Actively Recruiting
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
Led by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Updated on 2025-10-27
10
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
P
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans and non-Veterans, ages 21 to 65
- Able to read and write in English and sign the informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- ECG showing no significant heart conduction issues or arrhythmias
- No significant medical contraindications as judged by the study physician
- Current diagnosis of Alcohol Use Disorder (mild, moderate, or severe) as determined by MINI-5
- Experienced a lifetime traumatic event meeting Criterion A for PTSD as determined by screening and MINI-5
- PCL-5 score greater than 15 before starting the study medication
- At least one heavy drinking episode in the last 30 days (more than 4 standard drinks for men; more than 3 for women)
- Females of childbearing potential must use effective birth control for 1 month before and during the study
You will not qualify if you...
- Current bipolar disorder or psychotic disorders as determined by MINI-5
- Current substance use disorder other than alcohol, nicotine, or marijuana as determined by MINI-5
- Females who are pregnant, nursing, or planning pregnancy during the study
- Current physiological alcohol dependence requiring detox or higher care
- Recent history of complicated alcohol withdrawal, seizures, or delirium tremens
- Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) score greater than 4 at screening
- History of major medical illnesses including liver disease, heart disease, or chronic pain deemed contraindicated
- Clinically significant cardiac issues including chronic hypertension, syncope, orthostatic hypotension, low resting heart rate, low blood pressure, or prolonged QTc interval
- Significant hepatic conditions or renal impairment
- Currently taking medications for alcoholism, sedatives, antihypertensives, alpha-2 adrenergic agonists, or related drugs
- Allergy to dexmedetomidine
- Participation in a drug clinical trial within 30 days prior to screening
- Any condition that would prevent fulfilling study visit schedule or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
I
Ismene Petrakis, MD
CONTACT
J
Jenelle Newcomb, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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