A Better Way Forward For Veterans: Wearable Neurostimulation for Opioid Withdrawal

The purpose of this series of clinical trials is to test a novel closed-loop cognitive augmentation system to enhance attention, task performance under stress, and resilience to cybersickness. The system will automatically apply transcutaneous auricular neurostimulation (tAN) at optimal times according to cognitive state metrics derived from multimodal biosensors. This system will be validated incrementally through several experiments to refine a prototype neural interface.

This is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. Two wearable sensors will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels. The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

This study is designed as a randomized, double-blind, sham-controlled trial performed in a healthy human model of acute stress. The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor. This study utilizes the Sparrow Hawk to deliver tAN with a compact, single use, ergonomic form factor designed for military applications.

The IMBUE RETAIN trial is a 2-year pilot randomized clinical trial designed to achieve milestones determining the feasibility, tolerability, and device adherence of administering tAN therapy to a population with co-occurring PTSD/OUD population in the context of buprenorphine therapy initiation and stabilization. The objective of this study is to establish the preliminary efficacy of tAN-facilitated buprenorphine treatment retention at 3-months as well as assess the effect of tAN on PTSD symptom severity and opioid withdrawal symptoms. This study will power a larger pivotal trial in the same population.