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

NCT ID: NCT01930422

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-02-28

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Real tDCS

Direct transcranial electrical stimulation (tDCS procedure)

Group Type: EXPERIMENTAL

tDCS procedure

Intervention Type: DEVICE

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.

Placebo tDCS

Sham procedure

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rose-Marie ROUQUET, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital, Toulouse

Toulouse, Midi-Pyrénées, France

Countries

France

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Other Identifiers

AOL 2012

Identifier Type: OTHER

Identifier Source: secondary_id

12 392 02

Identifier Type: -

Identifier Source: org_study_id