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An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder
RecruitingRegisteredCTG
Open-label, Phase IIa single-dose study (n=13) evaluating safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 with relapse-prevention psychological support in patients with Alcohol Use Disorder.
Details
Open-label Phase IIa treatment study in patients with moderate to severe alcohol use disorder testing a single intranasal administration of BPL-003 combined with structured relapse-prevention psychological support; follow-up assessments extend to 12 weeks.
Primary outcomes focus on safety and tolerability; secondary and exploratory measures include pharmacodynamic effects and alcohol-use outcomes across the 12-week follow-up.
Topics:Alcohol Use Disorder (AUD)
Registry
Registry linkNCT05674929