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Deep Transcranial Magnetic Stimulation (dTMS) to Induce Smoking Cessation (SmokCessdTMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03264313
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : September 5, 2017
Information provided by (Responsible Party):
Manoel Jacobsen Teixeira, University of Sao Paulo General Hospital

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 receive placebo stimulation.

Condition or disease Intervention/treatment Phase
Smoking Cessation Transcranial Magnetic Stimulation Device: Deep Transcranial Magnetic Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of the Use of Deep Transcranial Magnetic Stimulation (dTMS) on Smoking Cessation.
Actual Study Start Date : January 16, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: dTMS active
patients undergoing of dTMS real
Device: Deep Transcranial Magnetic Stimulation
Patients undergoing of Deep Transcranial Magnetic Mtimulation (dTMS) for smoking cessation
Other Name: dTMS

Sham Comparator: dTMS Sham
patients undergoing to placebo dTMS
Device: Deep Transcranial Magnetic Stimulation
Patients undergoing of Deep Transcranial Magnetic Mtimulation (dTMS) for smoking cessation
Other Name: dTMS

Primary Outcome Measures :
  1. Decrease on Monoximetry level [ Time Frame: before each session at phase 1 (6 weeks = sessions from 1 to 18) ]
    The researchers will perform the measurement of the rate of expired carbon monoxide through a monoximeter.

Secondary Outcome Measures :
  1. Changes on Cotinine blood level [ Time Frame: at session 1 and after session 18 (6 weeks) ]
    The test uses a device that measures the levels of cotinine through a drop of blood obtained from a slight bite on the tip of the participant's finger.

Other Outcome Measures:
  1. Diary [ Time Frame: once a week at the first phase: 6 weeks ]
    Self reported daily number of cigarettes

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03264313

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Contact: Bianca B Bellini, MD 00551132571697
Contact: Marco A Marcolin, PhD 00551132571697

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Incor - Instituto do Coração do HCFMUSP Recruiting
São Paulo, Brazil, 05403900
Contact: Bellini    00551132571697   
Sponsors and Collaborators
University of Sao Paulo General Hospital
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Study Chair: Marco A Marcolin, PhD University of São Paulo

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Responsible Party: Manoel Jacobsen Teixeira, Professor, University of Sao Paulo General Hospital Identifier: NCT03264313     History of Changes
Other Study ID Numbers: 35068014400000068
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: No

Keywords provided by Manoel Jacobsen Teixeira, University of Sao Paulo General Hospital:
Smoking Cessation
transcranial magnetic stimulation