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Behavioural Intervention
Transcranial Magnetic Stimulation for Smoking Addiction
N/A
Recruiting
Led By Nicole Petersen, Ph.D
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial is testing if transcranial magnetic stimulation can help smokers quit by stimulating different parts of the brain. There will be a sham procedure to control for placebo effects.
Who is the study for?
This trial is for individuals aged 18-45 with Tobacco Use Disorder who smoke at least 10 cigarettes daily and have done so for over a year. Participants must be in good health without major diseases or psychiatric disorders, not use other tobacco forms frequently, and not be pregnant or seeking nicotine dependence treatment.
What is being tested?
The study tests if rTMS can reduce cigarette cravings and withdrawal symptoms. It involves four sessions targeting different brain areas at UCLA, with each session followed by an MRI scan and questionnaires. Men's and women's responses to the treatment are compared.
What are the potential side effects?
rTMS is generally considered safe but may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The MRI might cause discomfort due to its enclosed nature.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Positive and Negative Affect Schedule (PANAS)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Shiffman-Jarvik Withdrawal Scale
+1 moreSecondary study objectives
Baseline Magnetic Resonance Imaging (MRI)
Post-stimulation Magnetic Resonance Imaging (MRI)
Side effects data
From 2005 Phase 2 trial • 50 Patients • NCT0000498059%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Repetitive Transcanial Magnetic Stimulation
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: TMS on dlPFCExperimental Treatment1 Intervention
Device: repetitive transcranial magnetic stimulation (rTMS)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the dorsolateral prefrontal cortex (dlPFC).
Other Name: rTMS (active stimulation)
Group II: TMS on SFGExperimental Treatment1 Intervention
Device: repetitive transcranial magnetic stimulation (real)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the superior frontal gyrus (SFG).
Other Name: rTMS (active stimulation)
Group III: TMS on PPCExperimental Treatment1 Intervention
Device: repetitive transcranial magnetic stimulation (rTMS)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the posterior parietal cortex (PPC).
Other Name: rTMS (active stimulation)
Group IV: TMS on v5Placebo Group1 Intervention
Device: repetitive transcranial magnetic stimulation (rTMS)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target visual cortex (v5).
Other Name: rTMS (sham stimulation)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
repetitive transcranial magnetic stimulation (rTMS)
2003
Completed Phase 2
~390
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,266,940 Total Patients Enrolled
9 Trials studying Tobacco Use Disorder
1,022 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,169,566 Total Patients Enrolled
46 Trials studying Tobacco Use Disorder
26,191 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,595 Previous Clinical Trials
3,328,683 Total Patients Enrolled
281 Trials studying Tobacco Use Disorder
49,648 Patients Enrolled for Tobacco Use Disorder
Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,722 Total Patients Enrolled
10 Trials studying Tobacco Use Disorder
1,995 Patients Enrolled for Tobacco Use Disorder
Nicole Petersen, Ph.DPrincipal InvestigatorFaculty
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious mental illness.You have a current problem with using drugs, except for tobacco.You have a preference for menthol-flavored products.You have metal implants in your body.You have a diagnosis of tobacco addiction according to the latest guidelines.You have a condition that causes seizures.You use marijuana more than once a week.There are other situations that the researchers think could be unsafe for you to participate in the study.You should be in good overall health without any heart, liver, kidney, or autoimmune diseases, diabetes, or cancer.You must have been smoking for at least 1 year and currently smoke at least 10 cigarettes per day.You have a medical condition that could potentially make the study unsafe for you.You have used tobacco products other than cigarettes for more than 10 days in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: TMS on v5
- Group 2: TMS on SFG
- Group 3: TMS on PPC
- Group 4: TMS on dlPFC
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.