Clinical trial NCT01710410: Transcranial Direct Current Stimulation in a Smoking Cessation Trial
Official title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: transcranial direct current stimulation
nicotine dependence
dorsolateral prefrontal cortex
nicotine replacement therapy
nicotine patch
addiction
smoking cessation
neuroplasticity
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Nuraleve, Inc.
First posted: 2012-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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

Primary outcomes:
measure: Smoking Cessation
timeFrame: Participants will be followed for the duration of the study, an expected average of 9 months.
Secondary outcomes:
Other outcomes:
measure: Smoking cessation rate following transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) versus the right DLPFC.
timeFrame: Participants will be followed for the duration of the study, an expected average of 9 months.
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health (Nicotine Dependence Clinic)
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Laurie Zawertailo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.