Transcranial Direct Current Stimulation in a Smoking Cessation Trial
- Conditions
- Nicotine Dependence
- Interventions
- Device: sham transcranial Direct Current StimulationDevice: active transcranial Direct Current Stimulation
- Registration Number
- NCT01710410
- Lead Sponsor
- Centre for Addiction and Mental Health
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DLPFC tDCS sham transcranial Direct Current Stimulation Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp. DLPFC tDCS (left anode/right cathode) active transcranial Direct Current Stimulation 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. DLPFC tDCS (left cathode/right anode) active transcranial Direct Current Stimulation 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre for Addiction and Mental Health (Nicotine Dependence Clinic)
🇨🇦Toronto, Ontario, Canada