BRIDGE Device for Treatment of Opioid Withdrawal
NCT04162145, Not applicable, Terminated, BrightView LLC
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | BRIDGE Device for Treatment of Opioid Withdrawal | ClinicalTrials.gov |
| NCT number | NCT04162145 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 12 participants, actual | ClinicalTrials.gov |
| Lead sponsor | BrightView LLC | ClinicalTrials.gov |
| Conditions | Opioid Withdrawal, Pain, Craving | ClinicalTrials.gov |
| Interventions | Active BRIDGE device placement, Inactive BRIDGE device placement | ClinicalTrials.gov |
| First posted | 2019-11-14 | ClinicalTrials.gov |
| Last updated | 2020-06-25 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Comparison of change from baseline of Clinical Opiate Withdrawal Scale (COWS) scores between active BRIDGE device group and sham BRIDGE device group at one hour | 3 months | The primary outcome is comparison of change from baseline of the Clinical Opiate Withdrawal Scale (COWS) scores( score: 5-12=Mild; 13-24=Moderate; 25-36=Moderately Severe; More than 36=Severe Withdrawal) between active BRIDGE device group and sham BRIDGE device group at one hour. The two groups will be compared using a two-sided two sample t-test at an alpha of 0.001 at an interim analysis of the first 24 completing and at an alpha of 0.049 after 50 have completed. For all the efficacy parameters (e.g. Clinical Opiate Withdrawal Scale, Visual Analog Scale, Opioid Craving Scale and the Stroop test using CNS Vital Signs) the descriptive statistics will include N, mean median, standard error (SE), minimum and maximum or percentage and exact Clopper Pearson 95% confidence interval. | ClinicalTrials.gov |
| Secondary | Comparison of change from baseline of Clinical Opiate Withdrawal Scale (COWS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months | 3 months | As a secondary analysis the investigators will examine the change over time of the Clinical Opiate Withdrawal Scale (COWS) scores between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months. The effects in the model will include the baseline score, treatment groups, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit week will be treated as the repeated variable within a patient. Patient, treatment, and visit will be treated as class variables. Unstructured covariance matrix will be used initially, and additional types (e.g., auto- regression, Toeplitz, CS, etc.) will be tried to assess the robustness of the unstructured matrix. Comparison between treatments will be based on contrasts of least square treatment means at each week of interest. Least square means, standard errors, and 95% confidence intervals (CI) of treatment difference will be reported for the two groups. | ClinicalTrials.gov |
| Secondary | Comparison of change from baseline of pain Visual Analog Scale (VAS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months | 3 months | As a secondary analysis the investigators will examine the change over time of the pain Visual Analog Scale (VAS) scores (0= not at ll, 10=extremely) between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months. | ClinicalTrials.gov |
| Secondary | Comparison of change from baseline of Opioid Craving Scale (OCS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months | 3 months | As a secondary analysis the investigators will examine the change over time of the Opioid Craving Scale (OCS) scores (0= not at all, 10=extremely) between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months. The effects in the model will include the baseline score, treatment groups, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit week will be treated as the repeated variable within a patient. Patient, treatment, and visit will be treated as class variables. Unstructured covariance matrix will be used initially, and additional types (e.g., auto- regression, Toeplitz, CS, etc.) will be tried to assess the robustness of the unstructured matrix. Comparison between treatments will be based on contrasts of least square treatment means at each week of interest. Least square means, standard errors, and 95% confidence intervals (CI) of treatment difference will be reported for the two groups. | ClinicalTrials.gov |
| Secondary | Comparison of change from baseline of cognition Stroop test scores using CNS Vital Signs software between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months | 3 months | As a secondary analysis the investigators will examine the change over time of cognitive function measured by the Stroop test (CNS Vital Signs) between groups using a mixed-effects model repeated measures (MMRM) analysis incorporating treatment period data up to 3 months. The test has three parts. In the first, the words RED, YELLOW, BLUE and GREEN (printed in black) appear at random on the screen, and the subject presses the space bar as soon as he or she sees the word. This generates a simple reaction time score.The subject is asked to press the space bar when the color of the word matches what the word says. This generates a complex reaction time score. In the third part, the subject is asked to press the space bar when the color of the word does not match what the word says. This part also generates a complex reaction time score, called the "Stroop reaction time. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Simple Reaction Time | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)