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Clinical trial investigates possible treatment for PTSD

Matthew Rizzo, PhD

UNMC researchers are collaborating with research-focused biopharmaceutical company ANANDA Scientific Inc., on a clinical trial evaluating Nantheia™ ATL5,  an investigational cannabidiol (CBD) drug, using ANANDA’s proprietary delivery technology, to treat PTSD.

From military veterans to survivors of domestic violence, sexual assault or human trafficking, people with post-traumatic stress disorder (PTSD) often face challenges of depression, anxiety, anger, self-destructive behaviors and sleeplessness. As a result, PTSD can lead to social isolation and declines in quality of life.

The research study is led by principal investigator Matthew Rizzo, MD, the Reynolds Professor and chair of the UNMC Department of Neurological Sciences and chief physician for neurological services at Nebraska Medicine. Dr. Rizzo’s research team includes Brigette Vaughan, an advanced practice registered nurse and instructor, and Ying Zhang, PhD, chair of the UNMC Department of Biostatistics.

“PTSD is challenging to diagnose and causes great suffering in our community that demands urgent action,” Dr. Rizzo said. He is hopeful the investigational drug, Nantheia™ ATL5, will provide clinicians with an alternative investigational treatment option.

“We’ve come to understand better how trauma affects the brain, not just in the moments surrounding the trauma, but for years after,” said military veteran Jerry Walker, PhD, executive director, Mental Health Services at TimelyCare and former UNMC faculty member. “Some major life events fundamentally reshape how we experience the world and thus respond to it. This plays out in structural and functional changes in the brain, which is why identifying and effectively treating this condition is so important.”

Investigators hope this research study may inspire additional studies on PTSD and related conditions, as well as illuminate how psychiatric diseases affect people’s brains in the real world.

“We now understand that trauma isn’t about what happened to you ‘back then’ as much as it is what is still affecting your nervous system now,” said Lou Lukas, MD, associate professor of palliative medicine at UNMC and a member of the research team. “Some traumatic experiences leave active remnants in a person’s system that are later associated with chronic diseases, mental health problems and lower quality of life. Studying new molecules such as CBD, psilocybin and MDMA is giving us new insights both as to how the body holds those remnants and the tools to help release them so we can restore vitality.”

The phase II double-blind, placebo-controlled, randomized clinical trial plans to enroll 210 participants.

Dr. Rizzo’s team seeks people – with and without PTSD – between the ages of 21 and 65. Participants with PTSD will be in the research study for about three months, including eight weeks of research study medication treatment.  Individuals without PTSD will participate for about three weeks. All participants will answer questions about their physical and mental health and be asked to wear a Fitbit to track their activity and sleep. All will be compensated for their time and travel.

Persons interested in participating can fill out this form.

Call 402-559-6870 or email mbhl@unmc.edu to learn more information about this study.

The IRB number is 159-22-FB.