Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse. (TabacStim2)
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| ClinicalTrials.gov Identifier: NCT04591743 |
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Recruitment Status :
Recruiting
First Posted : October 19, 2020
Last Update Posted : October 27, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Cessation | Device: Active TCS Device: Placebo TCS Drug: nicotine treatment Other: Questionnaires | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 78 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 29, 2020 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Experimental group |
Device: Active TCS
TCS active at 1 Hz on the right DLPFC for 6 weeks Drug: nicotine treatment at least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d) Other: Questionnaires EVA on "craving", TCQ, QSU, BDI-II, CO tester, IGT, BART |
| Placebo Comparator: Placebo group |
Device: Placebo TCS
Inactive TCS (placebo coil) at 1 Hz on right DLPFC for 6 weeks Drug: nicotine treatment at least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d) Other: Questionnaires EVA on "craving", TCQ, QSU, BDI-II, CO tester, IGT, BART |
- Continuous Abstinence Rate [ Time Frame: Through study completion, an average of 12 months ]Continuous Abstinence Rate within 6 weeks of starting to quit smoking
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 ClinicalTrials.gov identifier (NCT number): NCT04591743
| Contact: Benoit TROJAK | 03.80.29.37.69 ext +33 | benoit.trojak@chu-dijon.fr |
| France | |
| Chu Dijon Bourgogne | Recruiting |
| Dijon, France, 21000 | |
| Contact: Benoit TROJAK 03.80.29.37.69 ext +33 benoit.trojak@chu-dijon.fr | |
| Responsible Party: | Centre Hospitalier Universitaire Dijon |
| ClinicalTrials.gov Identifier: | NCT04591743 |
| Other Study ID Numbers: |
TROJAK CRBFC-E 2019 |
| First Posted: | October 19, 2020 Key Record Dates |
| Last Update Posted: | October 27, 2020 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Recurrence Disease Attributes Pathologic Processes Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |