MORGANTOWN - The nation's first clinical trial to treat opioid addiction using brain implants designed to shock away the mechanisms that lead to physical addiction will be conducted in West Virginia beginning next month.
The study, greenlighted by the Food and Drug Administration in February, will be led by Dr. Ali Rezai, director of the West Virginia University Rockefeller Neuroscience Institute in Morgantown and fueled by a grant from the National Institute of Drug Abuse.
The initial phase of the two-part study will first follow four participants, each with "life-threatening" levels of addiction and having failed multiple lesser options, as they respond to implants placed on the brain's reward system - firing electrical pulses to steer away the course of addiction in the brain.
Known as deep brain stimulation, Rezai likened it 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 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.
The initial two-year study will mainly serve as a proof of concept and safety before expanding to 16-patient randomized and controlled study in the second phase.
DBS is not a first-line treatment for addiction, and the device can cost as much as $100,000 in the United States. But Rezai said implants could someday be used as commonly and safely as they're used to treat Parkinson's disease - a viable option for those with severe addiction, as well as yielding more predictive information on how addiction works.
On the ethics of a brain implant, Rezai noted the device does not change how a person thinks, only how their biology reacts to a stimuli.
Treating addiction through implants in West Virginian was publicly touted by Gov. Jim Justice in his 2016 State of the State address. Rezai said the trial, in casting West Virginia as a place were solutions for be found, has received continual support from Justice and West Virginia's congressional delegation.
Globally, there are eight registered DBS clinical trials for drug addiction, according to a U.S. National Institutes of Health database. Six are in China.
China has a long, troubled history of using brain surgery to treat addiction. Doctors destroyed small clumps of tissue in the brains of heroin users, garnering huge profits and leaving behind a trail of patients with mood disorders, lost memories and altered sex drives.
Western attempts to push forward with human trials of deep brain stimulation for drug addiction have foundered, but the vast suffering wrought by the U.S. opioid epidemic may be changing the risk-reward calculus for doctors and regulators.
More than 500,000 Americans died of drug overdoses in the decade ending in 2017, adding urgency to the search for new, more effective treatments.
The Associated Press contributed to this report.