tDCS plus varenicline to help people quit smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who smoke ≥8 cigarettes per day and are seeking treatment are randomized to receive either active or sham transcranial direct current stimulation (tDCS) in addition to varenicline (1 mg twice daily). The tDCS schedule includes 10 daily sessions over the first two weeks (Monday–Friday) followed by five biweekly booster sessions, with in-person follow-ups at 6 and 12 months to measure smoking behavior and safety. Primary outcomes are short-term and sustained abstinence rates and comparison of adverse events between the active and sham groups. The trial is conducted at the Centre for Addiction and Mental Health in Toronto and excludes participants with seizure history, implanted electrical devices, recent use of other cessation medications, or unstable psychiatric illness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

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)

Where it's running

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

Study contacts

• Principal investigator: Laurie A Zawertailo, PhD — Centre for Addiction and Mental Health
• Study coordinator: Laurie A Zawertailo, PhD
• Email: laurie.zawertailo@camh.ca
• Phone: 416-535-8501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.