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Alpha-2 Adrenergic Agonist

BXCL501 Dose Range 40µg to 160µg for Post-Traumatic Stress Disorder

Phase 1

Waitlist Available

Led By Ismene Petrakis, MD

Research Sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

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 from day 1 through day 28

Awards & highlights

Study Summary

This trial aims to find out if Dexmedetomidine HCl (BXCL501) is safe and potentially effective for treating alcohol use disorder (AUD) with posttraumatic stress disorder (PT

Who is the study for?

This trial is for individuals with alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD). Participants should be outpatients, meaning they aren't staying in a hospital. Specific eligibility details are not provided, but typically participants must meet certain health criteria to join.Check my eligibility

What is being tested?

The study is testing the safety and early effectiveness of two doses of Dexmedetomidine HCl (BXCL501), taken under the tongue at 40µg and 80µg, for treating AUD with PTSD. The goal is to see if it's safe enough for larger trials.See study design

What are the potential side effects?

While specific side effects are not listed here, Dexmedetomidine can commonly cause dry mouth, low blood pressure, slow heart rate, and drowsiness. Side effects may vary based on dosage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 through day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 through day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 through day 28 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 Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28.

Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28.

Number and Proportion of Adverse Events

Secondary outcome measures

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 affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28.

Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28.

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: BXCL501 Dose Range 40µg to 160µgExperimental Treatment2 Interventions

Participants will receive 40µg on days 1-2. On days 3 and 4, participants will receive 40µg twice per day. On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening. On days 7-28 participants will receive 80µg in the morning and evening. Dose escalation will follow the above schedule based on tolerability assessed by clinician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2021

Completed Phase 1

~10

Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg

2021

Completed Phase 1

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pharmacotherapies for Alcohol and Substance Use Disorders AllianceLead Sponsor

6 Previous Clinical Trials

219 Total Patients Enrolled

VA Connecticut Healthcare SystemFED

81 Previous Clinical Trials

6,655 Total Patients Enrolled

Yale UniversityOTHER

1,853 Previous Clinical Trials

2,738,551 Total Patients Enrolled

Frequently Asked Questions

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

Would it be possible for me to participate in this medical study?

"Individuals aged between 21 and 65 years old diagnosed with alcohol use disorder are eligible for this trial, which has a capacity of enrolling up to 10 participants."

Answered by AI

Are individuals above the age of 25 eligible to participate in this recruitment for the clinical trial?

"To be considered for participation in this clinical research, individuals must be at least 21 years old but no older than 65."

Answered by AI

What is the safety profile of BXCL501 at doses ranging from 40µg to 160µg in individuals under medical care?

"Our team at Power has assigned a safety rating of 1 to the BXCL501 dosing range of 40µg to 160µg, considering this trial is in Phase 1 where there is minimal existing evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

2024. "Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06335407.