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Theta Burst TMS as a Tool to Change Smoking Behavior

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status and phase

Completed
Early Phase 1

Conditions

Addiction
Smoking

Treatments

Device: continuous theta burst stimulation (real)
Device: continuous theta burst stimulation (sham)

Study type

Interventional

Funder types

Other

Identifiers

NCT02939339
00042165

Details and patient eligibility

About

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.

Full 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).

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups

real treatment
Experimental group
Description:
continuous theta burst stimulation (real) will be delivered
Treatment:
Device: continuous theta burst stimulation (real)
sham treatment
Sham Comparator group
Description:
continuous theta burst stimulation (sham) will be delivered
Treatment:
Device: continuous theta burst stimulation (sham)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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