Status:
RECRUITING
Bayesian Neurobehavioral Phenotyping: From Mechanism Identification to Personalized Neuromodulation Treatments. R61 PHASE
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Smoking
Eligibility:
All Genders
21-60 years
Phase:
NA
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) respo...
Detailed Description
Primary Objectives: 1. Determine the extent to which neuroaffective individual differences moderate rTMS treatment effects. Our working hypothesis is that smokers characterized by the LPP+ profile wi...
Eligibility Criteria
Inclusion
- Age 21 to 60 years
- Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit.
- Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit.
- Able to follow verbal and written instructions in English and complete all aspects of the study.
- Have an address and telephone number where they may be reached.
- 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.
- Meet safety criteria for EEG.
- Be willing to vape from an e-cigarette during specified tasks.
- 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.
- Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry)
- Provides written informed consent and agree to all assessments and study procedures.
- Agrees to complete telehealth (live audio-video conference and/or phone) and in-person visits and to be contacted via text.
Exclusion
- rTMS exposure for treatment or research purposes in the last 6 months.
- History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- 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).
- History of brain surgery, implanted electronic device, metal in the head.
- 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)
- History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
- Reports vision problems that are not treated.
- 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.
- Reports current diagnosis or history of type I diabetes.
- Currently using insulin.
- Have undergone bariatric surgery.
- Currently being enrolled in a weight loss program.
- Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
- Self-report a history of or current diagnosis of a mental health condition.
- Reports insomnia (\<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
- Reports \<4 hours of sleep the day of the visit
- Reports using marijuana on a daily basis.
- Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
- Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
- 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.
- 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).
- Being pregnant or lactating
- Self-reported noise-induced hearing loss or tinnitus.
- Currently participating in any other research study.
- 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.
Key Trial Info
Start Date :
February 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06991062
Start Date
February 19 2025
End Date
December 1 2028
Last Update
December 23 2025
Active Locations (1)
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1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030