tDCS Plus Varenicline for Smoking Cessation

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Be able to provide informed written consent
• Stated willingness to comply with all study procedures
• Age 18-85 years
• Smoke ≥ 8 cigarettes per day (CPD)
• Is seeking treatment for tobacco dependence
• Willing to attend the required clinic appointments (Two consecutive weeks, Monday through Friday)
• Otherwise healthy (i.e. not suffering from any major illness/condition that would impact their participation in the study)

🚫 You may not be able to join if…

• Use of smoking cessation medication (e.g. buproprion, varenicline, NRT, cytisine) in the past 3 months
• Current regular use of nicotine-containing products besides cigarettes (e.g. electronic cigarettes, etc.)
• Unstable psychiatric illness that would adversely impact study participation and compliance (determined by the QI)
• History of seizures/epilepsy
• Lifetime history of concussions or head traumas
• Current pregnancy or plans to become pregnant
• Current pacemakers or implanted electrical devices
• Current metal embedded in the skull
• Presence of skin lesions, open wounds, or bruising at stimulation sites; or
• Contraindications to varenicline use (e.g. pregnant/breastfeeding, alcohol dependence, kidney disease/renal impairment, known hypersensitivity to varenicline)

Where this trial is running

• Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Who to contact

Laurie A Zawertailo, PhD · 416-535-8501 · laurie.zawertailo@camh.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06798324.