Personalized brain treatments for smokers using rTMS

Bayesian Neurobehavioral Phenotyping: From Mechanism Identification to Personalized Neuromodulation Treatments. R61 PHASE

This study is testing if personalized brain treatments using rTMS can help smokers reduce their nicotine cravings by looking at how their brains respond to emotions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06991062 on ClinicalTrials.gov

What this trial studies

This clinical research focuses on understanding how individual differences in brain responses to emotional triggers can influence the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in smokers. The study aims to determine how neuroaffective and neurocognitive profiles affect treatment outcomes, specifically looking at nicotine self-administration reduction. By assessing the time required for various procedures, the research seeks to optimize future personalized rTMS interventions for smoking cessation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 60 who smoke at least 5 cigarettes per day and meet specific health and safety criteria.

Not a fit: Patients who do not smoke or those with unstable living conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective, personalized treatments for smoking cessation based on individual brain responses.

How similar studies have performed: While the approach of personalized rTMS is innovative, similar studies have shown promise in using neuromodulation techniques for various conditions, indicating potential for success.

Eligibility criteria

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. Have undergone bariatric surgery.
24. Currently being enrolled in a weight loss program.
25. Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
26. Self-report a history of or current diagnosis of a mental health condition.
27. Reports insomnia (\<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
28. Reports \<4 hours of sleep the day of the visit
29. Reports using marijuana on a daily basis.
30. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
31. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
32. 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.
33. 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).
34. Being pregnant or lactating
35. Self-reported noise-induced hearing loss or tinnitus.
36. Currently participating in any other research study.
37. 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.

37\. 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.

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

Where this trial is running

Houston, Texas

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Francesco Versace, PHD — M.D. Anderson Cancer Center
• Study coordinator: Francesco Versace, PHD

Conditions Smoking