tDCS Plus Varenicline for Smoking Cessation
Using Non-Invasive Brain Stimulation (tDCS) as an Adjunct to Varenicline for the Treatment of Tobacco Dependence: a Randomized Controlled Trial
Centre for Addiction and Mental Health
160 participants
Mar 10, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 Criteria10
- 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)
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Interventions
Transcranial 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 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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06798324