Who is eligible for clinical trial NCT06798324?

Participants must meet protocol criteria for Nicotine Dependence. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06798324 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-08-07

tDCS Plus Varenicline for Smoking Cessation (NCT06798324)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Centre for Addiction and Mental Health

🩺 Plain-English Summary (8th-Grade Level)

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: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (11 items).

Location: Centre for Addiction and Mental Health — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Centre for Addiction and Mental Health — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