Low Intensity Focused Ultrasound for Smoking Addiction

Overseen By Alina Siatka

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Clozapine

Disqualifiers: Substance dependence, Pregnancy, Unstable illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people quit smoking using low intensity focused ultrasound (LIFU), which employs sound waves to influence brain activity. Many smokers struggle to quit despite trying various methods, and this research aims to offer a fresh approach by targeting deeper brain areas linked to nicotine addiction. Participants will receive either the actual LIFU treatment or a sham (inactive) version to compare results. Individuals who have smoked for at least five years, consume more than five cigarettes a day, and have made several serious attempts to quit may be suitable for this study. As an unphased study, this trial provides a unique opportunity to investigate a novel treatment approach for smoking cessation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be in ongoing smoking cessation treatment or using nicotine replacements. If you're taking more than 400 mg of clozapine daily, you must also be on anti-seizure medication.

What prior data suggests that this low intensity focused ultrasound is safe for smoking cessation?

Research has shown that low intensity focused ultrasound (LIFU) safely affects brain activity. In one study, participants tolerated LIFU well, experiencing no major side effects, and brain scans revealed no changes after treatment. Although LIFU is not yet widely used to help people quit smoking, it is considered as safe as other non-invasive treatments. This indicates that it is generally safe and does not harm the brain, making it a promising option for those wanting to stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low intensity focused ultrasound (LIFU) for smoking addiction because it offers a non-invasive and drug-free approach to helping people quit smoking. Unlike current treatments like nicotine replacement therapies and medications such as varenicline or bupropion, LIFU uses sound waves to target specific areas of the brain involved in addiction. This innovative technique aims to reduce cravings and withdrawal symptoms without the side effects often associated with pharmaceuticals. Additionally, the potential for a treatment that does not rely on daily medication could provide a more accessible and appealing option for many individuals struggling with smoking addiction.

What evidence suggests that low intensity focused ultrasound is effective for smoking addiction?

Studies have shown that low intensity focused ultrasound (LIFU) can help people quit smoking by targeting specific brain areas linked to nicotine addiction. Research indicates that LIFU changes brain activity in areas connected to cravings, potentially reducing the urge to smoke. Early results suggest that focusing on the brain's insula with LIFU can ease quitting and lessen cravings. This trial will compare active LIFU treatment with a sham LIFU treatment to evaluate its effectiveness. Although this method is still new, it offers hope for those who have struggled with other ways to quit. Initial tests have examined safety and its ability to change brain activity related to addiction. ^{1 2 3 6 7}

Who Is on the Research Team?

Xiaoming Du, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for smokers aged 20-60 who've been smoking for at least 5 years and have struggled to quit despite serious attempts. It's not specified, but typically participants should be in good health with no conditions that could interfere with the study.

Inclusion Criteria

2. Must not meet

I have been smoking for at least 5 years and am between 20 and 60 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive low intensity focused ultrasound (LIFU) therapy or sham LIFU treatment

4 weeks

8 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Low intensity focused ultrasound

Trial Overview

The study tests a new therapy called low intensity focused ultrasound (LIFU) to help people stop smoking. Participants will receive either active LIFU stimulations or sham (fake) treatments to see if it can reduce their urge to smoke by targeting specific brain areas.

How Is the Trial Designed?

Group I: Active low intensity focused ultrasound (LIFU) Experimental Treatment 1 Intervention

Participants in this group will receive active LIFU treatment

Group II: Sham LIFU Placebo Group 1 Intervention

Participants in this group will receive sham LIFU treatment

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07298902

Non-Invasive Deep Brain Neuromodulation for Smoking ...

This study will develop novel low intensity focused ultrasound (LIFU) therapy to help people to quit cigarette smoking. Smoking is associated ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/11070401

Low Intensity Focused Ultrasound for Tobacco Use Disorder

Remarkably, humans with damage to the insula were able to stop smoking easily and without experiencing cravings or relapse. LIFU can selectively target the dAI ...

3.

brainstimjrnl.com

brainstimjrnl.com/article/S1935-861X(24)01229-4/fulltext

Preliminary Results for Low Intensity Focused Ultrasound for ...

We present preliminary results from an ongoing study, using LIFU to modulate the AI to determine its causal role in smoking cue-induced craving.

4.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1211566/full

Low-intensity focused ultrasound targeting the nucleus ...

Outcomes were the safety, tolerability, and feasibility during the LIFU procedure and throughout the 90-day follow-up. Outcomes also included ...

5.

withpower.com

withpower.com/trial/phase-tobacco-use-disorder-11-2025-2230c

Low Intensity Focused Ultrasound for Smoking Addiction

This study will develop novel low intensity focused ultrasound (LIFU) therapy to help people to quit cigarette smoking.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11612502/

The therapeutic potential of low-intensity focused ultrasound ...

LIFU is a promising modality for precise and invasive modulation of brain activity, capable of redefining the landscape of SUD treatment.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06405074

Low Intensity Focused Ultrasound for Tobacco Use ...

Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively ...