tDCS + Varenicline for Smoking Cessation

Recruiting in Palo Alto (17 mi)

Overseen byLaurie A Zawertailo, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Centre for Addiction and Mental Health

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for individuals seeking to quit smoking and are struggling with tobacco use disorder. Participants should be willing to undergo daily sessions of tDCS and take varenicline as prescribed. Specific eligibility details were not provided, so interested individuals should inquire further.

Inclusion Criteria

Is seeking treatment for tobacco dependence

Smoke ≥ 8 cigarettes per day (CPD)

Be able to provide informed written consent

+4 more

Exclusion Criteria

Current regular use of nicotine-containing products besides cigarettes (e.g. electronic cigarettes, etc.)

Current pacemakers or implanted electrical devices

I have used smoking cessation aids in the last 3 months.

+7 more

Participant Groups

The study tests if active tDCS combined with the medication varenicline helps people stop smoking better than a sham (fake) tDCS plus varenicline. It includes daily sessions for two weeks, bi-weekly boosters thereafter, and follow-ups at 6 and 12 months.

2Treatment groups

Active Control

Placebo Group

Group I: Experimental Group (Active tDCS plus Varenicline)Active Control2 Interventions

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.

Group II: Control GroupPlacebo Group2 Interventions

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.