Home › Quitting Smoking (Tobacco Use Disorder) › NCT06405074

Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula

Who can join

Ages 18 to 75 · All sexes

Inclusion Criteria:

1. Male and female veterans aged 18-75 years
2. Meet the Diagnostic and Statistical Manual, Fifth edition (DSM-5) criteria for current TUD (moderate to severe) as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
3. Currently smoking \> 10 cigarettes per day with no period of abstinence \> 3 months in the last year
4. Current use of tobacco in last year is limited to cigarettes
5. Currently in Contemplation Stage of motivation for behavior change with respect to smoking as assessed by the University of Rhode Island Change Assessment Scale

Exclusion Criteria:

1. Not under current treatment for smoking cessation.
2. No history of head injury, seizures, neurologic disorders including cerebrovascular disease, multiple sclerosis, or neurodegenerative diseases or major medical illness
3. Current substance use disorder for a psychoactive substance (except nicotine)
4. DSM-5 psychiatric disorder requiring current treatment
5. Ferromagnetic implants or other contraindications for MRI
6. Taking any psychotropic medication such as antidepressants, anxiolytics and antipsychotics.
7. 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.
8. currently pregnant or breast feeding

About the study

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.

What is being tested

• low intensity focused ultrasound (LIFU) (device)

Sponsor: Washington D.C. Veterans Affairs Medical Center · Participants: 44 · Started: Apr 1, 2022

Contact the study team

• Mary R. Lee, MD · Phone: 202-745-8000

Official record on ClinicalTrials.gov — NCT06405074

Locations in the U.S.

Conditions

• Quitting Smoking (Tobacco Use Disorder)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.