Back to resultsTheta Burst TMS as a Tool to Change Smoking Behavior
Primary Purpose
Smoking, Addiction
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
continuous theta burst stimulation (real)
continuous theta burst stimulation (sham)
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria:
- smoke at least 10 cigarettes a day (on average)
Exclusion Criteria:
- comorbid mental or physical illness (managed or unmanaged)
- pregnancy
- use of prescription medication that might affect smoking or nicotine metabolism,
- use of smokeless tobacco or alternative nicotine products
- use illicit drugs of abuse (verified through urine screen and self-report),
- score of above a 7 on the Alcohol Use Disorders Identification Test (indicative of non-risky use),
- a history of epilepsy or seizures not otherwise specified (other than childhood febrile seizures)
- a history of chronic migraines,
- failure to meet all criteria on a standardized MRI/TMS safety screen (including but not limited to implanted electronic devices, bullets or metallic fragments above the waist, hair clips and piercings above the waist that cannot be removed)
- presence of any barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove).
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
real treatment
sham treatment
Arm Description
continuous theta burst stimulation (real) will be delivered
continuous theta burst stimulation (sham) will be delivered
Outcomes
Primary Outcome Measures
Percent BOLD signal change in the MPFC
The effect of real vs. sham cTBS to the leftt MPFC as a tool to modulate the brain response to craving will be assessed by comparing the brain activity in the limbic circuit before and after TMS.
Secondary Outcome Measures
Full Information
NCT ID
NCT02939339
First Posted
September 1, 2016
Last Updated
July 19, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02939339
Brief Title
Theta Burst TMS as a Tool to Change Smoking Behavior
Official Title
Theta Burst TMS as a Tool to Change Smoking Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.
Detailed Description
Prior and recent evidence suggests a role of medial prefrontal cortex (mPFC) in cigarette smoking. The present study will examine whether a five-day regimen of theta-burst transcranial magnetic stimulation (TMS) reduces cigarette smoking outside of the lab (examined through self-report and physiological measures) and motivation to smoke inside the lab (examined through behavioral tasks and functional MRI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Addiction
Keywords
Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
real treatment
Arm Type
Experimental
Arm Description
continuous theta burst stimulation (real) will be delivered
Arm Title
sham treatment
Arm Type
Sham Comparator
Arm Description
continuous theta burst stimulation (sham) will be delivered
Intervention Type
Device
Intervention Name(s)
continuous theta burst stimulation (real)
Other Intervention Name(s)
cTBS (active)
Intervention Description
a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
Intervention Type
Device
Intervention Name(s)
continuous theta burst stimulation (sham)
Other Intervention Name(s)
cTBS (sham)
Intervention Description
a sham version of a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
Primary Outcome Measure Information:
Title
Percent BOLD signal change in the MPFC
Description
The effect of real vs. sham cTBS to the leftt MPFC as a tool to modulate the brain response to craving will be assessed by comparing the brain activity in the limbic circuit before and after TMS.
Time Frame
immediately after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
smoke at least 10 cigarettes a day (on average)
Exclusion Criteria:
comorbid mental or physical illness (managed or unmanaged)
pregnancy
use of prescription medication that might affect smoking or nicotine metabolism,
use of smokeless tobacco or alternative nicotine products
use illicit drugs of abuse (verified through urine screen and self-report),
score of above a 7 on the Alcohol Use Disorders Identification Test (indicative of non-risky use),
a history of epilepsy or seizures not otherwise specified (other than childhood febrile seizures)
a history of chronic migraines,
failure to meet all criteria on a standardized MRI/TMS safety screen (including but not limited to implanted electronic devices, bullets or metallic fragments above the waist, hair clips and piercings above the waist that cannot be removed)
presence of any barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen A Hanlon, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21792580
Citation
Sinha R. New findings on biological factors predicting addiction relapse vulnerability. Curr Psychiatry Rep. 2011 Oct;13(5):398-405. doi: 10.1007/s11920-011-0224-0.
Results Reference
background
PubMed Identifier
16055761
Citation
Kalivas PW, Volkow ND. The neural basis of addiction: a pathology of motivation and choice. Am J Psychiatry. 2005 Aug;162(8):1403-13. doi: 10.1176/appi.ajp.162.8.1403.
Results Reference
background
PubMed Identifier
10229058
Citation
Sinha R, Catapano D, O'Malley S. Stress-induced craving and stress response in cocaine dependent individuals. Psychopharmacology (Berl). 1999 Mar;142(4):343-51. doi: 10.1007/s002130050898.
