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Completed

NCT Number: NCT04325659

An Innovative Intervention for OUD 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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Addiction Opioid Dependence Opioid Withdrawal Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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)

Treatment and study plan

Bridge Device

Device

An FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal

Other names: NSS-2 Bridge Device

Lofexidine

Drug

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.

Other names: Lucemyra

Placebo

Drug

Inactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days.

Sham Bridge Device

Device

Inactive Bridge Device which is applied and looks identical to the active Bridge Device

Other names: Sham NSS-2 Bridge Device

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Number of Participants Retained

    Time frame: At the end of day 9

    The number of participants who are retained (dichotomous: retained, not retained) during the 9 day intervention. Greater retention is indicative of better intervention outcome.

  2. Withdrawal Severity as Measured by the SOWS Peak Daily Score

    Time frame: Up to day 5

    Peak SOWS Score (range: 0-64). Lower peak SOWS scores are indicative of better withdrawal suppression.

  3. Withdrawal Severity as Measured by Area Under the Curve SOWS Score

    Time frame: Four times a day (0800, 1200, 1600, 2000) days 1-5

    Area under the curve SOWS scores (range: 0-320). Smaller area under the curve SOWS scores are indicative of better withdrawal suppression.

  4. Withdrawal Severity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) Peak Score

    Time frame: End of Day 5

    Peak daily SOWS score (range: 0-64). Lower peak daily SOWS scores are indicative of better withdrawal suppression.

  5. Number of Participants Who Initiate Naltrexone at the End of the Study

    Time frame: At the end of day 9

    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.

Other outcomes

  1. Number of Concomitant Medications Used

    Time frame: Up to 5 days

    Number of concomitant medications used per day. A smaller number of concomitant medications used per day is indicative of better treatment efficacy.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Evaluating a Neuromodulator Medical Device (Bridge Device) for Opioid Use Disorder Treatment

Acronym: Bridge

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2020
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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