Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Participant able to provide written informed consent
Participant is 18 to 65-years old
Participant has confirmed opioid use disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5
Participants is entering an OUD treatment program

Exclusion Criteria

Participant requires tapering from another substance at entry to treatment
Participant is pregnant or lactating
Participant has a history of hemophilia or psoriasis vulgaris
Participant has a cardiac pacemaker implant device
Participant has irritated or broken skin at the site of intended device placement
Participant is currently participating in, or was enrolled in another clinical trial within the last 30 days
Participant has a history of poor wound healing
Participant has a severe autoimmune disease or uncontrolled diabetes
Participant has an open wound/abscess infection/MRSA
Participant has a history of a chronic pain in the last 90 days
Participant has a serious medical condition which in the judgment of the principal investigator or his/her designee would make study participation unsafe, or would make intervention compliance difficult
Participant has a psychiatric illness (bipolar disorder, schizophrenia, or other psychotic disorder, active suicidal ideation with a plan within the last month or suicide attempt)

Primary Outcome Measures

Name	Time	Method
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score	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	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.

Secondary Outcome Measures

Name	Time	Method
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score	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	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.

Locations (1): Caron Treatment Centers
🇺🇸
Wernersville, Pennsylvania, United States
Caron Treatment Centers
🇺🇸Wernersville, Pennsylvania, United States