Deep TMS for Heavy Drinking in Alcohol Use Disorder
This study is testing the safety and effectiveness of BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for reducing heavy drinking in people with Alcohol Use Disorder (AUD). Deep TMS is a device that uses magnetic pulses. You could be between 18 and 86 years old and have been diagnosed with moderate to severe AUD to join. The study will compare alcohol use in two groups: one receiving Deep TMS and another receiving a sham (inactive) treatment. The main goal is to see if Deep TMS helps more people achieve zero heavy drinking days over 2-4 months. The current recruitment status is unclear.
- Study design
- This is a double-blind, randomized, controlled, multi-center trial with 186 planned participants. It compares two groups: one receiving Deep TMS and another receiving a sham treatment.
- What's involved
- Participants will have 30 treatment sessions over 15 visits during a 3-5 week acute phase, followed by one treatment session per week during a maintenance and follow-up phase.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for measuring heavy drinking days is at 2-4 months after treatment. The study includes a maintenance treatment and follow-up phase, but the exact duration of follow-up is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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)
At a glance
Conditions
Where it's being run
9 sites across 9 statesWho to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Difference in proportion of patients who attain zero (0) heavy drinking days2-4 months
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, 3 and 4 following initiation of the Acute Phase, based on TLFB reporting and supportive PEth results. 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.