Tobacco DependencerTMSNCT00973622
Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation
A study testing repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz) and repetitive transcranial magnetic stimulation (rTMS) 20Hz in people with Tobacco Dependence, run by University of Arkansas at 1 site in United States.
Trial summary
This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz) and repetitive transcranial magnetic stimulation (rTMS) 20Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.
Read the 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.
- Conditions
- Tobacco Dependence
- Being tested
- repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz), repetitive transcranial magnetic stimulation (rTMS) 20Hz, SHAM repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Tobacco cessation, Tobacco dependence, Transcranial Magnetic Stimulation, Nicotine Dependence, Delayed Discounting
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)Device
Also called "TMS" or Transcranial Magnetic Stimulation
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) 20HzDevice
Also called "TMS" or Transcranial Magnetic Stimulation
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)Device
Also called "TMS" or Transcranial Magnetic Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking. Receives: Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz); Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz; Device: SHAM repetitive transcranial magnetic stimulation (rTMS) |
| Non-smokers | Experimental | Healthy adult non-smokers aged 19-55 Receives: Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz); Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz; Device: SHAM repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Difference Score for the Log Value of K.
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.
Measured: baseline and immediately after stimulation, an average of 25 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine E Sheffer, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973622
- Sponsor's protocol ID
- 110881
- Acronym
- rTMS
- Status last verified
- Jul 2013
- First submitted
- 26 Aug 2009
- Last updated
- 24 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT00973622
- Acronym / sponsor ID
- rTMS / 110881
- Conditions
- Tobacco Dependence
- Keywords
- Tobacco cessation, Tobacco dependence, Transcranial Magnetic Stimulation, Nicotine Dependence, Delayed Discounting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Posted 24 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz), Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz, Device: SHAM repetitive transcranial magnetic stimulation (rTMS)Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking. |
| Non-smokers | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz), Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz, Device: SHAM repetitive transcranial magnetic stimulation (rTMS)Healthy adult non-smokers aged 19-55 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)Also: "TMS" or Transcranial Magnetic StimulationAll 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. | Device | Non-smokers, Smokers |
| repetitive transcranial magnetic stimulation (rTMS) 20HzAlso: "TMS" or Transcranial Magnetic StimulationAll 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. | Device | Non-smokers, Smokers |
| SHAM repetitive transcranial magnetic stimulation (rTMS)Also: "TMS" or Transcranial Magnetic StimulationThe 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. | Device | Non-smokers, Smokers |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine E Sheffer, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz) and repetitive transcranial magnetic stimulation (rTMS) 20Hz in people with Tobacco Dependence, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Difference Score for the Log Value of K. (time frame: baseline and immediately after stimulation, an average of 25 seconds.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.