Status:
COMPLETED
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Lead Sponsor:
Spark Biomedical, Inc.
Conditions:
Opioid-use Disorder
Opioid Withdrawal
Eligibility:
All Genders
18-65 years
Phase:
NA
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 symptom...
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 assessm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04731935
Start Date
March 18 2021
End Date
May 26 2021
Last Update
August 19 2021
Active Locations (1)
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1
Recovery Unplugged
Austin, Texas, United States, 78745