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Transcranial Magnetic Stimulation Effects on Nicotine Craving

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (Neuronetics)
Sham Transcranial Magnetic Stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine, craving, smoking, TMS, prefrontal cortex

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2012
Last Updated
March 30, 2020
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01690130
Brief Title
Transcranial Magnetic Stimulation Effects on Nicotine Craving
Official Title
Transcranial Magnetic Stimulation Effects on Nicotine Craving
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
nicotine, craving, smoking, TMS, prefrontal cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Transcranial Magnetic Stimulation
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (Neuronetics)
Other Intervention Name(s)
Neuronetics® Model 3600
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Magnetic Stimulation
Other Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Change From Baseline in Cue Nicotine Craving Rating Score
Description
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.
Time Frame
Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)
Secondary Outcome Measure Information:
Title
the Change From Baseline in Resting Motor Threshold
Description
Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response
Time Frame
20 minutes before (baseline) and 20 minutes after rTMS experiment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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

Citations:
PubMed Identifier
19183128
Citation
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.
Results Reference
background
PubMed Identifier
12927012
Citation
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.
Results Reference
background
PubMed Identifier
23485014
Citation
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.
Results Reference
derived

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Transcranial Magnetic Stimulation Effects on Nicotine Craving

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