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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorAfasci Inc

About 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.

Eligibility criteria

Qualifiers

Age between 21 and 65

Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.

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

Report drinking at least 28 drinks per week if male, 21 drinks per week if female, in the 28 days prior to consent.

Disqualifiers

Current treatment for alcohol use or a history of treatment in the 30 days before enrollment or treatment seeking

Current (last 12 months) DSM-5 diagnosis of dependence on any psychoactive substances other than nicotine

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

Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder

Trial design

Treatments tested in this trial

  • AFA-281

Treatment groups

36 Participants
are divided into 3 treatment groups

Sponsors and collaborators