Focused Ultrasound for Tobacco Use Disorder
(LIFU_TUD Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking any psychotropic medications (like antidepressants, anxiolytics, and antipsychotics) and any other medications that can affect brain activity, such as certain antibiotics, antihistamines, or muscle relaxants.
What data supports the effectiveness of the treatment Low Intensity Focused Ultrasound (LIFU) for tobacco use disorder?
Research suggests that non-invasive brain stimulation (NIBS), which includes techniques like LIFU, shows promise in treating tobacco use disorder by reducing cravings and improving cognitive functions. Studies indicate that NIBS could be a potential intervention for smoking cessation by influencing brain activity related to smoking behavior.12345
Is Low Intensity Focused Ultrasound (LIFU) safe for humans?
How is Low Intensity Focused Ultrasound (LIFU) different from other treatments for tobacco use disorder?
Low Intensity Focused Ultrasound (LIFU) is a non-invasive brain stimulation technique that targets specific brain areas to reduce cravings and improve cognitive functions, unlike traditional treatments like nicotine-replacement therapies or medications that work by altering neurotransmitter systems. This approach is unique because it directly influences brain activity without the need for drugs.12358
What is the purpose of this trial?
The goal of this clinical trial is to to inhibit the dorsal anterior insula (dAI) with low intensity focused ultrasound (LIFU) to determine the causal role for the dAI in smoking cue induced craving in individuals with tobacco use disorder (TUD); smoking cue induced craving is a clinically important behavior which has been associated with the severity of nicotine addiction. The main question\[s\] it aims to answer are:* the safety and tolerability of dAI LIFU compared to sham stimulation in individuals with TUD* the effects of LIFU vs sham to left dAI functional magnetic resonance imaging (fMRI) BOLD activity and craving in response to smoking cue exposure.Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.Participants will undergo functional magnetic resonance imaging where we will measure the effect of LIFU vs sham on 1) dAI blood-oxygen-level-dependent (BOLD) activation in response to smoking (compared to neutral) cue exposure and 2) cue-induced craving in individuals with TUD. Each participant will receive LIFU and sham stimulation.
Research Team
Mary R Lee, MD
Principal Investigator
Veterans Affairs Medical Center, Washington DC
Eligibility Criteria
This trial is for individuals with Tobacco Use Disorder who want to explore a new treatment. Participants must be able to undergo MRI scans and neurological assessments. The study excludes those with certain medical conditions or metal implants that could interfere with MRI, pregnant women, and people unable to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LIFU and sham stimulation to assess the effects on dAI BOLD activity and craving in response to smoking cues
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Low Intensity Focused Ultrasound
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington D.C. Veterans Affairs Medical Center
Lead Sponsor