Status:
COMPLETED
Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
Lead Sponsor:
Bioprojet
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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, ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03424824
Start Date
January 9 2018
End Date
November 24 2021
Last Update
January 21 2022
Active Locations (3)
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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
Saint Petersburg, Russia, 188661