RECRUITING

rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

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Conditions

Cigarette SmokerCurrent Every Day SmokerCurrent Smoker

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial studies best dose and how well repetitive transcranial magnetic stimulation (rTMS) works in promoting smoking cessation and preventing relapse in current smokers. rTMS is a form of brain stimulation therapy that controls nerve cell activity, increases blood flow in the brain, and improves cognitive function.

Official Title

Enhancing Relapse Prevention With rTMS: Dose-Response Parameters for Smoking Cessation

Quick Facts

Study Start:2018-11-10
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03865472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants will be right-handed lung cancer patients
  2. * Negative urine drug screen at the baseline assessment
  3. * Ability to read at the 8th grade level
  4. * Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
  5. * Participants must smoke between 5 and 25 cigarettes per day with the intent to quit smoking in the next 30 days
  6. * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  7. * Study 1: Participants will be right-handed lung cancer or head and neck cancer patients
  8. * Study 1: Age 18+
  9. * Study 1: Negative urine drug screen at the baseline assessment
  10. * Study 1: Ability to read at the 8th grade level
  11. * Study 1: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
  12. * Study 1: Participants must smoke at least 4 cigarettes per day and intend to quit smoking in the next 60 days
  13. * Study 1: Is a patient - with primary non-small and small cell LC or with primary non-skin squamous cell HNC
  14. * Study 2: Participants will be healthy right-handed adults
  15. * Study 2: Age 18-65 years old
  16. * Study 2: Negative urine drug screen at the baseline assessment
  17. * Study 2: Ability to read at the 8th grade level
  18. * Study 2: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
  19. * Study 2: Participants must smoke between 5 and 25 cigarettes per day with the intent to quit smoking in the next 30 days
  20. * Study 2: Meet the criteria for heavy alcohol use: \> 7 drinks per week for women, \> 15 drinks per week for men OR binge drinking \>= 5 days in the past month. Binge drinking is defined as \>= 4 drinks for women and \>= 5 drinks for men, consumed within 2 hours of each other
  21. * Study 2: Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  1. * Has a personal history of epilepsy
  2. * Has a history of anticonvulsant medication use
  3. * Has a personal history of head injury
  4. * Has a History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the magnetic resonance imaging (MRI) (e.g., tumor, aneurism, etc.)
  5. * Has uncontrolled major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
  6. * Has any metal implants or neuro-stimulators in the head, neck, or cochlea
  7. * Has a pacemaker
  8. * Personal history of migraine headaches
  9. * Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
  10. * Currently using medications for tobacco cessation (e.g., nicotine replacement, bupropion, varenicline, etc)
  11. * Pregnant or planning to become pregnant in the next 24 weeks
  12. * Current regular use of forms of tobacco other than cigarettes including e-cigarettes
  13. * Participants who score above 48.3 on the Claustrophobia Questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo an magnetic resonance imaging (MRI) without distress
  14. * Individuals who score \>15, indicative of moderate-severe Alcohol Use Disorder, on the Alcohol Use Disorders Identification Test (AUDIT).
  15. * Unwilling or unable to follow protocol requirements
  16. * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
  17. * Study 1:Has a personal history of Brain metastases
  18. * Study 1: Unable to use nicotine patches
  19. * Study 1: Has a Personal history of epilepsy
  20. * Study 1: Has a History of anticonvulsant medication use
  21. * Study 1: Has a Personal history of head injury
  22. * Study 1: History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
  23. * Study 1: A diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
  24. * Study 1: Has any Metal implants or neuro-stimulators in the head, neck, or cochlea
  25. * Study 1: Has a pacemaker
  26. * Study 1: Personal history of Migraine headaches
  27. * Study 1: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
  28. * Study 1: Currently using bupropion or varenicline for smoking cessation
  29. * Study 1: Pregnant or planning to become pregnant in the next 24 weeks
  30. * Study 1: Current regular use of forms of tobacco other than cigarettes
  31. * Study 1: Participants who score above 48.3 on the Claustrophobia Questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo a magnetic resonance imaging (MRI) scan without distress
  32. * Study 1: Unwilling or unable to follow protocol requirements
  33. * Study 1: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
  34. * Study 2: Has a personal history of epilepsy
  35. * Study 2: Has a history of anticonvulsant medication use
  36. * Study 2: Has a personal history of head injury
  37. * Study 2: Has a history of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
  38. * Study 2: Has a diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
  39. * Study 2: Has any metal implants or neuro-stimulators in the head, neck, or cochlea
  40. * Study 2: Has a pacemaker
  41. * Study 2: Personal history of Migraine headaches
  42. * Study 2: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
  43. * Study 2: Currently using medications for tobacco cessation (e.g., nicotine replacement, bupropion, varenicline, etc.)
  44. * Study 2: Pregnant or planning to become pregnant in the next 24 weeks
  45. * Study 2: Current regular use of forms of tobacco other than cigarettes
  46. * Study 2: Participants who score above 48.3 on the Claustrophobia Questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo a magnetic resonance imaging (MRI) without distress
  47. * Study 2: Meet the criteria for severe alcohol use disorder (AUD) (\> 6 symptoms) or have ever met Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V) criteria for alcohol withdrawal. Heavy drinking and AUD are not mutually exclusive.
  48. * Study 2: Unwilling or unable to follow protocol requirements
  49. * Study 2: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study

Contacts and Locations

Principal Investigator

Christine Sheffer
PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute
Buffalo, New York, 14263
United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Christine Sheffer, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-10
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2018-11-10
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cigarette Smoker
  • Current Every Day Smoker
  • Current Smoker