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

Launched by WASHINGTON D.C. VETERANS AFFAIRS MEDICAL CENTER · May 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new method called low intensity focused ultrasound (LIFU) to help people who struggle with tobacco use disorder (TUD), which is when someone has a strong dependence on tobacco. The researchers want to see if LIFU can help reduce cravings that people feel when they see things that remind them of smoking. They will compare LIFU to a "sham" treatment (which is like a placebo) to find out if LIFU is safe and how it affects brain activity when people are exposed to smoking cues.

To participate in this study, you need to be a veteran aged 18 to 65 who currently smokes at least 10 cigarettes a day and has not stopped smoking for more than three months in the past year. You should also be thinking about wanting to quit smoking, but not currently be in a treatment program for quitting. Participants will undergo brain scans and assessments to determine the effects of the treatment on cravings and brain activity. It’s important to note that certain medical conditions and medications may exclude you from participating, so be sure to discuss your medical history with the research team.

Gender

ALL

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