MORGANTOWN — Efforts by researchers at West Virginia University Rockefeller Neuroscience Institute and WVU Medicine are underway as an initial patient received a device as part of the facility’s clinical trial of using deep brain stimulation to fight opioid addiction.
On Tuesday, Nov. 5, officials with WVU announced the launch of the trial — the first of its kind in the U.S. — as the team successfully implanted a Medtronic DBS device in the addiction and reward center of a patient’s brain. The trial’s first participant is a 33-year-old man, who has struggled with substance use disorder, specifically excessive opioid and benzodiazepine use, for more than a decade with multiple overdoses and relapses.
Funded through a grant from the National Institute on Drug Abuse, the clinical trial is led by principal investigator, Dr. Ali Rezai, executive chair of the RNI, and a multidisciplinary team of neurosurgical, psychiatric, neuroscience and other experts.
Rezai, in a previous interview with The Herald-Dispatch, likened the implanted device to an in-brain pacemaker, which has been used for more than 30 years already to treat Parkinson’s disease — though this is the first time the device will be applied to addiction in the United States.
The trial will involve multiple outside partners and teams including neurologists, psychologists and case workers to track each patient’s progress, as well as studying the biomarkers associated with addiction in each patient’s brain during treatment.
“Addiction is a brain condition, and in addiction you have to deal with our biology as well as our environment,” Rezai said, “and we need to explore new technologies, such as the use of DBS, to help those severely impacted by opioid use disorder.”
The initial two-year study will mainly serve as a proof of concept and safety before expanding to a 16-patient randomized and controlled study in the second phase.
West Virginia has the highest age-adjusted rate of drug overdose deaths involving opioids. In 2017, drug overdose deaths involving opioids in West Virginia occurred at a rate of 49.6 deaths per 100,000 persons, according to NIDA.
The first phase of this clinical trial involves four participants. To qualify, patients will have failed standards of care across multiple levels of WVU Medicine’s comprehensive inpatient, residential and outpatient treatment programs that include medication, as well as psychological and social recovery efforts.
“Despite our best efforts using current, evidence-based treatment modalities, there exist a number of patients who simply don’t respond. Some of these patients remain at very high risk for ongoing catastrophic health problems and even death. DBS could prove to be a valuable tool in our fight to keep people alive and well,” said Dr. James Berry, interim chair of the WVU Department of Behavioral Medicine and Psychiatry and director of Addiction Services at RNI, in a news release.
DBS, or brain pacemaker surgery, involves implantation of tiny electrodes into specific brain areas to regulate the structures involved in addiction and behavioral self-control. This study will also investigate the mechanism of the addiction in the brain. The U.S. Food and Drug Administration has approved DBS for treating patients with Parkinson’s disease, essential tremor, dystonia, epilepsy and obsessive-compulsive disorder. The RNI team routinely uses DBS to treat patients with these disorders, according to WVU officials.