A Study of AFA-281 for Alcohol Use Disorder

This study is looking at a drug called AFA-281 to see if it's safe and how well it works for people with alcohol use disorder (AUD). Researchers want to see if AFA-281 can help reduce alcohol cravings, change how people respond to alcohol, and affect things like pain, anxiety, depression, and sleep. You might be able to join if you are between 21 and 65 years old and have been diagnosed with moderate or severe AUD in the past year. The study is currently unclear about its recruitment status and plans to enroll 36 participants.

Study design
This is a randomized, double-blind, placebo-controlled study involving 36 participants. Participants will be assigned to receive either 60 mg of AFA-281, 120 mg of AFA-281, or a placebo (an inactive substance).
What's involved
The total study duration is about 42 days, including a 2-week screening period. Participants will start with a lower dose, increase it over 2 weeks, and then maintain that dose for another 2 weeks. In the fourth week, participants will have 7 daily visits for assessments and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Alcohol cravings and subjective response to alcohol will be measured weekly through Week 4. The overall study duration is approximately 42 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06710431

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

Not Yet Recruiting
PHASE2Ages 21–65InterventionalTreatment
Afasci Inc
~36 participants
Updated 2024-11-29 on ClinicalTrials.gov
What's tested:AFA-281

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cue-induced alcohol craving
Measured over predose and weekly through Week 4
+4 more outcomes measured
Alcohol Abuse
Alcohol Abuse/addiction
Anxiety
Pain Threshold
Depression Disorders
Sleep Disorder
1 sites across 1 states
California1
  • Lara Ray, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Opens a ready-to-send draft in your own email app — review before sending.

  • Cue-induced alcohol cravingpredose and weekly through Week 4

    Questionnaire measures the level of alcohol craving

  • Stress-induced alcohol cravingpredose and weekly through Week 4

    Alcohol urge questionnaire after stressful stimuli

  • Subjective response to alcoholpredose and weekly through Week 4

    Biphasic alcohol effects scale and profile of negative mood states

  • Pain assessmentspredose and weekly through Week 4

    Latency to first feel pain and pain intensity scoring using the McGill Pain Questionnaire

  • Safety and tolerability assessmentPredose and Daily

    Daily questions via CAROMA system