Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Last updated: December 5, 2024
Sponsor: Masimo Corporation
Overall Status: Completed

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Bridge™ sham device

Bridge™ active device

Clinical Study ID

NCT05924945
DENE0001
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andStatistical Manual of Mental Disorders-5

  • Participants is entering an OUD treatment program

Exclusion

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 trialwithin 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 principalinvestigator or his/her designee would make study participation unsafe, or wouldmake intervention compliance difficult

  • Participant has a psychiatric illness (bipolar disorder, schizophrenia, or otherpsychotic disorder, active suicidal ideation with a plan within the last month orsuicide attempt)

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Bridge™ sham device
Phase:
Study Start date:
June 08, 2023
Estimated Completion Date:
August 19, 2024

Connect with a study center

  • Caron Treatment Centers

    Wernersville, Pennsylvania 19565
    United States

    Site Not Available

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