Alcohol Use Disorder study: Dexmedetomidine
Official title Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
ClinicalTrials.gov ID: NCT06335407
What this study is testing
What is Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg?
An investigational sublingual film being studied as a potential treatment for alcohol use disorder with comorbid PTSD. is designed to activate alpha‑2 adrenergic receptors in the brain.
Also referred to as Dexmedetomidine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether Dexmedetomidine is safe for people who drink too much and also have PTSD. It also looks for early signs that it might help.
- Who it's for
- You may be able to join if you have alcohol use disorder and PTSD and you live in the area where the study is held.
- What's involved
- You will take the medicine under your tongue at home and report how you feel. You will also visit the clinic for check‑ins and give blood samples.
- Time commitment
- The study lasts about 4 weeks, with a few clinic visits and daily home dosing.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- 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 that demonstrates no clinically significant conduction issues or arrhythmias;
- Have no clinically significant contraindications, in the judgement of the PI/study physician, for study participation (based on self-reported medical...
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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 that demonstrates no clinically significant conduction issues or arrhythmias;
- 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);
- Have a current diagnosis of Alcohol use disorder (AUD) (mild, moderate, or severe) as determined by MINI-5;
- Have a lifetime traumatic event in their lifetime that meets Criterion A for PTSD as determined by screening interview and the MINI-5;
- Have a PCL-5 score \> 15 prior to starting the study medication;
- Must have \> 1 heavy drinking episodes (\>4 standard drink units (SDU) for men; \>3 SDU for women) in the last 30 days (assessed by the Timeline Follow Back (TLFB));
- Females of childbearing potential (not surgically sterilized (tubal ligation/hysterectomy) or not post-menopausal (no menstrual period for \> 6 months)) must be willing to use a medically acceptable and effective birth...
- 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
- 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)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- West Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at West Haven, Connecticut, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.