← Back to Search

Alpha-2 Adrenergic Agonist

Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg for Alcoholism

Phase 1
Waitlist Available
Led By Ismene Petrakis, MD
Research Sponsored by Pharmacotherapies for Alcohol and Substance Abuse Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on each test day (1-3), from baseline (prior to stress condition) to the end of the ptsd stress reactivity conditions
Awards & highlights

Study Summary

This trial will test if a drug called Dexmedetomidine HCl is safe to use for treating people with both alcohol use disorder and posttraumatic stress disorder.

Eligible Conditions
  • Alcoholism
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on each test day (1-3), from baseline (prior to stress condition) to the end of the ptsd stress reactivity conditions
This trial's timeline: 3 weeks for screening, Varies for treatment, and on each test day (1-3), from baseline (prior to stress condition) to the end of the ptsd stress reactivity conditions for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in alcohol craving, as measured by the Yale Craving Scale (YCS), by treatment group during alcohol cue induced craving.
Change in alcohol craving, as measured by the Yale Craving Scale (YCS), by treatment group during stress reactivity conditions.
Anxiety
+23 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µgExperimental Treatment6 Interventions
BXCL501 is a thin film formulation of dexmedetomidine (DEX) for sublingual (SL) administration. The product is a small, solid-dose film formulation, approximately 286 mm2 in area and 0.7 mm thick, designed to solubilize in the SL space within 1-3 minutes. At the time of dosing, subjects will be verbally instructed on how to take the investigational product sublingually, and that they should retain the investigational product in the sublingual cavity until dissolved.
Group II: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µgExperimental Treatment6 Interventions
BXCL501 is a thin film formulation of dexmedetomidine (DEX) for sublingual (SL) administration. The product is a small, solid-dose film formulation, approximately 286 mm2 in area and 0.7 mm thick, designed to solubilize in the SL space within 1-3 minutes. At the time of dosing, subjects will be verbally instructed on how to take the investigational product sublingually, and that they should retain the investigational product in the sublingual cavity until dissolved.
Group III: PlaceboPlacebo Group6 Interventions
Placebo and study drug will look exactly the same in order to maintain the double-blind; study drug and placebo are administered exactly the same.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
2021
Completed Phase 1
~10
Ethanol Infusion
2021
Completed Phase 1
~10
Alcohol Cue Reactivity
2021
Completed Phase 1
~10
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg
2021
Completed Phase 1
~10
PTSD Reactivity Condition
2021
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Pharmacotherapies for Alcohol and Substance Abuse ConsortiumLead Sponsor
3 Previous Clinical Trials
189 Total Patients Enrolled
2 Trials studying Alcoholism
69 Patients Enrolled for Alcoholism
United States Department of DefenseFED
861 Previous Clinical Trials
227,184 Total Patients Enrolled
16 Trials studying Alcoholism
896 Patients Enrolled for Alcoholism
Congressionally Directed Medical Research ProgramsFED
47 Previous Clinical Trials
7,039 Total Patients Enrolled
5 Trials studying Alcoholism
93 Patients Enrolled for Alcoholism

Media Library

Dexmedetomidine (BXCL501) - 40µg (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04827056 — Phase 1
Alcoholism Research Study Groups: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, Placebo
Alcoholism Clinical Trial 2023: Dexmedetomidine (BXCL501) - 40µg Highlights & Side Effects. Trial Name: NCT04827056 — Phase 1
Dexmedetomidine (BXCL501) - 40µg (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04827056 — Phase 1
Alcoholism Patient Testimony for trial: Trial Name: NCT04827056 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current cap on test-subjects taking part in this research endeavor?

"Affirmative. Clinicaltrials.gov indicates that this research project, initially publicized on November 9th 2021, is actively recruiting participants. 10 subjects need to be sourced from a single medical centre."

Answered by AI

Is enrollment currently available for this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is actively recruiting participants at the moment, with 10 people needed from 1 medical facility to complete the study. The investigation was first posted on November 9th 2021 and has been updated most recently on September 27th 2022."

Answered by AI

Is it possible to join this experiment?

"This clinical trial intends to recruit 10 individuals aged 21-65 with an alcohol use disorder. Participants must be literate in English, possess no clinically significant issues as per a physical examination and ECG results, have experienced at least one traumatic event that meets the criteria for posttraumatic stress disorder (PTSD), demonstrate >1 heavy drinking episodes within the last month via Timeline Follow Back (TLFB) assessments, not actively seeking treatment for their AUD, and females of childbearing potential who are willing to utilize medically acceptable contraception methods for 3 months prior to commencement and throughout the duration of this study."

Answered by AI

Is eligibility for the trial restricted to participants under 25 years old?

"The age limit for enrolment in this trial is 21 to 65 years old. Consequently, there are 350 trials targeting patients below the age of majority and 1123 dedicated specifically to elderly participants."

Answered by AI

To what maladies is PTSD Reactivity Condition usually prescribed?

"PTSD Reactivity Condition is primarily used to ameliorate medical conditions, but can be useful in treating other ailments such as ventilations, mechanical problems, cyclic vomiting syndrome and intubation."

Answered by AI

Has there been any additional research done on the subject of PTSD Reactivity Condition?

"Presently, 23 clinical studies are in their final phase of analysis to evaluate PTSD Reactivity Condition. Out of the 110 active trials, Karachi Sindh is home to several and 207 total sites host research for this condition."

Answered by AI

How severe can the effects of PTSD Reactivity Condition be on individuals?

"Our team at Power provided PTSD Reactivity Condition with a rating of 1, as this is an early phase trial wherein the safety and efficacy have only been partially assessed."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Florida
Connecticut
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
VA Connecticut Healthcare System
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Lost child need help to cope.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study
2021. "Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827056.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top