Theta Burst TMS as a Tool to Change Smoking Behavior

Early Phase 1

Completed

• Conditions: Smoking; Addiction
• Interventions: Device: continuous theta burst stimulation (sham); Device: continuous theta burst stimulation (real)

• Registration Number: NCT02939339
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

Detailed Description

Prior and recent evidence suggests a role of medial prefrontal cortex (mPFC) in cigarette smoking. The present study will examine whether a five-day regimen of theta-burst transcranial magnetic stimulation (TMS) reduces cigarette smoking outside of the lab (examined through self-report and physiological measures) and motivation to smoke inside the lab (examined through behavioral tasks and functional MRI).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• smoke at least 10 cigarettes a day (on average)

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Exclusion Criteria

• comorbid mental or physical illness (managed or unmanaged)
• pregnancy
• use of prescription medication that might affect smoking or nicotine metabolism,
• use of smokeless tobacco or alternative nicotine products
• use illicit drugs of abuse (verified through urine screen and self-report),
• score of above a 7 on the Alcohol Use Disorders Identification Test (indicative of non-risky use),
• a history of epilepsy or seizures not otherwise specified (other than childhood febrile seizures)
• a history of chronic migraines,
• failure to meet all criteria on a standardized MRI/TMS safety screen (including but not limited to implanted electronic devices, bullets or metallic fragments above the waist, hair clips and piercings above the waist that cannot be removed)
• presence of any barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham treatment	continuous theta burst stimulation (sham)	continuous theta burst stimulation (sham) will be delivered
real treatment	continuous theta burst stimulation (real)	continuous theta burst stimulation (real) will be delivered

Primary Outcome Measures

Name	Time	Method
Percent BOLD signal change in the MPFC	immediately after the treatment	The effect of real vs. sham cTBS to the leftt MPFC as a tool to modulate the brain response to craving will be assessed by comparing the brain activity in the limbic circuit before and after TMS.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States