Alcohol Use DisorderNCT07281261
tAN for Substance Use Disorder
A study testing Sparrow Ascent in people with Alcohol Use Disorder and Alcohol Abuse, run by Spark Biomedical, Inc. at 1 site in United States.
Trial summary
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders
- What is being tested?
- Sparrow Ascent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female (evenly recruited) aged 18-64 years old
- Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
- Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
- Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale [PAWSS] > 4 at admission)
- Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised [CIWA-Ar] ≥ 8 at screening)
- Positive urine test for alcohol at screening
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- Be able to provide written informed consent
- Female subjects must be non-nursing and not pregnant
- Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.
Who cannot join
- In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN
- Current use of tobacco
- Is pregnant or nursing
- Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
- Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Menninger Clinic
Houston, Texas, 77035
Elisabeth Stevens, 713-275-2896, estevens@menninger.edu
Hyuntaek Oh, PhD
About this study
Official title: Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.
- Conditions
- Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State
- Being tested
- Sparrow Ascent, Sparrow Ascent (Sham)
- Keywords
- Alcohol, Alcohol Use Disorder, Substance Use Disorder, Transcutaneous Auricular Neurostimulation, tAN, Neurostimulation, Vagus Nerve Stimulation, Auricular Neurostimulation, Transcutaneous
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparrow AscentDevice
Also called Transcutaneous Auricular Neurostimulation
The Sparrow Ascent is an FDA-cleared (K230796) wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and around the auricle. The system is comprised of a Patient Controller, cable, and 24-hour disposable earpiece.
Sparrow Ascent (Sham)Device
Also called Transcutaneous Auricular Neurostimulation (Sham)
Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN | Experimental | Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each tAN treatment session. Active tAN stimulation will be administered in addition to the participant's standard of care treatment. Receives: Device: Sparrow Ascent |
| Sham tAN | Sham comparator | Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each sham tAN treatment session. Sham tAN stimulation will be administered in addition to the participant's standard of care treatment. Receives: Device: Sparrow Ascent (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
The CIWA-Ar is a validated, clinician-administered scale used to assess the severity of alcohol withdrawal symptoms. The tool rates ten symptom domains-including nausea, tremor, anxiety, agitation, sweating, sensory disturbances, and orientation-to generate a total score that reflects withdrawal severity and guides clinical management. Higher scores indicate more severe withdrawal.
Measured: Every 4 hours during the tAN treatment (Days 2-6)
Average benzodiazepine use
Benzodiazepines are commonly used to manage symptoms of alcohol withdrawal and are administered as needed based on clinical severity. Tracking benzodiazepine usage provides an indirect measure of withdrawal intensity, as higher medication requirements typically reflect more severe withdrawal symptoms, while lower usage indicates milder withdrawal.
Measured: Every 4 hours during the tAN treatment (Days 2-6)
Secondary outcomes (3)
Penn Alcohol Craving Scale (PACS)
PACS is a validated self-report questionnaire that measures the intensity, frequency, and duration of alcohol craving over the past week. It consists of five items assessing desire to drink, anticipated likelihood of drinking, and perceived control over drinking-related thoughts. Each item is rated on a 0-6 scale, with higher total scores indicating greater craving severity.
Measured: Before Day 2 and after tAN treatment on Day 6
Montgomery-Asberg Depression Scale (MADRS)
MADRS is a clinician-administered measure designed to assess the severity of depressive symptoms. The scale includes 10 items that evaluate core features of depression such as mood, anxiety, sleep disturbance, concentration, and suicidal ideation. Each item is scored from 0 to 6, with higher total scores indicating more severe depression.
Measured: Before Day 2 and after tAN treatment on Day 6
Suicidal Behaviors Questionnaire-Revised (SBQ-R)
SBQ-R is a validated, self-report measure used to assess past suicidal thoughts and behaviors, as well as current risk. The questionnaire includes four items that evaluate lifetime suicidal ideation and attempts, recent ideation, threat of future suicidal behavior, and self-reported likelihood of acting on suicidal thoughts. Scores range from low to high risk, with higher scores indicating greater concern for suicidal behavior.
