NCT03424824

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	BP1.3656 low dose	Tablet, once daily oral administration at the low dose
DRUG	BP1.3656 intermediate dose	Tablet, once daily oral administration at the intermediate dose
DRUG	Placebo	Tablet, once daily oral administration
DRUG	BP1.3656 high dose	Tablet, once daily oral administration at the high dose

Timeline

• Start date: 2018-01-09
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2018-02-07
• Last updated: 2022-01-21

Locations

3 sites across 3 countries: Bulgaria, France, Russia