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Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation

NCT ID: NCT00973622

Last Updated: 2013-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tobacco Dependence

Keywords

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Tobacco cessation Tobacco dependence Transcranial Magnetic Stimulation Nicotine Dependence Delayed Discounting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Smokers

Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.

Group Type EXPERIMENTAL

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

Intervention Type 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.

repetitive transcranial magnetic stimulation (rTMS) 20Hz

Intervention Type 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.

SHAM repetitive transcranial magnetic stimulation (rTMS)

Intervention Type 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.

Non-smokers

Healthy adult non-smokers aged 19-55

Group Type EXPERIMENTAL

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

Intervention Type 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.

repetitive transcranial magnetic stimulation (rTMS) 20Hz

Intervention Type 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.

SHAM repetitive transcranial magnetic stimulation (rTMS)

Intervention Type 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.

Interventions

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

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.

Intervention Type DEVICE

repetitive transcranial magnetic stimulation (rTMS) 20Hz

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.

Intervention Type DEVICE

SHAM repetitive transcranial magnetic stimulation (rTMS)

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.

Intervention Type DEVICE

Other Intervention Names

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"TMS" or Transcranial Magnetic Stimulation "TMS" or Transcranial Magnetic Stimulation "TMS" or Transcranial Magnetic Stimulation

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine E Sheffer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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110881

Identifier Type: -

Identifier Source: org_study_id