Status:
COMPLETED
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
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial...
Detailed Description
Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms. This is a double blin...
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 con-sent 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. pace-makers, cochlear prosthesis, neuro-stimulators
- Abnormal ear anatomy or ear infection present
- Women of childbearing potential, not using adequate contraception as per investigator judgment 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 :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04075214
Start Date
November 19 2019
End Date
December 14 2020
Last Update
August 19 2021
Active Locations (1)
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1
Recovery Unplugged
Austin, Texas, United States, 78745