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High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284219
First Posted: January 31, 2006
Last Update Posted: June 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

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 Intervention
Heavy Smoking Device: Transcranial Magnetic Stimulation 10Hz Device: Magnetic stimulation using a special sham coil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • number of cigarettes smoked

Estimated Enrollment: 50
Study Start Date: July 2005
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:Smoking over 20 Cig a day -

Exclusion Criteria:epilepsy, psychiatry history

  Contacts and Locations
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
Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Revital A Amiaz, MD Sheba Medical Center
Study Director: Abraham Zangen, Phd Weizmann Institute of Science
  More Information

Responsible Party: Revital Amiaz, MD - Senior psychiatrist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00284219     History of Changes
Other Study ID Numbers: SHEBA-04-3401-RA-CTIL
First Submitted: January 30, 2006
First Posted: January 31, 2006
Last Update Posted: June 30, 2011
Last Verified: June 2011

Keywords provided by Sheba Medical Center:
rTMS, smoking, dopamine, acotinine