BXCL501 for Acute Stress Disorder

(BASIS Trial)

Recruiting at 3 trial locations

Overseen By Romina Soudavari, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Opioids, Sedatives, Antihistamines, others

Disqualifiers: Pregnancy, Cardiac disease, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, including those for alcoholism, some sedative antidepressants, and specific blood pressure medications. However, non-sedative antidepressants for PTSD are allowed.

What data supports the effectiveness of the drug BXCL501 for treating acute stress disorder?

The research suggests that drugs blocking norepinephric hyperactivity, like prazosin, show promise in treating stress-related conditions such as PTSD. This indicates that similar mechanisms might be effective for acute stress disorder, potentially supporting the use of BXCL501 if it has similar properties. ^{1 2 3 4 5}

Is BXCL501 safe for humans?

There is no specific safety data available for BXCL501 in the provided research articles. ^{2 4 6 7 8}

What is the purpose of this trial?

This study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency Department (ED) after Motor Vehicle Collision (MVC). Specifically, the investigators will perform the BXCL501 (BASIS) Trial, a double-blind placebo-controlled Randomized Controlled Trial (RCT) to determine if BXCL501 (dexmedetomidine hydrochloride sublingual film) initiated in the ED in the hours after MVC to high risk individuals, treats/reduces ASR/ASD symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 100 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.

Research Team

Samuel McLean, MD

Principal Investigator

University of North Carollina at Chapel Hill

Stacey House, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals who have experienced a Motor Vehicle Collision and are at high risk of developing acute stress reactions or post-traumatic stress. Participants will receive treatment in the Emergency Department and must be able to take medication sublingually (under the tongue).

Inclusion Criteria

Consent to receive unencrypted communications

Has a smartphone with continuous service for ≥ 1 year

Able to speak and read English

Exclusion Criteria

Prisoner status

Hypomagnesia (<1.7 mg/dL) or hypokalemia (< 3.0 Milliequivalents (mEq/L))

Chronic daily opioid use prior to MVC (> 20 mg oral daily morphine equivalents)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive BXCL501 or placebo in the ED and continue treatment for 14 days with a sublingual film

2 weeks

Initial visit in ED, daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of psychological and somatic symptoms, neurocognitive function, and adverse events

12 weeks

Multiple assessments at Week 1, 3, 6, 12

Treatment Details

Interventions

• BXCL501

Trial Overview The study tests BXCL501, a medication given under the tongue, against a placebo to see if it can reduce symptoms of acute stress reaction and prevent long-term post-traumatic stress after a car accident. It's a double-blind study with 100 participants.

Participant Groups

Group I: BXCL501 (dexmedetomidine HCl) Experimental Treatment 1 Intervention

Participants will be instructed to take an initial dose of BXCL501 (equivalent to 1 film, 120mcg) in the ED as part of enrollment procedures. If the time between the first dose and the planned bedtime of the participant is greater than 6 hours, participants will be instructed to take the second dose at bedtime on the day of enrollment. If the time between the first dose and the planned bedtime of the participant is less than 6 hours participants will be instructed to take the second dose before bedtime on the day following enrollment. Following the initial dosing on the day of enrollment, all participants will be instructed to take a dose of study medication before bedtime until they have completed 14 days of treatment.

Group II: Placebo Placebo Group 1 Intervention

Participants will be instructed to take an initial dose of placebo (equivalent to 1 film, 120mcg) in the ED as part of enrollment procedures. If the time between the first dose and the planned bedtime of the participant is greater than 6 hours, participants will be instructed to take the second dose at bedtime on the day of enrollment. If the time between the first dose and the planned bedtime of the participant is less than 6 hours participants will be instructed to take the second dose before bedtime on the day following enrollment. Following the initial dosing on the day of enrollment, all participants will be instructed to take a dose of study medication before bedtime until they have completed 14 days of treatment.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Vanderbilt University School of Medicine

Collaborator

Trials

16

Recruited

13,900+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

Walter Reed Army Institute of Research (WRAIR)

Collaborator

Trials

111

Recruited

108,000+

Findings from Research

Cognitive-behavioral interventions have shown positive effects for treating Acute Stress Disorder (ASD), while psychodynamic therapy, cognitive-behavioral therapy, and EMDR are promising for Posttraumatic Stress Disorder (PTSD).

Selective Serotonin Reuptake Inhibitors (SSRIs) are the most studied and effective medications for both ASD and PTSD, offering a broader therapeutic effect and better tolerance compared to tricyclic antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic possibilities after traumatic experiences]. Kapfhammer, HP.[2008]

References

1. Croatia pubmed.ncbi.nlm.nih.gov

[Therapeutic possibilities after traumatic experiences]. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

The alpha1-adrenergic antagonist prazosin improves sleep and nightmares in civilian trauma posttraumatic stress disorder. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Treatment-refractory posttraumatic stress disorder (TRPTSD): a review and framework for the future. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of Post-Traumatic Stress Disorders with the Alpha-1 Adrenergic Antagonist Prazosin. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Neurophysiological and clinical effects of the NMDA receptor antagonist lanicemine (BHV-5500) in PTSD: A randomized, double-blind, placebo-controlled trial. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Paroxetine treatment, following behavioral suppression of PTSD-like symptoms in mice, prevents relapse by activating the infralimbic cortex. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Treatment of posttraumatic stress disorder: the impact of paroxetine. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Prazosin in the treatment of PTSD. [2014]