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

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tDCS procedure
Sham procedure
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Direct transcranial electrical stimulation (tDCS), Sham procedure, Tobacco consumption, Craving

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real tDCS

Placebo tDCS

Arm Description

Direct transcranial electrical stimulation (tDCS procedure)

Sham procedure

Outcomes

Primary Outcome Measures

Relative change of individual salivary cotinine.

Secondary Outcome Measures

Relative change of individual salivary cotinine
Exhaled carbon monoxide.
Number of cigarettes smoked per day
Technical feasibility of outpatient
The feasibility is assessed by the number of smokers following the entire protocol.
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).

Full Information

First Posted
June 20, 2013
Last Updated
February 21, 2014
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01930422
Brief Title
Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption
Acronym
TABELEC
Official Title
Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Direct transcranial electrical stimulation (tDCS), Sham procedure, Tobacco consumption, Craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real tDCS
Arm Type
Experimental
Arm Description
Direct transcranial electrical stimulation (tDCS procedure)
Arm Title
Placebo tDCS
Arm Type
Sham Comparator
Arm Description
Sham procedure
Intervention Type
Device
Intervention Name(s)
tDCS procedure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative change of individual salivary cotinine.
Time Frame
Outcome measure is assessed at Day1 and Day5
Secondary Outcome Measure Information:
Title
Relative change of individual salivary cotinine
Time Frame
Outcome measure is assessed at Day5 and between Day15 and Day20.
Title
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.
Title
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
Title
Technical feasibility of outpatient
Description
The feasibility is assessed by the number of smokers following the entire protocol.
Time Frame
Outcome measure is assessed between day 15 and 20.
Title
Measurement of craving
Description
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).
Time Frame
Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose-Marie ROUQUET, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Toulouse
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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

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