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Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction

Primary Purpose

Addiction, Smoking

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sham tDCS
active tDCS
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring tobacco, smoking, tDCS, DLPFC

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age from 18 to 55 years old
  • Tobacco consumption from 10 to 25 cigarettes, for at least 1 year
  • Strong tobacco dependence at the Fagerstrom Test (score >= 5)
  • Motivation to quit with a score >=12 at the Motivation to Quit Smoking Scale (Q-MAT)
  • Informed consent

Exclusion Criteria:

  • Concomitant Axe I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
  • Other addictive disorder (DSM IV)
  • No history of smoking cessation drug the previous year
  • Psychotropic treatment
  • Pregnancy or nursing

Sites / Locations

  • Hopital le Vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

sham tDCS

active tDCS

Arm Description

sham transcranial direct current stimulation The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region

active anodal tDCS over the right dorsolateral prefrontal cortex The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region Intensity of the stimulation: 2 mA Duration of the stimulation: 20 min 10 sessions, 2 per day

Outcomes

Primary Outcome Measures

Smoking
Self-reported number of cigarettes smoked each day

Secondary Outcome Measures

Exhaled carbon monoxide
measured using a CO monitor (MicroCo, Milford, MA, USA).
Craving
measured using a 5-item Likert-type scale questionnaire of smoking urge
fMRI brain reactivity during a smoking cue-reactivity task
measured using an event-related fMRI paradigm

Full Information

First Posted
January 27, 2011
Last Updated
January 24, 2018
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT01288183
Brief Title
Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction
Official Title
Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking and constitute a treatment of tobacco addiction.
Detailed Description
Tobacco is estimated to cause more than 5 millions yearly deaths in the developed world. Although most smokers would like to quit, relapse rates remain high. It seems that this relapse is linked with the process of craving, which is a powerful desire to smoke elicited by smoking deprivation or exposure to situations or cues that are associated with smoking. Neuroimaging studies have shown that the dorsolateral prefrontal cortex (DLPFC), and especially the right part, is critically involved in processing the craving of smoking. Increasing the activity of the DLPFC by noninvasive brain stimulation has been demonstrated to be effective in decreasing craving symptoms in cigarette smokers. The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking. tDCS is a painless and safe brain stimulation method capable of modulating cortical excitability. The nature of these modulations depends on stimulation polarity: anodal tDCS is thought to cause neuronal depolarisation and thus enhancing cortical excitability whereas cathodal stimulation is proposed to reduce excitability. The investigators hypothesize that anodal tDCS applied repetitively to the right DLPFC could constitute a treatment of tobacco addiction. Therefore, the investigators will conduct a sham-tDCS-controlled, randomized, double-blind study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Smoking
Keywords
tobacco, smoking, tDCS, DLPFC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
sham transcranial direct current stimulation The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region
Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
active anodal tDCS over the right dorsolateral prefrontal cortex The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region Intensity of the stimulation: 2 mA Duration of the stimulation: 20 min 10 sessions, 2 per day
Intervention Type
Procedure
Intervention Name(s)
sham tDCS
Intervention Description
sham condition as delivered by the stimulator "study mode" (2mA during 40s and brief current pulses until the end of the stimulation) 20 minutes, 10 sessions, 2 per day
Intervention Type
Procedure
Intervention Name(s)
active tDCS
Intervention Description
anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day
Primary Outcome Measure Information:
Title
Smoking
Description
Self-reported number of cigarettes smoked each day
Time Frame
Baseline (three days before starting tDCS regimen) to one-month after
Secondary Outcome Measure Information:
Title
Exhaled carbon monoxide
Description
measured using a CO monitor (MicroCo, Milford, MA, USA).
Time Frame
Baseline, one-week (after the last tDCS session) and one-month later
Title
Craving
Description
measured using a 5-item Likert-type scale questionnaire of smoking urge
Time Frame
For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after)
Title
fMRI brain reactivity during a smoking cue-reactivity task
Description
measured using an event-related fMRI paradigm
Time Frame
Baseline and one-week (after the last tDCS session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age from 18 to 55 years old Tobacco consumption from 10 to 25 cigarettes, for at least 1 year Strong tobacco dependence at the Fagerstrom Test (score >= 5) Motivation to quit with a score >=12 at the Motivation to Quit Smoking Scale (Q-MAT) Informed consent Exclusion Criteria: Concomitant Axe I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) Other addictive disorder (DSM IV) No history of smoking cessation drug the previous year Psychotropic treatment Pregnancy or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEROME BRUNELIN, PhD
Organizational Affiliation
Hopital le Vinatier
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emmanuel POULET, MD, PhD
Organizational Affiliation
Hopital le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital le Vinatier
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

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Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction

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