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NCT Number: NCT07298902

Non-Invasive Deep Brain Neuromodulation for Smoking Cessation

This study will develop novel low intensity focused ultrasound (LIFU) therapy to help people to quit cigarette smoking. Smoking is associated with cancers of the lung. Available smoking cessation methods help many to quit. However, for the many who continue to smoke despite the strong desire to quit and after exhausting existing therapeutic approaches, new treatment methods are needed. Without more effective treatment, many will continue to smoke, and our progress on cancer prevention through smoking cessation may decelerate as these associated cancer risks will remain. Brain imaging research has identified specific areas of the brain linked to severe nicotine addiction, but up to now there are no effective ways to directly target most of these deeper brain regions. LIFU is a new and safe method to modulate brain functions that can either inhibit overactive activity or restore normal activity levels. The purpose of this study is to provide a novel ultrasound-based neuromodulation strategy for smoking cessation in people who have difficulty to quit smoking despite numerous serious attempts in their lives. LIFU works by sending acoustic pressure modulating neural activity in the human brain.

Recruiting

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Key information

Conditions

Nicotine Addiction Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be a smoker for 5 or more years and within 20 to 60 years of age
  • Must not meet exclusion criteria for MRI scanning (e.g., non-fixed magnetizable objects)
  • Must not have ongoing unstable medical, neurological or psychiatric illness as determined by a combination of history, medical record, and/or examination.
  • Must be a current smoker with average of 5 cigarettes or more a day for the last month or longer.
  • Report 3 or more trials of smoking cessation attempts using nicotine replacement, e-cig, TMS, varenicline or other smoking cessation drugs, psychotherapy or other means.

Exclusion criteria

  • Failed TMS screening questionnaire.
  • Significant alcohol or other drug use (substance dependence within the recent months) or positive urine toxicology screen for substance not prescribed other than nicotine or marijuana dependence.
  • Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
  • Taking > 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
  • Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
  • In ongoing smoking cessation treatment, clinical trial, or nicotine replacements (except for the current study)

Treatment and study plan

Low intensity focused ultrasound with active stimulations

Device

Participants will receive two LIFU sessions a week for 4 weeks.

low intensity focused ultrasound with sham stimulations

Device

Participants will receive two LIFU sessions a week for 4 weeks.

Primary outcomes

  1. Cigarette per day (CPD)

    Time frame: Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).

    Cigarette per day (CPD) is measured to index smoking reduction and cessation.

  2. Brain connectivity as indicated by resting state functional connectivity (rsFC) value as assessed by functional magnetic resonance imaging (fMRI)

    Time frame: session 1 (about 1-2 days after baseline) and session 8 (about 4 weeks after baseline).

    The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the transcranial magnetic stimulation (TMS) effect on smoking reduction/cessation.

Secondary outcomes

  1. End-expired carbon monoxide (CO)

    Time frame: Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).

    End-expired CO measure is an instant measure of smoking status, with higher CO level indicating more severe recent smoking behavior.

  2. Urinary cotinine level

    Time frame: Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).

    Urinary cotinine is an index of smoking status, with higher cotinine concentrations indicating more severe smoking behavior.

  3. Quit rate (%)

    Time frame: Session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).

    Quit rate is an index of smoking cessation effects of the treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Alina Siatka

CONTACT

[email protected]

713-486-2740

Xiaoming Du, PhD

CONTACT

[email protected]

443-882-9717

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 23, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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