Opioid-use DisorderNCT04075214
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
A study testing transcutaneous auricular neurostimulation (tAN) in people with Opioid-use Disorder and Opioid Withdrawal, run by Spark Biomedical, Inc. at 1 site in United States.
Trial summary
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Opioid Withdrawal
- What is being tested?
- transcutaneous auricular neurostimulation (tAN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 14 Dec 2020
- 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
- No healthy volunteers
- 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 con-sent 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. pace-makers, cochlear prosthesis, neuro-stimulators
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- Abnormal ear anatomy or ear infection present
- Women of childbearing potential, not using adequate contraception as per investigator judgment 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: Delivering Transcutaneous Auricular Neurostimulation (tAN) to Improve Symptoms Associated With Opioid Withdrawal
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.
Read the detailed description
Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms. This is a double blind, randomized, controlled, multi-center study in which subjects will be randomized in a 1:1 ratio to one of two groups: 1) active transcutaneous auricular neurostimulation (tAN) or 2) delayed-active tAN to determine reduction of symptoms related to opioid withdrawal. Subjects in the active tAN group will receive tAN immediately whereas those in the delayed-active tAN will have their therapy turned on after a 30 minute delay (inactive period). All subjects will be informed of their group assignment at the conclusion of the randomized, double blind period (following initial 30 minutes of active or inactive therapy) and all will continue to receive active tAN throughout the five-day study. Each clinical site will have pre-determined and qualified clinical opiate withdrawal scale (COWS) accessor(s) that will be blind to the subjects group designation during the randomized, double blind period and will not be informed that all subjects receive active therapy throughout the remainder of the study. This will ensure a non-biased assessment of the COWS score and maintain single blinding throughout the duration of the study.
- Conditions
- Opioid-use Disorder, Opioid Withdrawal
- Being tested
- transcutaneous auricular neurostimulation (tAN)
- 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.
transcutaneous auricular neurostimulation (tAN)Device
Phoenix tAN system
| Study group | Role | What they receive |
|---|---|---|
| delayed-active tAN | Sham comparator | Not described Receives: Device: transcutaneous auricular neurostimulation (tAN) |
| active tAN | Experimental | Not described Receives: Device: transcutaneous auricular neurostimulation (tAN) |
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 active 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 (5)
Clinical opiate withdrawal scale (COWS) score
Comparison of mean percent change in COWS score in delayed active tAN versus active tAN groups at 30 minutes
Measured: 30 minutes
Clinical opiate withdrawal scale (COWS) responder rate
Comparison of the proportion of participants with a clinically significant reduction in COWS score (defined as a 15% or greater reduction) in delayed-active tAN versus active tAN groups at 30 minutes
Measured: 30 minutes
Clinical opiate withdrawal scale (COWS) score
Mean percent change in COWS score from baseline to 30 minutes after start of active 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 active 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 active 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 posted30 Aug 2019
- Study start19 Nov 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 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
- NCT04075214
- Sponsor's protocol ID
- SBM-OWP-02
- Status last verified
- Jul 2021
- First submitted
- 28 Aug 2019
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186/s42234-022-00095-x.
PubMed 35978394
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
- Delivering Transcutaneous Auricular Neurostimulation (tAN) to Improve Symptoms Associated With Opioid Withdrawal
- ClinicalTrials.gov ID
- NCT04075214
- Acronym / sponsor ID
- SBM-OWP-02
- Conditions
- Opioid-use Disorder, Opioid Withdrawal
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 30 Aug 2019 (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.
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.
Detailed description
Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms. This is a double blind, randomized, controlled, multi-center study in which subjects will be randomized in a 1:1 ratio to one of two groups: 1) active transcutaneous auricular neurostimulation (tAN) or 2) delayed-active tAN to determine reduction of symptoms related to opioid withdrawal. Subjects in the active tAN group will receive tAN immediately whereas those in the delayed-active tAN will have their therapy turned on after a 30 minute delay (inactive period). All subjects will be informed of their group assignment at the conclusion of the randomized, double blind period (following initial 30 minutes of active or inactive therapy) and all will continue to receive active tAN throughout the five-day study. Each clinical site will have pre-determined and qualified clinical opiate withdrawal scale (COWS) accessor(s) that will be blind to the subjects group designation during the randomized, double blind period and will not be informed that all subjects receive active therapy throughout the remainder of the study. This will ensure a non-biased assessment of the COWS score and maintain single blinding throughout the duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed-active tAN | Sham comparator | Device: transcutaneous auricular neurostimulation (tAN) |
| active tAN | Experimental | Device: transcutaneous auricular neurostimulation (tAN) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not 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 con-sent 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 |
|---|---|---|
| transcutaneous auricular neurostimulation (tAN)Phoenix tAN system | Device | active tAN, delayed-active tAN |
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 active 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.
5 secondary outcomes
Clinical opiate withdrawal scale (COWS) score
Time frame: 30 minutes
Clinical opiate withdrawal scale (COWS) responder rate
Time frame: 30 minutes
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.
- Derived from this study: PubMed 35978394Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186/s42234-022-00095-x.
- 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 transcutaneous auricular neurostimulation (tAN) 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. Some participants in this study may receive a placebo. 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?
On the ClinicalTrials.gov record for NCT04075214, which also lists 1 linked publication.
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.