Effect of Sublingual Dexmedetomidine Formulation - Outpatient Trial
Phase 1
10
about 10 months
21–65
1 site in CT
What this study is about
This trial is testing a new way to give Dexmedetomidine, a drug used for alcohol use disorder and post-traumatic stress disorder, under the tongue. The goal is to see if this sublingual formulation (BXCL501) is safe for people with these conditions in an outpatient setting.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg
- 2.Take Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Assignment is predetermined by the study protocol.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
dexmedetomidine
oral
Primary: Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28., Number and Proportion of Adverse Events
Secondary: Change in PTSD symptoms (measured via the PTSD Checklist for Diagnostic and Statistical Manual (DSM-5) - Posttraumatic Stress Disorder Checklist (PCL-5) from baseline (pre-treatment) through day 28., Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28., Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28., Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28.
Psychiatry / Mental Health