Measured: Before Day 2 and after tAN treatment on Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start28 Jan 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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
- Model description
- This study is designed as a randomized, single-blind, sham-controlled trial. Participants will be randomized in a 1:1 ratio to one of two treatment groups: (1) Active tAN and (2) Sham tAN
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Menninger Clinic, Baylor College of Medicine, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Navid Khodaparast, PhD, Principal investigator, Spark Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281261
- Sponsor's protocol ID
- SBM-AUD-01
- Other IDs
- H-56001, R41AA032157
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder
- ClinicalTrials.gov ID
- NCT07281261
- Acronym / sponsor ID
- SBM-AUD-01
- Conditions
- Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State
- Keywords
- Alcohol, Alcohol Use Disorder, Substance Use Disorder, Transcutaneous Auricular Neurostimulation, tAN, Neurostimulation, Vagus Nerve Stimulation, Auricular Neurostimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Menninger Clinic, Baylor College of Medicine, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Dec 2025 (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 study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a randomized, single-blind, sham-controlled trial. Participants will be randomized in a 1:1 ratio to one of two treatment groups: (1) Active tAN and (2) Sham tAN
| Arm | Type | Receives |
|---|---|---|
| Active tAN | Experimental | Device: Sparrow AscentParticipants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each tAN treatment session. Active tAN stimulation will be administered in addition to the participant's standard of care treatment. |
| Sham tAN | Sham comparator | Device: Sparrow Ascent (Sham)Participants will have the device applied on-site (at the Menninger Clinic) and will be required to wear the device for a minimum of 4 hours of stimulation per day. Study assessments will be collected at the time of, prior to, and at the conclusion of each sham tAN treatment session. Sham tAN stimulation will be administered in addition to the participant's standard of care treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female (evenly recruited) aged 18-64 years old
- Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
- Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
- Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale [PAWSS] > 4 at admission)
- Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised [CIWA-Ar] ≥ 8 at screening)
Key exclusion criteria (5 listed)
- In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN
- Current use of tobacco
- Is pregnant or nursing
- Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
- Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM
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 AscentAlso: Transcutaneous Auricular NeurostimulationThe Sparrow Ascent is an FDA-cleared (K230796) wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and around the auricle. The system is comprised of a Patient Controller, cable, and 24-hour disposable earpiece. | Device | Active tAN |
| Sparrow Ascent (Sham)Also: Transcutaneous Auricular Neurostimulation (Sham)Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device. | Device | Sham tAN |
Primary outcome
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
Time frame: Every 4 hours during the tAN treatment (Days 2-6)
The CIWA-Ar is a validated, clinician-administered scale used to assess the severity of alcohol withdrawal symptoms. The tool rates ten symptom domains-including nausea, tremor, anxiety, agitation, sweating, sensory disturbances, and orientation-to generate a total score that reflects withdrawal severity and guides clinical management. Higher scores indicate more severe withdrawal.
Average benzodiazepine use
Time frame: Every 4 hours during the tAN treatment (Days 2-6)
Benzodiazepines are commonly used to manage symptoms of alcohol withdrawal and are administered as needed based on clinical severity. Tracking benzodiazepine usage provides an indirect measure of withdrawal intensity, as higher medication requirements typically reflect more severe withdrawal symptoms, while lower usage indicates milder withdrawal.
3 secondary outcomes
Penn Alcohol Craving Scale (PACS)
Time frame: Before Day 2 and after tAN treatment on Day 6
Montgomery-Asberg Depression Scale (MADRS)
Time frame: Before Day 2 and after tAN treatment on Day 6
Suicidal Behaviors Questionnaire-Revised (SBQ-R)
Time frame: Before Day 2 and after tAN treatment on Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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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.
Navid Khodaparast, PhD principal investigator
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 Ascent in people with Alcohol Use Disorder and Alcohol Abuse, 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyuntaek Oh, PhD ((713) 275-5019, hyuntaek.oh@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (time frame: Every 4 hours during the tAN treatment (Days 2-6)). The study lists 2 primary outcomes in all. 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 28 Sep 2026.