Back to resultsEvaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence (rTMS TABAC)
Primary Purpose
Smoking Cessation, Addiction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
active rTMS
sham rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation
Eligibility Criteria
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)
Sites / Locations
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
active rTMS
placebo rTMS
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline score of Tabacco Craving Questionnaire (TCQ)
Secondary Outcome Measures
Full Information
NCT ID
NCT02812810
First Posted
June 20, 2016
Last Updated
June 22, 2016
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02812810
Brief Title
Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence
Acronym
rTMS TABAC
Official Title
Evaluation of the Efficacy of Low-frequency rTMS on Craving in Smoking Dependence: Single-centre Randomized, Controlled Blinded Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active rTMS
Arm Type
Experimental
Arm Title
placebo rTMS
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
active rTMS
Intervention Type
Device
Intervention Name(s)
sham rTMS
Primary Outcome Measure Information:
Title
Change from Baseline score of Tabacco Craving Questionnaire (TCQ)
Time Frame
at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence
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