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Clinical Trials/NCT01710410
NCT01710410
Withdrawn
Phase 2

Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers

Centre for Addiction and Mental Health1 site in 1 countryOctober 2016

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Nicotine Dependence
Sponsor
Centre for Addiction and Mental Health
Locations
1
Primary Endpoint
Smoking Cessation
Status
Withdrawn
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laurie Zawertailo

Principal Investigator

Centre for Addiction and Mental Health

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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