Cyclobenzaprine for Post-Traumatic Stress Disorder

(OASIS Trial)

This trial examines the safety and effectiveness of Cyclobenzaprine HCl, a muscle relaxant, in reducing stress symptoms after a car crash. Researchers aim to determine if taking this treatment shortly after the incident decreases immediate stress reactions and long-term post-traumatic stress symptoms. Participants will take either the study medication or a placebo over two weeks to evaluate these effects. This trial suits individuals who have visited the emergency room after a car accident and are returning home, particularly those with significant pain and a high risk for stress disorders. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Yes, you may need to stop taking certain medications. The trial excludes participants using specific medications like SSRIs, SNRIs, TCAs, and others listed in the protocol. If you're taking any of these, you might need to stop them before joining the trial.

Research has shown that TNX-102 SL, a form of cyclobenzaprine taken under the tongue, is generally well-tolerated. In earlier studies, most patients did not experience serious side effects. Common side effects included drowsiness and dry mouth, typical for this type of medication. Evidence also indicates that it helps improve sleep and reduce symptoms of stress disorders. This treatment is under study for conditions like PTSD and fibromyalgia. Although this trial remains in the early stages, its testing indicates it has passed initial safety checks.¹²³⁴⁵

Unlike most treatments for PTSD, which typically involve psychotherapy and medications like SSRIs or SNRIs, Cyclobenzaprine HCl is a muscle relaxant that offers a new approach by potentially addressing the condition through its effects on sleep and muscle tension. Researchers are excited about this treatment because it may provide faster relief of PTSD symptoms, potentially improving sleep quality, which is often disrupted in PTSD patients. Cyclobenzaprine's unique mechanism of targeting both muscle relaxation and sedation could complement existing therapies, offering a novel avenue for managing symptoms more effectively.

Research has shown that Cyclobenzaprine HCl, particularly in the form TNX-102 SL, might aid conditions like PTSD by improving sleep problems. In this trial, participants will receive either Cyclobenzaprine HCl or a placebo. One study found that a higher dose of Cyclobenzaprine (5.6 mg) at bedtime improved PTSD symptoms more than a placebo, especially in sleep and social interactions. This suggests it could also help reduce immediate stress reactions and prevent long-term stress after traumatic events. Early findings indicate the treatment is well-tolerated and may support recovery by addressing sleep issues, which are often a major component of stress disorders.¹²⁶⁷⁸