Substance Use DisordersNCT03762798
Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone
A study testing The Bridge in people with Substance Use Disorders and Substance Abuse, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance Use Disorders, Substance Abuse, Substance Use
- What is being tested?
- The Bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Lutheran Hospital
Cleveland, Ohio, 44113
About this study
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
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.
Read the 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.
- Being tested
- The Bridge
- Keywords
- substance abuse, the bridge
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BridgeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All participants will receive the Bridge device. Receives: Device: The Bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start19 Nov 2018
- Primary completion25 Oct 2020
- Study completion1 Dec 2020
Why it stopped: Not able to enroll participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Streem, MD, The Cleveland Clinic
- Investigators
- David W Streem, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762798
- Sponsor's protocol ID
- 18-863
- Status last verified
- Sep 2021
- First submitted
- 28 Nov 2018
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03762798
- Acronym / sponsor ID
- 18-863
- Keywords
- substance abuse, the bridge
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to enroll participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: The BridgeAll participants will receive the Bridge device. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The BridgeThe 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. | Device | Treatment |
Primary outcome
Primary Objective
Time frame: Three Months
Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Streem, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Bridge in people with Substance Use Disorders and Substance Abuse, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.