Nicotine DependenceNCT01690130
Transcranial Magnetic Stimulation Effects on Nicotine Craving
A study testing Transcranial Magnetic Stimulation (Neuronetics) in people with Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Transcranial Magnetic Stimulation (Neuronetics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 2014
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the detailed description
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.
- Conditions
- Nicotine Dependence
- Being tested
- Transcranial Magnetic Stimulation (Neuronetics), Sham Transcranial Magnetic Stimulation
- Keywords
- nicotine, craving, smoking, TMS, prefrontal cortex
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (Neuronetics)Device
Also called Neuronetics® Model 3600
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.
Sham Transcranial Magnetic StimulationDevice
Also called Transcutaneous Electrical Nerve 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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses. Receives: Device: Transcranial Magnetic Stimulation (Neuronetics); Device: Sham Transcranial Magnetic Stimulation |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA) Receives: Device: Transcranial Magnetic Stimulation (Neuronetics); Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Change From Baseline in Cue Nicotine Craving Rating Score
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.
Measured: Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)
Secondary outcomes (1)
the Change From Baseline in Resting Motor Threshold
Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response
Measured: 20 minutes before (baseline) and 20 minutes after rTMS experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startJun 2009
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690130
- Sponsor's protocol ID
- Brain Stimulation Lab / MUSC
- Status last verified
- Mar 2020
- First submitted
- 7 Sep 2012
- Last updated
- 1 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Amiaz R, Levy D, Vainiger D, Grunhaus L, Zangen A. Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. Addiction. 2009 Apr;104(4):653-60. doi: 10.1111/j.1360-0443.2008.02448.x. Epub 2009 Jan 12.
PubMed 19183128Eichhammer P, Johann M, Kharraz A, Binder H, Pittrow D, Wodarz N, Hajak G. High-frequency repetitive transcranial magnetic stimulation decreases cigarette smoking. J Clin Psychiatry. 2003 Aug;64(8):951-3. doi: 10.4088/jcp.v64n0815.
PubMed 12927012Li X, Hartwell KJ, Owens M, Lematty T, Borckardt JJ, Hanlon CA, Brady KT, George MS. Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Biol Psychiatry. 2013 Apr 15;73(8):714-20. doi: 10.1016/j.biopsych.2013.01.003. Epub 2013 Feb 26.
PubMed 23485014
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation Effects on Nicotine Craving
- ClinicalTrials.gov ID
- NCT01690130
- Acronym / sponsor ID
- Brain Stimulation Lab / MUSC
- Conditions
- Nicotine Dependence
- Keywords
- nicotine, craving, smoking, TMS, prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Posted 21 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magnetic Stimulation (Neuronetics), Device: Sham Transcranial Magnetic StimulationTranscranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses. |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Device: Transcranial Magnetic Stimulation (Neuronetics), Device: Sham Transcranial Magnetic StimulationSham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (Neuronetics)Also: Neuronetics® Model 3600Transcranial 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. | Device | Sham Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation |
| Sham Transcranial Magnetic StimulationAlso: Transcutaneous Electrical Nerve Stimulation DeviceThe 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. | Device | Sham Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation |
Primary outcome
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.
1 secondary outcome
the Change From Baseline in Resting Motor Threshold
Time frame: 20 minutes before (baseline) and 20 minutes after rTMS experiment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19183128Amiaz R, Levy D, Vainiger D, Grunhaus L, Zangen A. Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. Addiction. 2009 Apr;104(4):653-60. doi: 10.1111/j.1360-0443.2008.02448.x. Epub 2009 Jan 12.
- Background: PubMed 12927012Eichhammer P, Johann M, Kharraz A, Binder H, Pittrow D, Wodarz N, Hajak G. High-frequency repetitive transcranial magnetic stimulation decreases cigarette smoking. J Clin Psychiatry. 2003 Aug;64(8):951-3. doi: 10.4088/jcp.v64n0815.
- Derived from this study: PubMed 23485014Li X, Hartwell KJ, Owens M, Lematty T, Borckardt JJ, Hanlon CA, Brady KT, George MS. Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Biol Psychiatry. 2013 Apr 15;73(8):714-20. doi: 10.1016/j.biopsych.2013.01.003. Epub 2013 Feb 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (Neuronetics) in people with Nicotine Dependence, run by Medical University of South Carolina 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 3 inclusion and 8 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 1 Apr 2020. 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. Some participants in this study may receive a placebo. 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 21 Nov 2018). 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?
the Change From Baseline in Cue Nicotine Craving Rating Score (time frame: Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690130, which also lists 3 linked publications.
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 1 Apr 2020.