Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Bridge™ active device

Bridge™ sham 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