tDCS Plus Varenicline for Smoking Cessation

PHASE4RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

January 20, 2028

Study Completion Date

August 1, 2028

Conditions
Nicotine DependenceTobacco SmokingSmoking CessationNicotine Use DisorderTobacco Use DisorderSubstance Use Disorders
Interventions
DEVICE

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.

DRUG

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."

DEVICE

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.

Trial Locations (1)

M5T 1P7

RECRUITING

Centre for Addiction and Mental Health, Toronto

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

Centre for Addiction and Mental Health

OTHER