Using focused ultrasound to reduce cravings in smokers

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

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

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Washington D.C. Veterans Affairs Medical Center (Federal)
• Locations: 1 site (Washington D.C., District of Columbia)
• Trial ID: NCT06405074 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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 performed: 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.

Eligibility 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 this trial is running

Washington D.C., District of Columbia

• 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

Conditions Tobacco Use Disorder; low intensity focused ultrasound; functional magnetic resonance imaging; insula