rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers
This trial studies the 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.
Inclusion Criteria
- Participants will be healthy right-handed adults
- Age 18 years old or over
- Negative urine drug screen at the baseline assessment
- Ability to read at the 8th grade level
- Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
- Participants must smoke between 5 and 25 cigarettes per day with the intent to quit smoking in the next 30 days
- Participant 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
- Study 1: Participants will be right-handed lung cancer or head and neck cancer patients
- Study 1: Age 18 years or older
- Study 1: Negative urine drug screen at the baseline assessment
- Study 1: Ability to read at the 8th grade level
- Study 1: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
- Study 1: Participants must smoke at least 4 cigarettes per day and intend to quit smoking in the next 60 days
- Study 1: Participant 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
- Study 1: Has been diagnosed with primary non-small and small cell LC or with primary non-skin squamous cell HNC (self-reported)
- Study 2: Participants will be healthy right-handed adults
- Study 2: Age 18 years old or over
- Study 2: Negative urine drug screen at the baseline assessment
- Study 2: Ability to read at the 8th grade level
- Study 2: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
- Study 2: Participants must smoke between 5 and 25 cigarettes per day with the intent to quit smoking in the next 30 days
- 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
- Study 2: Participant 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.
Exclusion Criteria
- Has a personal history of epilepsy
- Has a history of anticonvulsant medication use
- Has a personal history of head injury
- Has a history of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the magnetic resonance imaging (MRI) (e.g., tumor, aneurism, etc.)
- Has a diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
- Has any metal implants or neuro-stimulators in the head, neck, or cochlea that prevent an MRI being performed
- Has a pacemaker
- Personal history of migraine headaches
- Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
- Currently using medications for tobacco cessation (e.g., nicotine replacement, bupropion, varenicline, etc…)
- Is pregnant or planning to become pregnant in the next 24 weeks
- Current regular use of forms of tobacco other than cigarettes
- 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
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to participate in the study
- Study 1: Has a personal history of brain metastases
- Study 1: Unable to use nicotine patches
- Study 1: Has a personal history of epilepsy
- Study 1: Has a history of anticonvulsant medication use
- Study 1: Has a personal history of serious head injury
- Study 1: Has a history of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
- Study 1: Has uncontrolled major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
- Study 1: Has any metal implants or neuro-stimulators in the head, neck, or cochlea that prevent an MRI being performed
- Study 1: Has a pacemaker
- Study 1: Personal history of migraine headaches
- Study 1: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
- Study 1: Currently using bupropion or varenicline for smoking cessation
- Study 1: Is pregnant or planning to become pregnant in the next 24 weeks
- Study 1: Current regular use of forms of tobacco other than cigarettes including e-cigarettes
- 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) without distress
- Study 1: Individuals who score > 15, indicative of moderate-severe alcohol use disorder, on the Alcohol Use Disorders Identification Test (AUDIT)
- Study 1: Unwilling or unable to follow protocol requirements
- Study 1: Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to participate in the study
- Study 2: Has a personal history of epilepsy
- Study 2: Has a history of anticonvulsant medication use
- Study 2: Has a personal history of head injury
- Study 2: Has a history of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
- Study 2: Has a diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
- Study 2: Has any metal implants or neuro-stimulators in the head, neck, or cochlea that prevent a MRI being performed
- Study 2: Has a pacemaker
- Study 2: Personal history of migraine headaches
- Study 2: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
- Study 2: Currently using medications for tobacco cessation (e.g., nicotine replacement, bupropion, varenicline, etc.)
- Study 2: Is pregnant or planning to become pregnant in the next 24 weeks
- Study 2: Current regular use of forms of tobacco other than cigarettes
- 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
- Study 2: Have ever met Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V) criteria for alcohol withdrawal
- Study 2: Unwilling or unable to follow protocol requirements
- Study 2: Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to participate in the study
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03865472.
Locations matching your search criteria
United States
New York
Buffalo
PRIMARY OBJECTIVES:
I. To examine the effects of stimulation duration (stimulation days) and intensity (pulses per day) on outcomes among smokers (sample size [n]=258) motivated to quit. (Initial study)
II. To identify the most promising dosing strategy by balancing effect sizes and undesirable effects. (Initial study)
III. To examine the effects of 16 20Hz rTMS sessions combined with intensive cognitive-behavioral treatment and nicotine replacement on smoking cessation, developmental disability (DD) rates, cognitive-behavioral skill acquisition, and nicotine patch adherence among patients with lung cancer (LC) or head and neck cancer (n=30). (Study 1)
IV. To examine the feasibility and potential efficacy of 20Hz rTMS on the left dorsolateral prefrontal cortex (DLPFC) for concurrent smoking abstinence and reductions in alcohol use among smokers who are heavy drinkers (n=20). (Study 2)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo rTMS once daily (QD) or twice daily (BID) over 16 minutes for 8, 12, or 16 days. Patients undergo magnetic resonance imaging (MRI) during screening.
ARM II: Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days. Patients undergo MRI during screening.
After completion of study treatment, patients are followed up at 4, 8, 12, 18, and 24 weeks.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorChristine Sheffer
- Primary IDi 65718
- Secondary IDsNCI-2018-03300
- ClinicalTrials.gov IDNCT03865472