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:

MedlinePlus related topics: Smoking

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

ClinicalTrials.gov processed this record on September 27, 2016

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