Cyclobenzaprine for Post-Traumatic Stress Disorder

(OASIS Trial)

Recruiting at 5 trial locations

Overseen By Chad Cannon, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will examine the safety and efficacy of TNX-102 SL 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 Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 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

Christopher Jones, MD

Principal Investigator

Cooper University Health Care

Samuel McLean, MD

Principal Investigator

University of North Carollina at Chapel Hill

Eligibility Criteria

This trial is for individuals who have recently been in a motor vehicle collision and are at high risk of developing acute stress reactions or disorders. Participants will receive treatment shortly after the event and must be willing to undergo assessments over several weeks.

Inclusion Criteria

I am between 18 and 55 years old.

Able to speak and read English

I am willing and able to follow all study rules and attend all appointments.

Exclusion Criteria

I am scheduled to be admitted to the hospital.

I have a serious injury, like a major bone break.

I am currently recovering from a recent heart attack.

Treatment Details

Interventions

• Cyclobenzaprine HCl (Muscle Relaxant)

Trial Overview The study tests if TNX-102 SL, taken sublingually, can reduce symptoms of acute stress reaction/disorder right after a traumatic event like a car crash. It's compared with a placebo in a double-blind setup where neither doctors nor patients know who gets the real medicine.

Participant Groups

Group I: Cyclobenzaprine HCl Experimental Treatment 1 Intervention

Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of Cyclobenzaprine HCl in the ED as part of enrollment procedures. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation.

Group II: Placebo Placebo Group 1 Intervention

Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of placebo in the ED as part of enrollment procedures. The placebo is the same formulation as active except the Cyclobenzaprine HCl content is replaced by Mannitol to maintain the same tablet weight and dimensions. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

Cooper University Health Care

Collaborator

Trials

2

Recruited

2,000+

Tonix Pharmaceuticals, Inc.

Industry Sponsor

Trials

31

Recruited

4,900+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+