Nicotine TMS EFT Smoking Pilot Study

Medical University of South Carolina (MUSC)

Status and phase: Completed; Early Phase 1

Conditions: Smoking, Cigarette; Nicotine Dependence; Addiction; Smoking

Treatments: Device: Sham cTBS; Device: Real cTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT03579953

74722

Details and patient eligibility

About

Prior and recent evidence suggests a role of medial prefrontal cortex (MPFC) in cigarette smoking. Episodic Future Thinking (EFT) has also been shown to be associated with increased delayed discounting and reduced cigarette self administration. In the present study, we will examine whether a single administration of theta-burst transcranial magnetic stimulation (tbTMS) can increase Episodic Future Thinking and delayed discounting while reducing craving for nicotine.

Full description

The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS) as a potential treatment for nicotine addiction. Theta burst TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether tbTMS over the forehead can produce a reduction in things that may prompt individuals to want to smoke cigarettes. TMS has been approved by the Food and Drug Administration as an investigational tool as well as a therapy for depression. However, TMS is not approved by the Food and Drug Administration as a treatment for nicotine cravings and other addictions.

This study consists of one consent session and one TMS session. Participants will be asked to complete a series of questionnaires and computer assessments about nicotine both before and after a single tbTMS session.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-65 years of age
2. Smoke at least 10 cigarettes a day (on average)
3. Not be pregnant
4. Meet all criteria on a standardized TMS safety screen (including to but not limited to implanted electronic devices, bullets or metallic fragments above the neck, hair clips that cannot be removed)
5. No 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)

Exclusion criteria

1. Report comorbid mental or physical illness (managed or unmanaged)
2. Currently using prescription medication that might affect smoking or nicotine metabolism
3. Using smokeless tobacco or alternative nicotine products
4. History of epilepsy or seizures (other than childhood febrile seizures)
5. History of chronic migraines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Real cTBS to MPFC

Experimental group

Description:

One session of real cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).

Treatment:

Device: Real cTBS

Sham cTBS to MPFC

Sham Comparator group

Description:

One session of sham cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).

Treatment:

Device: Sham cTBS