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

NCT06335407 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-27

No results posted yet for this study

Summary

The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • VA Connecticut Healthcare System

    collaborator FED

  • BioXcel Therapeutics Inc

    collaborator INDUSTRY

  • Yale University

    collaborator OTHER

  • RTI International

    collaborator OTHER

  • Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

    lead OTHER

Principal Investigators

  • Ismene Petrakis, MD · VA Connecticut Healthcare System

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2026-03-30
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06335407 on ClinicalTrials.gov