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

Primary Purpose

Substance Use Disorders, Substance Abuse, Substance Use

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Bridge
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring substance abuse, the bridge

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cleveland Clinic Lutheran Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

All participants will receive the Bridge device.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 28, 2018
Last Updated
September 17, 2021
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03762798
Brief Title
Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone
Official Title
Can The Bridge Facilitate Successful Transition From Medication-Assisted Treatment (MAT) With Low-dose Sublingual Buprenorphine to Oral Naltrexone in Patients With Extended Remission of Opiate Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Not able to enroll participants.
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
October 25, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. After determination that the subject meets the inclusion criteria and does not meet any of the exclusion criteria for the study, the subject will receive the device which will be applied in the clinical office setting on an outpatient basis. Buprenorphine MAT will be stopped immediately and the subject will be followed on an outpatient basis to ensure the process has been successful. The subject will have the option to return to the office for a follow-up assessment in 1-4 days after device application. Seven to ten days after the last dose of buprenorphine, a urine sample will be collected for drug testing and a prescription for naltrexone will be provided. Then three visits on a roughly monthly basis will be scheduled. At each visit a urine sample for drug testing will be collected. After three follow-up visits are completed, if the drug testing demonstrates continued sobriety, the subject will be released from the study and may or may not continue treatment with naltrexone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Substance Abuse, Substance Use, Substance Dependence
Keywords
substance abuse, the bridge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
All participants will receive the Bridge device.
Intervention Type
Device
Intervention Name(s)
The Bridge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Objective
Description
Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period
Time Frame
Three Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Streem, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Lutheran Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44113
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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