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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

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 weeks
Treatment ~ Varies
Follow Up ~at 12 and 24 weeks after quit date
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 and 24 weeks after quit date for reporting.

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 more

Trial 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
13,917 Previous Clinical Trials
41,014,153 Total Patients Enrolled
10 Trials studying Cigarette Smokers
1,669 Patients Enrolled for Cigarette Smokers
Roswell Park Cancer InstituteLead Sponsor
412 Previous Clinical Trials
32,480 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

Repetitive Transcranial Magnetic Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03865472 — N/A
Cigarette Smokers Research Study Groups: Arm I (rTMS), Arm II (sham rTMS)
Cigarette Smokers Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT03865472 — N/A
Repetitive Transcranial Magnetic Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865472 — N/A
~4 spots leftby Dec 2024