Opioid-use DisorderNCT04731935
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
A study testing Sparrow Therapy System in people with Opioid-use Disorder and Opioid Withdrawal, run by Spark Biomedical, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Opioid Withdrawal
- What is being tested?
- Sparrow Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Current opioid dependence; prescriptive or non-prescriptive
- COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
- 18-65 years of age
- English proficiency
- Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements
Who cannot join
- Current evidence of an uncontrolled and/or clinically significant medical condition
- History of seizures or epilepsy
- History of neurological diseases or traumatic brain injury
- Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
- Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
- Presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators)
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- Abnormal ear anatomy or ear infection present
- Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for the duration of the study
- Females who are pregnant or lactating
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Safety and Efficacy of a Novel Electrode Configuration for Delivering Transcutaneous Auricular Neurostimulation to Improve Symptoms Associated With Opioid Withdrawal
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
Read the detailed description
This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy.
- Conditions
- Opioid-use Disorder, Opioid Withdrawal
- Being tested
- Sparrow Therapy System
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms
- Medical subject headings
- Opioid-Related Disorders, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparrow Therapy SystemDevice
Transcutaneous auricular neurostimulation
| Study group | Role | What they receive |
|---|---|---|
| tAN Therapy | Experimental | tAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for a total of 120 hours (5 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. Receives: Device: Sparrow Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical opiate withdrawal scale (COWS) score
Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.
Measured: 60 minutes
Secondary outcomes (3)
Clinical opiate withdrawal scale (COWS) score
Mean percent change in COWS score from baseline to 30 minutes after start of tAN therapy.
Measured: 30 minutes
Clinical opiate withdrawal scale (COWS) score
Mean percent change in COWS score from baseline to 120 minutes after start of tAN therapy.
Measured: 120 minutes
Clinical opiate withdrawal scale (COWS) score
Mean percent change in COWS score from baseline to Days 2 through 5 after start of tAN therapy.
Measured: Days 2-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start18 Mar 2021
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Navid Khodaparast, PhD, Study director, Spark Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731935
- Sponsor's protocol ID
- SBM-OWP-04
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Safety and Efficacy of a Novel Electrode Configuration for Delivering Transcutaneous Auricular Neurostimulation to Improve Symptoms Associated With Opioid Withdrawal
- ClinicalTrials.gov ID
- NCT04731935
- Acronym / sponsor ID
- SBM-OWP-04
- Conditions
- Opioid-use Disorder, Opioid Withdrawal
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
Detailed description
This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment.
| Arm | Type | Receives |
|---|---|---|
| tAN Therapy | Experimental | Device: Sparrow Therapy SystemtAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for a total of 120 hours (5 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current opioid dependence; prescriptive or non-prescriptive
- COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
- 18-65 years of age
- English proficiency
- Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements
Key exclusion criteria (10 listed)
- Current evidence of an uncontrolled and/or clinically significant medical condition
- History of seizures or epilepsy
- History of neurological diseases or traumatic brain injury
- Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
- Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
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 |
|---|---|---|
| Sparrow Therapy SystemTranscutaneous auricular neurostimulation | Device | tAN Therapy |
Primary outcome
Clinical opiate withdrawal scale (COWS) score
Time frame: 60 minutes
Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.
3 secondary outcomes
Clinical opiate withdrawal scale (COWS) score
Time frame: 30 minutes
Clinical opiate withdrawal scale (COWS) score
Time frame: 120 minutes
Clinical opiate withdrawal scale (COWS) score
Time frame: Days 2-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- 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.
Navid Khodaparast, PhD study director
Spark Biomedical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Therapy System in people with Opioid-use Disorder and Opioid Withdrawal, run by Spark Biomedical, Inc. 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 5 inclusion and 10 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 19 Aug 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical opiate withdrawal scale (COWS) score (time frame: 60 minutes). 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 19 Aug 2021.