tAN for Substance Use Disorder

Spark Biomedical

Status: Not yet enrolling

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

Treatments: Device: Sparrow Ascent (Sham); Device: Sparrow Ascent

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07281261

H-56001 (Other Identifier)

R41AA032157 (U.S. NIH Grant/Contract)

SBM-AUD-01

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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] > 15 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Active tAN

Experimental group

Description:

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.

Treatment:

Device: Sparrow Ascent

Sham tAN

Sham Comparator group

Description:

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.

Treatment:

Device: Sparrow Ascent (Sham)