Key Points
- This research will evaluate focused ultrasound neuromodulation to treat patients with psychostimulant use disorder who use methamphetamine alone.
- The Foundation is funding this clinical trial, which is a unique opportunity to study the role of focused ultrasound in patients with a single drug addiction.
A clinical trial has begun in Seoul, Korea (NCT06474026), to investigate whether focused ultrasound can safely and effectively treat psychostimulant use disorder—a serious condition involving abuse of methamphetamine, cocaine, or other stimulants. Led by Professor Jin Woo Chang, MD, PhD, at Korea University Anam Hospital, this study will use Insightec’s Exablate 4000 focused ultrasound system for delivering noninvasive neuromodulation in study participants. Researchers are targeting the nucleus accumbens, a region of the brain that plays a central role in craving and reward processing.
The single-center, randomized, open-label feasibility study will enroll up to 30 patients diagnosed with methamphetamine addiction who are currently participating in inpatient or intensive outpatient addiction treatment programs. The first three participants have now been treated. After 15 patients have been enrolled, investigators will conduct an interim analysis. If the results from the analysis indicate continuing with enrollment, another 15 participants will be treated for a total of 30 research subjects.
Participants will be randomized to receive either a sham procedure followed by active treatment, or active treatment alone. Outcomes will be measured through urine drug screenings, self-reported craving severity, neurocognitive assessments, and functional MRI brain imaging. The study will also track mood, anxiety, attention, and impulsivity over a six-month follow-up period.
Other recent research has explored using focused ultrasound to modulate brain circuits involved in addiction. A clinical trial in the United States targeted the nucleus accumbens in individuals with opioid use disorder, demonstrating feasibility and safety of low-intensity focused ultrasound for transient neuromodulation.
“Methamphetamine use disorder is common in Asia, but multiple drug addiction is rare in Korea. Addiction is a disease that impacts not only the patients, but also their families, communities, and public health systems,” said Dr. Chang. “It is our hope that focused ultrasound can offer prolonged symptom relief for more effective, lasting recovery.”
The Focused Ultrasound Foundation is funding this investigator-initiated study. To learn more, visit the official clinical trial listing at clinicaltrials.gov/study/NCT06474026.