Recruiting

Personalized Neuromodulation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06991062

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

Brief summary:

The goal of this clinical research study is to learn more about whether individual differences in brain responses to emotional triggers impact rTMS (repetitive transcranial magnetic stimulation) responses in people who smoke.

Conditions

Smoking

Study ID

NCT06991062

Start date

Feb 19, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 21 to 60 years
2. Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit.
3. Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit.
4. Able to follow verbal and written instructions in English and complete all aspects of the study.
5. Have an address and telephone number where they may be reached.
6. Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.
7. Meet safety criteria for EEG.
8. Be willing to vape from an e-cigarette during specified tasks.
9. Meet safety criteria for rTMS. Note that if a participant is not eligible for rTMS but is eligible for EEG, they may complete the EEG portion of the study.
10. Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry)
11. Provides written informed consent and agree to all assessments and study procedures.
12. Agrees to complete telehealth (live audio-video conference and/or phone) and in-person visits and to be contacted via text.

Exclusion Criteria:
13. rTMS exposure for treatment or research purposes in the last 6 months.
14. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
15. Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
16. History of brain surgery, implanted electronic device, metal in the head.
17. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
18. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
19. Reports vision problems that are not treated.
20. Has a hairstyle not compatible with the EEG and unwilling to modify hairstyle (e.g., braids, ponytails, dreadlocks, non-removable hair extensions or wigs, etc.) to accommodate the EGG net that is required to be worn on the scalp during the experimental procedure.
21. Reports current diagnosis or history of type I diabetes.
22. Currently using insulin.
23. Self-report a history of or current diagnosis of a mental health condition. 24 Reports insomnia (<4 hours sleep per night, in 3 or more nights per week in the last 3 months)

25\. Reports <4 hours of sleep the day of the visit 26. Reports using marijuana on a daily basis. 27. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.

28\. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).

29\. Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days.

30\. Current use of certain medications (last 3 months): Investigational drugs. Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).

Medications known to increase risk of seizure Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix). Nicotine replacement therapy with the intent to quit smoking (e.g., patches, gum, lozenge, pouches, etc).

31\. Being pregnant or lactating 32. Self-reported noise-induced hearing loss or tinnitus. 33. Currently participating in any other research study. 34. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.

35\. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.

36\. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: FP1 (cTBS) then F3 (iTBS)

Participants will be recruit using on-line, social media, radio, and print advertisements.

experimental: F3 (iTBS) then Fp1 (cTBS)

Participants will be recruit using on-line, social media, radio, and print advertisements.

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

TMS is a non-invasive procedure in which a coil is placed over the scalp, and focused magnetic pulses are applied to parts of the brain through the coil.

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Francesco Versace, PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-21.