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

{ "BXCL501 for Alcohol Use Disorder and PTSD", "This study is testing a sublingual (under the tongue) film called Dexmedetomidine HCl (BXCL501) to see if it's safe and potentially effective for people with Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). Researchers want to see if BXCL501 can help with anxiety and doesn't cause too many side effects. You might be able to join if you are a veteran or non-veteran between 21 and 65 years old, can read and write English, and are willing to follow study procedures. The study will measure changes in blood pressure and anxiety levels over 28 days, and also track any side effects. The study is currently recruiting 10 participants.", "design": "This is a Phase 1b, open-label (meaning you and the study staff will know what treatment you are receiving), single-arm study, meaning all participants will receive the study drug. It aims to enroll at least 10 participants.", "commitments": "You would receive BXCL501 as a sublingual film for 28 days, with the dose increasing over the first 6 days. You would need to comply with all study procedures and be available for the study's duration.", "compensation": "Not stated in the trial record.", "follow_up": "Your blood pressure, anxiety levels, and any adverse events will be monitored from day 1 through day 28.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06335407

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

Recruiting
PHASE1Ages 21–65Interventional
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
~10 participants
Updated 2025-10-27 on ClinicalTrials.gov
What's tested:Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µgDexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.
Measured over From day 1 through day 28
+2 more outcomes measured
Alcohol Use Disorder (AUD)
Post Traumatic Stress Disorder (PTSD)
1 sites across 1 states
Connecticut1
  • Ismene Petrakis, MD · PRINCIPAL_INVESTIGATOR · VA Connecticut Healthcare System

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  • Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.From day 1 through day 28

    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).

  • Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28.From day 1 through 28 days

    Participants will take the STAI-6 assessment on baseline, day 5, day 7, and weeks 2-4. The change in STAI-6 score is computed as the difference in measurements taken across all study timepoints from the baseline visit (pre-treatment).

  • Number and Proportion of Adverse EventsFrom day 1 through 28 days

    Adverse Events will be monitored and documented through each dose escalation phase after the first dose administration.