Status:
UNKNOWN
Deep Transcranial Magnetic Stimulation (dTMS) to Induce Smoking Cessation
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Smoking Cessation
Transcranial Magnetic Stimulation
Eligibility:
All Genders
22-70 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of dTMS used as a tool for the smoking cessation; therefore, the subjects will be randomized to be treated on the active group or to re...
Detailed Description
Smoking is the leading cause of preventable deaths in the world. Tobacco use causes more than 5 million deaths per year worldwide. Among interventions methods that have been found to be effective, th...
Eligibility Criteria
Inclusion
- Current heavy (\> 10 cigarettes / day) and chronic smokers (who have smoked for more than 1 year, with no abstinence greater than 3 months during the past year);
- Motivated to quit smoking;
- Capable to receive TMS treatment (satisfactory answers at the Safety Questionnaire for Transcranial Magnetic Stimulation);
- Consent report signed by the study participant.
Exclusion
- Using nicotine replacement therapy or drugs to aid in smoking cessation (eg Bup, etc.) or dealing with behavioral therapy for smoking cessation.
- Functional or cognitive disorder, diagnosis according to DSM-5.
- Psychiatric Disorder active in the last year, according to DSM-5 (Axis I). Exception to depressive and anxious disorders, provided that in a stable condition.
- Substance or drug abuse or dependency in the current or in the last year prior to selection.
- Subjects who smoke any other type of tobacco or substances.
- Subjects with a high risk of violence or suicide assessed during the interview.
- Subjects suffering from any physical instability such as high blood pressure (\> 150 mmHg systolic / diastolic\> 110 mmHg) or acute or unstable heart disease.
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head injury or trauma with loss of consciousness for \> 5 minutes.
- History of any metal in the head (outside the mouth).
- Metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- Individuals with a significant neurological disorder or insult;
- Subjects suffering from frequent and severe migraine headaches.
- Subjects suffering from significant hearing loss.
- Subjects taking pro-convulsant medications (e.g., antipsychotic medications).
- Previous treatment with TMS.
- Subjects who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the experiment.
- Participation in a clinical trial within the last 30 days before the beginning of this clinical trial or similar participation in another clinical trial.
- Known or suspected pregnancy or lactation.
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Key Trial Info
Start Date :
January 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03264313
Start Date
January 16 2017
End Date
January 1 2020
Last Update
September 5 2017
Active Locations (1)
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1
Incor - Instituto do Coração do HCFMUSP
São Paulo, Brazil, 05403900