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

NCT01930422 | Completed

• 2 other identifiers: 12 392 02AOL 2012
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Direct transcranial electrical stimulation (tDCS); Sham procedure; Tobacco consumption; Craving

Outcome Measures

Primary Outcomes (1)

• Relative change of individual salivary cotinine.

  Outcome measure is assessed at Day1 and Day5

Secondary Outcomes (5)

• Relative change of individual salivary cotinine

  Outcome measure is assessed at Day5 and between Day15 and Day20.

• 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.

• Number of cigarettes smoked per day

  Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20

• Technical feasibility of outpatient

  Outcome measure is assessed between day 15 and 20.

• Measurement of craving

  Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.

Study Arms (2)

Real tDCS

EXPERIMENTAL

Direct transcranial electrical stimulation (tDCS procedure)

Device: tDCS procedure

Placebo tDCS

SHAM COMPARATOR

Sham procedure

Device: Sham procedure

Interventions

tDCS procedure 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.

Real tDCS

Sham procedure 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.

Placebo tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Co-addiction (cannabis, alcohol, other drugs)
• HAD test: D ≥ 8; A + D ≥ 19
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital, Toulouse

Toulouse, Midi-Pyrénées, 31059, France

Location

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MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Rose-Marie ROUQUET, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: August 29, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

FR (1)