NCT06335407View on ClinicalTrials.gov

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 28, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

October 29, 2025

Conditions
Alcohol Use Disorder (AUD)Post Traumatic Stress Disorder (PTSD)
Interventions
DRUG

Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg

BXCL 501 40µg will be administered orally, as individual films in the Sub Lingual (SL) space.

DRUG

Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg

BXCL 501 80µg will be administered orally, as individual films in the SL space

Trial Locations (1)

06516

VA Connecticut Healthcare System, West Haven

Sponsors

Collaborators (1)

BioXcel Therapeutics Inc
All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Congressionally Directed Medical Research Programs

FED

collaborator

VA Connecticut Healthcare System

FED

collaborator

BioXcel Therapeutics Inc

INDUSTRY

collaborator

Yale University

OTHER

collaborator

RTI International

OTHER

lead

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

OTHER