Non-Invasive Deep Brain Neuromodulation for Smoking Cessation

NCT07298902 | Not Yet Recruiting FDA Device

• 1 other identifier: HSC-MS-25-1070
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Addiction

Keywords

low intensity focused ultrasound

Outcome Measures

Primary Outcomes (2)

• Cigarette per day (CPD)

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

  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).

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

  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.

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

Secondary Outcomes (3)

• End-expired carbon monoxide (CO)

  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 level

  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).

• Quit rate (%)

  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).

Study Arms (2)

Active low intensity focused ultrasound (LIFU)

EXPERIMENTAL

Participants in this group will receive active LIFU treatment

Device: Low intensity focused ultrasound with active stimulations

Sham LIFU

SHAM COMPARATOR

Participants in this group will receive sham LIFU treatment

Device: low intensity focused ultrasound with sham stimulations

Interventions

low intensity focused ultrasound with sham stimulations DEVICE

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

Sham LIFU

Low intensity focused ultrasound with active stimulations DEVICE

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

Active low intensity focused ultrasound (LIFU)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be a smoker for 5 or more years and within 20 to 60 years of age

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Xiaoming Du, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoming Du, PhD

CONTACT

443-882-9717; Xiaoming.Du@uth.tmc.edu

Alina Siatka

CONTACT

713-486-2740; Alina.Siatka@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)