AFA-281 for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AFA-281 to determine its effectiveness in helping people with alcohol use disorder (AUD) manage cravings and improve mood, sleep, and other symptoms. Participants will receive either a placebo or one of two doses of AFA-281 to compare effects. It suits individuals who have had AUD for at least a year, currently drink heavily, and are not receiving any treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot be currently treated for alcohol use or have a history of treatment in the 30 days before enrollment.
Is there any evidence suggesting that AFA-281 is likely to be safe for humans?
Research has shown that AFA-281 appears safe. Studies have found no concerns about its effects on the heart, indicating it does not seem to harm it. Tests with healthy adults demonstrated that AFA-281 was well absorbed when taken orally.
While earlier studies lack detailed information on specific side effects, the progression of AFA-281 to a Phase 2 trial suggests it was well-tolerated in earlier stages. This phase typically follows tests in healthy volunteers and focuses on specific patient groups, providing more safety information. Those considering joining this trial for Alcohol Use Disorder can find some reassurance in these findings but should always discuss potential risks with their doctors.12345Why do researchers think this study treatment might be promising for alcoholism?
Most treatments for alcoholism, like naltrexone or acamprosate, work by altering brain chemistry to reduce cravings or minimize withdrawal symptoms. But AFA-281 works differently, targeting specific neural pathways believed to directly influence addictive behaviors. Researchers are excited about AFA-281 because it offers a novel mechanism of action, potentially providing a more targeted and effective approach to treating alcoholism. The trial is also testing different doses, which could help determine the most effective and safest dosage for patients. This could lead to a treatment option that not only reduces cravings but also has fewer side effects compared to existing medications.
What evidence suggests that AFA-281 might be an effective treatment for alcoholism?
Research has shown that AFA-281 might help treat alcohol use disorder. Early animal studies found that AFA-281 lowered both alcohol consumption and interest, and it also reduced the urge to seek alcohol. These findings suggest that AFA-281 could help lessen cravings and alcohol use in people. Although more research is needed, these early results offer promise for those dealing with alcohol use.12356
Who Is on the Research Team?
Lara Ray, PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AFA-281 or placebo, starting at a lower dose and increasing over 2 weeks, then maintaining the dose for an additional 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AFA-281
Find a Clinic Near You
Who Is Running the Clinical Trial?
Afasci Inc
Lead Sponsor