Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction
2 other identifiers
interventional
75
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2009
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2009
CompletedFirst Submitted
Initial submission to the registry
December 11, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2013
CompletedApril 5, 2018
August 28, 2013
4.1 years
December 11, 2009
April 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nicotine craving by Tobacco Craving Questionnaire and visual-analogue scales.
2 weeks
Secondary Outcomes (1)
Cigarette use by self-report, salivary cotinine level, and expired breath CO levels.
2 weeks
Study Arms (2)
Group A
ACTIVE COMPARATORActive TMS
Group B
SHAM COMPARATORSham TMS
Interventions
Eligibility Criteria
You may qualify if:
- i) Eighteen years of age or older
- ii) Current nicotine dependence (by DSM-IV criteria or Fagerstrom Test for Nicotine Dependence score greater than or equal to 3) and averaging smoking 10 or more cigarettes per day for at least one year.
- iii) Reading level of at least 6th grade, based on the Wide Range Achievement Test (WRAT)
- iv) Ability to give valid informed consent
- v) Right-handed
- vi) If the subject is female, of childbearing potential, and sexually active, she agrees to use a medically acceptable contraception, and not become pregnant for the duration of the study. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. Female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use either: (1) contraceptive pill or IUD or depot hormonal preparation (ring, injection implant); and/or (2) a barrier method of contraception such as diaphragm, sponge with spermicide, or condom. Women who are not sexually active do not have to agree to use one of the acceptable contraception methods. Contraceptive measures will be reviewed with female subjects at each visit prior to the TMS session.
- vii) Self-report experiencing nicotine craving when exposed to nicotine-associated cues
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Drug Abuse (NIDA)lead
- University of Marylandcollaborator
Study Sites (2)
National Institute on Drug Abuse
Baltimore, Maryland, 21224, United States
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228, United States
Related Publications (3)
Allen EA, Pasley BN, Duong T, Freeman RD. Transcranial magnetic stimulation elicits coupled neural and hemodynamic consequences. Science. 2007 Sep 28;317(5846):1918-21. doi: 10.1126/science.1146426.
PMID: 17901333BACKGROUNDBECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PMID: 13688369BACKGROUNDBestmann S, Baudewig J, Siebner HR, Rothwell JC, Frahm J. Functional MRI of the immediate impact of transcranial magnetic stimulation on cortical and subcortical motor circuits. Eur J Neurosci. 2004 Apr;19(7):1950-62. doi: 10.1111/j.1460-9568.2004.03277.x.
PMID: 15078569BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Gorelick, M.D.
National Institute on Drug Abuse (NIDA)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 11, 2009
First Posted
December 14, 2009
Study Start
July 13, 2009
Primary Completion
August 28, 2013
Study Completion
August 28, 2013
Last Updated
April 5, 2018
Record last verified: 2013-08-28