The West Virginia University Rockefeller Neuroscience Institute (RNI) and WVU Medicine have announced that they are launching a new clinical trial. The program, which is the first of its kind in the United States, will be using a technique called DBS (deep brain stimulation) on patients living with opioid use disorder that has proven resistant to treatment.
The clinical trial is being funded by the National Institute on Drug Abuse (NIDA). Dr. Ali Rezai was the principal investigator and the study also included a team of psychiatric, neuroscience, neurosurgical, along with other specialists in their field.
DBS Surgery Explained
In DBS (brain pacemaker surgery), minuscule electrodes are implanted into distinct brain areas. Once in place, the electrodes regulate the structures involved in self-control and addiction. The US Food and Drug Administration (FDA) has approved this treatment method for treating patients with several medical conditions, including epilepsy, obsessive-compulsive disorder (OCD), Parkinson’s disease and dystonia (a movement disorder where the patient’s muscles contract repetitively). The RNI team uses DBS as a treatment for patients with these disorders regularly.
The first person to undergo the procedure was a man (33 years of age). He had been living with substance abuse disorder for more than 10 years. He had been using opioids and benzodiazepines and had experienced more than one overdose and had relapsed several times. The team implanted a Medtronic DBS device in the addiction and reward center of the man’s brain.
Small Patient Group for Phase One of Clinical Trial
Four participants are involved in the initial portion of the clinical trial. To qualify, the patients must 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.”
Dr. James Berry, the interim chair of the WVU Department of Behavioral Medicine and Psychiatry and director of Addiction Services at RNI, said that despite the treatment options available, some patients don’t respond. These patients are at a high risk of ongoing health problems and may even lose their life if their substance abuse problem isn’t successfully treated.
West Virginia has the highest level of opioid overdose deaths (age-adjusted). According to NIDA, drug overdose fatalities due to opioids in the state occurred at a rate of 49.6 deaths per 100,000 population (2017).