Feasibility and acceptability of wearing a neuromodulation device at night in individuals in recovery from opioid use disorder.

Introduction: Opioid use disorder (OUD) is a serious and persistent problem in the United States with limited non-pharmacological treatment options, especially for the concomitant sleep disorders experienced by most individuals with addiction. While new, non-invasive interventions such as low-intensity focused ultrasound (LIFU) have shown promise in targeting the brain regions impacted throughout addiction and recovery, the devices used are not amenable to outpatient treatment in their current form factor and cannot be used at night during sleep. To bridge this gap and provide a much-needed treatment option for repeated, at-home use, we developed a wearable LIFU device out-of-clinic use.

Methods: This study evaluated the feasibility and acceptability of the portable treatment device among individuals recovering from OUD in an unsupervised, at-home setting. 31 subjects were recruited from a Baltimore, Maryland (USA) outpatient treatment facility and, along with a separate group of 14 healthy controls (HC), were asked to wear a prototype EEG-only (non-LIFU) device for 7 consecutive nights to assess their willingness and adherence to nightly use. Participants used a smartphone application, TrialKit (ePRO), to self-report nightly sleep data (e.g. duration, quality, possible disturbances, and device comfort).

Results: Of the 31 OUD participants recruited, 30 (97%) successfully completed the at-home study, and the majority responded that they would participate in future studies using the head wearable device (OUD, 87%; HC, 71%). OUD participants were statistically more likely than HCs to respond that they would consider using the device in the future to help them sleep (OUD, 70%; HC, 29%). Despite some participants facing technological issues (e.g. lack of reliable phone access or cellular data plans), the OUD group demonstrated high study compliance on par with the healthy control group.

Discussion: Participant's daily ePRO and exit interview results established that at-home use of advanced treatment technology is feasible in a population group challenged with recovering from OUD. Even more so, numerous participants noted strong willingness to participate in future LIFU-enabled intervention studies to address their persistent sleep issues during recovery.