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

NCT02812810 | Completed

• 1 other identifier: TROJAK DRCI 2010
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Addiction

Outcome Measures

Primary Outcomes (1)

• Change from Baseline score of Tabacco Craving Questionnaire (TCQ)

  at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation

Study Arms (2)

active rTMS

EXPERIMENTAL

Device: active rTMS

placebo rTMS

PLACEBO COMPARATOR

Device: sham rTMS

Interventions

sham rTMS DEVICE

placebo rTMS

active rTMS DEVICE

active rTMS

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Centre Hospitalier Universitaire

Dijon, 21079, France

Location

Related Publications (1)

• Trojak B, Meille V, Achab S, Lalanne L, Poquet H, Ponavoy E, Blaise E, Bonin B, Chauvet-Gelinier JC. Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial. Brain Stimul. 2015 Nov-Dec;8(6):1168-74. doi: 10.1016/j.brs.2015.06.004. Epub 2015 Jun 16.

  PMID: 26590478 RESULT

MeSH Terms

Conditions

Smoking Cessation; Behavior, Addictive

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

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: June 20, 2016
• First Posted: June 24, 2016
• Study Start: September 1, 2011
• Primary Completion: February 1, 2015
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)