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
Afasci Inc
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.
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 do…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age between 21 and 65 2. 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. 3. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for moderate or severe AUD 4. Report drinking at least 28 drinks per week if male, 21 drinks per week if female, in the 28 days prior to consent. 5. Must be surgically sterile (vasectomy, tubal ligation, or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., c…
Interventions
- DrugAFA-281
AFA-281
Location
- University of CaliforniaLos Angeles, California