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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-03300 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| i 65718 | Other Identifier | Roswell Park Cancer Institute | |
| R01CA229415 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (rTMS) | Experimental | Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days. |
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| Arm II (sham rTMS) | Sham Comparator | Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to relapse | 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. | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Point-prevalence abstinence rates | Will use logistic regression models to examine binary 12 and 24-week point prevalence abstinence. | At 12 and 24 weeks after quit date |
| Delay discounting rates |
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Inclusion Criteria:
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 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)
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
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| Name | Affiliation | Role |
|---|---|---|
| Christine Sheffer | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36937103 | Derived | Shevorykin A, Carl E, Liskiewicz A, Hanlon CA, Bickel WK, Mahoney MC, Vantucci D, Bensch L, Thorner H, Marion M, Sheffer CE. Perceived research burden of a novel therapeutic intervention: A study of transcranial magnetic stimulation for smoking cessation. Front Rehabil Sci. 2023 Mar 3;4:1054456. doi: 10.3389/fresc.2023.1054456. eCollection 2023. | |
| 35874156 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2025 | Feb 6, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Repetitive Transcranial Magnetic Stimulation |
| Procedure |
Undergo rTMS |
|
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| Sham Intervention | Procedure | Undergo sham rTMS |
|
Will be examined through using repeated measures Generalized Linear models.
| At 12 and 24 weeks after quit date |
| Cognitive-behavioral Therapy Skills Questionnaire | Cognitive behavioral skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) | Up to 24 weeks |
| Side effects | Potential undesirable effects will be measured up to 24 weeks. | Up to 24 weeks |
| Forever Free (FF) Booklet content Exposure | Will be measured in terms of number of content segments in each booklet. | Up to 24 weeks |
| 32357940 | Derived | 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. |