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Non-Invasive Deep Brain Neuromodulation for Smoking Cessation

NCT ID: NCT07298902

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-29

Study Completion Date

2030-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nicotine Addiction

Keywords

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low intensity focused ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active low intensity focused ultrasound (LIFU)

Participants in this group will receive active LIFU treatment

Group Type EXPERIMENTAL

Low intensity focused ultrasound with active stimulations

Intervention Type DEVICE

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

Sham LIFU

Participants in this group will receive sham LIFU treatment

Group Type SHAM_COMPARATOR

low intensity focused ultrasound with sham stimulations

Intervention Type DEVICE

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

Interventions

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Low intensity focused ultrasound with active stimulations

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

Intervention Type DEVICE

low intensity focused ultrasound with sham stimulations

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.


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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Xiaoming Du

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoming Du, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Xiaoming Du, PhD

Role: CONTACT

Phone: 443-882-9717

Email: [email protected]

Alina Siatka

Role: CONTACT

Phone: 713-486-2740

Email: [email protected]

Facility Contacts

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Xiaoming Du, PhD

Role: primary

Alina Siatka

Role: backup

Other Identifiers

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HSC-MS-25-1070

Identifier Type: -

Identifier Source: org_study_id