AFA-281 for Alcoholism

Overseen By Simon Xie, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Afasci Inc

Must not be taking: Narcotics, Amphetamines, Sedatives, others

Disqualifiers: Schizophrenia, Bipolar, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 5 6}

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

I am between 21 and 65 years old.

Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for moderate or severe AUD

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

Exclusion Criteria

History of significant sensitivity to any drug

Current DSM-5 diagnosis of substance use disorder for any substance other than alcohol and nicotine

Liver enzymes AST, ALT, or GGT ≥ 3 times upper normal limit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

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

4 weeks

7 daily visits in week 4 for assessments and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AFA-281

Trial Overview 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.

How Is the Trial Designed?

Group I: Low dose of AFA-281 Active Control 1 Intervention

AFA-281 at 60 mg per day

Group II: High dose AFA-281 Active Control 1 Intervention

AFA-281 at 120 mg per day

Group III: AFA-281 placebo control Placebo Group 1 Intervention

AFA-281 placebo control group

Who Is Running the Clinical Trial?

Afasci Inc

Lead Sponsor

Trials

4

Recruited

490+

Published Research Related to This Trial

Pharmacological treatments for alcohol use disorders (AUD), such as acamprosate, naltrexone, nalmefene, and disulfiram, are effective but underused, highlighting the need for better implementation despite their proven efficacy.

Each medication has a distinct safety profile that must be carefully considered alongside individual patient circumstances, including their drinking patterns and any comorbid conditions, to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. Sinclair, JM., Chambers, SE., Shiles, CJ., et al.[2018]

Alcohol use disorder (AUD) is common but often under-treated, with only three approved medications, highlighting the need for more diverse and effective treatment options.

The review discusses various pharmacotherapies, including both approved and novel agents, showing promise for improving treatment efficacy and supporting personalized medicine approaches for individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. Burnette, EM., Nieto, SJ., Grodin, EN., et al.[2022]

In a study involving 18 heavy social drinkers, baclofen was found to be safe when combined with alcohol, showing only modest increases in heart rate and blood pressure without any reported adverse effects.

Baclofen did not enhance the positive effects of alcohol or increase alcohol craving, indicating it has minimal abuse potential and is well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute interaction of baclofen in combination with alcohol in heavy social drinkers. Evans, SM., Bisaga, A.[2018]

Nalmefene is the first drug approved in the E.U. specifically to reduce alcohol consumption in alcohol-dependent patients, showing significant efficacy over 6 months by reducing total alcohol intake by an average of 7.6 g/day and heavy drinking days by 2 days per month.

The drug is generally well tolerated with good compliance rates (over 80% adherence) among patients using it as needed, making it a promising new approach in treating alcohol dependence alongside brief psychosocial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nalmefene and its use in alcohol dependence. Gual, A., Bruguera, P., López-Pelayo, H.[2017]

Nalmefene is the first medication approved for reducing alcohol consumption in heavy drinking alcohol-dependent patients, providing an alternative treatment option for those who may not be ready to pursue complete abstinence.

While nalmefene shows promise in changing the treatment approach for alcohol use disorder (AUD), further research is needed on its safety in special populations and its effectiveness compared to other medications for alcohol reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of nalmefene for the treatment of alcohol use disorder: an update. López-Pelayo, H., Zuluaga, P., Caballeria, E., et al.[2020]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10815882

Development of a Novel Medication for Alcohol Use ... In our preliminary studies, AFA-281 decreased alcohol intake and preference, and suppressed alcohol-seeking behavior in rodents.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06719908

A Phase I Study of the Interaction of Alcohol With Oral AFA- ... This study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of co-administration of AFA-281 and ethanol in healthy, male and female ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/560448

A Study of the Safety and Exploratory Efficacy of Oral AFA-281 ... This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain ...

4. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT06710431

Oral AFA-281 in Patients with Alcohol Use Disorder This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response ...

5. withpower.com withpower.com/trial/afa-281-for-alcoholism-6ff39

AFA-281 for Alcoholism · Info for Participants This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06710431

A Study of the Safety and Exploratory Efficacy of Oral AFA- ... This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain ...