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

Primary Purpose

Nicotine Dependence

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
active transcranial Direct Current Stimulation
sham transcranial Direct Current Stimulation
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring transcranial direct current stimulation, nicotine dependence, dorsolateral prefrontal cortex, nicotine replacement therapy, nicotine patch, addiction, smoking cessation, neuroplasticity

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Centre for Addiction and Mental Health (Nicotine Dependence Clinic)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

DLPFC tDCS (left anode/right cathode)

DLPFC tDCS (left cathode/right anode)

DLPFC tDCS

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Smoking Cessation
Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure

Secondary Outcome Measures

Full Information

First Posted
September 21, 2012
Last Updated
June 9, 2016
Sponsor
Centre for Addiction and Mental Health
Collaborators
Nuraleve, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01710410
Brief Title
Transcranial Direct Current Stimulation in a Smoking Cessation Trial
Acronym
tDCS
Official Title
Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Nuraleve, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
transcranial direct current stimulation, nicotine dependence, dorsolateral prefrontal cortex, nicotine replacement therapy, nicotine patch, addiction, smoking cessation, neuroplasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLPFC tDCS (left anode/right cathode)
Arm Type
Experimental
Arm 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.
Arm Title
DLPFC tDCS (left cathode/right anode)
Arm Type
Experimental
Arm 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.
Arm Title
DLPFC tDCS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
active transcranial Direct Current Stimulation
Intervention Description
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
Intervention Type
Device
Intervention Name(s)
sham transcranial Direct Current Stimulation
Intervention Description
Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
Primary Outcome Measure Information:
Title
Smoking Cessation
Description
Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure
Time Frame
Participants will be followed for the duration of the study, an expected average of 9 months.
Other Pre-specified Outcome Measures:
Title
Smoking cessation rate following transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) versus the right DLPFC.
Description
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.
Time Frame
Participants will be followed for the duration of the study, an expected average of 9 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Zawertailo, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health (Nicotine Dependence Clinic)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1P5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19619607
Citation
Boggio PS, Liguori P, Sultani N, Rezende L, Fecteau S, Fregni F. Cumulative priming effects of cortical stimulation on smoking cue-induced craving. Neurosci Lett. 2009 Sep 29;463(1):82-6. doi: 10.1016/j.neulet.2009.07.041. Epub 2009 Jul 18.
Results Reference
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PubMed Identifier
19914283
Citation
Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
Results Reference
background
PubMed Identifier
18312035
Citation
Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.
Results Reference
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Links:
URL
http://www.camh.ca
Description
Centre for Addiction and Mental Health (investigator-driven, not initiated, study)
URL
http://www.braininstitute.ca/
Description
Ontario Brain Institute
URL
http://www.nuraleve.com
Description
Nuraleve, Inc. (regulatory sponsor with Health Canada)

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Transcranial Direct Current Stimulation in a Smoking Cessation Trial

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