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NCT06335407 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.

Recruiting
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT06335407 is a Phase 1 study of Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD) that is actively recruiting participants, run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. The registered enrollment target is 10 participants, below the 1,824-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06335407, a Phase 1 study of Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), is actively recruiting participants, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.

RECRUITING
Registry status
Phase 1
Development phase
10 participants
Enrollment target
1
Study location

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 Studied

Alcohol Use Disorder (AUD) Post Traumatic Stress Disorder (PTSD)

Interventions

  • DRUG Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg
  • DRUG Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg

Study Locations (1)

Connecticut

  • VA Connecticut Healthcare System - West Haven

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2025-07-28
Est. Completion 2026-05-31
Phase Phase 1

Sponsor

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06335407

The ClinicalTrials.gov registry entry for NCT06335407 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,824-participant average among 30 other Alcohol Use Disorder (AUD) trials with a reported enrollment target (99% lower). The listed sponsor is Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alcohol Use Disorder (AUD) appearing as the primary indexed condition, and to 2 interventions - of which Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg is the first listed.

NCT06335407 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT06335407 about?

NCT06335407 is a clinical study titled "Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study". 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 ...

What is the current status of trial NCT06335407?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2025-07-28. Estimated completion is 2026-05-31.

What conditions does trial NCT06335407 study?

This clinical trial studies the following conditions: Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD).

What interventions are being tested in trial NCT06335407?

The interventions under investigation include: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg (DRUG), Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg (DRUG).

Who is sponsoring clinical trial NCT06335407?

This trial is sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06335407 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.