Opioid Use Disorder
Conditions
Brief summary
The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.
Interventions
DEVICEBridge™ active device
Bridge is a percutaneous nerve field stimulation device
DEVICEBridge™ sham device
The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
Sponsors
Masimo Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A randomization table will be kept with the sponsor. Subjects and study site staff (investigators, researchers, care providers) will be blinded to the group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant able to provide written informed consent * Participant is 18 to 65-years old * Participant has confirmed opioid use disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 * Participants is entering an OUD treatment program
Exclusion criteria
* Participant requires tapering from another substance at entry to treatment * Participant is pregnant or lactating * Participant has a history of hemophilia or psoriasis vulgaris * Participant has a cardiac pacemaker implant device * Participant has irritated or broken skin at the site of intended device placement * Participant is currently participating in, or was enrolled in another clinical trial within the last 30 days * Participant has a history of poor wound healing * Participant has a severe autoimmune disease or uncontrolled diabetes * Participant has an open wound/abscess infection/MRSA * Participant has a history of a chronic pain in the last 90 days * Participant has a serious medical condition which in the judgment of the principal investigator or his/her designee would make study participation unsafe, or would make intervention compliance difficult * Participant has a psychiatric illness (bipolar disorder, schizophrenia, or other psychotic disorder, active suicidal ideation with a plan within the last month or suicide attempt)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use | The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Score Range: The COWS score can range from 0 to 48. Interpretation: 0-4: No withdrawal 5-12: Mild withdrawal 13-24: Moderate withdrawal 25-36: Moderately severe withdrawal 37-48: Severe withdrawal High scores mean more severe withdrawal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use | The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. High scores mean worse symptom intensity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bridge™ Active Device The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Bridge™ active device: Bridge is a percutaneous nerve field stimulation device | 6 |
| Bridge™ Sham Device The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses
Bridge™ sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses. | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Total | Bridge™ Active Device | Bridge™ Sham Device |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 6 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 13 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Score Range: The COWS score can range from 0 to 48. Interpretation: 0-4: No withdrawal 5-12: Mild withdrawal 13-24: Moderate withdrawal 25-36: Moderately severe withdrawal 37-48: Severe withdrawal High scores mean more severe withdrawal.
Time frame: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use
Population: The study was terminated prematurely due to sponsor decision with no clinical rationale for the termination. This was a prospective study investigating the test device. Of 13 subjects using the device, only 6 completed the study. The sample size is well below the threshold needed to perform reliable statistical comparisons. We reported all demographic data and outcome measure data from the limited sample. Further data reporting would be statistically inappropriate due to the sample size.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score device use 120 min (raw data) | 2 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score device use 4 days (raw data) | 1 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score device use 60 min (raw data) | 6 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score pre-device placement, 0 min device use (raw data) | 16 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score device use 30 min (raw data) | 8 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score device use 120 min (raw data) | 5 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score device use 2 days (raw data) | 4 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score device use 3 days (raw data) | 6 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score device use 4 days (raw data) | 5 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 4 COWS score device use 5 days (raw data) | 3 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score pre-device placement, 0 min device use (raw data) | 20 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score device use 30 min (raw data) | 7 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score device use 60 min (raw data) | 7 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score device use 2 days (raw data) | 4 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score device use 3 days (raw data) | 2 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 5 COWS score device use 5 days (raw data) | 0 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score pre-device placement, 0 min device use (raw data) | 16 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score device use 30 min (raw data) | 11 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score device use 60 min (raw data) | 10 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score device use 120 min (raw data) | 8 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score device use 2 days (raw data) | 8 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score device use 3 days (raw data) | 8 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score device use 4 days (raw data) | 9 score on a scale |
| Bridge™ Active Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 6 COWS score device use 5 days (raw data) | 4 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score device use 2 days (raw data) | 16 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score device use 60 min (raw data) | 3 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score device use 120 min (raw data) | 5 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score device use 2 days (raw data) | 9 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score device use 4 days (raw data) | 3 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score device use 30 min (raw data) | 5 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score device use 60 min (raw data) | 3 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score device use 120 min (raw data) | 6 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score device use 2 days (raw data) | 10 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score device use 3 days (raw data) | 8 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score device use 4 days (raw data) | 0 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score device use 5 days (raw data) | 7 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score pre-device placement, 0 min device use (raw data) | 15 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score device use 30 min (raw data) | 7 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score device use 3 days (raw data) | 13 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score device use 4 days (raw data) | 15 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 2 COWS score device use 5 days (raw data) | 13 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score pre-device placement, 0 min device use (raw data) | 17 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score device use 30 min (raw data) | 14 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score device use 60 min (raw data) | 10 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score device use 120 min (raw data) | 9 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 1 COWS score pre-device placement, 0 min device use (raw data) | 18 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score device use 3 days (raw data) | 3 score on a scale |
| Bridge™ Sham Device | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | Subject 3 COWS score device use 5 days (raw data) | 5 score on a scale |
Secondary
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. High scores mean worse symptom intensity.
