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ClinicalTrials.gov public records Last synced Sep 3, 2026, 11:39 AM EDT

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Showing 1–22 of 22 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Conditions
Delirium
Interventions
Intravenous Dexmedetomidine, Sublingual Dexmedetomidine, Intravenous Placebo, Sublingual Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
60 Years and older
Enrollment
1,800 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
14
States / cities
Los Angeles, California • San Francisco, California • Chicago, Illinois + 9 more
Active, not recruiting Phase 1Phase 2 Interventional

Sublingual Dexmedetomidine for Treating Opioid Withdrawal

NCT05712707
Conditions
Opioid Use Disorder, Opioid Withdrawal
Interventions
BXCL501 (180 micrograms), BXCL501 (240 micrograms), Placebo, Lofexidine (Positive Control)
Drug · Other
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
4
States / cities
New Haven, Connecticut • Eatontown, New Jersey • Marlton, New Jersey + 1 more
Conditions
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
Interventions
Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Completed Phase 1Phase 2 Interventional Results available

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

NCT04251910
Conditions
Agitation,Psychomotor, Dementia
Interventions
Sublingual film containing Dexmedetomidine, Sublingual Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
5
States / cities
Homestead, Florida • Miami Lakes, Florida • Springfield, Massachusetts + 2 more
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Dexmedetomidine Hydrochloride, Placebos
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years to 65 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
New Haven, Connecticut
Conditions
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Interventions
Placebo, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, Ethanol Infusion, PTSD Reactivity Condition, Alcohol Cue Reactivity
Drug · Procedure · Behavioral
Lead sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Other
Eligibility
21 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
West Haven, Connecticut
Conditions
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
Interventions
BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
10 Years to 17 Years
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
5
States / cities
Anaheim, California • Hialeah, Florida • Atlanta, Georgia + 2 more
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
151 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
11
States / cities
Phoenix, Arizona • Long Beach, California • Daytona Beach, Florida + 8 more
Conditions
Familial Dysautonomia
Interventions
Dexmedetomidine Sublingual
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years to 80 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
New York, New York
Conditions
Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine
Interventions
Dexmedetomidine, Lorazepam 2 MG/ML
Drug
Lead sponsor
Temple University
Other
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
Sublingual film containing dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
7
States / cities
Los Alamitos, California • Daytona Beach, Florida • Maitland, Florida + 4 more
Conditions
Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychomotor Agitation
Interventions
BXCL501 Sublingual Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
5
States / cities
Chino, California • Oceanside, California • Orange, California + 2 more
Conditions
Familial Dysautonomia
Interventions
Matching placebo, Dexmedetomidine
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
16 Years to 80 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
New York, New York
Conditions
Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
452 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
24
States / cities
Bellflower, California • Cerritos, California • Culver City, California + 19 more
Conditions
Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders
Interventions
Sublingual film containing Igalmi
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
2
States / cities
Little Rock, Arkansas • Rogers, Arkansas
Conditions
Agitation, Dementia
Interventions
BXCL501, Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
3
States / cities
North Miami, Florida • Springfield, Massachusetts • Toms River, New Jersey
Conditions
Opioid Withdrawal
Interventions
Dexmedetomidine, Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
225 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
3
States / cities
Miami Lakes, Florida • Marlton, New Jersey • New York, New York
Conditions
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Interventions
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
Drug
Lead sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Other
Eligibility
21 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
West Haven, Connecticut
Conditions
Agitation, Schizophrenia
Interventions
Sublingual film containing BXCL501 (Dexmedetomidine), Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
12
States / cities
Little Rock, Arkansas • Cerritos, California • Lemon Grove, California + 9 more
Conditions
Acute Stress Reaction, Acute Stress Disorder, Post-traumatic Stress Disorder
Interventions
BXCL501 (dexmedetomidine HCl), Placebo
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 65 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026
U.S. locations
3
States / cities
Jacksonville, Florida • St Louis, Missouri • Charlottesville, Virginia
Conditions
Sleep, Circadian Rhythm
Interventions
Dexmedetomidine sublingual film, Placebo Sublingual Film
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
65 Years and older
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2028
U.S. locations
2
States / cities
Boston, Massachusetts