Accelerated rTMS for the Reduction of Nicotine Craving

Study Overview
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Brief Summary
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The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.

Official Title
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Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals

Conditions
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Nicotine Use Disorder, Nicotine Dependence

Intervention / Treatment
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* Device: Active rTMS with MagVenture MagPro double blind rTMS system
* Device: Sham rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient Adults aged 18-70 Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of >10ppm day of visit. Ability to provide informed consent Exclusion Criteria Current treatment with varenicline or bupropion Currently making a smoking quit attempt (not currently smoking). Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer. Current episode of major depression determined by MINI interview. Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI. Current daily consumption of alcohol or current alcohol use disorder. Current substance use disorder except for nicotine or cannabis use disorder. Currently pregnant or lactating. Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion. Unstable medical conditions Suicidal ideation or history of suicide attempt within the last six months. Inability or unwillingness of subject or legal guardian/representative to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blind, control
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rTMS<br>5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. | Device: Active rTMS with MagVenture MagPro double blind rTMS system<br>* 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.<br>|
| Sham Comparator: Sham<br>5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. | Device: Sham rTMS<br>* Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability Measured by Percent of Participants Completing the rTMS Course | Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments. | 1 day (single visit) | 
| Decrease in Cue Induced Nicotine Craving | Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving. | During the one day visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce in Self Reported Smoking | An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course. | 1 week and 2 weeks after rTMS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, rTMS, Transcranial Magnetic Stimulation, Smoking, Nicotine