Transcranial Direct Current Stimulation in a Smoking Cessation Trial (tDCS)

Center for Addiction and Mental Health (CAMH)

Status and phase: Withdrawn; Phase 2

Conditions: Nicotine Dependence

Treatments: Device: sham transcranial Direct Current Stimulation; Device: active transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01710410

016-2015

Details and patient eligibility

About

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.

Full description

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:

1. Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure.
2. 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).

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

DLPFC tDCS (left anode/right cathode)

Experimental group

Description:

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.

Treatment:

Device: active transcranial Direct Current Stimulation

DLPFC tDCS (left cathode/right anode)

Experimental group

Description:

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.

Treatment:

Device: active transcranial Direct Current Stimulation

DLPFC tDCS

Sham Comparator group

Description:

Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.

Treatment:

Device: sham transcranial Direct Current Stimulation