Clinical trial NCT03579953: Nicotine TMS EFT Smoking Pilot Study
Official title: Theta-Burst Stimulation As A Tool To Change Smoking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Smoking
Nicotine Dependence
Addiction
Smoking, Cigarette
Keywords: Brain Stimulation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in craving after a single session of cTBS
timeFrame: For the duration of the study, approximately 24 hours following real or sham cTBS
Secondary outcomes:
measure: Changes in delayed discounting after a single session of cTBS
timeFrame: For the duration of the study, approximately 24 hours following real or sham cTBS
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Colleen A Hanlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: