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

Exclusion Criteria14

• Current bipolar disorder or psychotic disorders as determined by MINI-5;
• Current diagnosis of a substance use disorder (other than alcohol, nicotine, or marijuana) as determined by MINI-5;
• Females who are pregnant, nursing, or planning to become pregnant during study participation;
• Current physiological alcohol dependence requiring a higher level of care (e.g., detox) as determined by study physician conducting physical examination and CIWA score. Tolerance to alcohol will be allowed.
• Recent history of complicated alcohol withdrawal, alcohol withdrawal seizures, or delirium tremens (DTs);
• Score \> 4 on Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) at screening;
• History of major medical illnesses including liver disease, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the participant to be in the study;
• Clinically significant history of cardiac disease including (a) chronic hypertension (even if adequately controlled by antihypertensive medications); (b) history of syncope or other syncopal attacks; (c) current evidence of orthostatic hypotension (defined as a decrease in systolic BP of 20 mm Hg or decrease in diastolic BP of 10mm Hg within 3 minutes); (d) resting heart rate of \<55 beats per minute; (e) systolic blood pressure \<110mmHg or diastolic BP \<70mmHg; or (f) participants with a QTC interval \>440msec (males) or \>460msec (females).
• Clinically significant medical conditions including hepatic (ascites, bilirubin \>10% above the upper limit of normal \[ULN\] or liver function tests \[LFT\] \>3 × ULN);
• Renal impairment as measured by BUN/Creatinine;
• Currently taking the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation including sedative/hypnotics, barbiturates, antihistamines, sedative antidepressants (e.g. doxepin, mirtazapine, trazodone), and triptans (e.g., sumatriptan); c) antihypertensive medications; d) alpha-2-adrenergic agonists (clonidine, guanfacine, lofexidine); or adrenergic agents prescribed for other reasons are excluded (prazosin). (Permitted Concomitant Medications: The concomitant medications allowed in the study include non-sedative antidepressants used to treat PTSD);
• History of allergic reactions to dexmedetomidine or known allergy to dexmedetomidine;
• Participation in a clinical trial of a pharmacological agent within 30 days prior to screening;
• Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the study visit schedule or requirements