- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03865472
rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers
Enhancing Relapse Prevention With rTMS: Dose-Response Parameters for Smoking Cessation
Study Overview
Status
Detailed Description
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.
II. To identify the most promising dosing strategy by balancing effect sizes and undesirable effects.
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 lung cancer (LC) patients (n=30). (Study 1 and Study 2) 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 1 and 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.
ARM II: Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New York
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Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
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Contact:
- Christine Sheffer
- Phone Number: 716-845-1186
- Email: Christine.Sheffer@roswellpark.org
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Principal Investigator:
- Christine Sheffer
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants will be right-handed lung cancer patients
- 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 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
- Study 1: Participants will be right-handed lung cancer or head and neck cancer patients
- Study 1: Age 18+
- 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: Is a patient - with primary non-small and small cell LC or with primary non-skin squamous cell HNC
- Study 2: Participants will be healthy right-handed adults
- Study 2: Age 18-65 years old
- 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 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
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 uncontrolled 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
- 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)
- Pregnant or planning to become pregnant in the next 24 weeks
- Current regular use of forms of tobacco other than cigarettes including e-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 an magnetic resonance imaging (MRI) without distress
- Individuals who score >15, indicative of moderate-severe Alcohol Use Disorder, on the Alcohol Use Disorders Identification Test (AUDIT).
- 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 head injury
- Study 1: History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
- Study 1: A diagnosis of 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
- 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: Pregnant or planning to become pregnant in the next 24 weeks
- Study 1: Current regular use of forms of tobacco other than 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) scan without distress
- 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
- 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: 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: 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.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (rTMS)
Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
|
Ancillary studies
Undergo rTMS
Other Names:
|
Sham Comparator: Arm II (sham rTMS)
Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
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Ancillary studies
Undergo sham rTMS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Latency to relapse
Time Frame: Up to 30 days
|
Latency to relapse will be defined as the number of days from the quit day to relapse.
Relapse will be defined as smoking for seven consecutive days.
Will use Cox proportional-hazards (CPH) models to examine latency to relapse outcome.
Ties in failure times will be handled using methods developed by Efron.
Compliance with the CPH assumptions will be tested by coding the factors as time-dependent covariates.
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Up to 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point-prevalence abstinence rates
Time Frame: At 12 and 24 weeks after quit date
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Will use logistic regression models to examine binary 12 and 24-week point prevalence abstinence.
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At 12 and 24 weeks after quit date
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Delay discounting rates
Time Frame: At 12 and 24 weeks after quit date
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Will be examined through using repeated measures Generalized Linear models.
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At 12 and 24 weeks after quit date
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Cognitive-behavioral Therapy Skills Questionnaire
Time Frame: Up to 24 weeks
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Cognitive behavioral skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ)
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Up to 24 weeks
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Side effects
Time Frame: Up to 24 weeks
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Potential undesirable effects will be measured up to 24 weeks.
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Up to 24 weeks
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Forever Free (FF) Booklet content Exposure
Time Frame: Up to 24 weeks
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Will be measured in terms of number of content segments in each booklet.
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Up to 24 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Sheffer, Roswell Park Cancer Institute
Publications and helpful links
General Publications
- Shevorykin A, Carl E, Mahoney MC, Hanlon CA, Liskiewicz A, Rivard C, Alberico R, Belal A, Bensch L, Vantucci D, Thorner H, Marion M, Bickel WK, Sheffer CE. Transcranial Magnetic Stimulation for Long-Term Smoking Cessation: Preliminary Examination of Delay Discounting as a Therapeutic Target and the Effects of Intensity and Duration. Front Hum Neurosci. 2022 Jul 5;16:920383. doi: 10.3389/fnhum.2022.920383. eCollection 2022.
- Carl E, Liskiewicz A, Rivard C, Alberico R, Belal A, Mahoney MC, Quisenberry AJ, Bickel WK, Sheffer CE. Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial. BMC Psychol. 2020 May 1;8(1):42. doi: 10.1186/s40359-020-00403-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- i 65718 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2018-03300 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA229415 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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