Transcranial Direct Current Stimulation in a Smoking Cessation Trial

NCT01710410 | Withdrawn Phase 2

• 1 other identifier: 016-2015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

transcranial direct current stimulation; nicotine dependence; dorsolateral prefrontal cortex; nicotine replacement therapy; nicotine patch; addiction; smoking cessation; neuroplasticity

Outcome Measures

Primary Outcomes (1)

• 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.

Other Outcomes (1)

• 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.

Study Arms (3)

DLPFC tDCS (left anode/right cathode)

EXPERIMENTAL

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.

Device: active transcranial Direct Current Stimulation

DLPFC tDCS (left cathode/right anode)

EXPERIMENTAL

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.

Device: active transcranial Direct Current Stimulation

DLPFC tDCS

SHAM COMPARATOR

Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.

Device: sham transcranial Direct Current Stimulation

Interventions

active transcranial Direct Current Stimulation DEVICE

Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.

DLPFC tDCS (left anode/right cathode); DLPFC tDCS (left cathode/right anode)

sham transcranial Direct Current Stimulation DEVICE

Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.

DLPFC tDCS

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Nuraleve, Inc.: collaborator

Study Sites (1)

Centre for Addiction and Mental Health (Nicotine Dependence Clinic)

Toronto, Ontario, M5T 1P5, Canada

Location

Related 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.

  PMID: 19619607 BACKGROUND

• 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.

  PMID: 19914283 BACKGROUND

• 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.

  PMID: 18312035 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Tobacco Use Disorder; Behavior, Addictive; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Health Behavior

Study Officials

• Laurie Zawertailo, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 19, 2012
• Study Start: October 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

CA (1)