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Behavioural Intervention
Transcranial Magnetic Stimulation for Smoking Addiction
N/A
Recruiting
Led By Travis E Baker, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between the ages of 18 and 55 years old
Be between 18 and 65 years old
Must not have
History of autoimmune, endocrine, viral, or vascular disorder affecting the brain
History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (day of testing)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find the best way to use brain stimulation to help smokers by testing different protocols. They will also assess how these protocols affect decision-making and cravings. The study will involve two sessions and
Who is the study for?
This trial is for individuals who are struggling with tobacco use disorder or smoking addiction. Participants should be dependent smokers to qualify.
What is being tested?
The study aims to find the best Transcranial Magnetic Stimulation (TMS) pulse protocol that can influence reward activity in the brain, potentially helping with decision-making and reducing cravings in smokers.
What are the potential side effects?
While not explicitly stated, TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of disorders like autoimmune or viral that affect the brain.
Select...
I have a neurological disorder that affects my brain or physical abilities.
Select...
I have never been diagnosed with bipolar disorder, schizophrenia, PTSD, dementia, or major depression.
Select...
I am on constant medication for my brain or nerves.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 (day of testing)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (day of testing)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-related Brain Potential: Reward Positivity
Secondary study objectives
Approach Learning
Other study objectives
Nicotine Craving
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Inhibitory TMSExperimental Treatment1 Intervention
For condition 1b, 600 or 1200 pulses of iTBS. iTBS will be administered at 80% of each participant's RMT in a burst-firing pattern (3 pulses at 50 Hz) for a 2 s train, followed by an 8 s period of rest. Across sessions, participants will receive one of two iTBS protocols (randomized): 600 pulses (190 s) or 1200 pulses (570 s).
Group II: Excitatory TMSExperimental Treatment1 Intervention
For condition 1a, 3600 pulses of 10-Hz TMS or 3600 pulses of cTBS. 10 Hz rTMS (110% RMT stimulation intensity; 10 Hz frequency; 5 s on and 26 s off; 3600 pulses per session; total duration of 40 min). cTBS (80% RMT, (3 pulses at 50 Hz with a repeated frequency of 5 Hz, 200 ms intervals, containing 1800 pulses, 60 second break, 1800 pulses; total duration of 5 minutes).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
452 Previous Clinical Trials
69,537 Total Patients Enrolled
Travis E Baker, PhDPrincipal InvestigatorRutgers University