NCT00901459

A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DEVICE	Active rTMS Condition	Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.
DEVICE	rTMS Location Control Condition	Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the motor cortex (MC) during the presentation of smoking and control cues.
DEVICE	rTMS Frequency Control Condition	High frequency rTMS (90% Motor Threshold at 10 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-05-13
• Last updated: 2013-01-25
• Results posted: 2013-01-25

Locations

1 site across 1 country: United States