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

This study has suspended participant recruitment.
(Funding)
Sponsor:
Information provided by (Responsible Party):
Martin Zack, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01710410
First received: September 21, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is an effective add-on treatment in a validated smoking cessation protocol 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) as add-on Treatment in a Validated Smoking Cessation Protocol for Nicotine Dependent Smokers

Resource links provided by NLM:


Further study details as provided by 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 one year. ] [ Designated as safety issue: No ]
    Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure when combined with cognitive-behavioural group therapy plus nicotine patch.


Secondary Outcome Measures:
  • Smoking cessation rate following transcranial direct current stimulation applied to the dorsolateral prefrontal cortex or orbitofrontal cortex. [ Time Frame: Participants will be followed for the duration of the study, an expected average of one year. ] [ Designated as safety issue: No ]
    Measure whether the benefits of active tDCS to the OFC (anode-left/cathode-right) is greater than the conventional configuration (anode-left/cathode-right) to the DLPFC.


Other Outcome Measures:
  • Smoking cessation rate following transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex and orbitofrontal cortex versus the right dorsolateral prefrontal cortex and orbitofrontal cortex. [ Time Frame: Participants will be followed for the duration of the study, an expected average of one year. ] [ Designated as safety issue: No ]
    Measure whether the benefits of active tDCS (anode-left/cathode-right) to the OFC and to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right) to the respective regions.


Estimated Enrollment: 66
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (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.
Experimental: OFC tDCS (left anode/right cathode)
Active transcranial Direct Current Stimulation (tDCS) administered to the left OFC. 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: OFC tDCS (left cathode/right anode)
Active transcranial Direct Current Stimulation (tDCS) administered to the right OFC. 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.
Sham Comparator: OFC tDCS
Sham transcranial Direct Current Stimulation (tDCS) delivered to the OFC. 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 in addition to standard smoking cessation treatment (cognitive behavioural therapy and nicotine patch) reliably increases quit rates.

METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC) 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 when combined with cognitive-behavioural group therapy plus nicotine patch.
  2. The benefits of active tDCS to the OFC (anode-left/cathode-right) will be greater than the (anode-left/cathode-right)DLPFC configuration.
  3. The benefits of active tDCS (anode-left/cathode-right) to the OFC and to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right) to the respective regions.
  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Martin Zack, Ph.D. Centre for Addiction and Mental Health
  More Information

Additional Information:
Publications:
Responsible Party: Martin Zack, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01710410     History of Changes
Other Study ID Numbers: #006/2012-01
Study First Received: September 21, 2012
Last Updated: November 14, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
transcranial Direct Current Stimulation
nicotine dependence
dorsolateral prefrontal cortex
orbitofrontal cortex
cognitive behavioural therapy
nicotine replacement therapy
nicotine patch
addiction
smoking cessation
neuroplasticity

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

ClinicalTrials.gov processed this record on July 24, 2014