Transcranial Direct Current Stimulation in a Smoking Cessation Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of transcranial direct current stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine dependent smokers.

Detailed Description
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BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that involves the application of brief weak electric current to the scalp. tDCS may induce neuroplasticity, thereby engaging some of the same systems that figure prominently in the pathological neuroplasticity caused by addictive drugs. OBJECTIVE: To assess whether tDCS delivered along with nicotine patch reliably increases a) quit rates, b) duration of abstinence, and c) percentage of participants abstinent at follow-up. METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the dorsolateral prefrontal cortex (DLPFC) in both cerebral hemispheres. HYPOTHESES: Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure. The benefits of active left anodal stimulation (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right).

Official Title
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Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Device: active transcranial Direct Current Stimulation
* Device: sham transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nicotine dependent treatment-seeking smoke minimum of 15 cigarettes per day able to provide written informed consent able and willing to attend weekly appointments, inter-treatment and follow-up assessment able and willing to wear nicotine patch Exclusion Criteria: currently taking GABA receptor agonists, NMDA receptor antagonists, dopamine receptor agonists/antagonists, SSRIs, L-dopa, anticholinergics pregnancy or lactation any serious medical condition requiring treatment or medication including high blood pressure, heart problems, asthma, epilepsy brain/neurological injury/disease/disorder skin disease current DSM-IV Axis I psychiatric disorder metal or medical device implants current treatment for alcohol or drug use current use of herbal/holistic preparations current use of recreational drugs

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DLPFC tDCS (left anode/right cathode)<br>Active transcranial Direct Current Stimulation (tDCS) administered to the left DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. | Device: active transcranial Direct Current Stimulation<br>* Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.<br>|
| Experimental: DLPFC tDCS (left cathode/right anode)<br>Active transcranial Direct Current Stimulation (tDCS) administered to the right DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. | Device: active transcranial Direct Current Stimulation<br>* Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.<br>|
| Sham Comparator: DLPFC tDCS<br>Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp. | Device: sham transcranial Direct Current Stimulation<br>* Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation | Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure | Participants will be followed for the duration of the study, an expected average of 9 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, nicotine dependence, dorsolateral prefrontal cortex, nicotine replacement therapy, nicotine patch, addiction, smoking cessation, neuroplasticity