Actively Recruiting

Phase 4
Age: 18Years - 85Years
All Genders
NCT06798324

tDCS Plus Varenicline for Smoking Cessation

Led by Centre for Addiction and Mental Health · Updated on 2025-08-12

160

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

Sponsors

C

Centre for Addiction and Mental Health

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to determine if active transcranial direct current stimulation (tDCS) plus varenicline is an effective, safe and accessible treatment option for smoking cessation. The main questions this trial aims to answer are: 1. Does active tDCS plus varenicline improve short-term and long-term smoking abstinence rates compared to sham tDCS plus varenicline? 2. Are the safety profiles between active tDCS plus varenicline and sham tDCS plus varenicline different? The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment.

CONDITIONS

Official Title

tDCS Plus Varenicline for Smoking Cessation

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed written consent
  • Willing to follow all study procedures
  • Age between 18 and 85 years
  • Smoke at least 8 cigarettes daily
  • Seeking treatment for tobacco dependence
  • Willing to attend clinic appointments for two consecutive weeks, Monday through Friday
  • Generally healthy without major illness affecting study participation
Not Eligible

You will not qualify if you...

  • Used smoking cessation medications (e.g., bupropion, varenicline, nicotine replacement therapy, cytisine) in the past 3 months
  • Regular use of nicotine products other than cigarettes (e.g., e-cigarettes)
  • Unstable psychiatric illness affecting participation or compliance
  • History of seizures or epilepsy
  • Lifetime history of concussions or head injuries
  • Currently pregnant or planning pregnancy
  • Have pacemakers or implanted electrical devices
  • Metal embedded in the skull
  • Skin lesions, open wounds, or bruising at stimulation sites
  • Contraindications to varenicline use such as alcohol dependence, kidney problems, or known hypersensitivity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M5T 1P7

Actively Recruiting

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Research Team

L

Laurie A Zawertailo, PhD

CONTACT

K

Kameron Iturralde, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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