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ORIGINAL RESEARCH article

Front. Psychiatry
Sec. Addictive Disorders
Volume 15 - 2024 | doi: 10.3389/fpsyt.2024.1481795
This article is part of the Research Topic Addictive Disorders and Digital Medicine: Technology-based solutions for Addictive Disorders View all 5 articles

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

Provisionally accepted
Kristy L Meads Kristy L Meads 1Steve Huettner Steve Huettner 1Dexter Amata Dexter Amata 1Hailey Johnson Hailey Johnson 1,2Jaime Devine Jaime Devine 3Shenali Warnakulasuriya Shenali Warnakulasuriya 1Keith R Murphy Keith R Murphy 1Cameron Harrison Good Cameron Harrison Good 1*
  • 1 Attune Neurosciences, Bel Air, United States
  • 2 Stevenson University, Stevenson, Maryland, Maryland, United States
  • 3 Institute for Behavioral Research, Baltimore, United States

The final, formatted version of the article will be published soon.

    Opioid use disorder (OUD) is a serious and persistent problem in the United States with limited nonpharmacological 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. This study evaluated the feasibility and acceptability of the portable treatment device among individuals recovering from OUD in an unsupervised, at-home setting. Subjects were recruited from a Baltimore, Maryland (USA) outpatient treatment facility and, along with a separate group of healthy controls, 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). Of the 31 OUD participants recruited, 30 (97%) successfully completed the at-home study. Despite 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. 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.

    Keywords: Addiction, Sleep, insomnia, human factors, focused ultrasound, sex differences, Methadone, ePRO

    Received: 16 Aug 2024; Accepted: 14 Nov 2024.

    Copyright: © 2024 Meads, Huettner, Amata, Johnson, Devine, Warnakulasuriya, Murphy and Good. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Cameron Harrison Good, Attune Neurosciences, Bel Air, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.