Results Reference
background
PubMed Identifier
16738229
Citation
Lee JL, Milton AL, Everitt BJ. Cue-induced cocaine seeking and relapse are reduced by disruption of drug memory reconsolidation. J Neurosci. 2006 May 31;26(22):5881-7. doi: 10.1523/JNEUROSCI.0323-06.2006.
Results Reference
background
PubMed Identifier
21961707
Citation
Volkow ND, Wang GJ, Fowler JS, Tomasi D. Addiction circuitry in the human brain. Annu Rev Pharmacol Toxicol. 2012;52:321-36. doi: 10.1146/annurev-pharmtox-010611-134625. Epub 2011 Sep 27.
Results Reference
background
PubMed Identifier
15616172
Citation
Bolla K, Ernst M, Kiehl K, Mouratidis M, Eldreth D, Contoreggi C, Matochik J, Kurian V, Cadet J, Kimes A, Funderburk F, London E. Prefrontal cortical dysfunction in abstinent cocaine abusers. J Neuropsychiatry Clin Neurosci. 2004 Fall;16(4):456-64. doi: 10.1176/jnp.16.4.456.
Results Reference
background
PubMed Identifier
12880834
Citation
Bolla KI, Eldreth DA, London ED, Kiehl KA, Mouratidis M, Contoreggi C, Matochik JA, Kurian V, Cadet JL, Kimes AS, Funderburk FR, Ernst M. Orbitofrontal cortex dysfunction in abstinent cocaine abusers performing a decision-making task. Neuroimage. 2003 Jul;19(3):1085-94. doi: 10.1016/s1053-8119(03)00113-7.
Results Reference
background
PubMed Identifier
21193273
Citation
Hanlon CA, Wesley MJ, Stapleton JR, Laurienti PJ, Porrino LJ. The association between frontal-striatal connectivity and sensorimotor control in cocaine users. Drug Alcohol Depend. 2011 Jun 1;115(3):240-3. doi: 10.1016/j.drugalcdep.2010.11.008. Epub 2010 Dec 28.
Results Reference
background
PubMed Identifier
20603217
Citation
Gu H, Salmeron BJ, Ross TJ, Geng X, Zhan W, Stein EA, Yang Y. Mesocorticolimbic circuits are impaired in chronic cocaine users as demonstrated by resting-state functional connectivity. Neuroimage. 2010 Nov 1;53(2):593-601. doi: 10.1016/j.neuroimage.2010.06.066. Epub 2010 Jul 11.
Results Reference
background
PubMed Identifier
7919934
Citation
Bear MF, Malenka RC. Synaptic plasticity: LTP and LTD. Curr Opin Neurobiol. 1994 Jun;4(3):389-99. doi: 10.1016/0959-4388(94)90101-5.
Results Reference
background
PubMed Identifier
15450156
Citation
Malenka RC, Bear MF. LTP and LTD: an embarrassment of riches. Neuron. 2004 Sep 30;44(1):5-21. doi: 10.1016/j.neuron.2004.09.012.
Results Reference
background
PubMed Identifier
15664172
Citation
Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
Results Reference
background
PubMed Identifier
15845575
Citation
Di Lazzaro V, Pilato F, Saturno E, Oliviero A, Dileone M, Mazzone P, Insola A, Tonali PA, Ranieri F, Huang YZ, Rothwell JC. Theta-burst repetitive transcranial magnetic stimulation suppresses specific excitatory circuits in the human motor cortex. J Physiol. 2005 Jun 15;565(Pt 3):945-50. doi: 10.1113/jphysiol.2005.087288. Epub 2005 Apr 21.
Results Reference
background
PubMed Identifier
20631303
Citation
Verbruggen F, Aron AR, Stevens MA, Chambers CD. Theta burst stimulation dissociates attention and action updating in human inferior frontal cortex. Proc Natl Acad Sci U S A. 2010 Aug 3;107(31):13966-71. doi: 10.1073/pnas.1001957107. Epub 2010 Jul 14.
Results Reference
background
PubMed Identifier
20633446
Citation
Cho SS, Ko JH, Pellecchia G, Van Eimeren T, Cilia R, Strafella AP. Continuous theta burst stimulation of right dorsolateral prefrontal cortex induces changes in impulsivity level. Brain Stimul. 2010 Jul;3(3):170-6. doi: 10.1016/j.brs.2009.10.002. Epub 2009 Oct 31.
Results Reference
background
PubMed Identifier
21452949
Citation
Jacobson L, Javitt DC, Lavidor M. Activation of inhibition: diminishing impulsive behavior by direct current stimulation over the inferior frontal gyrus. J Cogn Neurosci. 2011 Nov;23(11):3380-7. doi: 10.1162/jocn_a_00020. Epub 2011 Mar 31.
