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Behavioural Intervention
rTMS for Smoking Cessation
N/A
Recruiting
Led By Christine Sheffer
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and 24 weeks after quit date
Awards & highlights
Summary
This trial is testing how well a brain stimulation therapy called rTMS works in promoting smoking cessation and preventing relapse in smokers.
Who is the study for?
This trial is for right-handed adults who smoke 5-25 cigarettes daily and want to quit within the next 30 days. They must be able to read at an 8th-grade level, pass a safety questionnaire, have no drug use, and not be heavy alcohol users. It's not for those with metal implants in the head/neck, pacemakers, certain mental health disorders, or on seizure-lowering or tobacco cessation meds.
What is being tested?
The trial is testing repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain therapy that may help control nerve activity and promote smoking cessation. Participants will either receive rTMS or a sham intervention while their cognitive function and blood flow in the brain are monitored.
What are the potential side effects?
Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms of facial muscles. Rarely it can cause seizures. The sham intervention should have no active side effects but may cause placebo effect responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 and 24 weeks after quit date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 and 24 weeks after quit date
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Latency to relapse
Secondary study objectives
Cognitive-behavioral Therapy Skills Questionnaire
Delay discounting rates
Forever Free (FF) Booklet content Exposure
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (rTMS)Experimental Treatment2 Interventions
Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
Group II: Arm II (sham rTMS)Placebo Group2 Interventions
Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,700 Total Patients Enrolled
10 Trials studying Cigarette Smokers
1,669 Patients Enrolled for Cigarette Smokers
Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,118 Total Patients Enrolled
2 Trials studying Cigarette Smokers
44 Patients Enrolled for Cigarette Smokers
Christine ShefferPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I smoke 5-25 cigarettes daily and plan to quit within a month.I smoke at least 4 cigarettes daily and plan to quit within 60 days.I have lung cancer or head and neck cancer, not including skin cancer.I am currently using bupropion or varenicline to quit smoking.I smoke 5-25 cigarettes daily and plan to quit within 30 days.I am a healthy, right-handed adult.I am currently on medication that could increase my risk of seizures.I am currently using medication to help me stop smoking.I drink more than 7 (women)/15 (men) drinks weekly or binge drink 5 days a month.I am 18 years old or older.I have had a stroke, aneurysm, brain surgery, or abnormal brain MRI findings.I am right-handed and have lung or head and neck cancer.I have taken medication for seizures before.I have taken medication for seizures before.I have had a stroke, aneurysm, brain surgery, or abnormal brain MRI findings.I have taken medication for seizures before.I have had a stroke, aneurysm, brain surgery, or abnormal brain MRI findings.I am comfortable with undergoing an MRI without feeling distressed.I do not have uncontrolled depression, bipolar, schizophrenia, or severe tinnitus.I am currently taking medication that could increase my risk of seizures.I have had brain metastases.I am currently using medication to help me stop smoking.I, or my legal representative, have signed the consent form after understanding this study's investigational nature.I am taking medication that could increase my risk of seizures.I have a history of migraine headaches.I have been diagnosed with depression, bipolar, schizophrenia, or tinnitus.I have a personal history of migraine headaches.I have a personal history of migraine headaches.I am comfortable with undergoing an MRI scan.I am between 18 and 65 years old.I have been diagnosed with major depression, bipolar, schizophrenia, or tinnitus.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (rTMS)
- Group 2: Arm II (sham rTMS)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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