Skip to content
Bored Studies
Recruiting

tAN for Substance Use Disorder

Spark Biomedical, Inc. · with The Menninger Clinic, Baylor College of Medicine · NCT07281261

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–64 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
January 28, 2026
Record last updated
September 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Sparrow Ascent; Sparrow Ascent (Sham)

Conditions: Alcohol Use Disorder; Alcohol Abuse; Substance Use Disorders; Substance Use Disorders Alcohol Use Withdrawal State

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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
  • 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.

Exclusion Criteria

  • 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

Recruiting US locations

  • The Menninger Clinic

    Houston, TX 77035

    Site contact: Elisabeth Stevens · 713-275-2896 · estevens@menninger.edu

Study contacts (from the official record)

  • Hyuntaek Oh, PhD · (713) 275-5019 · hyuntaek.oh@bcm.edu
  • Caroline Benner · (210) 624-8046 · clinicaltrials@sparkbiomedical.com
tAN for Substance Use Disorder (NCT07281261) | Bored Studies