Repetitive Transcranial Magnetic Stimulation for Smoking

Overseen By George Kypriotakis, PHD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antidepressants, Antipsychotics, Smoking cessation

Disqualifiers: Neurological disorders, Cardiac disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

George Kypriotakis, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking adults aged 21-60 who smoke at least 5 cigarettes or similar products daily. Participants must have a stable residence, not be pregnant or lactating, and meet safety criteria for rTMS and EEG. They should agree to vape during tasks and remove any metal above the neck for procedures. Exclusions include certain medical conditions, mental health diagnoses, substance abuse treatment, other study participation, recent rTMS exposure, specific medication use in the last three months.

Inclusion Criteria

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

Exclusion Criteria

Being pregnant or lactating

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)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment to assess the impact of neuroaffective and neurocognitive differences on smoking behavior

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests if individual brain responses to emotional triggers affect how people who smoke respond to repetitive Transcranial Magnetic Stimulation (rTMS). It involves telehealth and in-person visits where participants will undergo rTMS while their brain activity is monitored using EEG.

Participant Groups

Group I: FP1 (cTBS) then F3 (iTBS) Experimental Treatment 1 Intervention

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

Group II: F3 (iTBS) then Fp1 (cTBS) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+