Completed

Transcranial Magnetic Stimulation Effects on Nicotine Craving

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What is being tested

Transcranial Magnetic Stimulation (Neuronetics)

+ Sham Transcranial Magnetic Stimulation

+ Transcranial Magnetic Stimulation (Neuronetics)

Device
Who is being recruted

Behavior+3

+ Mental Disorders

+ Substance-Related Disorders

From 18 to 50 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorMedical University of South Carolina
Last updated: April 1, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01690130
Principal SponsorMedical University of South Carolina
Last updated: April 1, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSubstance-Related DisordersChemically-Induced DisordersSmokingTobacco Use Disorder

Criteria

3 inclusion criteria required to participate
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
Right handed males and females, between the ages of 18 and 50
8 exclusion criteria prevent from participating
Any medication (e.g., propranolol) or unstable medical condition that may interfere with psychophysiological (e.g., heart rate) monitoring
Current substance use disorders other than nicotine and caffeine use, in the past 30 days
any unstable major axis I psychiatric disorder in the past month (e.g. psychotic disorders)
history of brain surgery or history of loss of consciousness > 15 minutes
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

Sham
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)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical University of South Carolina

Charleston, United StatesOpen Medical University of South Carolina in Google Maps
CompletedOne Study Center