Time frame: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use
Population: The study was terminated prematurely due to sponsor decision with no clinical rationale for the termination. This was a prospective study investigating the test device. Of 13 subjects using the device, only 6 completed the study. The sample size is well below the threshold needed to perform reliable statistical comparisons. We reported all demographic data and outcome measure data from the limited sample. Further data reporting would be statistically inappropriate due to the sample size.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score device use 5 days (raw data) | 5 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score device use 30 min (raw data) | 26 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score device use 60 min (raw data) | 22 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score device use 120 min (raw data) | 14 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score pre-device placement, 0 min device use (raw data) | 36 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score device use 30 min (raw data) | 25 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score device use 4 days (raw data) | 6 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score pre-device placement, 0 min device use (raw data) | 32 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score device use 30 min (raw data) | 12 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score device use 60 min (raw data) | 10 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score device use 120 min (raw data) | 9 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score device use 2 days (raw data) | 11 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 4 SOWS score device use 3 days (raw data) | 11 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score pre-device placement, 0 min device use (raw data) | 47 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score device use 2 days (raw data) | 12 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score device use 3 days (raw data) | 10 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score device use 4 days (raw data) | 4 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 5 SOWS score device use 5 days (raw data) | 4 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score device use 60 min (raw data) | 24 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score device use 120 min (raw data) | 19 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score device use 2 days (raw data) | 17 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score device use 3 days (raw data) | 11 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score device use 4 days (raw data) | 8 score on a scale |
| Bridge™ Active Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 6 SOWS score device use 5 days (raw data) | 6 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score device use 5 days (raw data) | 9 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score device use 30 min (raw data) | 49 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score pre-device placement, 0 min device use (raw data) | 40 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score device use 30 min (raw data) | 42 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score device use 60 min (raw data) | NA score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score device use 120 min (raw data) | 24 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score device use 2 days (raw data) | 38 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score device use 3 days (raw data) | 28 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score device use 4 days (raw data) | 19 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 1 SOWS score device use 5 days (raw data) | 28 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score pre-device placement, 0 min device use (raw data) | 23 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score device use 30 min (raw data) | 10 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score device use 60 min (raw data) | 10 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score device use 120 min (raw data) | 10 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score device use 2 days (raw data) | 16 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score device use 3 days (raw data) | 19 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score device use 4 days (raw data) | 32 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 2 SOWS score device use 5 days (raw data) | 34 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score device use 60 min (raw data) | 35 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score device use 120 min (raw data) | 37 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score device use 2 days (raw data) | 43 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score device use 3 days (raw data) | 18 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score device use 4 days (raw data) | 9 score on a scale |
| Bridge™ Sham Device | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | Subject 3 SOWS score pre-device placement, 0 min device use (raw data) | 46 score on a scale |