An interventional study of Sparrow Ascent and Sparrow Ascent (Sham) in Alcohol Use Disorder, Alcohol Abuse and Substance Use Disorders, sponsored by Spark Biomedical, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Spark Biomedical, Inc. · Not applicable, Interventional, and Treatment
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Among 1,073 studies in Alcoholism with a site in United States — 187 open to participants now, 228 under way, 15 of them phase 3. Alcoholism · United States.
Among the 1,073 studies in Alcoholism with a site in United States, this one is the 819th largest by planned enrollment of the 989 interventional ones that give a count, is one of 55 that started in 2026, is one of 436 with no phase, reaches primary completion later than 121 of the 227 other live ones, and was the 1,034th registered.
1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
Browse Alcoholism studies →187 of the 1,073 studies in Alcoholism with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
Ages 18+
University of Pennsylvania · Sites in United States
Ages 21–65
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 18–120
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 21–100 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
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1,073 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 138 · Phase 2 312 · Phase 3 77 · Phase 4 96
First in 1992; this study’s year is marked. 55 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 88 across 1,430 interventional studies indexed under Alcoholism.
Median enrollment 80 across the 989 interventional studies, 109 across the 79 observational. Of the 778 that completed or were terminated, 370 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
64 of 1,073 have an industry lead sponsor. The 10 most frequent:
Spark Biomedical, Inc. is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Spark Biomedical, Inc. has 1 study filed under Alcoholism — fewer than ten, so there is no comparison to draw.
83 of the studies in Alcoholism with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06173973Phase 3University of PennsylvaniaEffects of Ketone Supplementation on Acute Alcohol Withdrawal | 2026-12 |
| NCT05015881Phase 3University of PennsylvaniaRelationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder | 2026-12 |
| NCT04616781Phase 3University of PennsylvaniaKetone Ester Intervention in Alcohol Use Disorder | 2026-12 |
| NCT06702007Phase 3University of WashingtonElectronic Harm Reduction Treatment for Alcohol | 2027-01 |
| NCT05613608Phase 3University of Colorado, DenverAlcohol Use Disorder and Cannabidiol | 2027-04 |
Add all 83 to your calendar (.ics) → With an account.
Among the 1,073 studies in Alcoholism with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Sparrow Ascent
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.
Device: Sparrow Ascent (Sham)
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.
Also known as: Transcutaneous Auricular Neurostimulation
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.
Also known as: Transcutaneous Auricular Neurostimulation (Sham)
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.
Time frame: 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.
Time frame: Every 4 hours during the tAN treatment (Days 2-6)
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.
Time frame: 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.
Time frame: 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.
Time frame: Before Day 2 and after tAN treatment on Day 6
Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
PAWSS is a validated clinician-administered screening tool used to identify individuals at risk for developing moderate to severe alcohol withdrawal. The scale includes 10 items assessing historical, clinical, and laboratory factors associated with withdrawal risk. A total score of 4 or higher indicates high risk for complicated withdrawal.
Time frame: Screening
Started Jan 2026 (actual). Primary completion is estimated for Aug 2027, 19 months after the start.
Of 493 interventional studies with no phase under Alcoholism, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 19 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion Aug 2026 → Aug 2027 and completion Aug 2026 → Aug 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Spark Biomedical, Inc.