RecruitingPhase 1NCT06335407

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

Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) on Ethanol in Heavy Drinkers With PTSD - Outpatient Study


Sponsor

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Enrollment

10 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a sublingual (under-the-tongue) formulation of dexmedetomidine — a sedative-type medication — in veterans and non-veterans who have both alcohol use disorder and PTSD, to see if it can help reduce alcohol cravings and stress-related symptoms. **You may be eligible if...** - You are between 21 and 65 years old - You can read and write in English - You have been diagnosed with alcohol use disorder (mild, moderate, or severe) - You have experienced a traumatic event that qualifies for PTSD criteria - You have a current PTSD symptom score above 15 on the PCL-5 scale - You have a normal heart rhythm (no significant EKG abnormalities) **You may NOT be eligible if...** - You have serious heart rhythm problems or cardiovascular disease - You have liver or kidney disease that could affect drug metabolism - You are currently dependent on opioids or other sedatives - You are pregnant or planning pregnancy - You have certain other psychiatric or neurological conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg

BXCL 501 40µg will be administered orally, as individual films in the Sub Lingual (SL) space.

DRUGDexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg

BXCL 501 80µg will be administered orally, as individual films in the SL space


Locations(1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States

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NCT06335407


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