University of Virginia
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU) is safe and may help reduce gambling-related symptoms in adults seeking treatment for gambling disorder. The main questions it aims to answer are: * Is LIFU safe and well tolerated in adults with gambling disorder? * Does LIFU reduce gambling behavior compared with a sham (inactive) procedure? Researchers will compare participants who receive active LIFU with participants who receive sham LIFU to see whether active treatment leads to greater reductions in gambling behavior. Participants will: * Be randomly assigned to receive either active LIFU or sham LIFU. * Receive nine treatment sessions delivered over three treatment days within a five-day period. * Participate in weekly telehealth cognitive behavioral therapy (CBT). * Complete assessments of gambling behavior, gambling urges, mood, and quality of life. * Attend follow-up visits for up to 90 days after active LIFU treatment. Low-intensity focused ultrasound is a noninvasive technique that uses focused sound waves to influence brain activity. Researchers believe this approach may affect brain circuits involved in reward, cravings, and decision-making that contribute to gambling disorder.
Inclusion Criteria: * Adults 18 to 60 years old. * Currently diagnosed with gambling disorder, confirmed by a clinical interview. * Seeking treatment for gambling disorder, including people currently participating in or transitioning from addiction treatment programs. * In generally good enough physical health to safely participate in study procedures. * Not pregnant and not planning to become pregnant during study participation. * Able to speak and read English well enough to provide informed consent and complete study assessments. * Able to safely undergo MRI scans (for example, no metal im…
Active low-intensity focused ultrasound (LIFU) neuromodulation targeting the left and right nucleus accumbens. Each treatment course comprises three 10-minute sessions per day (5 minutes to the left nucleus accumbens and 5 minutes to the right nucleus accumbens) delivered on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT).
Sham low-intensity focused ultrasound procedures that are identical to active treatment except that no therapeutic ultrasound energy is delivered. Each treatment course comprises three 10-minute sessions per day on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT). After completion of the Day 30 primary endpoint assessments and unblinding, participants may cross over to receive open-label active LIFU.