Theta Burst TMS as a Tool to Change Smoking Behavior

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02939339

Enrollment

Registered

2016-10-20

Start date

2015-10-31

Completion date

2017-08-01

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction, Smoking

Keywords

Transcranial Magnetic Stimulation

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).

Interventions

DEVICEcontinuous theta burst stimulation (real)

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

DEVICEcontinuous theta burst stimulation (sham)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026