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NCT04827056 · ClinicalTrials.gov registry record · Phase 1
Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study
A Phase 1 study, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04827056: Completed Phase 1 study, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
NCT04827056 is a Phase 1 study that has completed, run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04827056, a Phase 1 study, has completed, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
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) and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. Safety endpoints will be compared following an alcohol challenge without and concurrent with BXCL501 treatment.
Primary Outcome
Anxiety is measured via blood pressure (systolic and diastolic). Participants will undergo stress (PTSD) reactivity conditions (both neutral and trauma) on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in blood pressure is computed as the difference in measurements taken across the PTSD Reactivity Conditions to the measurement collected immediately prior to the stress condi
Interventions
- DRUG Placebo
- DRUG Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg
- DRUG Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
- PROCEDURE Ethanol Infusion
- BEHAVIORAL PTSD Reactivity Condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2023-06-02 |
| Phase | Phase 1 |
What the finished NCT04827056 record still lists
NCT04827056 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04827056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04827056 about?
NCT04827056 is a clinical study titled "Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction 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) and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical tria...
What is the current status of trial NCT04827056?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-11-09. Estimated completion is 2023-06-02.
What interventions are being tested in trial NCT04827056?
The interventions under investigation include: Placebo (DRUG), Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg (DRUG), Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg (DRUG), Ethanol Infusion (PROCEDURE), PTSD Reactivity Condition (BEHAVIORAL).
Who is sponsoring clinical trial NCT04827056?
This trial is sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04827056's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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