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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

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.

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Detailed Description

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Conditions

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Smoking Cessation Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active rTMS

Group Type EXPERIMENTAL

active rTMS

Intervention Type DEVICE

placebo rTMS

Group Type PLACEBO_COMPARATOR

sham rTMS

Intervention Type DEVICE

Interventions

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active rTMS

Intervention Type DEVICE

sham rTMS

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No