Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Using focused ultrasound to reduce cravings in smokers

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

Run by Washington D.C. Veterans Affairs Medical Center · NCT06405074 · Data updated 2026-11-12

This study is testing if a new ultrasound treatment can help reduce cravings for cigarettes in people trying to quit smoking.

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment44 (estimated)
SponsorWashington D.C. Veterans Affairs Medical Center
Federal
Locations1 site (Washington D.C., District of Columbia)
StatusRecruiting
StartedApril 1, 2022
Main results expectedMarch 31, 2026
Study endsMarch 31, 2026
Registry record updatedNovember 20, 2024
Trial IDNCT06405074 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are male and female veterans aged 18-75 who meet the criteria for moderate to severe tobacco use disorder and currently smoke more than 10 cigarettes per day.

Probably not a fit

Patients currently undergoing treatment for smoking cessation or those with significant neurological disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to inhibit the dorsal anterior insula (dAI) using low intensity focused ultrasound (LIFU) to explore its role in smoking cue-induced cravings among individuals with tobacco use disorder (TUD). Participants will undergo anatomical and functional MRI assessments to evaluate the safety and tolerability of LIFU compared to sham stimulation. The study will measure changes in brain activity and craving responses when exposed to smoking cues. This innovative approach seeks to provide a non-invasive treatment option for those struggling with nicotine addiction.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cravings and improve cessation rates for individuals with tobacco use disorder.

How similar studies have gone: While non-invasive neuromodulation techniques like transcranial magnetic stimulation have shown promise, the use of low intensity focused ultrasound for this purpose is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Veterans Affairs Medical Center
    Washington D.C., District of Columbia, United States
    Recruiting

Study contacts

  • Principal investigator: Mary R Lee, MD — Veterans Affairs Medical Center, Washington DC
  • Study coordinator: Mary R. Lee, MD
  • Email: mary.lee3@va.gov
  • Phone: 202-745-8000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Personalized brain-targeted TMS for smoking cessation

    A personalized brain-guided Transcranial Magnetic Stimulation (TMS) approach is tested against a standard TMS method to see if it better changes reward brain activity and reduces cravings and smoking in adults with tobacco use disorder.

    Recruiting Rutgers, The State University of New Jersey · Newark, New Jersey · NCT07812753

  • Multilevel program to increase LDCT lung cancer screening and help African American smokers quit

    This program will try combining low-dose CT screening with culturally tailored smoking-cessation support to help African American smokers who are eligible for LDCT quit and get screened.

    Recruiting at 2 sites Louisiana State University Health Sciences Center in New Orleans · New Orleans, Louisiana and 1 other locations · NCT07576595

  • TUBSIS 2.0 — an online program to help adults reduce or quit smoking and vaping

    This program tests whether a free, anonymous, 4-week web-based course using mindfulness, self-compassion, and behavior-change techniques helps German-, English-, and Turkish-speaking adults who smoke or vape reduce or quit tobacco.

    Recruiting University of Zurich · Zurich · NCT07568483

  • Impact of Menthol vs. Non-Menthol Cigarettes on Abuse Liability

    This study tests whether menthol cigarettes have different abuse potential than non-menthol cigarettes in menthol cigarette users, using a within-subject design across lab sessions and daily diaries.

    Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07564648

  • Ear acupressure plus nicotine replacement to ease withdrawal in psychiatric inpatients

    This study will test whether adding ear acupressure (ear seeds) to standard nicotine replacement therapy helps psychiatric inpatients who must stop smoking reduce withdrawal symptoms, cravings, and anxiety.

    Recruiting TsaoTun Psychiatric Center, Department of Health, Taiwan · Nantou City · NCT07466875

  • Facilitating Tobacco Treatment in Veterans with Serious Mental Illness

    This project tests an external facilitation approach to help VA clinics prescribe smoking medications more often to Veterans with serious mental illness who smoke.

    Recruiting VA Office of Research and Development · Baltimore, Maryland · NCT07455526

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.