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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Transcutaneous auricular neurostimulation
Recovery Unplugged
Austin, Texas, United States
Clinical opiate withdrawal scale (COWS) score
Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.
Time frame: 60 minutes
Clinical opiate withdrawal scale (COWS) score
Mean percent change in COWS score from baseline to 30 minutes after start of tAN therapy.
Time frame: 30 minutes
Clinical opiate withdrawal scale (COWS) score
Mean percent change in COWS score from baseline to 120 minutes after start of tAN therapy.
Time frame: 120 minutes
Clinical opiate withdrawal scale (COWS) score
Mean percent change in COWS score from baseline to Days 2 through 5 after start of tAN therapy.
Time frame: Days 2-5
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