Nicotine AddictionNCT07298902
Non-Invasive Deep Brain Neuromodulation for Smoking Cessation
A study testing Low intensity focused ultrasound with active stimulations in people with Nicotine Addiction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- Low intensity focused ultrasound with active stimulations
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Xiaoming Du, PhD, 443-882-9717, Xiaoming.Du@uth.tmc.edu
Alina Siatka, 713-486-2740, Alina.Siatka@uth.tmc.edu
About this study
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
- Being tested
- Low intensity focused ultrasound with active stimulations, low intensity focused ultrasound with sham stimulations
- Keywords
- low intensity focused ultrasound
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity focused ultrasound with active stimulationsDevice
Participants will receive two LIFU sessions a week for 4 weeks.
low intensity focused ultrasound with sham stimulationsDevice
Participants will receive two LIFU sessions a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active low intensity focused ultrasound (LIFU) | Experimental | Participants in this group will receive active LIFU treatment Receives: Device: Low intensity focused ultrasound with active stimulations |
| Sham LIFU | Sham comparator | Participants in this group will receive sham LIFU treatment Receives: Device: low intensity focused ultrasound with sham stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette per day (CPD)
Cigarette per day (CPD) is measured to index smoking reduction and cessation.
Measured: 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.
Measured: session 1 (about 1-2 days after baseline) and session 8 (about 4 weeks after baseline).
Secondary outcomes (3)
End-expired carbon monoxide (CO)
End-expired CO measure is an instant measure of smoking status, with higher CO level indicating more severe recent smoking behavior.
Measured: 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
Urinary cotinine is an index of smoking status, with higher cotinine concentrations indicating more severe smoking behavior.
Measured: 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 (%)
Quit rate is an index of smoking cessation effects of the treatment.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start13 Apr 2026
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Du, The University of Texas Health Science Center, Houston
- Investigators
- Xiaoming Du, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298902
- Sponsor's protocol ID
- HSC-MS-25-1070
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Deep Brain Neuromodulation for Smoking Cessation
- ClinicalTrials.gov ID
- NCT07298902
- Acronym / sponsor ID
- HSC-MS-25-1070
- Conditions
- Nicotine Addiction
- Keywords
- low intensity focused ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active low intensity focused ultrasound (LIFU) | Experimental | Device: Low intensity focused ultrasound with active stimulationsParticipants in this group will receive active LIFU treatment |
| Sham LIFU | Sham comparator | Device: low intensity focused ultrasound with sham stimulationsParticipants in this group will receive sham LIFU treatment |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity focused ultrasound with active stimulationsParticipants will receive two LIFU sessions a week for 4 weeks. | Device | Active low intensity focused ultrasound (LIFU) |
| low intensity focused ultrasound with sham stimulationsParticipants will receive two LIFU sessions a week for 4 weeks. | Device | Sham LIFU |
Primary outcome
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.
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.
3 secondary outcomes
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoming Du, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity focused ultrasound with active stimulations in people with Nicotine Addiction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoming Du, PhD (443-882-9717, Xiaoming.Du@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.