Actively Recruiting
tAN for Substance Use Disorder
Led by Spark Biomedical, Inc. · Updated on 2026-04-08
20
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
S
Spark Biomedical, Inc.
Lead Sponsor
T
The Menninger Clinic
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
tAN for Substance Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 64 years old
- Male or female participants (evenly recruited)
- Meet DSM-5 criteria for moderate or above alcohol use disorder at screening using SCID-5
- Show at least moderate risk of alcohol use at screening using WHO-ASSIST
- Have high risk for moderate to severe alcohol withdrawal syndrome (PAWSS > 4 at admission)
- Have severe withdrawal symptoms (CIWA-Ar > 15 at screening)
- Positive urine test for alcohol at screening
- Able to provide written informed consent
- Female subjects must be non-nursing and not pregnant
- Meet MRI safety screening requirements from the Center for Advanced MR Imaging at BCM
You will not qualify if you...
- Expected to fail to complete the study due to likely relocation or intolerance to tAN
- Current tobacco use
- Pregnant or nursing
- Contraindications to MRI (such as pacemaker, cochlear implants, metal in eyes, or other metal implants)
- Do not meet pre-screening MRI questions from the Center for Advanced MR Imaging at BCM
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Menninger Clinic
Houston, Texas, United States, 77035
Actively Recruiting
Research Team
H
Hyuntaek Oh, PhD
CONTACT
C
Caroline Benner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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