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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Afasci Inc
Study ID
NCT06710431
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AFA-281 — DRUG
    AFA-281

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Nov 2024
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: AFA-281 placebo control
    AFA-281 placebo control group
  • Active Comparator: Low dose of AFA-281
    AFA-281 at 60 mg per day
  • Active Comparator: High dose AFA-281
    AFA-281 at 120 mg per day

Primary Outcome Measure

Cue-induced alcohol craving [ Time Frame: predose and weekly through Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CaliforniaLos AngelesCalifornia90095
Lara Ray, MD
[email protected]
310-319-4700

Find similar trials in Los Angeles, CA

By research site
University of California· Los Angeles, CA

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