Opioid-Related DisordersPhase 2/3BridgeNCT04325659
An Innovative Intervention for OUD Treatment
A Phase 2/3 study testing Bridge Device and Lofexidine in people with Opioid-Related Disorders and Opioid Dependence, run by Johns Hopkins University at 1 site in United States.
Trial summary
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment. Importantly, medical devices reviewed by the FDA are cleared (based on safety) rather than approved (based on efficacy), which means the BD did not need to demonstrate efficacy before it… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Opioid Dependence, Opioid Addiction
- What is being tested?
- Bridge Device and Lofexidine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 20 Apr 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old
- Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe) based upon Mini-International Neuropsychiatric Interview (MINI)
- Provides a urine sample that tests positive for opioids during screening or have evidence of opioid withdrawal
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- No significant psychiatric illnesses besides OUD
- Seeking treatment to stop using illicit opioids
- Willing to comply with the study protocol
- Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation
Who cannot join
- Pregnant or breast feeding
- Receiving opioid agonist treatment
- Significant medical illness (e.g., insulin dependent diabetes)
- Significant psychiatric illness (e.g., schizophrenia)
- Use of medical cannabis
- Contraindications for use of the Bridge Device, morphine, lofexidine or naloxone (e.g., hemophilia, psoriasis and other skin conditions, a cardiac pacemaker)
Show all 16Show fewer
- Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification
- Hypotension (diastolic blood pressure of less than 60 mm Hg or systolic blood pressure of less than 90 mm Hg on screening examination)
- Prolonged corrected QT interval interval on screening ECG (defined as >0.44 seconds for males and >0.46 seconds for females)
- Hepatic or renal impairment, as indicated by the following lab results at the screening session:
- Aspartate aminotransferase or alanine transaminase >3x upper limit of normal (ULN)
- Total Bilirubin >2x ULN.
- Creatinine >1.5x ULN.
- Treatment with a strong 2D6 inhibitor (e.g., paroxetine, thioridazine, cinacalcet, bupropion, methotrimeprazine, fluoxetine, midostaurin, propafenone, glycerol phenylbutyrate, halofantrine, cisapride, dacomitinib, orphenadrine, quinidine)
- Have a known allergy to any of the study medications
- Have circumstances that would interfere with study participation (e.g., impending jail)
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
Official title: Evaluating a Neuromodulator Medical Device (Bridge Device) for Opioid Use Disorder Treatment
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment. Importantly, medical devices reviewed by the FDA are cleared (based on safety) rather than approved (based on efficacy), which means the BD did not need to demonstrate efficacy before it became commercially available. As a result, the device was not required to have a sham-controlled trial for FDA clearance and there is no active research, to the investigators' knowledge, that specifically addresses the degree to which opioid withdrawal can be treated through neuromodulation. To rigorously evaluate the efficacy of the BD for treating OUD, the investigators will enroll persons with active OUD, not currently receiving medications for OUD. Participants will be recruited and admitted to the Clinical Research Unit (CRU) for a 2-3 week period. During participants' residential stay, participants will be stabilized for 7-11 days on four times daily morphine (30 mg, SC) and undergo a precipitated withdrawal challenge using the opioid antagonist naloxone, approximately >= 4 days of morphine maintenance. This is a standard practice for the investigators' study and allows the investigators to objectively assess dependence. The BD and study medication will begin following morphine stabilization. Participants will be randomly assigned to one of three conditions (1) active BD with placebo (BD/P), (2) sham BD with lofexidine (SBD/L), or (3) sham BD and placebo (SBD/P). Participants will use the BD for 5 days and will receive study drug for 7 days. Participants will be monitored for an additional 4 days after device removal to determine whether withdrawal resumes. Participants will undergo a second naloxone challenge after removal of the device/capsule completion to verify lack of opioid tolerance and will be encouraged to begin treatment with oral naltrexone followed by extended release naltrexone. Throughout the residential stay, all participants will be given referral to and assisted with engaging in outpatient treatment following study discharge.
- Being tested
- Bridge Device, Lofexidine, Placebo, Sham Bridge Device
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridge DeviceDevice
Also called NSS-2 Bridge Device
An FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal
LofexidineDrug
Also called Lucemyra
FDA-approved medication for the treatment of opioid withdrawal. Participants will receive capsules 4 times daily for 7 days. The active dose is 0.72 mg four times daily for Days 1-5, for a total daily dose of 2.88 mg. Doses on Days 6 and 7 will be 1.44 (2 active, 2 placebo capsules) and 0.72 mg (1 active, 3 placebo capsules), respectively.
