NCT00284219

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

First QC Date

January 30, 2006

Last Update Submit

June 29, 2011

Conditions

Heavy Smoking

Keywords

rTMS, smoking, dopamine, acotinine

Outcome Measures

Primary Outcomes (1)

  • number of cigarettes smoked

Study Arms (2)

Real high frequency rTMS

ACTIVE COMPARATOR

The patients will undergo a series of treatments of high frequency rTMS

Device: Transcranial Magnetic Stimulation 10Hz

Sham high frequency rTMS

SHAM COMPARATOR

The patients will receive a series of sham treatments.

Device: Magnetic stimulation using a special sham coil

Interventions

Transcranial Magnetic Stimulation 10HzDEVICE

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.

Real high frequency rTMS
Magnetic stimulation using a special sham coilDEVICE

Sham stimulation will be given at the same location as the active, with special sham coil.

Sham high frequency rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Revital A Amiaz, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Abraham Zangen, Phd

    Weizmann Institute of Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

July 1, 2005

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

IL(1)