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Completed

NCT Number: NCT00973622

Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation

This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

Tobacco use is the greatest cause of preventable death in the US and cigarette smokers exhibit substantial relapse following treatment. Understanding the brain mechanisms involved in tobacco dependence is an important step toward reducing the high rate of relapse associated with current behavioral and pharmacological treatments for smoking cessation. This study seeks to examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior. A concept central to this study is that "quitting" tobacco necessitates making conscious choices not to smoke (to delay gratification) and these choices are influenced by the balance of activity between the frontal-parietal systems that process the value of rewards and limbic systems that are involved with immediate gratification. We aim to: 1) determine how two different levels of cortical excitation (10 Hz and 20Hz), induced by different rTMS frequencies, influence reward and risk-taking choices and cigarette consumption. Additionally, we aim to 2) determine how limbic activation due to acute nicotine withdrawal and/or satiation modifies the effects in aim 1. Twenty non-smoking and 20 smoking participants will receive two levels of high frequency rTMS and comparable sham stimulation (using electrical scalp stimulation) delivered over the left prefrontal cortex. Smokers will also crossover between nicotine satiation and acute withdrawal conditions to determine how rTMS interacts with limbic activation associated with nicotine use and withdrawal. In addition, changes in preattentional (brainstem-thalamus processing as measured using the P50 midlatency auditory evoked potential) and attentional (thalamocortical processing as measured using the Psychomotor Vigilance Task; PVT) will be assessed before and after treatment to quantitatively determine changes in preattentional/arousal and attentional function.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19-55
  • Must speak English
  • Must be right handed
  • Must pass the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TAAS)
  • Smoking participants must be highly dependent with a score of 6 or greater on the Fagerstrom Test for Nicotine Dependence

Exclusion criteria

  • Positive test for drugs of abuse
  • Positive pregnancy test
  • A personal or family history of epilepsy
  • A history of anticonvulsant medication use
  • A personal history of head injury
  • A history of aneurysm, stroke, or previous cranial neurosurgery
  • A diagnosis of bipolar disorder
  • A neurological or psychiatric disorder for which hospitalization was required
  • Tinnitus
  • Metal implants in the head, neck or cochlea
  • A pacemaker
  • Migraines
  • A history of taking medications that lower seizure threshold (i.e. such as tricyclic antidepressants or bupropion)
  • Claustrophobia (due to the MRI)
  • Used any form of tobacco in the past two years if they desire to be a non-smoking participant
  • Plans to quit smoking in the next 30 days if they desire to be a smoking participant
  • Current use of any medications for tobacco cessation (i.e. nicotine replacement, bupropion, varenicline, etc.)
  • A report of a high motivation to quit smoking (score 7 or great on the Motivation scale)

Treatment and study plan

repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)

Device

All participants will receive 90 10-pulse trains of 1 sec duration with an interval of 20 seconds. Smokers will receive the treatment twice, once in a nicotine-satiated condition, and once in a nicotine-withdrawal condition.

Other names: "TMS" or Transcranial Magnetic Stimulation

repetitive transcranial magnetic stimulation (rTMS) 20Hz

Device

All participants will receive 45 20-pulse trains of 1 second duration with an interval of 20 seconds. Smokers will receive the treatment twice, once in a nicotine-satiated condition, and once in a nicotine-withdrawal condition.

Other names: "TMS" or Transcranial Magnetic Stimulation

SHAM repetitive transcranial magnetic stimulation (rTMS)

Device

The look and sound of active rTMS is reproduced with the same coil used in the active conditions. The magnetic field in the sham coil is markedly attenuated at only 5% of stimulator output. The feel of active stimulation will be reproduced by delivering monophasic current pulses to the left, frontalis muscle with a Isolated Stimulator and two carbon rubber electrodes. Smokers will receive Sham rTMS in both the nicotine-satiated and nicotine-withdrawal conditions.

Other names: "TMS" or Transcranial Magnetic Stimulation

Primary outcomes

  1. A Difference Score for the Log Value of K.

    Time frame: baseline and immediately after stimulation, an average of 25 seconds.

    K is a output value, a summary statistic, derived from a hyperbolic function that summarizes the rate at which monetary values are discounted according to the time they are received. The value of K can either increase or decrease from its baseline value. For example, an increase in K would indicate that the participant is choosing to receive larger amounts of money at a later point in time. A decrease would suggest the opposite - lesser amounts of money at an earlier point in time). The difference score is calculated from baseline to that immediately after 10 or 20 Hz rTMS.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Acronym: rTMS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2009
Registry last updated
Sep 24, 2013

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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