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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Study ID
NCT06335407
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Alcohol Use Disorder (AUD)
  • Post Traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg — DRUG
    BXCL 501 40µg will be administered orally, as individual films in the Sub Lingual (SL) space.
  • Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg — DRUG
    BXCL 501 80µg will be administered orally, as individual films in the SL space

Study Details

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.

Key Dates

Start date
Jul 28, 2025
Status verified
Oct 2025
Primary completion
Mar 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Other: BXCL501 Dose Range 40µg to 160µg
    Participants will receive 40µg on days 1-2. On days 3 and 4, participants will receive 40µg twice per day. On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening. On days 7-28 participants will receive 80µg in the morning and evening. Dose escalation will follow the above schedule based on tolerability assessed by clinician.

Primary Outcome Measure

Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28. [ Time Frame: From day 1 through day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516
Jenelle Newcomb, BA
[email protected]
(203) 932-5711
Ismene Petrakis, MD
[email protected]
(203) 932-5711
Ismene Petrakis, MD (PRINCIPAL_INVESTIGATOR)
John Krystal, MD (SUB_INVESTIGATOR)

Find similar trials in West Haven, CT

By research site
VA Connecticut Healthcare System· West Haven, CT

Related Studies