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.
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)
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
Parallel
Active Transcranial Direct Current Stimulation (tDCS)
DeviceTranscranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation. Active tDCS involves brief (e.g., 20-min) application of weak electric current (e.g., 2 mA) to the scalp. The tDCS device that will be used for this study is the Soterix 1x1 mini-CT.
Varenicline 1mg BID
DrugVarenicline is the most effective approved treatment for quitting smoking. Varenicline as per standard prescribing for dose escalation (i.e. Days 1 to 3: 0.5 mg once daily; Days 4 to 7: 0.5 mg twice daily; Days 8 to end of treatment: 1 mg twice daily) will be given concurrently over the same 2 weeks as the tDCS protocol and continue for an additional 10 weeks as per standard treatment duration recommended on the product monograph for a total of 12 weeks of varenicline treatment. Dose adjustments due to adverse events will be allowed (i.e. decrease to 0.5 mg twice daily). The target quit date for smoking cessation will be on the last day of the two weeks of daily tDCS which corresponds to the recommended quit date after starting varenicline treatment.
Sham Transcranial Direct Current Stimulation (tDCS)
DeviceSham tDCS consists of 30s of 2 mA at the beginning and at the end of the 6 session (ramp up and down), then receiving 0 mA stimulation for the middle 19 min. The tDCS device that will be used for this study is the Soterix 1x1 mini-CT.
30-Day Continuous Abstinence at End-Of-Treatment
Proportion of the sample that has been abstinent from smoking for 30 days at end of treatment (treatment weeks 9-12), verified with a negative urinary cotinine test.
Long-term Sustained Abstinence at Follow-Up
Continuous abstinence at 6-months (weeks 9 to 26) and 12-month (weeks 9 to 52) follow-up (verified with a negative urinary cotinine test).
Adverse events
Adverse events will be recorded throughout the treatment and in follow-up visits.
Working Memory Scores
The N-back Task will be used throughout the study to evaluate changes in working memory.
Attentional Bias
Attentional bias towards smoking cues, sensation-seeking cues, and negative affect cues will be evaluated throughout the study using eye-tracking technology.
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Centre for Addiction and Mental Health
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
