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

NCT04591743 | Completed

• 1 other identifier: TROJAK CRBFC-E 2019
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Continuous Abstinence Rate

  Continuous Abstinence Rate within 6 weeks of starting to quit smoking

  Through study completion, an average of 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Device: Active TCS; Drug: nicotine treatment; Other: Questionnaires

Placebo group

PLACEBO COMPARATOR

Device: Placebo TCS; Drug: nicotine treatment; Other: Questionnaires

Interventions

Active TCS DEVICE

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

Experimental group

Placebo TCS DEVICE

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

Placebo group

nicotine treatment DRUG

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

Experimental group; Placebo group

Questionnaires OTHER

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

Experimental group; Placebo group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: June 29, 2020
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

FR (1)