Clinical trial NCT04731935: Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Official title: A Pilot Study to Evaluate Safety and Efficacy of a Novel Electrode Configuration for Delivering Transcutaneous Auricular Neurostimulation to Improve Symptoms Associated With Opioid Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid Withdrawal
Keywords: auricular neurostimulation
vagus nerve stimulation
transcutaneous
withdrawal symptoms
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.

Detailed description: This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy.

Eligibility criteria: Inclusion Criteria:

* Current opioid dependence; prescriptive or non-prescriptive
* COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
* 18-65 years of age
* English proficiency
* Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

* Current evidence of an uncontrolled and/or clinically significant medical condition
* History of seizures or epilepsy
* History of neurological diseases or traumatic brain injury
* Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
* Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
* Presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators)
* Abnormal ear anatomy or ear infection present
* Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for the duration of the study
* Females who are pregnant or lactating
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Primary outcomes:
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: 60 minutes
Secondary outcomes:
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: 30 minutes
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: 120 minutes
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: Days 2-5
Other outcomes:
measure: Heart rate variability measured by R to R interval
timeFrame: Days 2-5
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Day 5
measure: Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5)
timeFrame: Day 5
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: Day 5
Locations:
city: Austin
country: United States
facility: Recovery Unplugged
state: Texas
Study officials:
affiliation: Spark Biomedical, Inc.
name: Navid Khodaparast, PhD
role: STUDY_DIRECTOR
References: