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
2 other identifiers
interventional
160
1 country
1
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 29, 2025
CompletedStudy Start
First participant enrolled
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
August 12, 2025
August 1, 2025
2.9 years
January 8, 2025
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 9-12
Secondary Outcomes (5)
Long-term Sustained Abstinence at Follow-Up
Weeks 9-26 and Weeks 9-52
Adverse events
Week 1-52
Working Memory Scores
Week 1-52
Attentional Bias
Week 1-52
Inhibitory Control Scores
Week 1-52
Study Arms (2)
Experimental Group (Active tDCS plus Varenicline)
ACTIVE COMPARATORThe experimental group will receive active tDCS sessions plus 12 weeks of 1 mg varenicline bid. Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. 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.
Control Group
SHAM COMPARATORThe control group will receive sham (fake) tDCS sessions plus 12 weeks of 1 mg varenicline bid. Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. 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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1P7, Canada
Related Publications (2)
Zawertailo L, Zhang H, Rahmani N, Rajji TK, Selby P. Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. PLoS One. 2022 Dec 8;17(12):e0277408. doi: 10.1371/journal.pone.0277408. eCollection 2022.
PMID: 36480510BACKGROUNDZhang H, Rajji TK, Selby P, Melamed O, Attwells S, Zawertailo L. Augmenting varenicline treatment with transcranial direct current stimulation (tDCS) increases smoking abstinence rates at end of treatment. Brain Stimul. 2023 Jul-Aug;16(4):1083-1085. doi: 10.1016/j.brs.2023.07.001. Epub 2023 Jul 3. No abstract available.
PMID: 37406928BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurie A Zawertailo, PhD
Centre for Addiction and Mental Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 8, 2025
First Posted
January 29, 2025
Study Start
March 10, 2025
Primary Completion (Estimated)
January 20, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
August 12, 2025
Record last verified: 2025-08