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

Completed · Phase 2

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT00901459

Run by

Duke University

People needed

21

Starts

2009-05-01

Expected to finish

2010-08-01

Last updated by the study team

2013-01-25

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 50 years of age;
• dependent smoker of > 10 cigarettes per day of cigarettes yielding >0.5mg nicotine (by Federal Trade Commission rated yields);
• have smoked cigarettes for at least three cumulative years;
• an afternoon carbon monoxide reading of at least 10ppm;
• be in general good health based on physical examination, EKG, serum chemistries, CBC, and urinalysis and
• show evidence of greater craving following exposure to in vivo smoking versus control cues

You may not qualify if…

• Individuals with a clinically defined neurological disorder or insult including, but not limited to, any condition likely to be associated with increased intracranial pressure;
• space occupying brain lesion;
• any history of seizure EXCEPT those therapeutically induced by ECT (Electro Convulsive Therapy);
• history of cerebrovascular accident;
• transient ischemic attack within two years;
• cerebral aneurysm;
• dementia;
• Parkinson's disease;
• Huntington's chorea;
• multiple sclerosis;
• current lung disease or lung disorder;
• hypertension (systolic >140 mmHg, diastolic > 90 mmHg);
• hypotension (< 90 mmHg, diastolic < 60 mmHg);
• coronary artery disease;
• cardiac rhythm disorder;
• impaired hepatic or renal function (based on documented diagnosis or abnormal chemistries) except gallstones or kidney stones;
• other major medical or psychiatric condition;
• use of any concurrent hypertensive, psychiatric, or psychoactive medication;
• any concurrent medication that lowers seizure threshold;
• smokeless tobacco, pipe, or cigar use in the past 30 days;
• nicotine replacement therapy, or other smoking cessation therapy within the past 30 days;
• increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for > 5 minutes;
• ECT treatment within 3 months prior to screening visit;
• failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher);
• a true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire;

Where it is running

• Duke Center for Nicotine & Smoking Cessation Research — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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