drugset / Trial / NCT04827056
Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study
Phase 1
Completed
10 enrolled
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
BioXcel Therapeutics Inc · collabCongressionally Directed Medical Research Programs · collabRTI International · collabUnited States Department of Defense · collabVA Connecticut Healthcare System · collabYale University · collab
RandomizedCrossoverTriple-blindOther
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.
Timeline
- Start
- 2021-11-09
- Primary completion
- 2023-05-02
- Completion
- 2023-06-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 40 ug | Oral |
| Subject | Dexmedetomidine | Other / unclassified | 80 ug | Oral |