Study Results
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View full resultsBasic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2018-01-01
2018-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active rTMS
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.
Active rTMS with MagVenture MagPro double blind rTMS system
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.
Sham
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Sham rTMS
Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Interventions
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Active rTMS with MagVenture MagPro double blind rTMS system
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.
Sham rTMS
Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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David Friedrich
Resident Physician
Principal Investigators
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David Friedrich, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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MUSC Institute of Psychiatry
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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00070449
Identifier Type: -
Identifier Source: org_study_id
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