- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00284219
High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Smoking over 20 Cig a day -
Exclusion Criteria:epilepsy, psychiatry history
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Real high frequency rTMS
The patients will undergo a series of treatments of high frequency rTMS
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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.
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Sham Comparator: Sham high frequency rTMS
The patients will receive a series of sham treatments.
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Sham stimulation will be given at the same location as the active, with special sham coil.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
number of cigarettes smoked
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Revital A Amiaz, MD, Sheba Medical Center
- Study Director: Abraham Zangen, Phd, Weizmann Institute of Science
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SHEBA-04-3401-RA-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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