Back to resultsRandomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BP1.3656 low dose
BP1.3656 intermediate dose
Placebo
BP1.3656 high dose
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
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)
Sites / Locations
- State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism
- CHU Amiens Picardie
- Leningrad Regional Narcology Dispensary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
BP1.3656 low dose
BP1.3656 intermediate dose
Placebo
BP1.3656 high dose
Arm Description
administration of BP1.3656 at 30 µg
administration of BP1.3656 at 60 µg
administration of placebo
administration of BP1.3656 at 90 µg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total daily alcohol consumption (TAC)
Total daily alcohol consumption (TAC) from baseline to the end of treatment
Percent of patients without Heavy Drinking Days (HDDs)
Percent of patients without HDDs during the 12-week medication phase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03424824
Brief Title
Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
Official Title
A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioprojet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BP1.3656 low dose
Arm Type
Experimental
Arm Description
administration of BP1.3656 at 30 µg
Arm Title
BP1.3656 intermediate dose
Arm Type
Experimental
Arm Description
administration of BP1.3656 at 60 µg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
administration of placebo
Arm Title
BP1.3656 high dose
Arm Type
Experimental
Arm Description
administration of BP1.3656 at 90 µg
Intervention Type
Drug
Intervention Name(s)
BP1.3656 low dose
Intervention Description
Tablet, once daily oral administration at the low dose
Intervention Type
Drug
Intervention Name(s)
BP1.3656 intermediate dose
Intervention Description
Tablet, once daily oral administration at the intermediate dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, once daily oral administration
Intervention Type
Drug
Intervention Name(s)
BP1.3656 high dose
Intervention Description
Tablet, once daily oral administration at the high dose
Primary Outcome Measure Information:
Title
Decrease in number of monthly Heavy Drinking Days (HDDs/month)
Description
Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total daily alcohol consumption (TAC)
Description
Total daily alcohol consumption (TAC) from baseline to the end of treatment
Time Frame
12 weeks
Title
Percent of patients without Heavy Drinking Days (HDDs)
Description
Percent of patients without HDDs during the 12-week medication phase
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Krupitsky, Pr
Organizational Affiliation
Leningrad Regional Narcology Dispensary, Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Leningrad Regional Narcology Dispensary
City
Leningrad
ZIP/Postal Code
188661
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
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