Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone

NCT03762798 | Withdrawn FDA Device

• 1 other identifier: 18-863
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single center study of The Bridge in patients with sustained remission of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of patients will be admitted to the study.

Conditions

Substance Use Disorders; Substance Abuse; Substance Use; Substance Dependence

Keywords

substance abuse; the bridge

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period

  Three Months

Study Arms (1)

Treatment

EXPERIMENTAL

All participants will receive the Bridge device.

Device: The Bridge

Interventions

The Bridge DEVICE

The Bridge (Also known as NSS-2) is a percutaneous, auricular field stimulator developed to alleviate pain through stimulation of peripheral cranial neurovascular bundles in the external ear that could potentially gain access to brain areas involved in fear, pain and nociception. After five days, the subject will return to the clinic for device removal and disposal.

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of opiate use disorder, any severity
• Age range 18-99 years old
• Not pregnant or breastfeeding
• Able to understand and provide informed consent.
• Able to understand and speak the English language.
• At least one year of abstinence from drugs of abuse including, but not limited to, all opiates, cannabis, benzodiazepines, barbiturates, alcohol and cocaine.
• Use of nicotine is excluded from this criterion.
• Use of any prescribed, controlled substance, taken according to the prescribing instructions, for no more than seven consecutive days, at least three months prior to the subject's study enrollment, is excluded from this criterion.
• Taking dose of buprenorphine less than or equal to no more than 4 mg daily for at least three months prior to starting the study.
• In the case of Zubsolv rapid-dissolve tablets, equivalent daily dose maximum would be 2.9mg.
• In the case of Bunavail buccal film, equivalent daily dose maximum would be 2.1mg.
• At least one year of self-reported, established 12-step based recovery work, including
• Home group membership and regular attendance of two 12- step meetings per week
• Regular work with 12-step sponsor who can attest that the subject has worked through step nine of the twelve steps of Alcoholics Anonymous or a similar 12-step based mutual help organization.

You may not qualify if:

• Exhibits active psychosis or suicide ideation or is otherwise psychiatrically unstable.
• Positive Utox2 Immunoassay, Quantitative Pain Panel Liquid Chromatography/Mass Spectroscopy, or Ethylglucuronide test for any nonprescribed substance or medication.
• Meets criteria for any other active substance use disorder except nicotine
• Allergic to naltrexone or has any condition of such nature and/or severity that would clinically contraindicate the prescribing of naltrexone.
• Any condition that contraindicates the use of NSS-2 including hemophilia, cardiac pacemakers and psoriasis vulgaris.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, 44113, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• David W Streem, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 4, 2018
• Study Start: November 19, 2018
• Primary Completion: October 25, 2020
• Study Completion: December 1, 2020
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)