Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment

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

Detailed Description
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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.

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

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: BP1.3656 low dose
* Drug: BP1.3656 intermediate dose
* Drug: Placebo
* Drug: BP1.3656 high dose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP1.3656 low dose<br>administration of BP1.3656 at 30 µg | Drug: BP1.3656 low dose<br>* Tablet, once daily oral administration at the low dose<br>|
| Experimental: BP1.3656 intermediate dose<br>administration of BP1.3656 at 60 µg | Drug: BP1.3656 intermediate dose<br>* Tablet, once daily oral administration at the intermediate dose<br>|
| Placebo Comparator: Placebo<br>administration of placebo | Drug: Placebo<br>* Tablet, once daily oral administration<br>|
| Experimental: BP1.3656 high dose<br>administration of BP1.3656 at 90 µg | Drug: BP1.3656 high dose<br>* Tablet, once daily oral administration at the high dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in number of monthly Heavy Drinking Days (HDDs/month) | Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total daily alcohol consumption (TAC) | Total daily alcohol consumption (TAC) from baseline to the end of treatment | 12 weeks | 
| Percent of patients without Heavy Drinking Days (HDDs) | Percent of patients without HDDs during the 12-week medication phase | 12 weeks |