image: Joel Sprunger, PhD.
Credit: Photo/University of Cincinnati
The University of Cincinnati’s Center for Addiction Research and Spark Biomedical are conducting a clinical trial to help patients with opioid use disorder (OUD) and post-traumatic stress disorder (PTSD) stick with medication treatment while finding the right dose.
The trial, funded by a $2.1 million National Institute on Drug Abuse grant, addresses a critical challenge: the high (50%) dropout rate for patients taking buprenorphine, a medication for maintenance treatment of opioid dependence.
The dual challenge of OUD and PTSD
"Opioid withdrawal brings symptoms like anxiety and sweating, while PTSD adds layers of hypervigilance, sleep problems, and exaggerated reactivity," said principal investigator Joel Sprunger, PhD, assistant professor of psychiatry and behavioral neuroscience in UC’s College of Medicine. “These overlapping issues significantly complicate the treatment process.”
The trial will utilize Spark Biomedical’s Sparrow Ascent – a patient-administered wearable device that delivers mild electrical stimulation to the cranial branches of the vagus and trigeminal nerves on and around the ear.
This method, known as transcutaneous auricular neurostimulation (tAN), is FDA-cleared for relieving opioid withdrawal symptoms and may also aid in alleviating symptoms of PTSD. This pilot trial will evaluate the feasibility, safety, and effectiveness of tAN in patients beginning buprenorphine therapy with these co-occurring conditions.
Clinical trial goals
The trial’s primary goal is to increase buprenorphine retention rates over a three-month period. This pilot clinical trial will involve 20 patients with both OUD and PTSD who are taking buprenorphine as part of their treatment at the Gibson Center for Behavioral Change in Cape Girardeau, Missouri.
Participants will be randomly assigned to receive either active tAN therapy using Sparrow Ascent or active sham stimulation at a level that won’t activate the targeted nerves.
The trial will also seek to learn how patients perceive and react to the use of Sparrow Ascent as part of their treatment of OUD and PTSD, alongside standard buprenorphine therapy.
“Autonomic imbalance is a common occurrence in PTSD, which is characterized by experiencing high sympathetic drive (‘fight or flight’) and low parasympathetic drive (‘rest and digest’),” said Navid Khodaparast, PhD, chief science officer at Spark Biomedical. “Additionally, PTSD sufferers experience lower levels of endorphin production which can lead to emotional distress. In this study, we believe tAN therapy will improve these PTSD symptoms, and ultimately help maintain long-term buprenorphine treatment.”
In addition to its effects on physical symptoms, Sprunger said the Sparrow Ascent is a tool that gives patients direct control over a part of their recovery.
About University of Cincinnati’s Center for Addiction Research
The Center for Addiction Research is dedicated to changing outcomes and saving lives through work on opioid, stimulant, cannabis and alcohol use disorders. Their mission is to develop and test interventions to address gaps in evidence-based treatment and to optimize outcomes for individuals struggling with addiction.
About Spark Biomedical
Spark Biomedical creates wearable neurostimulation solutions, dedicated to overcoming addiction and trauma-related challenges. They aim to address the full lifecycle of opioid use disorder, including opioid-sparing, withdrawal management, relapse prevention and PTSD/trauma abatement. For more information about Spark Biomedical, please contact Udim Obot at udim.obot@sparkbiomedical.com.