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

Sponsor

Bioprojet (Other)

Overall Status

Completed

CT.gov ID

NCT03424824

Collaborator

(none)

210

Enrollment

Locations

Arms

46.5

Actual Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: BP1.3656 low dose Drug: BP1.3656 intermediate dose Drug: Placebo Drug: BP1.3656 high dose	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 9, 2018

Actual Primary Completion Date :

Nov 24, 2021

Actual Study Completion Date :

Nov 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BP1.3656 low dose administration of BP1.3656 at 30 µg	Drug: BP1.3656 low dose Tablet, once daily oral administration at the low dose
Experimental: BP1.3656 intermediate dose administration of BP1.3656 at 60 µg	Drug: BP1.3656 intermediate dose Tablet, once daily oral administration at the intermediate dose
Placebo Comparator: Placebo administration of placebo	Drug: Placebo Tablet, once daily oral administration
Experimental: BP1.3656 high dose administration of BP1.3656 at 90 µg	Drug: BP1.3656 high dose Tablet, once daily oral administration at the high dose

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism	Sofia	Bulgaria	1303
2	CHU Amiens Picardie	Amiens	France	80054
3	Leningrad Regional Narcology Dispensary	Leningrad	Russian Federation	188661

Sponsors and Collaborators

Bioprojet

Investigators

Principal Investigator: Evgeny Krupitsky, Pr, Leningrad Regional Narcology Dispensary, Russia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bioprojet

ClinicalTrials.gov Identifier:

NCT03424824

Other Study ID Numbers:

P15-01 / BP1.3656
2017-000069-57

First Posted:

Feb 7, 2018

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alcoholism

Alcohol Drinking

Study Results

No Results Posted as of Jan 21, 2022