NCT03424824

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2018

Typical duration for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

3.9 years

First QC Date

January 26, 2018

Last Update Submit

January 6, 2022

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Total daily alcohol consumption (TAC)

    12 weeks

  • Percent of patients without Heavy Drinking Days (HDDs)

    12 weeks

Study Arms (4)

BP1.3656 low dose

EXPERIMENTAL

administration of BP1.3656 at 30 µg

Drug: BP1.3656 low dose

BP1.3656 intermediate dose

EXPERIMENTAL

administration of BP1.3656 at 60 µg

Drug: BP1.3656 intermediate dose

Placebo

PLACEBO COMPARATOR

administration of placebo

Drug: Placebo

BP1.3656 high dose

EXPERIMENTAL

administration of BP1.3656 at 90 µg

Drug: BP1.3656 high dose

Interventions

BP1.3656 low doseDRUG

Tablet, once daily oral administration at the low dose

BP1.3656 low dose
BP1.3656 intermediate doseDRUG

Tablet, once daily oral administration at the intermediate dose

BP1.3656 intermediate dose
PlaceboDRUG

Tablet, once daily oral administration

Placebo
BP1.3656 high doseDRUG

Tablet, once daily oral administration at the high dose

BP1.3656 high dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female alcohol use disorder
  • Ages 18-65
  • Absent or minimal alcohol withdrawal symptoms assessed
  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism

Sofia, 1303, Bulgaria

Location

CHU Amiens Picardie

Amiens, 80054, France

Location

Leningrad Regional Narcology Dispensary

Saint Petersburg, 188661, Russia

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Evgeny Krupitsky, Pr

    Leningrad Regional Narcology Dispensary, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 7, 2018

Study Start

January 9, 2018

Primary Completion

November 24, 2021

Study Completion

November 24, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)RU(1)BU(1)