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An Innovative Intervention for OUD Treatment (Bridge)

Primary Purpose

Opioid-Related Disorders, Opioid Dependence, Opioid Addiction

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bridge Device
Lofexidine
Placebo
Sham Bridge Device
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Behavioral Pharmacology Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Lofexidine/Sham Bridge Device

Sham Bridge Device /Placebo Study Drug

Active Bridge Device/ Placebo Study Drug

Arm Description

Lofexidine (Lucemyra) encapsulated

Inactive Bridge Device and placebo study drug

Active Bridge Device and placebo study drug

Outcomes

Primary Outcome Measures

Proportion of participants retained
The proportion of participants who are 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
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 COWS score
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
Peak daily COWS score (range: 0-48). Lower peak daily COWS scores are indicative of better withdrawal suppression.

Secondary Outcome Measures

Proportion of participants retained
The proportion of participants who are retained (dichotomous: retained, not retained) during the 9 day intervention. Greater retention is indicative of better intervention outcome.
Withdrawal severity as measured by the Subjective Opiate Withdrawal Scale (SOWS) peak score
Peak SOWS Score (range: 0-64). Lower peak SOWS scores are indicative of better withdrawal suppression.
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.
Withdrawal severity as measured by the SOWS peak daily score
Peak daily SOWS score (range: 0-64). Lower peak daily SOWS scores are indicative of better withdrawal suppression.
Proportion of Participants who initiate naltrexone at the end of the study
The proportion of participants who initiate naltrexone (dichotomous: yes, no) at the end of day 9. A larger proportion of participants is indicative of better naltrexone initiation success.
Number of concomitant medications used
Number of concomitant medications used per day. A smaller number of concomitant medications used per day is indicative of better treatment efficacy.

Full Information

First Posted
March 25, 2020
Last Updated
October 5, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04325659
Brief Title
An Innovative Intervention for OUD Treatment
Acronym
Bridge
Official Title
Evaluating a Neuromodulator Medical Device (Bridge Device) for Opioid Use Disorder Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Opioid Dependence, Opioid Addiction, Opioid Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lofexidine/Sham Bridge Device
Arm Type
Active Comparator
Arm Description
Lofexidine (Lucemyra) encapsulated
Arm Title
Sham Bridge Device /Placebo Study Drug
Arm Type
Placebo Comparator
Arm Description
Inactive Bridge Device and placebo study drug
Arm Title
Active Bridge Device/ Placebo Study Drug
Arm Type
Experimental
Arm Description
Active Bridge Device and placebo study drug
Intervention Type
Device
Intervention Name(s)
Bridge Device
Other Intervention Name(s)
NSS-2 Bridge Device
Intervention Description
An FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal
Intervention Type
Drug
Intervention Name(s)
Lofexidine
Other Intervention Name(s)
Lucemyra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days.
Intervention Type
Device
Intervention Name(s)
Sham Bridge Device
Other Intervention Name(s)
Sham NSS-2 Bridge Device
Intervention Description
Inactive Bridge Device which is applied and looks identical to the active Bridge Device
Primary Outcome Measure Information:
Title
Proportion of participants retained
Description
The proportion of participants who are retained (dichotomous: retained, not retained) during the 5 day intervention. Greater retention is indicative of a better treatment outcome.
Time Frame
Up to 5 days
Title
Withdrawal Severity as measured by Clinical Opiate Withdrawal Scale (COWS) peak score
Description
Peak COWS Score (range: 0-48). Lower peak COWS scores are indicative of better withdrawal suppression.
Time Frame
At the end of day 5
Title
Withdrawal Severity as measured by area under the curve COWS score
Description
Area under the curve COWS scores (range: 0-240). Smaller area under the curve COWS scores are indicative of better withdrawal suppression.
Time Frame
At the end of day 5
Title
Withdrawal Severity as measured by COWS peak daily score
Description
Peak daily COWS score (range: 0-48). Lower peak daily COWS scores are indicative of better withdrawal suppression.
Time Frame
Up to 5 days
Secondary Outcome Measure Information:
Title
Proportion of participants retained
Description
The proportion of participants who are retained (dichotomous: retained, not retained) during the 9 day intervention. Greater retention is indicative of better intervention outcome.
Time Frame
At the end of day 9
Title
Withdrawal severity as measured by the Subjective Opiate Withdrawal Scale (SOWS) peak score
Description
Peak SOWS Score (range: 0-64). Lower peak SOWS scores are indicative of better withdrawal suppression.
Time Frame
At the end of day 5
Title
Withdrawal severity as measured by area under the curve SOWS score
Description
Area under the curve SOWS scores (range: 0-320). Smaller area under the curve SOWS scores are indicative of better withdrawal suppression.
Time Frame
At the end of day 5
Title
Withdrawal severity as measured by the SOWS peak daily score
Description
Peak daily SOWS score (range: 0-64). Lower peak daily SOWS scores are indicative of better withdrawal suppression.
Time Frame
Up to 5 days
Title
Proportion of Participants who initiate naltrexone at the end of the study
Description
The proportion of participants who initiate naltrexone (dichotomous: yes, no) at the end of day 9. A larger proportion of participants is indicative of better naltrexone initiation success.
Time Frame
At the end of day 9
Title
Number of concomitant medications used
Description
Number of concomitant medications used per day. A smaller number of concomitant medications used per day is indicative of better treatment efficacy.
Time Frame
Up to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia L Bergeria, PhD
Phone
410-550-1979
Email
cberge21@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Strain
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Bergeria, Ph.D.
Phone
410-989-1756
Email
cberge21@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Tanya Chikosi
Phone
410-550-1233
Email
tchikos1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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An Innovative Intervention for OUD Treatment

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