Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction

Completed · Phase 1

Conditions studied: Nicotine Dependence

In brief

Background: * Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings. * Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether TMS delivered in single pulses can decrease activity in the parts of the brain that respond to nicotine craving. Objectives: \- To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in cigarette smokers. Eligibility: * Individuals 18 years of age and older who are physically healthy and have smoked 10 or more cigarettes per day for at least 1 year. * A small group of healthy nonsmoking control subjects 18 years of age and older will also participate in the study. Design: * The study will involve seven study visits and two follow-up visits. The control participants will have only two visits: one with a magnetic resonance imaging (MRI) scan and one with TMS to evaluate brain function and response. * Participants will have an initial assessment about tobacco use habits and craving patterns, and will provide blood and urine samples before beginning the study. * Participants will have two initial MRI brain scans. The first scan will look at the structure of the brain at rest. During the other scan, participants will look at images related to and not related to cigarette smoking. * The single pulse TMS sessions (with either actual TMS or inactive \[sham\] TMS) will be held daily for 5 consecutive days. Magnetic pulses will be triggered by cigarette-related picture cues and delivered at varying intervals before the participant sees a cigarette-related picture. During these testing visits, researchers will ask questions related to tobacco use and craving, and collect urine and breath samples for further study. * Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions, to evaluate memory and mood, and will have one final MRI brain scan at the end of the study.

Key facts

Study ID

NCT01031693

Run by

National Institute on Drug Abuse (NIDA)

People needed

75

Starts

2009-07-13

Expected to finish

2013-08-28

Last updated by the study team

2018-04-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• i) Personal or first-degree family history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness.
• ii) Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head that cannot be safely removed.
• iii) Metal shrapnel or bullet in the head or body including metal shavings.
• iv) Current use of any investigational drug or of any medications with anti or pro-convulsive action
• v) Increased intracranial pressure (lowers seizure threshold)
• vi) Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania
• vii) History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.
• viii) Pregnant or nursing women or women with reproductive potential who are sexually active and not using an acceptable form of contraception.
• ix) Any history of seizure
• x) Current dependence (DSM-IV criteria) on substances other than nicotine.

Where it is running

• National Institute on Drug Abuse — Baltimore, Maryland, United States
• Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue — Catonsville, Maryland, United States

Full record on ClinicalTrials.gov

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