tAN for Substance Use Disorder

Part of paid clinical trials in Houston, Texas.

Sponsor
Spark Biomedical, Inc.
Study ID
NCT07281261
Status
Recruiting
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Conditions

  • Alcohol Abuse
  • Alcohol Use Disorder
  • Substance Use Disorders
  • Substance Use Disorders Alcohol Use Withdrawal State

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Sparrow Ascent — DEVICE
    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
    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 Details

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.

Key Dates

Start date
Jan 28, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active tAN
    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.
  • Sham Comparator: Sham tAN
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Menninger ClinicHoustonTexas77035
Elisabeth Stevens
[email protected]
713-275-2896
Hyuntaek Oh, PhD (PRINCIPAL_INVESTIGATOR)
Daryl Shorter, MD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
The Menninger Clinic· Houston, TX

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