Transcranial Direct Current Stimulation in a Smoking Cessation Trial

Nicotine Dependence Clinical Trial

— tDCS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01710410
• Other study ID #: 016-2015
• Status: Withdrawn
• Phase: Phase 2
• First received: September 21, 2012
• Last updated: June 9, 2016
• Start date: October 2016
• Est. completion date: October 2016

Study information

• Verified date: June 2016
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Device:
• active transcranial Direct Current Stimulation
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
• sham transcranial Direct Current Stimulation
Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health (Nicotine Dependence Clinic)	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Nuraleve, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Primary	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.	No

External Links

•   Centre for Addiction and Mental Health (investigator-driven, not initiated, study)
•   Nuraleve, Inc. (regulatory sponsor with Health Canada)
•   Ontario Brain Institute