| NCT ID | NCT07281261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spark Biomedical, Inc. |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-01-28 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female (evenly recruited) aged 18-64 years old 2. Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5) 3. Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST 4. Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale \[PAWSS\] \> 4 at admission) 5. Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised \[CIWA-Ar\] ≥ 8 at screening) 6. Positive urine test for alcohol at screening 7. Be able to provide written informed consent 8. Female subjects must be non-nursing and not pregnant 9. Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM. Exclusion Criteria: 1. 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 2. Current use of tobacco 3. Is pregnant or nursing 4. Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.) 5. Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM
Contact & Investigator
Navid Khodaparast, PhD
PRINCIPAL INVESTIGATOR
Spark Biomedical, Inc.
Frequently Asked Questions
Who can join the NCT07281261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07281261 currently recruiting?
Yes, NCT07281261 is actively recruiting participants. Contact the research team at hyuntaek.oh@bcm.edu for enrollment information.
Where is the NCT07281261 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07281261 clinical trial?
NCT07281261 is sponsored by Spark Biomedical, Inc.. The principal investigator is Navid Khodaparast, PhD at Spark Biomedical, Inc.. The trial plans to enroll 20 participants.