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High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00284219
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
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Brief Summary:

Cigarette smoking is a major public health problem causing significant morbidity and mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break their addiction.

The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the mesolimbic dopamine systems in both animals and humans. For this reason, we investigated whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex can help people to withdraw smoking in comparison to placebo rTMS.

Smokers seeking to quit are recruited through newspaper advertisements. Participants were randomized to 10 days of either real or placebo high frequency rTMS.


Condition or disease Intervention/treatment Phase
Heavy Smoking Device: Transcranial Magnetic Stimulation 10Hz Device: Magnetic stimulation using a special sham coil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Real high frequency rTMS
The patients will undergo a series of treatments of high frequency rTMS
 Device: Transcranial Magnetic Stimulation 10Hz
3. rTMS subjects will receive 20 trains of rTMS at a rate of 10 Hz for 6 seconds (1200 pulses/session). Pulses will be administered over the left dorsolateral prefrontal cortex, defined as 5 cm anterior and in a parasagital plane to the point of maximum stimulation of the abductor pollicis muscle. Pulse intensity will be set at 100% motor threshold.
Sham Comparator: Sham high frequency rTMS
The patients will receive a series of sham treatments.
 Device: Magnetic stimulation using a special sham coil
Sham stimulation will be given at the same location as the active, with special sham coil.


Outcome Measures
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Primary Outcome Measures :
  1. number of cigarettes smoked

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Smoking over 20 Cig a day -

Exclusion Criteria:epilepsy, psychiatry history

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284219


Locations
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Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Revital A Amiaz, MD Sheba Medical Center
Study Director: Abraham Zangen, Phd Weizmann Institute of Science
More Information
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Responsible Party: Revital Amiaz, MD - Senior psychiatrist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00284219    
Other Study ID Numbers: SHEBA-04-3401-RA-CTIL
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011
Keywords provided by Sheba Medical Center:
rTMS, smoking, dopamine, acotinine