Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) on Ethanol in Heavy Drinkers With PTSD - Outpatient Study
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
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.
Description
BXCL501 is a sublingual film containing dexmedetomidine. Dexmedetomidine is an alpha-2 adrenergic receptor agonist and has higher intrinsic activity and is more potent in vitro than either clonidine or lofexidine. The drug has a high free brain to free plasma ratio after dosing in rats that persists after plasma concentrations are cleared. Dexmedetomidine does not depress respiratory function. It is not predicted to have abuse potential. BXCL501 will bypass 1st pass metabolism and produce fewer problems in participants with compromised liver function. This laboratory study is a phase 1b, open…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Veterans and non-Veterans, ages 21 to 65; 2. Able to read and write in English and sign the informed consent; 3. Willing to comply with all study procedures and be available for the duration of the study; 4. ECG that demonstrates no clinically significant conduction issues or arrhythmias; 5. Have no clinically significant contraindications, in the judgement of the PI/study physician, for study participation (based on self-reported medical history and brief physical examination); 6. Have a current diagnosis of Alcohol use disorder (AUD) (mild, moderate, or severe) as det…
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
Location
- VA Connecticut Healthcare SystemWest Haven, Connecticut