Recruiting

tDCS with Varenicline

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06798324

Conditions

Nicotine Dependence

Tobacco Smoking

Smoking Cessation

Nicotine Use Disorder

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Transcranial Direct Current Stimulation (tDCS)

Varenicline 1mg BID

Sham Transcranial Direct Current Stimulation (tDCS)

Study Details

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?

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.

Conditions

Nicotine Dependence

Tobacco Smoking

Smoking Cessation

Nicotine Use Disorder

Tobacco Use Disorder

Study ID

NCT06798324

Start date

Mar 10, 2025

Status verified date

Aug, 2025

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Jan 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Experimental Group (Active tDCS plus Varenicline)

The 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.

sham comparator: Control Group

The 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

Active Transcranial Direct Current Stimulation (tDCS)

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 1mg BID

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 Transcranial Direct Current Stimulation (tDCS)

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.

Primary outcome measure

  • 30-Day Continuous Abstinence at End-Of-Treatment [ Time Frame: Week 9-12 ]

Central Contacts and Locations

Central contacts

Laurie A Zawertailo, PhD

416-535-8501laurie.zawertailo@camh.ca

Kameron Iturralde, BSc

416-535-8501kameron.iturralde@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M5T 1P7

Contacts

Laurie A Zawertailo, PhD

416-535-8501laurie.zawertailo@camh.ca

Principal Investigator:

Laurie Zawertailo, PhD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Keywords

  • Smoking
  • Tobacco Use Disorder
  • Smoking Cessation
  • Substance Use Disorders
  • Brain Stimulation
  • Transcranial Direct Current Stimulation
  • Tobacco Cigarettes
  • tDCS
  • Varenicline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2025-08-12.