A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.

Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.

Inclusion Criteria:

• Male or female alcohol use disorder
• Ages 18-65
• Absent or minimal alcohol withdrawal symptoms assessed
• 18 kg/m2 ≤ BMI ≤ 35 kg/m2
• Excessive alcohol use during the 2 weeks between screening and baseline
• Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05).

Exclusion Criteria:

• History of delirium tremens, epilepsy, or withdrawal seizures
• Clinical depression or suicidality: Beck Depression Inventory (BDI) ≥ 16 and suicidality (Item G ≠ 0)
• Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids
• Clinically significant cardiovascular, hematologic, severe hepatic impairment
• History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
• Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox
• Receiving ongoing alcohol use disorder medication (e.g. Baclofen)