Clinical trial NCT01690130: Transcranial Magnetic Stimulation Effects on Nicotine Craving
Official title: Transcranial Magnetic Stimulation Effects on Nicotine Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: nicotine
craving
smoking
TMS
prefrontal cortex
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the Change From Baseline in Cue Nicotine Craving Rating Score
timeFrame: Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)
Secondary outcomes:
measure: the Change From Baseline in Resting Motor Threshold
timeFrame: 20 minutes before (baseline) and 20 minutes after rTMS experiment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
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.
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.
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.