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

36 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug AFA-281 for treating alcoholism?

Research shows that intramuscular naltrexone, a drug similar to AFA-281, significantly reduces hospital readmission rates for patients with alcohol use disorder, suggesting it may help prevent relapse. ^{1 2 3 4 5}

What safety data exists for AFA-281 (nalmefene) in humans?

Nalmefene has been studied for its safety in treating alcohol use disorder, showing a promising role with a need for more data in special populations like those with alcohol-related diseases or psychiatric conditions. It is generally considered safe, but its use should be tailored to individual needs and conditions. ^{6 7 8 9 10}

How does the drug AFA-281 differ from other treatments for alcoholism?

AFA-281 may be unique because it potentially involves the gut-brain axis and glucagon-like peptide-1 (GLP-1) pathways, which are being explored for their role in reducing alcohol consumption and related behaviors. This approach is different from traditional treatments that do not target these specific pathways. ^{7 11 12 13 14}

What is the purpose of this trial?

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 thresholds, anxiety, depression, and sleep.

Research Team

Lara Ray, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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Safety of nalmefene for the treatment of alcohol use disorder: an update. [2020]

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Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. [2018]

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