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

June 9, 2016 updated by: Laurie Zawertailo, Centre for Addiction and Mental Health

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1P5
        • Centre for Addiction and Mental Health (Nicotine Dependence Clinic)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: active transcranial Direct Current Stimulation
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
EXPERIMENTAL: 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.
Device: active transcranial Direct Current Stimulation
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
SHAM_COMPARATOR: 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.
Device: sham transcranial Direct Current Stimulation
Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Cessation
Time Frame: Participants will be followed for the duration of the study, an expected average of 9 months.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation rate following transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) versus the right DLPFC.
Time Frame: Participants will be followed for the duration of the study, an expected average of 9 months.
Measure whether the benefits of active tDCS (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right) to that region.
Participants will be followed for the duration of the study, an expected average of 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Nuraleve, Inc.

Investigators

  • Principal Investigator: Laurie Zawertailo, Ph.D., Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (ESTIMATE)

October 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 016-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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