tDCS Plus Varenicline for Smoking Cessation

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCentre for Addiction and Mental Health

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Active Transcranial Direct Current Stimulation (tDCS)
  • Varenicline 1mg BID
  • Sham Transcranial Direct Current Stimulation (tDCS)

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre for Addiction and Mental Health

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator