Device behind ear could ease pain of drug withdrawal

The prospect of enduring withdrawal pain dissuades many people addicted to opiates from even attempting to quit. Now, an Indiana company has a new device that could help make outpatient detox doable for thousands.

A little larger than a half dollar, the Neuro-Stim System Bridge fits behind the ear and sends electrical feedback to the brain, blocking the pain of detox. A person wears it for five days, long enough to make it through withdrawal, before turning to long-term assistance to stay sober, such as counseling and medication-assisted treatment.

“This is the first and only of its kind,” said Brian Carrico, vice president of sales for Innovative Health Solutions, the Versailles-based company behind the device. “This is groundbreaking. This will absolutely change the face of recovery.”

For the past six weeks the Union County Opiate Treatment Center has offered its clients the Bridge. The second-smallest county in the state, Union has no inpatient treatment centers, said Jeff Mathews, who co-runs the Liberty clinic started by the local health department.  Finding a way for people to succeed at outpatient detox was critical.

The 37 people who have used the Bridge have all made it through, Mathews said.

“It’s not a matter of if it will work. It’s a matter of will I ever see a case where it doesn’t work,” he said. “With the Bridge, you’re getting them clean in a way that they can deal with it. … The goal of this program is to get them to counseling.”

Addiction to opioids, a class of drugs that includes heroin and prescription painkillers such as oxycodone and fentanyl, has skyrocketed in recent years across the United States. About 1.9 million people have prescription painkiller use disorder, and 435,000 are regular users of heroin, according to the U.S. Department of Health and Human Services'  Substance Abuse and Mental Health Services Administration.

Once addicted, stopping can be daunting. A body that has become used to regular infusions of a drug will start producing a cascade of physical symptoms if it is denied that drug. Symptoms include muscle aches and pains, diarrhea, shakes and vomiting. Many people who try to quit using the drugs start using again within a few hours if only to ease the pain.

That's where the Bridge device can enter the picture, company officials say. People who have tried it report their pain alleviates within 20 to 30 minutes of receiving the device, which must be installed by a trained provider. They wear it for five days, remove it, undergo drug and disease testing, start on another a long-term drug used to treat opioid dependency, and enter counseling.

The theory behind the device stems from a field known as neuromodulation, which uses electrical signals to stimulate parts of the nervous system.

While neuromodulators already existed, including an earlier device by Innovative to treat chronic and acute pain, the company's director of scientific research sought to develop his own. Dr. Chris Brown worked on the theory that in chronic pain, parts of the brain become too active while other parts become  too idle. Brown compares tweaking the Bridge to adjusting a thermostat in a house where the temperature can be too hot or too cold, depending on how one runs the air conditioner or heater.

“We stimulate parts of the brain that actively control the perception of pain,” he said. “This isn’t a magic pill that makes everything go away. It removes that wall of pain.”

Trained providers implant the device and its electrodes just behind the ear, where the cranial nerves are closest to the surface. A battery-operated chip sends impulses to nerves to block the pain.

Overall, the theory differs little from approaches that have been around for many years and is basically electro-acupuncture, said Dr. Palmer MacKie, director of the Integrative Pain Program at Eskenazi Health, who has no connection to Innovative Health Solutions. What’s different here is that people implanting the Bridge must look for the vascular bundles near the ear, whose position may differ slightly from patient to patient.

“They have improved the delivery system.   … From the information I have seen both on pain and addiction, I think there’s room for optimism about the device,” MacKie said. “But I don’t think anything will revolutionize addiction or chronic pain management.”

Few rigorous scientific studies of such devices exist at this point, MacKie said. However, the devices are quite safe. More work needs to be done into how effective they are. He hopes to be able to start offering the Bridge to patients soon.

A company-sponsored study of fewer than 50 patients found that almost 90 percent of people who used the device made it through the first week of detox and into secondary therapy. The study has not yet been published in a peer-reviewed medical journal.

The Food and Drug Administration has cleared the device for use, but that imprimatur only attests to the safety of the device, not its efficacy.

For now, Innovative Health Solutions has been donating its devices, which cost $495 each, to the Union County program. Mathews said he hopes insurance will soon cover the cost of the device.

In other settings, having the device placed may cost more as a provider could charge for his or her services. In Union County, the health department provides the nurse practitioner.

Earlier this year, Shaun Tudor became one of the first patients to try the Bridge. The 24-year-old had tried to quit his heroin addiction a few times in the past, said his sister Brittany Tudor. He tried Suboxone. He tried methadone. He tried quitting cold turkey.

Each time, he wound up so sick he went right back to using, said Brittany, who tried to nurse him through the withdrawal. He even tried inpatient rehabilitation but was still in withdrawal upon release and he went right back to using.

On Feb. 29 he had the Bridge implanted. On his way to the treatment center, he was in withdrawal and shaky and miserable. By the time Brittany brought him back to her Richmond home, he could sit and watch a movie and eat dinner with her, something he hadn’t done in years.

The next few days were a little harder, but Shaun made it through withdrawal and into counseling and onto medication-assisted treatment. He has been sober ever since.

“This is the longest he has stayed clean, absolutely,” Brittany said. “The Bridge made withdrawal definitely tolerable.”

Recently, Shaun’s older daughter turned 4. Her father was there to celebrate her birthday while sober for the first time in her young life.

Call IndyStar reporter Shari Rudavsky at (317) 444-6354. Follow her on Twitter: @srudavsky