Non-Invasive Deep Brain Neuromodulation for Smoking Cessation

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07298902
Status
Not Yet Recruiting

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Conditions

  • Nicotine Addiction

Eligibility Criteria

Sex
ALL
Age
20 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Xiaoming Du, PhD
[email protected]
443-882-9717
Alina Siatka
[email protected]
713-486-2740

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