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 type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Washington D.C. Veterans Affairs Medical Center Federal |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | April 1, 2022 |
| Main results expected | March 31, 2026 |
| Study ends | March 31, 2026 |
| Registry record updated | November 20, 2024 |
| Trial ID | NCT06405074 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
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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.
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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.
-
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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.
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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.
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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.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.