Could a device attached to the ear become a game-changer in detox?

Could an electrical stimulation device that is FDA-cleared for treating pain offer what would be a game-changing breakthrough in bringing about pain-free opioid withdrawal? Some practitioners who already are using the BRIDGE device in opioid detox are attaching superlatives such as “real deal” and “grand slam” to the product—terms not often heard in this space.

“'Magical' is not something that scientists normally use,” says Arturo Taca, MD, a Missouri addiction specialist who regularly employs the external ear stimulator with patients and who co-authored the first published study of its application in opioid dependence treatment. “I have people detoxing without use of any rescue meds.”

Taca adds, “You see one patient undergo this, and you're kind of in this cult.”

The pain associated with opioid withdrawal remains a primary reason why opioid-dependent patients drop out of treatment, or never even get to the front door. Yet the question of whether the BRIDGE could ultimately become part of the solution on a widespread basis remains up for speculation.

Observers say the maker of the device, the Versailles, Ind.-based Innovative Health Solutions, is in the process of seeking a reclassification of the product, which could pave the way for billing codes that would allow its wider use in opioid detox. The company has kept a low profile during this process, but some providers already are using its product off-label in opioid detox (the accuracy of applying the “off-label” moniker in this case is somewhat hazy, Taca believes, because pain is clearly a prominent component of detox).

“I have some patients who are gainfully employed and can't afford to be sick for a week with withdrawal,” says Katrina Lock, a nurse practitioner in private practice who estimates that she has used the BRIDGE with about 70 patients in Indiana and Kentucky, in many cases as a conduit to medication treatment with injectable naltrexone (Vivitrol).

“I have never seen it not work,” Lock says of the device.

Study findings

Taca, who reports no financial interest in the device, says interest in the product has grown mainly in Western states such as California and Alaska. “When you take it to the east coast, they want data,” he says.

The initial published data have come in the form of an article that appeared last month in The American Journal of Drug and Alcohol Abuse. The paper outlined a study conducted by Taca and Adrian Miranda, MD, who works at the medical center at the Medical College of Wisconsin and has been interested in identifying a stimulator that could help treat a vomiting disorder in children.

The published open-label study involved 73 opioid-dependent adults (90% of whom had been using opioids for at least two years) at outpatient drug treatment clinics in five states. The device, which stimulates peripheral cranial neurovascular bundles that can gain access to brain areas involved in pain and fear, was placed at the external ear for each patient. Withdrawal symptoms were measured before and at several intervals after placement, using the Clinical Opioid Withdrawal Scale, and most patients were sent home after achieving symptom relief within an hour. No rescue medications had to be used in the hourlong period after placement of the device, the researchers reported.

The patients were instructed to leave the device on for five days and to return to the clinic for further evaluation. Sixty-four of the 73 patients in the study were able to transition successfully to medication-assisted treatment after using the BRIDGE.

“This pilot study is the first to demonstrate that the signs and symptoms of opioid withdrawal can be rapidly and effectively attenuated without the use of pharmacotherapy,” the co-authors of the study wrote in their paper. They added that “having a treatment that offers rapid and effective improvement could lead to improved compliance and better treatment outcomes. The results of the study may therefore have significant clinical implications.”

Need for further research

Taca, who is president of the Midwest region for the American Society of Addiction Medicine (ASAM), says that with his study having been a retrospective analysis with a relatively small sample size, “The [manufacturer] needs to do a controlled study.”

Even without additional research, or a formal indication for treatment of opioid withdrawal symptoms, the BRIDGE has gained attention in numerous circles, including from leading behavioral health management consultant Jim Peake. Lock, the nurse practitioner in the Midwest, says a lack of insurance coverage poses the greatest barrier to more widespread use at the present time, although she adds that parents or other family members uually are willing to pay the $700 out-of-pocket cost for placement of the device.

“Another nurse practitioner also uses it in my office,” says Lock. “People are coming here from West Virginia, Pennsylvania.”

Taca says the device is similar to another electrical stimulation product that had been used in the past, but with a slightly different design and different frequencies. “It makes the transition to Vivitrol a lot easier,” he says.