Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)

NCT07216872 | Recruiting FDA Device

• 1 other identifier: CTP-AUD-00
• Study Type: interventional
• Target: 186
• Locations: 2 countries
• Sites: 9

Brief Summary

The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment. This is a prospective, 6-month, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The study population will consist of subjects diagnosed with moderate to severe AUD. The study is comprised of three phases:

1. 1.Pre-study Screening and Baseline Phase
2. 2.Acute Treatment Phase and
3. 3.Maintenance Treatment and Follow up Phase

Conditions

Alcohol Use Disorder; Alcoholism; Alcohol Abuse; Alcohol Dependence; Alcohol Abuse/Dependence; Alcohol Addiction

Keywords

alcohol use disorder; alcoholism; alcohol abuse; alcohol dependence; alcohol addiction; DTMS; rfTMS; Brainsway

Outcome Measures

Primary Outcomes (1)

• Difference in proportion of patients who attain zero (0) heavy drinking days

  The difference in the proportion of patients who attain zero (0) heavy drinking days in the Treatment group versus the Sham control group in months 2-4 following initiation of the Acute Phase, based on TLFB reporting. Month 1 is considered a "Grace Period" as this is the time during which the full treatment dose of the Acute Phase is being delivered.

  2-4 months

Study Arms (2)

Treatment group

EXPERIMENTAL

The treatment group will receive active, Deep TMS treatment.

Device: Deep TMS (DTMS)

Control group

SHAM COMPARATOR

The Control group will receive inactive, sham treatment.

Device: Sham (No Treatment)

Interventions

Deep TMS (DTMS) DEVICE

The Deep TMS group will receive 30 active sessions in 15 visits (i.e., 2 treatments per visit) over a period of 3-5 weeks in the Acute Treatment Phase. In the Maintenance Treatment \& Follow-up phase subjects will receive one treatment session per week from the end of the Acute Treatment Phase until the 6-month follow-up visit. All treatment sessions will consist of 2 treatments per day with a 30 minute interval in between. Each treatment will last approximately 20 minutes.

Treatment group

Sham (No Treatment) DEVICE

The control group will receive 30 Sham sessions in 15 visits (i.e., 2 treatments per visit) over a period of 3-5 weeks in the Acute Treatment Phase. In the Maintenance Treatment \& Follow-up phase subjects will receive one treatment session per week from the end of the Acute Treatment Phase until the 6-month follow-up visit. All treatment sessions will consist of 2 treatments per day with a 30 minute interval in between. The control group will receive inactive/sham treatment with identical parameters to the Deep TMS treatment.

Control group

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18-86 years old.
• Subjects diagnosed with AUD and who meet criteria for moderate (4-5 out of the 12 symptoms) to severe (\> 6 out of the 12 symptoms) AUD according to the DSM-5 diagnostic criteria as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).
• Subjects who have a history of at least 24 heavy drinking days during the 90 days prior to screening (average \>=8 HDD/month), based on TLFB).
• Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.
• Subjects able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.
• Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation.

You may not qualify if:

• Subjects diagnosed with schizophrenia or chronic psychotic disorder as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).
• Subjects with present suicidal risk as assessed by the investigator or significant suicide risk based on MADRS item 10 score of 4 or 6, or a history of attempted suicide in the last year.
• Subjects who initiated treatment with any of the following medications which are known to effect alcohol consumption, within 30 days of the Screening visit: acamprosate, baclofen, buprenorphine, disulfiram, gabapentin, naltrexone, topiramate and varenicline.
• Subjects with a significant medical illness that is not well controlled (e.g., hepatic impairment, diabetes, hypertension, heart disease, septicemia, active tuberculosis, progressive neoplasm, frequent and severe migraine headaches, etc.).
• Subjects experiencing acute alcohol withdrawal. This will be determined using the Clinical Institute Withdrawal Assessment of Alcohol - revised (CIWA-Ar) wherein subjects with a value of \>7 will not be permitted to receive TMS on that day to mitigate any potential risk of a seizure. Treatments may be rescheduled and CIWA-AR and alcohol breath tests may be reassessed, although if more than the allowed treatment sessions are missed, the subject will be withdrawn from the study.
• Subjects with a history of epilepsy or seizure (not including history of alcohol withdrawal seizure, ECT induced seizures, or childhood febrile seizures).
• Individuals with a first-degree relative family history of seizure.
• Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.
• Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head (outside the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, shrapnel, surgical clips, fragments from welding or metal work).
• Subjects with cardiac pacemakers or active implantable electrodes/neurostimulators within 30 cm of the treatment coil.
• Subjects with a significant neurological disorder or insult including, but not limited to:
• Any condition likely to be associated with increased intracranial pressure
• Space occupying brain lesion
• History of cerebrovascular accident
• Transient ischemic attack within two years

Sponsors & Collaborators

• Brainsway: lead

Study Sites (9)

Alpha Neuron LLC

Tuscaloosa, Alabama, 35401, United States

RECRUITING

Kadima Neuropsychiatry

La Jolla, California, 92037, United States

RECRUITING

DTMS Center LLC

West Palm Beach, Florida, 33411, United States

RECRUITING

Rosecrance River North

Chicago, Illinois, 60654, United States

RECRUITING

ManuMind Interventional Psychiatry

Woodbury, New York, 11797, United States

RECRUITING

Optimum Wellness and TMS

Columbus, Ohio, 43215, United States

NOT YET RECRUITING

Active Path Mental Health

Portland, Oregon, 97223, United States

NOT YET RECRUITING

PsyCare

South Charleston, West Virginia, 25303, United States

RECRUITING

Soroka Medical Center

Beersheba, 8410501, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Ahava Stein

CONTACT

+972-9-7670002; ahava@asteinrac.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a randomized, double-blind, sham-controlled, multicenter trial.

Study Record Dates

• First Submitted: October 12, 2025
• First Posted: October 15, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

IL (1); US (8)