Access to the PPM Journal and newsletters is FREE for clinicians.

Non-Invasive Medical Device May Improve Opioid Withdrawal Success

November 24, 2017
The NSS-2 Bridge, the first wearable neurostimulation device that sits behind the ear and sends impulses aimed to disrupt symptoms of opioid withdrawal, received marketing authorization from the FDA.

Interviews with Arturo Taca, MD, and Tiziano Marovino, DPT, MPH

The US Food and Drug Administration granted marketing approval to Innovative Health Solutions, Inc for the Bridge following submission of an open-label pilot study in which nearly 89% of participants (n = 73) successfully transitioned to naltrexone.2

The Bridge was developed to interrupt pain and related symptoms commonly experienced during opioid withdrawal in patients who would be transition to naltrexone, an opioid receptor antagonist.2,3

The first 48 hours of opioid withdrawal presents the most critical phase in breaking the physical dependence of opioids, he said. Common physical symptoms typically include headaches, muscle pain, and aches, sweating, gastrointestinal pain (cramping), insomnia, anxiety lessening over five days. These symptoms are measured using the clinical opioid withdrawal scale (COWS).

“Neurostimulation provided by the Bridge device was associated with a significant reduction in opioid withdrawal scores, promoting a greater rate of transition to medication-assisted therapy, rather than relapse,” said Dr. Taca.

Using the Bridge neurostimulation device lessened pain and related opioid withdrawal symptoms.

Pilot Study Met Primary Endpoints

In an open-label, retrospective pilot study, 73 adults (66% male) from multiple sites were given the Bridge device.3 The baseline mean COWS score was 20.1 ± 6.1. Twenty minutes after Bridge placement, the mean score declined to 7.5 ± 5.9 (62.7% reduction, p < 0.001). The scores further decreased after 30 minutes 4.0 ±4.4 and 60 minutes 3.1 ±3.4 (84.6% reduction, p < 0.001). No rescue medications were administered during this period. The mean withdrawal score on the fifth day was 0.6 (97.1% reduction, p < 0.001).3

“The device was designed for use during the initial five days of a physician-supervised, opioid-withdrawal program,” said Arturo Taca, MD, a board-certified psychiatric and addiction pain specialist at INSYnergy, in Creve Coeur, Missouri. who approached Innovative Health Solutions with a concept that he wanted to develop to assist his patients in getting through the most difficult, early phase of withdrawal.

Emotional tone—restlessness, anxiety, fear—was measured on imaging, which are common barriers in patients facing withdrawal. Translating these psychological factors into pain perception and finding a means to help patients navigate the withdrawal phase and be better positioned to maintain the post-withdrawal protocol.

“The Bridge demonstrated a reduction in the frequency of firing in the amygdala of up to 55%, reducing anxiety as measured by imaging. A big component of anxiety and fear, which often become over-exaggerated in patients facing withdrawal,” Dr. Taca told Practical Pain Management.

Potential Opportunity for Relapse Prevention

““Most patients who have become addicted to a pain medication are looking to avoid replacing an opioid with another daily pill, they fear the withdrawal symptoms, and they are at risk for relapse, which often creates an emotional rollercoaster,” Dr. Taca told Practical Pain Management.

“I was looking to build on reports from the European use of electroacupuncture on persistent pain, thinking that would help my patients get through the first few days of withdrawal so they could receive an injection of naltrexone and complete a three-month comprehensive out-patient program,” said Dr. Taca. “During the program, we are able to tackle all controllable medical and psychological concerns that may arise, such as sleep apnea, anxiety, even issues such as improving diet to better manage body weight,” Dr. Taca said.

‘One of the greatest barriers to opioid withdrawal is to get patients stable,” he said, ”There are two factors that typically derail a patient: a desire to avoid medication when trying to get off opioids, and prohibitive cost and burden of in-patient rehabilitation. We were looking to design an outpatient psychosocial program that would ease patients through the most painful part of withdrawal so they could focus on the long-term work to avoid relapse.”

Lessening the Emotional and Physical Symptoms of Withdrawal

“Given that only 10% of patients with an opioid-use disorder manage to complete a withdrawal program successfully, I wanted to find a way to support my patients who wished to avoid taking another medication when transitioning off their opioid medication,” said Dr. Taca.

“The idea began three years ago when I was given an electroacupuncture device, P-Stim, which I tried with one patient. I recognized the potential in and value of involving the stimulation process but felt it needed longer duration functionality over the crucial three to five days of intense withdrawal,” Dr. Taca said.

He approached Innovation Health Solutions of Versailles, Indiana, to develop a device that would provide a distraction of pain and perceived lessening of withdrawal symptoms in patients entering an opioid withdrawal phase so they receive their first injection of naltrexone, and be capable of completing a three-month substance abuse program.

Large Clinical Trial Lends Supports to Naltrexone

As timing would have it, findings of a randomized, comparative effectiveness control trial of naltrexone and buprenorphine-naloxone, demonstrated equal efficacy of the two most common relapse-prevention medications.3

Supported by funding from the National Institute of Drug Addiction, lead author Joshua Lee, MD, an associate professor at New York University School of Medicine, said the results “support of the value of both treatments as effective for some patients.””

In the 24-week study, 570 adults were recruited from eight community-based, in-patient clinics who were randomized to receive either extended-release naltrexone or sublingual buprenorphine-naloxone for opioid withdrawal therapy.3

Clinical Perspective on Use of Bridge Device

“It seems that approval of the Bridge device signifies a shift in Food and Drug Administration (FDA) priorities as a way to address the health crisis of opioid-related deaths,” said Tiziano Marovino, DPT, MPH, DAIPM, a clinical research physical therapist and practitioner at Chronic Pain Solutions, an integrated rehabilitation center in Ypsilanti, Michigan.

How does the Bridge work? The Bridge device uses electricity applied to specific ear points with the goal of reducing signs and symptoms of withdrawal, which is a type of auriculo-therapy that relies on stimulation to key ear points, said Dr. Marovino.

“Although the Bridge neurostimulator appears to be a patented device suggesting the technology is new and unique, the application has been around since the 1990s and originally used for nicotine withdrawal,"4 he said, “While the device might be new, the method has been used for many years and finally seems it is gaining acceptance by mainstream providers."

“Auriculotherapy in general, whether we use electricity, light, sound, or mechanical stimulation (ie, needles) all may be effective,” Dr. Marovino told Practical Pain Management, “The critical aspect is not the device—it is the protocol as not all protocols work equally well.”

“Nonpharmaceutical solutions for either pain management and addiction care will likely take top priority with the new fast-track FDA approval programs.” Said Dr. Marovino, “Conventional FDA approval pathways appear to have been circumvented as a result of the emerging drug-related epidemic and the problems that result from it.

At present, the Bridge must be prescribed by the physician based a cash model.

“Our hope is that physicians will purchase the device and package the cost as part of a rehabilitation program,” said Dr. Taca, “The goal, of course, is to gain insurance reimbursement given the cost efficiency of avoiding in-patient services and risk of relapse.”

Both Dr. Taca and Dr. Moravino offered no financial conflicts to report.

Last updated on: November 28, 2017
Continue Reading:
Opioid Withdrawal: A New Look at Medication Options

Join The Conversation

Register or Log-in to Join the Conversation
close X