Results Reference
background
PubMed Identifier
16971058
Citation
Camprodon JA, Martinez-Raga J, Alonso-Alonso M, Shih MC, Pascual-Leone A. One session of high frequency repetitive transcranial magnetic stimulation (rTMS) to the right prefrontal cortex transiently reduces cocaine craving. Drug Alcohol Depend. 2007 Jan 5;86(1):91-4. doi: 10.1016/j.drugalcdep.2006.06.002. Epub 2006 Sep 12.
Results Reference
background
PubMed Identifier
18612892
Citation
Politi E, Fauci E, Santoro A, Smeraldi E. Daily sessions of transcranial magnetic stimulation to the left prefrontal cortex gradually reduce cocaine craving. Am J Addict. 2008 Jul-Aug;17(4):345-6. doi: 10.1080/10550490802139283. No abstract available.
Results Reference
background
PubMed Identifier
19630729
Citation
Barr MS, Fitzgerald PB, Farzan F, George TP, Daskalakis ZJ. Transcranial magnetic stimulation to understand the pathophysiology and treatment of substance use disorders. Curr Drug Abuse Rev. 2008 Nov;1(3):328-39. doi: 10.2174/1874473710801030328.
Results Reference
background
PubMed Identifier
22809824
Citation
Wing VC, Barr MS, Wass CE, Lipsman N, Lozano AM, Daskalakis ZJ, George TP. Brain stimulation methods to treat tobacco addiction. Brain Stimul. 2013 May;6(3):221-30. doi: 10.1016/j.brs.2012.06.008. Epub 2012 Jul 9.
Results Reference
background
PubMed Identifier
23874466
Citation
Hanlon CA, Canterberry M, Taylor JJ, DeVries W, Li X, Brown TR, George MS. Probing the frontostriatal loops involved in executive and limbic processing via interleaved TMS and functional MRI at two prefrontal locations: a pilot study. PLoS One. 2013 Jul 9;8(7):e67917. doi: 10.1371/journal.pone.0067917. Print 2013.
Results Reference
background
PubMed Identifier
15078569
Citation
Bestmann S, Baudewig J, Siebner HR, Rothwell JC, Frahm J. Functional MRI of the immediate impact of transcranial magnetic stimulation on cortical and subcortical motor circuits. Eur J Neurosci. 2004 Apr;19(7):1950-62. doi: 10.1111/j.1460-9568.2004.03277.x.
Results Reference
background
PubMed Identifier
12594717
Citation
Bohning DE, Shastri A, Lomarev MP, Lorberbaum JP, Nahas Z, George MS. BOLD-fMRI response vs. transcranial magnetic stimulation (TMS) pulse-train length: testing for linearity. J Magn Reson Imaging. 2003 Mar;17(3):279-90. doi: 10.1002/jmri.10271.
Results Reference
background
PubMed Identifier
22658708
Citation
Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.
Results Reference
background
PubMed Identifier
23932365
Citation
Vernet M, Bashir S, Yoo WK, Oberman L, Mizrahi I, Ifert-Miller F, Beck CJ, Pascual-Leone A. Reproducibility of the effects of theta burst stimulation on motor cortical plasticity in healthy participants. Clin Neurophysiol. 2014 Feb;125(2):320-6. doi: 10.1016/j.clinph.2013.07.004. Epub 2013 Aug 7.
Results Reference
background
PubMed Identifier
21466926
Citation
Wilcox CE, Teshiba TM, Merideth F, Ling J, Mayer AR. Enhanced cue reactivity and fronto-striatal functional connectivity in cocaine use disorders. Drug Alcohol Depend. 2011 May 1;115(1-2):137-44. doi: 10.1016/j.drugalcdep.2011.01.009. Epub 2011 Apr 3.
Results Reference
background
PubMed Identifier
22458561
Citation
Prisciandaro JJ, McRae-Clark AL, Myrick H, Henderson S, Brady KT. Brain activation to cocaine cues and motivation/treatment status. Addict Biol. 2014 Mar;19(2):240-9. doi: 10.1111/j.1369-1600.2012.00446.x. Epub 2012 Mar 28.
Results Reference
background
PubMed Identifier
16957531
Citation
Borckardt JJ, Nahas Z, Koola J, George MS. Estimating resting motor thresholds in transcranial magnetic stimulation research and practice: a computer simulation evaluation of best methods. J ECT. 2006 Sep;22(3):169-75. doi: 10.1097/01.yct.0000235923.52741.72.
Results Reference
background
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Theta Burst TMS as a Tool to Change Smoking Behavior
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