Transcranial Direct Current Stimulation in a Smoking Cessation Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2016-10-31

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.

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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:

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).

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DLPFC tDCS (left anode/right cathode)

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.

Group Type EXPERIMENTAL

active transcranial Direct Current Stimulation

Intervention Type DEVICE

Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.

DLPFC tDCS (left cathode/right anode)

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.

Group Type EXPERIMENTAL

active transcranial Direct Current Stimulation

Intervention Type DEVICE

Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.

DLPFC tDCS

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

Group Type SHAM_COMPARATOR

sham transcranial Direct Current Stimulation

Intervention Type DEVICE

Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.

Interventions

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active transcranial Direct Current Stimulation

Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.

Intervention Type DEVICE

sham transcranial Direct Current Stimulation

Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.

Intervention Type DEVICE

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes