Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study (NCT06335407) | Clinical Trial Compass
RecruitingPhase 1
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
United States10 participantsStarted 2025-07-28
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion 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;
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.
Timeframe: From day 1 through day 28
2
Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28.
Timeframe: From day 1 through 28 days
3
Number and Proportion of Adverse Events
Timeframe: From day 1 through 28 days
Trial details
NCT IDNCT06335407
SponsorPharmacotherapies for Alcohol and Substance Use Disorders Alliance
✕. 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).