Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption

Tobacco Use Disorder Clinical Trial

— TABELEC  

Official title:

Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930422
• Other study ID #: 12 392 02
• Secondary ID: AOL 2012
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: February 21, 2014
• Start date: July 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University Hospital, Toulouse
• 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 primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.

The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on the left dorsolateral prefrontal cortex region will reduce the craving induced causing a decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final visit between Day 15 and Day 20.

Description:

Smoking is a major public health problem and it is the leading cause of preventable death in the world. Care should include education, psychotherapy and treatments, but despite these therapeutics, the smoking cessation process is often characterized by relapses. The main risk factor for relapse is craving. Neurophysiological studies have provided evidence in the understanding of craving. This craving involves surface structures including the dorsolateral prefrontal cortex, accessible by neurostimulation. Repetitive neurostimulation applies on this structures involved in craving could therefore modulate it. Two non-invasive stimulation techniques exist: repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The choice of tDCS is based on its ease of use, excellent tolerance, its better quality of placebo and low cost.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 60 years old

• Smoking = 5 years

• Smoking = 15 manufactured cigarettes per day or = 10 rolled cigarettes per day

• Fagerström test = 5

• Smokers who have at least an attempt to stop of minimum 7 days

• Written informed consent signed by the patient

• Affiliated to medical insurance

Exclusion Criteria:

• Co-addiction (cannabis, alcohol, other drugs)

• HAD test: D = 8; A + D = 19

• Treatment by nicotine replacement therapy, bupropion or varenicline within 30 days prior inclusion

• Neuropsychiatric disease, considered serious by the investigator

• Psychotropic treatment (antidepressant, anxiolytic, antipsychotic)

• Skin scalp dermatosis

• Pregnancy or breastfeeding. Positive pregnancy test.

• Patient under guardianship, trusteeship or judicial protection

• Patient in inclusion period for another clinical research protocol

Study Design

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Device:
• tDCS procedure
The tDCS is a non-invasive neuromodulation method. A stimulator delivers a constant current of low intensity (1-2 mA) applied to the average of two bipolar electrodes placed on the scalp for 20 minutes. This constant current generates a static electric field that selectively modulates the activity of cortical neurones. A tingling sensation under the electrodes appears at the beginning and at the end of stimulation but it is transient and disappears quickly in 30 or 60 seconds.
• Sham procedure
The tDCS placebo differs from the real tDCS by the interruption of stimulation after 30 to 60 seconds and reactivation of this stimulation 30 to 60 seconds before the end of the session, which lasted 20 minutes. The tingling felt at the beginning and the end of the session will be the same as those experienced with real stimulation. The electrodes establishment does not differ with respect to tDCS.

Locations

Country	Name	City	State
France	University Hospital, Toulouse	Toulouse	Midi-Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

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* Note: There are 77 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change of individual salivary cotinine.		Outcome measure is assessed at Day1 and Day5	No
Secondary	Relative change of individual salivary cotinine		Outcome measure is assessed at Day5 and between Day15 and Day20.	No
Secondary	Exhaled carbon monoxide.		Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20.	No
Secondary	Number of cigarettes smoked per day		Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20	No
Secondary	Technical feasibility of outpatient	The feasibility is assessed by the number of smokers following the entire protocol.	Outcome measure is assessed between day 15 and 20.	No
Secondary	Measurement of craving	Measurement of craving from Day1 to Day5 and at the final visits assessed by a VAS: visual analogue scale from 0 (no urge to smoke at all) to 10 (intense desire compelling smoking) and the questionnaire called the 12-item French Tobacco Craving Questionnaire (FCTQ-12).	Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.	No