NCT01690130

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

November 21, 2018

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

4.7 years

First QC Date

September 7, 2012

Results QC Date

July 19, 2018

Last Update Submit

March 30, 2020

Conditions

Nicotine Dependence

Keywords

nicotinecravingsmokingTMSprefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)

Secondary Outcomes (1)

  • the Change From Baseline in Resting Motor Threshold

    20 minutes before (baseline) and 20 minutes after rTMS experiment

Study Arms (2)

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.

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)

Device: Transcranial Magnetic Stimulation (Neuronetics)Device: Sham Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation (Neuronetics)DEVICE

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.

Also known as: Neuronetics® Model 3600
Sham Transcranial Magnetic StimulationTranscranial Magnetic Stimulation
Sham Transcranial Magnetic StimulationDEVICE

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.

Also known as: Transcutaneous Electrical Nerve Stimulation Device
Sham Transcranial Magnetic StimulationTranscranial Magnetic Stimulation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

  • 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.

    PMID: 19183128BACKGROUND

  • 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.

    PMID: 12927012BACKGROUND

  • 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.

    PMID: 23485014DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
TMS in Nicotine Craving
Organization
Medical University of South Carolina
lixi@musc.edu
8437925729

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 21, 2012

Study Start

June 1, 2009

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 1, 2020

Results First Posted

November 21, 2018

Record last verified: 2020-03

Locations

US(1)