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Procedure

Focused Ultrasound for Tobacco Use Disorder (LIFU_TUD Trial)

N/A
Recruiting
Led By Mary R Lee, MD
Research Sponsored by Washington D.C. Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female veterans aged 18-65 years
Currently smoking more than 10 cigarettes per day with no period of abstinence exceeding 3 months in the last year
Must not have
Taking any medication other than psychotropic medications that is known to cross the blood brain barrier and achieve brain penetrance such that it will alter BOLD signal or lower seizure threshold, such as antibiotics, antihistamines or muscle relaxants
No history of head injury, seizures, neurologic disorders including cerebrovascular disease, multiple sclerosis, or neurodegenerative diseases or major medical illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately prior to 1 session lifu and within 1 hour post lifu; immediately prior to 1 session sham and with in 1 hour post sham
Awards & highlights

Summary

This trial aims to study the effects of using low intensity focused ultrasound to target a specific brain region called the dorsal anterior insula in individuals with tobacco use disorder. The main goals are to assess the safety

Who is the study for?
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.
What is being tested?
The trial tests if low intensity focused ultrasound (LIFU) can reduce cravings in smokers by targeting a brain area called the dorsal anterior insula. It compares LIFU's effects on brain activity and craving responses against sham (fake) treatments using functional magnetic resonance imaging (fMRI).
What are the potential side effects?
Potential side effects of LIFU may include discomfort at the treatment site, headache, or dizziness. Since this is an investigational procedure, part of the study's purpose is to assess safety and record any other unexpected side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a veteran between 18 and 65 years old.
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I currently smoke more than 10 cigarettes daily without quitting for more than 3 months in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on medications like antibiotics, antihistamines, or muscle relaxants that affect the brain.
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I have no history of major brain or neurological conditions.
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I am currently being treated for a mental health condition.
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I am taking medication for mental health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately prior to 1 session lifu and within 1 hour post lifu; immediately prior to 1 session sham and with in 1 hour post shamdays
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to 1 session lifu and within 1 hour post lifu; immediately prior to 1 session sham and with in 1 hour post shamdays for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Smoking cue-induced craving

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham/LIFUExperimental Treatment1 Intervention
double-blind, sham-controlled, crossover study in N=44 individuals with Tobacco Use Disorder
Group II: LIFU/ShamExperimental Treatment1 Intervention
double-blind, sham-controlled, crossover study in N=44 individuals with Tobacco Use Disorder

Find a Location

Who is running the clinical trial?

Washington D.C. Veterans Affairs Medical CenterLead Sponsor
41 Previous Clinical Trials
17,774 Total Patients Enrolled
Mary R Lee, MDPrincipal InvestigatorVeterans Affairs Medical Center, Washington DC
1 Previous Clinical Trials
25 Total Patients Enrolled
~17 spots leftby Mar 2026
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