Nicotine Dependence
Conditions
Keywords
transcranial direct current stimulation, nicotine dependence, dorsolateral prefrontal cortex, nicotine replacement therapy, nicotine patch, addiction, smoking cessation, neuroplasticity
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).
Interventions
DEVICEactive transcranial Direct Current Stimulation
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
DEVICEsham transcranial Direct Current Stimulation
Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
Sponsors
Nuraleve, Inc.
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation rate following transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) versus the right DLPFC. | 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. |
Countries
Canada
Outcome results
None listed