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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04827056
The ClinicalTrials.gov registry entry for NCT04827056 describes a study currently listed as completed, 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. 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 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04827056 reports 0 study locations.
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.
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