Deep Transcranial Magnetic Stimulation (dTMS) to Induce Smoking Cessation

NCT03264313 | Unknown DMC

• 1 other identifier: 35068014400000068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Transcranial Magnetic Stimulation

Keywords

tobacco; Smoking Cessation; TMS; Neuromodulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Decrease on Monoximetry level

  The researchers will perform the measurement of the rate of expired carbon monoxide through a monoximeter.

  before each session at phase 1 (6 weeks = sessions from 1 to 18)

Secondary Outcomes (1)

• Changes on Cotinine blood level

  at session 1 and after session 18 (6 weeks)

Other Outcomes (1)

• Diary

  once a week at the first phase: 6 weeks

Study Arms (2)

dTMS active

ACTIVE COMPARATOR

patients undergoing of dTMS real

Device: Deep Transcranial Magnetic Stimulation

dTMS Sham

SHAM COMPARATOR

patients undergoing to placebo dTMS

Device: Deep Transcranial Magnetic Stimulation

Interventions

Deep Transcranial Magnetic Stimulation DEVICE

Patients undergoing of Deep Transcranial Magnetic Mtimulation (dTMS) for smoking cessation

Also known as: dTMS

dTMS Sham; dTMS active

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Incor - Instituto do Coração do HCFMUSP

São Paulo, 05403900, Brazil

RECRUITING

Related Publications (1)

• Scholz JR, Bellini BB, Ziotti SDV, Abe TO, Arnaut D, Alberto RL, Marcolin MA, Tonstad S. Cue-Restricted Smoking as a behavioral adjunct for smoking cessation: Observational sub-analysis of a randomized trial of deep transcranial magnetic stimulation. Tob Prev Cessat. 2025 Oct 3;11. doi: 10.18332/tpc/209189. eCollection 2025.

  PMID: 41048875 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Marco A Marcolin, PhD

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Bianca B Bellini, MD

CONTACT

00551132571697; biancabellini@yahoo.com.br

Marco A Marcolin, PhD

CONTACT

00551132571697; contato@clinicamarcolin.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 29, 2017
• Study Start: January 16, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 5, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)