Nicotine Dependence study: Varenicline
Official title tDCS Plus Varenicline for Smoking Cessation
ClinicalTrials.gov ID: NCT06798324
What this study is testing
What is Varenicline 1mg BID?
This is an investigational oral medicine being studied as a potential treatment for nicotine dependence. It is designed to reduce cravings and withdrawal symptoms by affecting how nicotine works in the brain.
Also referred to as Champix, Chantix.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if combining a mild electrical brain stimulation with a medication called varenicline helps people stay smoke-free better than a fake stimulation. It also looks at whether the treatment is safe.
- Who it's for
- The study is looking for people who smoke and want to quit.
- What's involved
- Participants will receive daily brain stimulation sessions for two weeks, followed by occasional booster sessions. They will also take a prescription pill to help with cravings.
- Time commitment
- The treatment lasts several weeks, with in-person visits at 6 and 12 months to check if you are still smoke-free.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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
You likely can't join 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
See the full eligibility 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)
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.