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RECRUITING Phase 1

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

NCT06335407 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06335407 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06335407?

This trial is sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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