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Search / Trial NCT06798324

tDCS Plus Varenicline for Smoking Cessation

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Jan 22, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Smoking Tobacco Use Disorder Smoking Cessation Substance Use Disorders Brain Stimulation Transcranial Direct Current Stimulation Tobacco Cigarettes T Dcs Varenicline

ClinConnect Summary

This clinical trial is studying a new approach to help people quit smoking by combining two treatments: a method called transcranial direct current stimulation (tDCS) and a medication called varenicline. The main goal is to find out if this combination helps people stop smoking more effectively than using varenicline alone with a placebo (a fake treatment). The trial will also look at the safety of both treatments to see if there are any differences in side effects.

To participate, you need to be between 18 and 85 years old and smoke at least 8 cigarettes a day. You should also be willing to come to the clinic for 10 daily sessions over two weeks, followed by five follow-up appointments. It’s important that you are otherwise healthy and not currently using other smoking cessation medications. If you meet these criteria, you may have the chance to take part in a study that aims to improve smoking cessation treatments.

Gender

ALL

Eligibility criteria

  • 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)

About Centre For Addiction And Mental Health

The Centre for Addiction and Mental Health (CAMH) is Canada’s leading mental health and addiction teaching hospital, dedicated to advancing research, clinical care, and education in the field of mental health. With a commitment to improving the lives of individuals affected by mental illness and addiction, CAMH conducts innovative clinical trials aimed at developing and evaluating new treatment approaches. The institution fosters a collaborative environment that brings together researchers, clinicians, and community partners to translate scientific findings into effective interventions, ensuring the highest standards of care and support for patients. Through its robust research initiatives, CAMH strives to enhance understanding of mental health disorders and promote evidence-based practices in the treatment of addiction and mental health challenges.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Laurie A Zawertailo, PhD

Principal Investigator

Centre for Addiction and Mental Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported