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Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse. (TabacStim2)

Primary Purpose

Smoking Cessation

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Active TCS

Placebo TCS

nicotine treatment

Questionnaires

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient who has given oral consent
Adult patient
Patient wishing to stop smoking
Patient highly addicted to nicotine (≥ score 7 on Fagerström's self-questionnaire*)
Patient with at least 1 previous smoking cessation failure using recommended drug therapies (nicotine, vareniciline, bupropion)

Exclusion Criteria:

Patient not affiliated or not benefiting from national health insurance
Person deprived of their liberty by judicial or administrative decision
Protected adults (curatorship, guardianship)
Pregnant, parturient or breastfeeding woman
Patient of childbearing age with a positive pregnancy test at inclusion
Major patient incapable or unable to express consent
Patient abstinent in the previous 3 months
Patient with a substance use disorder (DSM-5 criteria) with other psychoactive substances other than tobacco
Patient with a contraindication to the practice of TCS; personal history of seizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves, hearing aid, ventricular bypass valve, sutures with wires or staples, foreign bodies in the eye, shrapnel, other prosthesis or cephalic ferromagnetic material.
Patient employed by the investigator or trial site
Patient with severe depression, defined by a score greater than or equal to 24 on the Hamilton Depression Rating Scale
Patient who has had a recent change (< 1 month) in the prescription of psychotropic treatment
Patient with severe and/or chronic psychiatric disorders, including schizophrenia, paranoia, and bipolar disorders type I and II.
Patient with severe heart, kidney, liver or lung failure or other condition that the physician believes may compromise the patient's participation in the study.
Patient simultaneously participating in another therapeutic trial

Sites / Locations

Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Continuous Abstinence Rate

Continuous Abstinence Rate within 6 weeks of starting to quit smoking

Secondary Outcome Measures

Full Information

NCT ID

NCT04591743

First Posted

October 12, 2020

Last Updated

October 26, 2020

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT04591743

Brief Title

Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse.

Acronym

TabacStim2

Official Title

Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse: Single-center, Randomized, Controlled, Blinded Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 29, 2020 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Tobacco control is a Public Health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent within 12 months of quitting. The use of nicotine substitutes only increases the chances of success in smoking cessation by 2 to 3%. Brain imaging research shows that the dorsolateral prefrontal cortex (DLPFC) is involved in tobacco addiction. Disorders induced in the CPFDL cause an irrepressible desire to smoke (craving) and explain a large part of the relapse at the time of smoking cessation. Transcranial magnetic stimulation (TMS) could be promising in smoking cessation. This technique allows direct stimulation of the DLPFC via a magnetic coil, so as to reduce the cortical activity of the DLPFC, and thus reduce tobacco craving. A first randomized controlled study was conducted at the Dijon University Hospital in Dijon in smokers who were heavily addicted and who had failed with the usual withdrawal strategies. In this study, it was found that the combination of nicotine substitutes (to reduce the physical symptoms of withdrawal) with 10 sessions of TCS (to reduce craving) made it possible to maintain abstinence from tobacco during the first 2 weeks of withdrawal (% abstinence = 88.8% active TCS group vs. 50% placebo TCS group; p=0.027). However, in this study, the therapeutic effect of the nicotine-TCS combination was not prolonged once the stimuli stopped. At 6 and 12 weeks from the start of withdrawal, abstinence rates in the active SMT and placebo SMT groups were no longer significantly different. It is therefore proposed to renew the protocol by adding maintenance brain stimulation to the initial protocol. Used in the treatment of depression, the maintenance brain stimuli could increase the chances of smoking cessation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Title

Placebo group

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

Active TCS

Intervention Description

TCS active at 1 Hz on the right DLPFC for 6 weeks

Intervention Type

Device

Intervention Name(s)

Placebo TCS

Intervention Description

Inactive TCS (placebo coil) at 1 Hz on right DLPFC for 6 weeks

Intervention Type

Drug

Intervention Name(s)

nicotine treatment

Intervention Description

at least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d)

Intervention Type

Other

Intervention Name(s)

Questionnaires

Intervention Description

EVA on "craving", TCQ, QSU, BDI-II, CO tester, IGT, BART

Primary Outcome Measure Information:

Title

Continuous Abstinence Rate

Description

Continuous Abstinence Rate within 6 weeks of starting to quit smoking

Time Frame

Through study completion, an average of 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient who has given oral consent Adult patient Patient wishing to stop smoking Patient highly addicted to nicotine (≥ score 7 on Fagerström's self-questionnaire*) Patient with at least 1 previous smoking cessation failure using recommended drug therapies (nicotine, vareniciline, bupropion) Exclusion Criteria: Patient not affiliated or not benefiting from national health insurance Person deprived of their liberty by judicial or administrative decision Protected adults (curatorship, guardianship) Pregnant, parturient or breastfeeding woman Patient of childbearing age with a positive pregnancy test at inclusion Major patient incapable or unable to express consent Patient abstinent in the previous 3 months Patient with a substance use disorder (DSM-5 criteria) with other psychoactive substances other than tobacco Patient with a contraindication to the practice of TCS; personal history of seizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves, hearing aid, ventricular bypass valve, sutures with wires or staples, foreign bodies in the eye, shrapnel, other prosthesis or cephalic ferromagnetic material. Patient employed by the investigator or trial site Patient with severe depression, defined by a score greater than or equal to 24 on the Hamilton Depression Rating Scale Patient who has had a recent change (< 1 month) in the prescription of psychotropic treatment Patient with severe and/or chronic psychiatric disorders, including schizophrenia, paranoia, and bipolar disorders type I and II. Patient with severe heart, kidney, liver or lung failure or other condition that the physician believes may compromise the patient's participation in the study. Patient simultaneously participating in another therapeutic trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Benoit TROJAK

Phone

03.80.29.37.69

Ext

+33

benoit.trojak@chu-dijon.fr

Facility Information:

Facility Name

Chu Dijon Bourgogne

City

Dijon

ZIP/Postal Code

21000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoit TROJAK

Phone

03.80.29.37.69

Ext

+33

benoit.trojak@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse.

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