High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00284219
First received: January 30, 2006
Last updated: June 29, 2011
Last verified: June 2011

January 30, 2006
June 29, 2011
July 2005
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number of cigarettes smoked [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00284219 on ClinicalTrials.gov Archive Site
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High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Heavy Smoking
  • 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.
  • Device: Magnetic stimulation using a special sham coil
    Sham stimulation will be given at the same location as the active, with special sham coil.
  • Active Comparator: Real high frequency rTMS
    The patients will undergo a series of treatments of high frequency rTMS
    Intervention: Device: Transcranial Magnetic Stimulation 10Hz
  • Sham Comparator: Sham high frequency rTMS
    The patients will receive a series of sham treatments.
    Intervention: Device: Magnetic stimulation using a special sham coil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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Inclusion Criteria:Smoking over 20 Cig a day -

Exclusion Criteria:epilepsy, psychiatry history

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Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00284219
SHEBA-04-3401-RA-CTIL
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Revital Amiaz, MD - Senior psychiatrist, Sheba Medical Center
Sheba Medical Center
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Principal Investigator: Revital A Amiaz, MD Sheba Medical Center
Study Director: Abraham Zangen, Phd Weizmann Institute of Science
Sheba Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP