The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Bridge is a percutaneous nerve field stimulation device
The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
Caron Treatment Centers
Wernersville, Pennsylvania, United States
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Score Range: The COWS score can range from 0 to 48. Interpretation: 0-4: No withdrawal 5-12: Mild withdrawal 13-24: Moderate withdrawal 25-36: Moderately severe withdrawal 37-48: Severe withdrawal High scores mean more severe withdrawal.
Time frame: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. High scores mean worse symptom intensity.
Time frame: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use
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