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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 Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD), sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06335407: Recruiting Phase 1 study of Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD), sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
NCT06335407 is a Phase 1 study of Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD) that is actively recruiting participants, run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. The registered enrollment target is 10 participants, below the 111-participant average among 31 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06335407, a Phase 1 study of Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD), 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.
Primary Outcome
Participants will undergo vital signs on baseline, day 5, day 7, and weeks 2-4. The change in blood pressure is computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-07-28 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What NCT06335407 shows while recruiting
NCT06335407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 111-participant average among 31 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Posttraumatic Stress Disorder (PTSD) 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 a single indexed study location in 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: Posttraumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD).
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06335407's enrollment target sits among peer trials
10 31st of 31 higher than 1 of 31 other Posttraumatic Stress Disorder (PTSD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Posttraumatic Stress Disorder (PTSD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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