NCT06710431

A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder

A Double-blind, Placebo-controlled, Phase IIA Human Laboratory Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Afasci Inc · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will determine the safety, tolerability, and exploratory efficacy of AFA-281. This study is a randomized, double-blind, placebo-controlled, human laboratory study of 36 community-based, non-treatment-seeking male and female individuals with current (i.e., past month) moderate-to-severe AUD (DSM-5). This study will be conducted by Dr. Lara Ray at UCLA. The total study duration is approximately 42 days including a 2-week screening period. Eligible participants will be randomized into one of three cohorts: 60 mg AFA-281, 120 mg AFA-281, or Placebo. Participants will start at a lower dose and increase the dose over 2 weeks then continue to maintain the dose for an additional 2 weeks. In week 4, participants will complete 7 daily visits to complete assessments and questionnaires.

Conditions

• Alcohol Abuse
• Alcohol Abuse/addiction
• Anxiety
• Pain Threshold
• Depression Disorders
• Sleep Disorder

Interventions

Type	Name	Description
DRUG	AFA-281	AFA-281

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-11-29
• Last updated: 2024-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study