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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424824
• Other study ID #: P15-01 / BP1.3656
• Secondary ID: 2017-000069-57
• Status: Completed
• Phase: Phase 2
• Start date: January 9, 2018
• Est. completion date: November 24, 2021

Study information

• Verified date: January 2022
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• BP1.3656 low dose
Tablet, once daily oral administration at the low dose
• BP1.3656 intermediate dose
Tablet, once daily oral administration at the intermediate dose
• Placebo
Tablet, once daily oral administration
• BP1.3656 high dose
Tablet, once daily oral administration at the high dose

Locations

Country	Name	City	State
Bulgaria	State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism	Sofia
France	CHU Amiens Picardie	Amiens
Russian Federation	Leningrad Regional Narcology Dispensary	Leningrad

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Countries where clinical trial is conducted

Bulgaria,  France,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total daily alcohol consumption (TAC)	Total daily alcohol consumption (TAC) from baseline to the end of treatment	12 weeks
Secondary	Percent of patients without Heavy Drinking Days (HDDs)	Percent of patients without HDDs during the 12-week medication phase	12 weeks