Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence

Study Overview
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Brief Summary
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The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation. Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Moreover, other therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective. The investigators propose a new therapeutic strategy for smoking cessation, which is based on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish craving for tobacco). The principal objective is to improve the success rate for smoking cessation attempts in patients who are highly dependent on nicotine, and who have failed using usual smoking cessation strategies.

Official Title
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Evaluation of the Efficacy of Low-frequency rTMS on Craving in Smoking Dependence: Single-centre Randomized, Controlled Blinded Pilot Study

Conditions
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Smoking Cessation, Addiction

Intervention / Treatment
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* Device: active rTMS
* Device: sham rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18-65 years old Wishing to stop smoking Highly dependent on nicotine (score ≥ 7 on the Fagerström self-questionnaire) History of at least 2 failed attempts to stop smoking despite recommended treatments (nicotine, vareniciline, bupropion) Exclusion Criteria: Abstinence in the 3 previous months Absence of effective contraception for women Progressive chronic disease Ongoing psychiatric disorders Current addiction to other substances or cessation of less than one year Current treatment with psychotropic agents Epilepsy and other contra-indications for rTMS (pacemaker, metallic clips or other electronic implants, head trauma, intracranial hypertension). Contra-indications for transdermal nicotine substitutes (recent myocardial infarction, unstable or worsening angina, Prinzmetal angina, severe heart rhythm disorders, recent stroke, skin disorders that could interfere with the use of transdermal treatments, hypersensitivity to one of the constituents). Personnel working in the psychiatric and addictology unit of the CHU (conflict of interest)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active rTMS<br> | Device: active rTMS<br> <br> |
| Placebo Comparator: placebo rTMS<br> | Device: sham rTMS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline score of Tabacco Craving Questionnaire (TCQ) |  | at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation |