Transcranial Magnetic Stimulation Effects on Nicotine Craving

Not Applicable

Completed

Conditions: Nicotine Dependence

Interventions: Device: Transcranial Magnetic Stimulation (Neuronetics)
Device: Sham Transcranial Magnetic Stimulation

Registration Number: NCT01690130

Lead Sponsor: Medical University of South Carolina

Brief Summary: The proposed study will measure the change of cortical excitability during nicotine craving and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine craving and cue-reactivity among adult regular smokers.

Detailed Description: This pilot protocol proposes to test and further develop TMS for the purpose of studying brain function in nicotine users.

Specific Primary Aims include:

Aim # 1. To test change of cortical excitability during nicotine craving in cigarette smokers and explore the potential use of TMS in cigarette smokers.

Aim # 2. Given the role of the prefrontal cortex (and connected regions) in craving, we will examine whether modulating prefrontal activity through rTMS will impact measures of craving and the reinforcing effects of nicotine.

Design:

The study was a randomized, blind, sham-controlled crossover study in which participants will involve two study visits. Participants will have an initial assessment about tobacco use habits and craving patterns. Participant will look at images related to and not related to cigarette smoking.

Participants will receive two different types of brain stimulation with repetitive TMS (10 Hz): sham rTMS and active rTMS over prefrontal cortex. Craving assessments will be performed before and after each stimulus experiment.

Participants will be measured cortical excitability with TMS before and after each stimulus experiment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

Inclusion Criteria

Right handed males and females, between the ages of 18 and 50
Daily smokers who smoke at least 10 cigarettes per day for at least past 1 year
Mentally capable of reading, writing, giving consent, following instructions

Exclusion Criteria

history of seizures
taking medications that lower seizure threshold
implanted metal devices (e.g., pacemakers, metal plates, wires)
pregnant
history of brain surgery or history of loss of consciousness >15 minutes
any unstable major axis I psychiatric disorder in the past month (e.g. psychotic disorders)
Current substance use disorders other than nicotine and caffeine use, in the past 30 days
Any medication (e.g., propranolol) or unstable medical condition that may interfere with psychophysiological (e.g., heart rate) monitoring

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial Magnetic Stimulation	Transcranial Magnetic Stimulation (Neuronetics)	Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.
Sham Transcranial Magnetic Stimulation	Transcranial Magnetic Stimulation (Neuronetics)	Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)
Transcranial Magnetic Stimulation	Sham Transcranial Magnetic Stimulation	Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.
Sham Transcranial Magnetic Stimulation	Sham Transcranial Magnetic Stimulation	Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)

Primary Outcome Measures

Name	Time	Method
the Change From Baseline in Cue Nicotine Craving Rating Score	Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)	Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.

Secondary Outcome Measures

Name	Time	Method
the Change From Baseline in Resting Motor Threshold	20 minutes before (baseline) and 20 minutes after rTMS experiment	Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response