Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Opioid Use Disorder Clinical Trial

Official title:

Impact of Bridge™ Device as a Non-pharmacological Approach to Treat Opioid Withdrawal in Opioid Use Disorder (OUD) Subjects in an Inpatient Treatment Center

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05924945
• Other study ID #: DENE0001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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)

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Device:
• Bridge™ active device
Bridge is a percutaneous nerve field stimulation device
• Bridge™ sham 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.

Locations

Country	Name	City	State
United States	Caron Treatment Centers	Wernersville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess change in Clinical Opiate Withdrawal Scale (COWS) score		pre-device placement to Day 5 (post-device removal)
Secondary	Assess change in Subjective Opiate Withdrawal Scale (SOWS) score		pre-device placement to Day 5 (post-device removal)