RecruitingNCT06335407
Dose and safety study of sublingual dexmedetomidine for alcohol use and PTSD
About this title
Read the official source — NCT06335407Medication studyAges 21–65United States
Understand this study
Who could participate?
Listed age limits: 21 years to 65 years.
What will I do during this study?
Participants use a sublingual film of BXCL501 for 28 days. The dose starts at 40 micrograms and is gradually adjusted over the first week, then taken twice daily if tolerated. Clinic visits take place on day 1, around day 5, and during weeks 1 to 4 to check side effects, alcohol use and trauma-related symptoms.
- Listed locations
- West HavenSee all locations and recruitment
- Study phase
- Phase 1Usually an early study focused on safety, tolerability, dosage, and side effects.
- Participation duration
- 28 days
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: July 28, 2025
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 10
- Sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 1Usually an early study focused on safety, tolerability, dosage, and side effects.
- Locations
- United States
- Age range
- From 21 Years to 65 Years
- Official registry ID
- NCT06335407
- Official title
Show the full official title
Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) on Ethanol in Heavy Drinkers With PTSD - Outpatient Study
Recruitment & locations
Currently recruitingA study may be recruiting, but some locations may no longer be accepting participants. Confirm availability with the research team.
West Haven
Interested in joining this study?
Questions about this study
Who is behind this study?
The study sponsor is Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
Does this study involve medication?
Yes. The study involves medication, including Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg and Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg.
Who can participate?
Listed age limits: 21 years to 65 years.
Is this study still recruiting?
The registry lists this study as recruiting.
