Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Public ClinicalTrials.gov record NCT07216872. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With Alcohol Use Disorder (AUD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Pre-study Screening and Baseline Phase 2. Acute Treatment Phase and 3. Maintenance Treatment and Follow up Phase Subjects of all ethnic and gender categories, ages ranging between 18-86 years will be screened for study eligibility according to the inclusion and exclusion criteria. Subjects who meet the eligibility criteria and are willing to sign an informed consent form will be enrolled in the study. The subjects' demographic and baseline characteristics, as well as their overall medical condition will be assessed prior to treatment administration. Eligible patients will be randomized with a 1:1 ratio to one of two study groups (treatment or sham) and stratified by site. Randomization will be employed to avoid bias in the assignment of subjects to treatment group. All subjects will undergo the same treatment regimen, regardless of the assigned treatment group. The acute treatment phase will include 15 treatment visits over a period of 3-5 weeks. The Maintenance Treatment \& Follow-up phase will include one treatment visit per week from the end of the Acute Treatment Phase until the 6 month follow-up visit. At each treatment session, prior to stimulation onset, alcohol related cues will be presented to the subject. After the offset of the alcohol cue presentation, active or sham Deep TMS stimulation will be administered. The study design is directed towards a comparison between active treatment and sham, up to 4 months and 6 months follow-up. Efficacy will be assessed using the primary efficacy measure of the percent heavy drinking days during months 2, 3 and 4, based on the Time Line Follow Back (TLFB) reporting and supportive PEth results. Additionally, several subject assessment scales will be used during the course of the study to assess alcohol use and alcohol craving. Safety will be assessed, including monitoring the severity, causality and frequency of all adverse events, vital signs, and physical and neurological examination.
Study identification
- NCT ID
- NCT07216872
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 186 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 86 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2025 (Actual)
- Primary completion
- Nov 1, 2027 (Estimated)
- Completion
- Dec 1, 2027 (Estimated)
- Last update posted
- Sep 9, 2026
2025 – 2027
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alpha Neuron LLC | Tuscaloosa | Alabama | 35401 | Recruiting |
| Kadima Neuropsychiatry | La Jolla | California | 92037 | Recruiting |
| DTMS Center LLC | West Palm Beach | Florida | 33411 | Recruiting |
| Rosecrance River North | Chicago | Illinois | 60654 | Recruiting |
| ManuMind Interventional Psychiatry | Woodbury | New York | 11797 | Recruiting |
| Optimum Wellness and TMS | Columbus | Ohio | 43215 | Recruiting |
| Active Path Mental Health | Portland | Oregon | 97223 | Recruiting |
| PsyCare | South Charleston | West Virginia | 25303 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07216872, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07216872 live on ClinicalTrials.gov.