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

February 21, 2014 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31059
        • University Hospital, Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real tDCS
Direct transcranial electrical stimulation (tDCS procedure)
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 Comparator: Placebo tDCS
Sham procedure
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative change of individual salivary cotinine.
Time Frame: Outcome measure is assessed at Day1 and Day5
Outcome measure is assessed at Day1 and Day5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change of individual salivary cotinine
Time Frame: Outcome measure is assessed at Day5 and between Day15 and Day20.
Outcome measure is assessed at Day5 and between Day15 and Day20.
Exhaled carbon monoxide.
Time Frame: Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20.
Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20.
Number of cigarettes smoked per day
Time Frame: Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20
Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20
Technical feasibility of outpatient
Time Frame: Outcome measure is assessed between day 15 and 20.
The feasibility is assessed by the number of smokers following the entire protocol.
Outcome measure is assessed between day 15 and 20.
Measurement of craving
Time Frame: Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Rose-Marie ROUQUET, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 21, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 392 02
  • AOL 2012 (Other Identifier: Toulouse University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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