Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Molecular Mechanisms of Pharmacological Action
- Physiological Effects of Drugs
- Smoking Cessation
- Substance Use Disorders
- Tobacco Dependence
- Tobacco Smoking
- Tobacco Use Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Sham Controlled Randomized TrialMasking: Double (Participant, Investigator)Masking Description: Double-BlindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 65 years
- Gender
- Both males and females
Description
While varenicline on its own is the most effective medication for smoking cessation, long-term abstinence is still relatively poor. The primary objective of this study is to evaluate the effectiveness of adjunct active tDCS with varenicline in treating tobacco dependence. This study is a double-blin...
While varenicline on its own is the most effective medication for smoking cessation, long-term abstinence is still relatively poor. The primary objective of this study is to evaluate the effectiveness of adjunct active tDCS with varenicline in treating tobacco dependence. This study is a double-blind, sham-controlled, randomized clinical trial where 50 daily dependent treatment seeking smokers will be recruited at the Nicotine Dependence Clinic in Toronto, Canada. Participants will be receiving twelve weeks of varenicline treatment (1mg b.i.d.) and randomized 1:1 to either active tDCS (active: 20 minutes at 2 mA) or sham tDCS (30 seconds at 2 mA, 19.5 minutes at 0 mA), daily (M-F) for the first 2 weeks and then every 2 weeks for the next 10 weeks. There will be 2 fMRI scans at baseline and 1 scan at end-of-treatment. Eye-tracking viewing tests will be conducted at baseline, weeks 4, 8, 12 and at 6 months follow up. During the 6 month follow-up, participants will be answering questions regarding their smoking behaviour and craving. Smoking status will be biochemically confirmed at each study visit using expired cotinine.
Tracking Information
- NCT #
- NCT03841292
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Laurie A Zawertailo, PhD Centre for Addiction and Mental Health