The goal of this clinical trial is to evaluate the safety, feasibility, and preliminary clinical benefit of focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH) in adults with treatment-resistant moderate-to-severe substance use disorder (SUD).
The main questions it aims to answer are:
Can FUS neuromodulation be safely delivered to the nucleus accumbens (NAc) and/or anterior insula (aI)? Does FUS neuromodulation result in reduced substance use severity, as measured by Timeline Followback (TLFB), by 4 weeks post-treatment?
Participants will:
Complete baseline clinical assessments, questionnaires, imaging, and safety assessments.
Undergo two MRI-guided FUS neuromodulation sessions approximately 4 weeks apart.
Attend follow-up visits for safety monitoring, symptom assessments, quality-of-life measures, and additional imaging where applicable.
Must be deemed to have capacity to provide informed consent (determined by the investigator)
Age between 18 to 70 (inclusive)
Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine/tobacco use disorder) in the moderate to severe range according to the DSM-5
Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care
Pregnant or intending to be pregnant during the study
Known active seizure disorder, significant head injury with an imaging verified lesion
Medical illness that is deemed to be unstable or may confound the effects of the intervention
Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)