Non-Invasive Brain Stimulation to Help Quit Smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial tests a novel ultrasound-based neuromodulation approach aimed at deeper brain regions involved in nicotine addiction. Participants will receive either active or sham ultrasound sessions to see if the treatment can support smoking cessation. The study uses imaging-guided delivery and compares outcomes between groups over time. It is designed for adults who have smoked for years and have tried other methods without lasting success. Safety, feasibility, and early signals of effectiveness are the primary goals.

Why it matters

Who can join: the full rules

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)

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Xiaoming Du, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Xiaoming Du, PhD
• Email: Xiaoming.Du@uth.tmc.edu
• Phone: 443-882-9717

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.