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Funding
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| Name | Class |
|---|---|
| Nuraleve, Inc. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLPFC tDCS (left anode/right cathode) | Experimental | 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. |
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| DLPFC tDCS (left cathode/right anode) | Experimental | 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. |
|
| DLPFC tDCS | Sham Comparator | Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active transcranial Direct Current Stimulation | Device | Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | 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. |
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| 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. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie Zawertailo, Ph.D. | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health (Nicotine Dependence Clinic) | Toronto | Ontario | M5T 1P5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19619607 | Background | 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. | |
| 19914283 | Background | 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. |
| Label | URL |
|---|---|
| Centre for Addiction and Mental Health (investigator-driven, not initiated, study) | View source |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016739 | Behavior, Addictive |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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| sham transcranial Direct Current Stimulation | Device | Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp. |
|
| 18312035 | Background | 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. |
| Ontario Brain Institute | View source |
| Nuraleve, Inc. (regulatory sponsor with Health Canada) | View source |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D015438 | Health Behavior |