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Completed

NCT Number: NCT02939339

Theta Burst TMS as a Tool to Change Smoking Behavior

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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).

Treatment and study plan

continuous theta burst stimulation (real)

Device

a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity

Other names: cTBS (active)

continuous theta burst stimulation (sham)

Device

a sham version of a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity

Other names: cTBS (sham)

Primary outcomes

  1. Percent BOLD signal change in the MPFC

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2016
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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