Recruiting

LIFU

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07298902

Conditions

Nicotine Addiction

Eligibility Criteria

Sex: All

Age: 20 - 60

Healthy Volunteers: Accepted

Interventions

Low intensity focused ultrasound with active stimulations

low intensity focused ultrasound with sham stimulations

Study Details

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

Study ID

NCT07298902

Start date

Apr 13, 2026

Status verified date

Jun, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Must be a smoker for 5 or more years and within 20 to 60 years of age
2. Must not meet exclusion criteria for MRI scanning (e.g., non-fixed magnetizable objects)
3. Must not have ongoing unstable medical, neurological or psychiatric illness as determined by a combination of history, medical record, and/or examination.
4. Must be a current smoker with average of 5 cigarettes or more a day for the last month or longer.
5. 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:

1. Failed TMS screening questionnaire.
2. 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.
3. Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
4. Taking > 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
5. 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.
6. In ongoing smoking cessation treatment, clinical trial, or nicotine replacements (except for the current study)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active low intensity focused ultrasound (LIFU)

Participants in this group will receive active LIFU treatment

sham comparator: Sham LIFU

Participants in this group will receive sham LIFU treatment

Interventions

Low intensity focused ultrasound with active stimulations

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

low intensity focused ultrasound with sham stimulations

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

Primary outcome measure

  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Xiaoming Du, PhD

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

Alina Siatka

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Xiaoming Du, PhD

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

Alina Siatka

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • low intensity focused ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-06-23.