PlaceboDrug
Inactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days.
Sham Bridge DeviceDevice
Also called Sham NSS-2 Bridge Device
Inactive Bridge Device which is applied and looks identical to the active Bridge Device
| Study group | Role | What they receive |
|---|---|---|
| Lofexidine/Sham Bridge Device | Active comparator | Lofexidine (Lucemyra) encapsulated Receives: Drug: Lofexidine; Device: Sham Bridge Device |
| Sham Bridge Device /Placebo Study Drug | Placebo comparator | Inactive Bridge Device and placebo study drug Receives: Drug: Placebo; Device: Sham Bridge Device |
| Active Bridge Device/ Placebo Study Drug | Experimental | Active Bridge Device and placebo study drug Receives: Device: Bridge Device; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Retained
The number of participants retained (dichotomous: retained, not retained) during the 5 day intervention. Greater retention is indicative of a better treatment outcome.
Measured: Up to 5 days
Withdrawal Severity as Measured by Clinical Opiate Withdrawal Scale (COWS) Peak Score
Peak COWS Score (range: 0-48). Lower peak COWS scores are indicative of better withdrawal suppression.
Measured: At the end of day 5
Withdrawal Severity as Measured by Area Under the Curve for COWS Score From Days 1-5 of Active Study Intervention
Area under the curve COWS scores (range: 0-240). Smaller area under the curve COWS scores are indicative of better withdrawal suppression.
Measured: Four times a day (0800, 1200, 1600, 2000) on each of days 1-5
Withdrawal Severity as Measured by COWS Peak Daily Score
Peak daily COWS score (range: 0-48). Lower peak daily COWS scores are indicative of better withdrawal suppression.
Measured: Up to 5 days
Secondary outcomes (5)
Number of Participants Retained
The number of participants who are retained (dichotomous: retained, not retained) during the 9 day intervention. Greater retention is indicative of better intervention outcome.
Measured: At the end of day 9
Withdrawal Severity as Measured by the SOWS Peak Daily Score
Peak SOWS Score (range: 0-64). Lower peak SOWS scores are indicative of better withdrawal suppression.
Measured: Up to day 5
Withdrawal Severity as Measured by Area Under the Curve SOWS Score
Area under the curve SOWS scores (range: 0-320). Smaller area under the curve SOWS scores are indicative of better withdrawal suppression.
Measured: Four times a day (0800, 1200, 1600, 2000) days 1-5
Withdrawal Severity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) Peak Score
Peak daily SOWS score (range: 0-64). Lower peak daily SOWS scores are indicative of better withdrawal suppression.
Measured: End of Day 5
Number of Participants Who Initiate Naltrexone at the End of the Study
The number of participants who initiate naltrexone (dichotomous: yes, no) at the end of day 9. A larger number of participants is indicative of better naltrexone initiation success.
Measured: At the end of day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start15 Nov 2020
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is of a device (the Bridge Device), not of a drug.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Eric Strain, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325659
- Sponsor's protocol ID
- IRB00241133
- Other IDs
- R01DA048761
- Acronym
- Bridge
- Status last verified
- May 2026
- First submitted
- 25 Mar 2020
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Neuromodulator Medical Device (Bridge Device) for Opioid Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT04325659
- Acronym / sponsor ID
- Bridge / IRB00241133
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Posted 9 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment. Importantly, medical devices reviewed by the FDA are cleared (based on safety) rather than approved (based on efficacy), which means the BD did not need to demonstrate efficacy before it became commercially available. As a result, the device was not required to have a sham-controlled trial for FDA clearance and there is no active research, to the investigators' knowledge, that specifically addresses the degree to which opioid withdrawal can be treated through neuromodulation. To rigorously evaluate the efficacy of the BD for treating OUD, the investigators will enroll persons with active OUD, not currently receiving medications for OUD. Participants will be recruited and admitted to the Clinical Research Unit (CRU) for a 2-3 week period. During participants' residential stay, participants will be stabilized for 7-11 days on four times daily morphine (30 mg, SC) and undergo a precipitated withdrawal challenge using the opioid antagonist naloxone, approximately >= 4 days of morphine maintenance. This is a standard practice for the investigators' study and allows the investigators to objectively assess dependence. The BD and study medication will begin following morphine stabilization. Participants will be randomly assigned to one of three conditions (1) active BD with placebo (BD/P), (2) sham BD with lofexidine (SBD/L), or (3) sham BD and placebo (SBD/P). Participants will use the BD for 5 days and will receive study drug for 7 days. Participants will be monitored for an additional 4 days after device removal to determine whether withdrawal resumes. Participants will undergo a second naloxone challenge after removal of the device/capsule completion to verify lack of opioid tolerance and will be encouraged to begin treatment with oral naltrexone followed by extended release naltrexone. Throughout the residential stay, all participants will be given referral to and assisted with engaging in outpatient treatment following study discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is of a device (the Bridge Device), not of a drug.
