- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690130
Transcranial Magnetic Stimulation Effects on Nicotine Craving
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcranial Magnetic Stimulation
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.
|
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.
Other Names:
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.
Other Names:
|
Sham Comparator: Sham Transcranial Magnetic Stimulation
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)
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the Change From Baseline in Resting Motor Threshold
Time Frame: 20 minutes before (baseline) and 20 minutes after rTMS experiment
|
Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response
|
20 minutes before (baseline) and 20 minutes after rTMS experiment
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Eichhammer 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.
- Li 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Brain Stimulation Lab / MUSC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nicotine Dependence
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditionsUnited States
-
University of California, San FranciscoNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)WithdrawnCardiovascular Risk Factor | Nicotine Dependence | Nicotine Dependence, Cigarettes | Nicotine Withdrawal | Tobacco ToxicityUnited States
-
University of VermontNational Institute on Drug Abuse (NIDA)CompletedNicotine Dependence, CigarettesUnited States
-
Freedom Laser, Inc.NST Consultants, Inc.Completed
-
University of VermontNational Institute of General Medical Sciences (NIGMS)CompletedNicotine Dependence, CigarettesUnited States
-
Milton S. Hershey Medical CenterCompleted
-
University of OsloCharles University, Czech Republic; The Research Council of NorwayRecruitingNicotine Dependence, CigarettesCzechia, Norway
-
University of OsloCharles University, Czech Republic; The Research Council of NorwayRecruiting
-
Duke UniversityNational Institute on Drug Abuse (NIDA)CompletedNicotine Dependence, CigarettesUnited States
-
Milton S. Hershey Medical CenterTerminatedNicotine Dependence, CigarettesUnited States
Clinical Trials on Transcranial Magnetic Stimulation (Neuronetics)
-
INTRuST, Post-Traumatic Stress Disorder - Traumatic...Medical University of South Carolina; University of California, San Diego; U.S... and other collaboratorsUnknownTraumatic Brain Injury | Posttraumatic Stress Disorder | Depressive EpisodeUnited States
-
Butler HospitalNeuronetics; Providence VA Medical CenterCompletedMajor Depressive Disorder | Posttraumatic Stress Disorder | Transcranial Magnetic Stimulation, RepetitiveUnited States
-
James A. Haley Veterans Administration HospitalCompletedDepression | Posttraumatic Stress DisorderUnited States
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)CompletedMajor Depressive DisorderUnited States
-
State University of New York - Upstate Medical...RecruitingHeadache | Brain Concussion | Mild Traumatic Brain Injury | Post-Concussion SymptomsUnited States
-
George Mason UniversityMedStar National Rehabilitation NetworkCompletedStroke | Stroke, Ischemic | Hemiparesis | Cerebral Vascular AccidentUnited States
-
Russian Academy of Medical SciencesCompletedStrokeRussian Federation
-
Centre hospitalier de l'Université de Montréal...Canadian Institutes of Health Research (CIHR)RecruitingMajor Depressive DisorderCanada
-
University Hospital TuebingenFederal Ministry of Health, Germany; University of Ulm; Department of Psychiatry... and other collaboratorsRecruitingMajor Depressive DisorderGermany
-
VA Office of Research and DevelopmentRecruitingDepression | Gulf War IllnessUnited States