Heavy SmokingNCT00284219
High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation
A study testing Transcranial Magnetic Stimulation 10Hz in people with Heavy Smoking, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Smoking
- What is being tested?
- Transcranial Magnetic Stimulation 10Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heavy Smoking
- Being tested
- Transcranial Magnetic Stimulation 10Hz, Magnetic stimulation using a special sham coil
- Keywords
- rTMS, smoking, dopamine, acotinine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation 10HzDevice
- 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.
Magnetic stimulation using a special sham coilDevice
Sham stimulation will be given at the same location as the active, with special sham coil.
| Study group | Role | What they receive |
|---|---|---|
| Real high frequency rTMS | Active comparator | The patients will undergo a series of treatments of high frequency rTMS Receives: Device: Transcranial Magnetic Stimulation 10Hz |
| Sham high frequency rTMS | Sham comparator | The patients will receive a series of sham treatments. Receives: Device: Magnetic stimulation using a special sham coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cigarettes smoked
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy SmokingStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Revital A Amiaz, MD, Principal investigator, Sheba Medical CenterAbraham Zangen, Phd, Study director, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284219
- Sponsor's protocol ID
- SHEBA-04-3401-RA-CTIL
- Status last verified
- Jun 2011
- First submitted
- 30 Jan 2006
- Last updated
- 30 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation
- ClinicalTrials.gov ID
- NCT00284219
- Acronym / sponsor ID
- SHEBA-04-3401-RA-CTIL
- Conditions
- Heavy Smoking
- Keywords
- rTMS, smoking, dopamine, acotinine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2005
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real high frequency rTMS | Active comparator | Device: Transcranial Magnetic Stimulation 10HzThe patients will undergo a series of treatments of high frequency rTMS |
| Sham high frequency rTMS | Sham comparator | Device: Magnetic stimulation using a special sham coilThe patients will receive a series of sham treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation 10Hz3. 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. | Device | Real high frequency rTMS |
| Magnetic stimulation using a special sham coilSham stimulation will be given at the same location as the active, with special sham coil. | Device | Sham high frequency rTMS |
Primary outcome
number of cigarettes smoked
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Revital A Amiaz, MD principal investigator
Sheba Medical Center
Abraham Zangen, Phd study director
Weizmann Institute of Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation 10Hz in people with Heavy Smoking, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cigarettes smoked. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2011.