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

Phase 2

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Drug: BP1.3656 low dose; Drug: BP1.3656 intermediate dose; Drug: Placebo; Drug: BP1.3656 high dose

• Registration Number: NCT03424824
• Lead Sponsor: Bioprojet

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Primary Completion: 2021-11-24
• Study Completion: 2021-11-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BP1.3656 low dose	BP1.3656 low dose	administration of BP1.3656 at 30 µg
BP1.3656 intermediate dose	BP1.3656 intermediate dose	administration of BP1.3656 at 60 µg
Placebo	Placebo	administration of placebo
BP1.3656 high dose	BP1.3656 high dose	administration of BP1.3656 at 90 µg

Primary Outcome Measures

Name	Time	Method
Decrease in number of monthly Heavy Drinking Days (HDDs/month)	12 weeks	Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism; 🇧🇬 Sofia, Bulgaria

CHU Amiens Picardie; 🇫🇷 Amiens, France

Leningrad Regional Narcology Dispensary; 🇷🇺 Leningrad, Russian Federation