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

Bioprojet

Status and phase: Completed; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Placebo; Drug: BP1.3656 high dose; Drug: BP1.3656 low dose; Drug: BP1.3656 intermediate dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03424824

2017-000069-57 (EudraCT Number)

P15-01 / BP1.3656

Details and patient eligibility

About

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

Full description

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 4 patient groups, including a placebo group

BP1.3656 low dose

Experimental group

Description:

administration of BP1.3656 at 30 µg

Treatment:

Drug: BP1.3656 low dose

BP1.3656 intermediate dose

Experimental group

Description:

administration of BP1.3656 at 60 µg

Treatment:

Drug: BP1.3656 intermediate dose

Placebo

Placebo Comparator group

Description:

administration of placebo

Treatment:

Drug: Placebo

BP1.3656 high dose

Experimental group

Description:

administration of BP1.3656 at 90 µg

Treatment:

Drug: BP1.3656 high dose