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

NCT01288183 | Completed

• 1 other identifier: 2010-A00180-39
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Addiction; Smoking

Keywords

tobacco; smoking; tDCS; DLPFC

Outcome Measures

Primary Outcomes (1)

• Smoking

  Self-reported number of cigarettes smoked each day

  Baseline (three days before starting tDCS regimen) to one-month after

Secondary Outcomes (3)

• Exhaled carbon monoxide

  Baseline, one-week (after the last tDCS session) and one-month later

• Craving

  For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after)

• fMRI brain reactivity during a smoking cue-reactivity task

  Baseline and one-week (after the last tDCS session)

Study Arms (2)

sham tDCS

SHAM COMPARATOR

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

Procedure: sham tDCS

active tDCS

ACTIVE COMPARATOR

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

Procedure: active tDCS

Interventions

sham tDCS PROCEDURE

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

sham tDCS

active tDCS PROCEDURE

anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day

active tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital le Vinatier

Bron, 69677, France

Location

MeSH Terms

Conditions

Behavior, Addictive; Smoking

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• JEROME BRUNELIN, PhD

  Hopital le Vinatier

  STUDY DIRECTOR

• Emmanuel POULET, MD, PhD

  Hopital le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PUPH

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

FR (1)