Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation (rTMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00973622
First received: August 26, 2009
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Tobacco Dependence
Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)
Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz
Device: SHAM repetitive transcranial magnetic stimulation (rTMS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • A Difference Score for the Log Value of K. [ Time Frame: baseline and immediately after stimulation, an average of 25 seconds. ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smokers
Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
Device: 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.
Other Name: "TMS" or Transcranial Magnetic Stimulation
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.
Other Name: "TMS" or Transcranial Magnetic Stimulation
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.
Other Name: "TMS" or Transcranial Magnetic Stimulation
Experimental: Non-smokers
Healthy adult non-smokers aged 19-55
Device: 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.
Other Name: "TMS" or Transcranial Magnetic Stimulation
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.
Other Name: "TMS" or Transcranial Magnetic Stimulation
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.
Other Name: "TMS" or Transcranial Magnetic Stimulation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973622

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Christine E Sheffer, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00973622     History of Changes
Other Study ID Numbers: 110881
Study First Received: August 26, 2009
Results First Received: January 23, 2013
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Tobacco cessation
Tobacco dependence
Transcranial Magnetic Stimulation
Nicotine Dependence
Delayed Discounting

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014