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New treatment option for Alcohol Use Disorder (AUD)
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?
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alcohol use disorder (aud).
Also referred to as BXCL501 40µg.
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
- 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.
- 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; (c) current...
- 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...
- 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's taking place
- 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 - 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?
Study sites include West Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.