Studying Nicotine Addiction With Transcranial Magnetic Stimulation

Completed

• Conditions: Nicotine Dependence

• Registration Number: NCT01702948
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

Background:

- Nicotine addiction often makes it difficult to stop smoking. Researchers want to understand the areas of the brain that are important in nicotine addiction. They will use a type of brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to look at part of the brain that may be involved in nicotine addiction. They will see how these areas affect brain function, thinking, and decision making. For this study, rTMS will first be tested on nonsmokers, then smokers will be recruited at a later time.

Objectives:

- To study areas of the brain involved in nicotine addiction.

Eligibility:

- Individuals at least 18 years of age who do not smoke.

Design:

* Participants will be screened with a physical exam and medical history. They will also provide a urine sample.

* There will be four study sessions. The first session will involve a magnetic resonance imaging (MRI) scan. The other three visits will involve rTMS and MRI scans.

* The first MRI scan will take a baseline picture of the brain. Participants will also practice the tasks for the other three sessions in a mock scanner.

* At the next three visits, participants will have rTMS and MRI scans. Two visits will involve rTMS; the other visit will involve mock rTMS with no actual magnetic stimulation. During the MRI scans, participants will perform tasks that involve decision making.

Detailed Description

Objective: To investigate the neurocircuitry cognitive and affective processing relevant to nicotine addiction using repetitive Transcranial Magnetic Stimulation (rTMS). Specifically, we will examine insula neurocircuitry using a unilateral H-coil to deliver rTMS to the Right dorsolateral prefrontal cortex (R DLPFC) and insula. We will examine the effect of various stimulation parameters on behavior as well as on task based activation and resting state functional connectivity (rsFC) during fMRI scanning.

Study population: Up to 60 healthy adults who are non-smokers will be enrolled to achieve 28 completers.

Design: Within subject design with each subject completing 4 sessions: rTMS at two different stimulation frequencies and 2 sham sessions.

Outcome measures: Behavior on a decision making task and task based and resting state blood oxygen level-dependent (BOLD) activation in neural circuits relevant to nicotine addiction during fMRI scanning.

Study Timeline

• Study Start: 2012-09-10
• Study First Submitted: 2012-10-06
• Study First Submitted QC: 2012-10-06
• Study First Posted: 2012-10-10
• Status Verified: 2017-10-03
• Study Completion: 2017-10-03
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Behavior on a decision making task and task based and resting state BOLD activation in neural circuits relevant to nicotine addiction during fMRI scanning.

Trial Locations

Locations (1)

National Institute on Drug Abuse; 🇺🇸 Baltimore, Maryland, United States