Evaluating the Safety and Effectiveness of BrainsWay Deep Transcranial Magnetic Stimulation to Reduce Heavy Drinking in Adults With Alcohol Use Disorder

What this Trial Is About

Researchers are evaluating the use of BrainsWay Deep Transcranial Magnetic Stimulation Deep TMS to treat individuals diagnosed with moderate to severe Alcohol Use Disorder AUD. The trial is a prospective, double-blind, randomized, controlled, multi-center study involving outpatients aged 18 to 86 years. It aims to compare alcohol use outcomes between a group receiving active Deep TMS treatment and a group receiving sham inactive treatment. This study includes subjects seeking treatment to reduce or stop heavy drinking. Participants are randomly assigned to either the Deep TMS group or the sham group in a 11 ratio. The acute treatment phase involves 15 visits over 3 to 5 weeks, with each visit including two treatment sessions spaced 30 minutes apart, each lasting about 20 minutes. Following this, the maintenance and follow-up phase includes one treatment session per week until the six-month follow-up visit. Before each treatment session, participants are exposed to alcohol-related cues, then receive either active or sham Deep TMS stimulation. Throughout the study, participants will have their alcohol use monitored using the percent of heavy drinking days during months 2 to 4 based on self-reported timelines and supportive lab results. Researchers will also use several assessment scales to evaluate alcohol use and craving. Safety is closely monitored by tracking adverse events, vital signs, and physical and neurological examinations. The entire study participation lasts up to six months, including treatment and follow-up phases.

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)