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

Smoking Cessation Clinical Trial

— rTMS TABAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812810
• Other study ID #: TROJAK DRCI 2010
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: June 22, 2016
• Start date: September 2011

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Addiction
• Smoking Cessation

Intervention

Device:
• active rTMS

• sham rTMS

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline score of Tabacco Craving Questionnaire (TCQ)		at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation	Yes