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

This study has been withdrawn prior to enrollment.
(Funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01710410
First Posted: October 19, 2012
Last Update Posted: June 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nuraleve, Inc.
Information provided by (Responsible Party):
Laurie Zawertailo, Centre for Addiction and Mental Health
  Purpose
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.

Condition Intervention Phase
Nicotine Dependence Device: active transcranial Direct Current Stimulation Device: sham transcranial Direct Current Stimulation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers

Resource links provided by NLM:


Further study details as provided by Laurie Zawertailo, Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: October 2016
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710410


Locations
Canada, Ontario
Centre for Addiction and Mental Health (Nicotine Dependence Clinic)
Toronto, Ontario, Canada, M5T 1P5
Sponsors and Collaborators
Centre for Addiction and Mental Health
Nuraleve, Inc.
Investigators
Principal Investigator: Laurie Zawertailo, Ph.D. Centre for Addiction and Mental Health
  More Information

Additional Information:
Publications:
Responsible Party: Laurie Zawertailo, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01710410     History of Changes
Other Study ID Numbers: 016-2015
First Submitted: September 21, 2012
First Posted: October 19, 2012
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Laurie Zawertailo, Centre for Addiction and Mental Health:
transcranial direct current stimulation
nicotine dependence
dorsolateral prefrontal cortex
nicotine replacement therapy
nicotine patch
addiction
smoking cessation
neuroplasticity

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action