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tDCS Plus Varenicline for Smoking Cessation

StatusRecruiting
PhasePhase 4
Started2025-03-10
View on ClinicalTrials.gov ↗

Amendment history

2025-08-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-01→confirmed 2025-03-10
Study sitesdetails revised at 1 of 1 site
2025-02-24
Study Identification, Study Status, Contacts/Locations v1
Start date2025-01-20→2025-03-01
Study sitescontacts updated at 1 of 1 site
Study titlerevised
TDCStDCS Plus Varenicline for Smoking Cessation
2025-01-22
Original filing
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.
Trial Details
NCT Number NCT06798324
Lead Sponsor Centre for Addiction and Mental Health
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Nicotine Dependence, Tobacco Smoking, Smoking Cessation, Nicotine Use Disorder, Tobacco Use Disorder, Substance Use Disorders
Enrollment 160 participants
Start Date 2025-03-10
Primary Completion 2028-01-20 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-12