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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • number of cigarettes smoked [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Smoking over 20 Cig a day -

Exclusion Criteria:epilepsy, psychiatry history

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 30, 2006
Last Updated: June 29, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 22, 2013