Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-03-19 @ 5:09 PM
Study NCT ID:
NCT00901459
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2009-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rTMS
Brief Summary:
The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational procedure, where a device called a "stimulator" provides electricity to a device that creates a magnetic field. This device is placed against the scalp in the front of the head so that the magnetic field is focused on an area of the brain that is thought to be involved in craving for cigarettes. rTMS is an investigational procedure so therefore being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). Changes in magnetic fields during rTMS administration change electrical currents which may affect brain activity and function.
Detailed Description:
The goal of this study is to evaluate the effects of rTMS on cue-induced craving in dependent smokers. We hypothesize that low frequency rTMS over the SFG will block cue-induced craving. In order to test this hypothesis, subjects will undergo three conditions:
1. active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
2. location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
3. frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues
1. active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
2. location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
3. frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: