Rehan Aziz, MDDr. Aziz has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.
REVIEW OF: Miranda A and Taca A, Am J Drug Alcohol Abuse 2017:1–8
A challenging barrier for patients with opioid use disorders is the discomfort that can occur during the “induction phase” of their treatment, which is the period between discontinuation of opioids and initiation of medication-assisted therapy (MAT). Difficulties with induction arise due to several factors, including fear of withdrawal itself and poorly managed withdrawal symptoms.
In 2017, the FDA cleared a device for the use of electrical stimulation to reduce opioid withdrawal symptoms. The prescription-only product, called NSS-2 BRIDGE®, is attached behind the ear using adhesives and does not require surgery. It generates low-voltage electrical current that stimulates percutaneous nerves around the ear. This results in diminished withdrawal-associated pain and negative emotional states. It is worn continuously for 5 days during the withdrawal period, which covers the full life of the device’s battery. BRIDGE® is thought to produce rapid and sustained improvements in withdrawal symptoms, leading to higher MAT transition rates.
The FDA’s approval of the device was based on an open-label, uncontrolled, retrospective study in adult patients. Seventy-three medical records were reviewed from outpatient clinics in several Midwestern states. Concerning patient characteristics, the mean length of opioid dependence was 70 months, and most used heroin. Outcomes assessed included withdrawal scores during the induction phase measured by the Clinical Opioid Withdrawal Scale (COWS), and the percentage of patients who transitioned to MAT after 5 days.
Overall, most patients had moderate withdrawal symptoms, and their average initial COWS score was 20.1. But using the device for 20 minutes produced a 63% drop in average COWS scores, to 7.5. Scores then dropped to 3.1 after 60 minutes and 0.6 after 5 days. On the fifth day, 64 of 73 participants (88%) returned to the clinic and successfully transitioned to MAT. No rescue medications were administered, and no adverse events were noted.
CATR’s Take This pilot study provides us with exciting data, but falls short of indicating whether use of this device leads to improved short- and long-term outcomes for patients with opioid use disorders. It is also unclear how the device compares to standard detox protocols. BRIDGE® costs approximately $500 and is not covered under insurance plans, limiting its utility in many patient populations. It is for one-time use and requires special training to place. Ultimately, BRIDGE® is an encouraging step in addiction treatment, but is unlikely to make a profound impact.