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Withdrawn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
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).
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
-
-
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.
|
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.
|
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.
|
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.
Collaborators
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
- 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.
- 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.
- 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.
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.