| Arm | Type | Receives |
|---|---|---|
| Lofexidine/Sham Bridge Device | Active comparator | Drug: Lofexidine, Device: Sham Bridge DeviceLofexidine (Lucemyra) encapsulated |
| Sham Bridge Device /Placebo Study Drug | Placebo comparator | Drug: Placebo, Device: Sham Bridge DeviceInactive Bridge Device and placebo study drug |
| Active Bridge Device/ Placebo Study Drug | Experimental | Device: Bridge Device, Drug: PlaceboActive Bridge Device and placebo study drug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years old
- Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe) based upon Mini-International Neuropsychiatric Interview (MINI)
- Provides a urine sample that tests positive for opioids during screening or have evidence of opioid withdrawal
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- No significant psychiatric illnesses besides OUD
Key exclusion criteria (16 listed)
- Pregnant or breast feeding
- Receiving opioid agonist treatment
- Significant medical illness (e.g., insulin dependent diabetes)
- Significant psychiatric illness (e.g., schizophrenia)
- Use of medical cannabis
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 |
|---|---|---|
| Bridge DeviceAlso: NSS-2 Bridge DeviceAn FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal | Device | Active Bridge Device/ Placebo Study Drug |
| LofexidineAlso: LucemyraFDA-approved medication for the treatment of opioid withdrawal. Participants will receive capsules 4 times daily for 7 days. The active dose is 0.72 mg four times daily for Days 1-5, for a total daily dose of 2.88 mg. Doses on Days 6 and 7 will be 1.44 (2 active, 2 placebo capsules) and 0.72 mg (1 active, 3 placebo capsules), respectively. | Drug | Lofexidine/Sham Bridge Device |
| PlaceboInactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days. | Drug | Active Bridge Device/ Placebo Study Drug, Sham Bridge Device /Placebo Study Drug |
| Sham Bridge DeviceAlso: Sham NSS-2 Bridge DeviceInactive Bridge Device which is applied and looks identical to the active Bridge Device | Device | Lofexidine/Sham Bridge Device, Sham Bridge Device /Placebo Study Drug |
Primary outcome
Number of Participants Retained
Time frame: Up to 5 days
The number of participants retained (dichotomous: retained, not retained) during the 5 day intervention. Greater retention is indicative of a better treatment outcome.
Withdrawal Severity as Measured by Clinical Opiate Withdrawal Scale (COWS) Peak Score
Time frame: At the end of day 5
Peak COWS Score (range: 0-48). Lower peak COWS scores are indicative of better withdrawal suppression.
Withdrawal Severity as Measured by Area Under the Curve for COWS Score From Days 1-5 of Active Study Intervention
Time frame: Four times a day (0800, 1200, 1600, 2000) on each of days 1-5
Area under the curve COWS scores (range: 0-240). Smaller area under the curve COWS scores are indicative of better withdrawal suppression.
Withdrawal Severity as Measured by COWS Peak Daily Score
Time frame: Up to 5 days
Peak daily COWS score (range: 0-48). Lower peak daily COWS scores are indicative of better withdrawal suppression.
5 secondary outcomes
Number of Participants Retained
Time frame: At the end of day 9
Withdrawal Severity as Measured by the SOWS Peak Daily Score
Time frame: Up to day 5
Withdrawal Severity as Measured by Area Under the Curve SOWS Score
Time frame: Four times a day (0800, 1200, 1600, 2000) days 1-5
Withdrawal Severity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) Peak Score
Time frame: End of Day 5
Number of Participants Who Initiate Naltrexone at the End of the Study
Time frame: At the end of day 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Eric Strain principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bridge Device and Lofexidine in people with Opioid-Related Disorders and Opioid Dependence, run by Johns Hopkins University 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 9 Jun 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Retained (time frame: Up to 5 days). The study lists 4 primary outcomes in all. 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 9 Jun 2026.