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Completed

NCT Number: NCT01690130

Transcranial Magnetic Stimulation Effects on Nicotine Craving

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation (Neuronetics)

Device

Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.

Other names: Neuronetics® Model 3600

Sham Transcranial Magnetic Stimulation

Device

The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.

Other names: Transcutaneous Electrical Nerve Stimulation Device

Primary outcomes

  1. the Change From Baseline in Cue Nicotine Craving Rating Score

    Time frame: 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 outcomes

  1. the Change From Baseline in Resting Motor Threshold

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 21, 2012
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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