Independent directory Public ClinicalTrials.gov records United States
Clear filters
ClinicalTrials.gov public records Last synced Sep 15, 2026, 12:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Showing 1–22 of 22 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
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
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
Opioid Dependence, Opioid Related Disorders
Interventions
SUBOXONE, RBP-6000, Placebo
Drug
Lead sponsor
Indivior Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
665 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
38
States / cities
Haleyville, Alabama • Hamilton, Alabama • Little Rock, Arkansas + 33 more
Conditions
Parkinson Disease, Off Episodes
Interventions
APL-130277, Placebo
Drug
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Eligibility
18 Years and older
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
32
States / cities
Birmingham, Alabama • Phoenix, Arizona • Scottsdale, Arizona + 27 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
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, 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
Healthy Volunteer, Opioid-use Disorder
Interventions
INDV-2000, Placebo, SUBOXONE® sublingual film
Drug
Lead sponsor
Indivior Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
64 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
3
States / cities
Baltimore, Maryland • DeSoto, Texas • San Antonio, Texas
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
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
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
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
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
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
Opioid-use Disorder, Suicidal Ideation
Interventions
Buprenorphine/Naloxone 8/2 milligram (mg) Sublingual Film, Morphine Sulfate 30 mg
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
New York, New York
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
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
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
Restless Legs Syndrome
Interventions
Apomorphine Sublingual Film, Placebo
Drug
Lead sponsor
William Ondo, MD
Other
Eligibility
21 Years to 80 Years
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Houston, Texas
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
Opioid Use Disorder
Interventions
Buprenorphine, buprenorphine and naloxone, hydromorphone, placebo
Drug
Lead sponsor
Indivior Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Overland Park, Kansas
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