcoholism

Phase 2

Waitlist Available

Led By Lara Ray, MD

Research Sponsored by Afasci Inc

Eligibility Criteria Checklist

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

Must have

Age between 21 and 65

Report drinking at least 28 drinks per week if male, 21 drinks per week if female, in the 28 days prior to consent

Must not have

Has an estimated creatinine clearance (CrCl) outside of normal range

Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose and weekly through week 4

Summary

"This trial will look at whether AFA-281 is safe and effective in reducing cravings and improving various symptoms in patients with Alcohol use disorder."

Who is the study for?

This trial is for individuals with Alcohol Use Disorder who may also experience sleep issues, depression, anxiety, or altered pain tolerance. Specific eligibility details are not provided but typically include age range, health status, and severity of alcoholism.

What is being tested?

The study tests the safety and potential effectiveness of a new oral medication called AFA-281 on reducing cravings for alcohol and improving related conditions like pain sensitivity, mood disorders (anxiety/depression), and sleep disturbances.

What are the potential side effects?

While specific side effects are not listed here, common ones for medications treating similar conditions can include nausea, dizziness, headache, fatigue or changes in appetite. Patients will be monitored closely for any adverse reactions.

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 65 years old.

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I have been drinking more than 28 (if male) or 21 (if female) alcoholic drinks weekly for the last month.

Exclusion Criteria

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

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My kidney function, measured by creatinine clearance, is not normal.

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I have tested positive for hepatitis A, B, C, or HIV.

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I have fainted or almost fainted when standing up quickly.

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I am currently diagnosed with major depression and have thoughts of suicide.

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I do not have any major health issues like heart, lung (except mild asthma), kidney, liver, stomach, blood, hormone-related conditions, skin problems, metabolic diseases, or severe mental health issues.

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I have had a head injury that caused me to lose consciousness or have seizures.

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I have had surgery on my stomach or intestines that could affect digestion.

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I haven't donated or lost significant blood or received a transfusion in the last 8 weeks.