An interventional study of Varenicline and Active tDCS in Tobacco Dependence, Smoking Cessation and Tobacco Smoking, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
The addition of tDCS as an adjunct to pharmacotherapy is a novel approach but one that is grounded in a growing evidence-base.The primary objective of this research is to provide preliminary evidence of the effectiveness of tDCS as an adjunct treatment to pharmacotherapy for smoking cessation. The investigators hypothesize that the addition of active tDCS to the left DLPFC will improve the effectiveness of varenicline as reflected by higher quit rates at end of treatment compared to the sham group. Smoking status will be biochemically confirmed at various time points using expired cotinine measures. Furthermore, the investigators will be collecting neuroimaging (fMRI) data as well as measures of attentional bias to explore the neurological and physiological correlates from using adjunct tDCS and varenicline therapy.
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.
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Active 2mA tDCS (Nuraleve, Canada) with the anode placed over the left dorsolateral prefrontal cortex (dlPFC) and the cathode placed over the right dlPFC for 20 minutes per session. Daily stimulation between Monday to Friday for the first two weeks and then booster sessions every other week for the next 10 weeks.
Drug: Varenicline · Device: Active tDCS
Sham tDCS (Nuraleve, Canada)(30 seconds of 2mA and 19.5 minutes of 0 mA) with the anode placed over the left dorsolateral prefrontal cortex (dlPFC) and the cathode placed over the right dlPFC for 20 minutes per session. Daily stimulation between Monday to Friday for the first two weeks and then booster sessions every other week for the next 10 weeks.
Drug: Varenicline · Device: Sham tDCS
Varenicline (Champix®), Pfizer Canada Inc., Kirkland, Quebec. Dispense for 12 weeks. One tablet (0.5mg) once daily for first three days, then one tablet (0.5 mg) twice daily for next four days, then 1 mg (one 1mg tablet) twice daily for the remainder of 12 weeks. Dose adjustments due to adverse events will be allowed (i.e. decrease to 0.5 mg twice daily).
Also known as: Champix
Active 2mA tDCS (Nuraleve, Canada) with the anode placed over the left dorsolateral prefrontal cortex (dlPFC) and the cathode placed over the right dlPFC for 20 minutes per session
Shame tDCS (Nuraleve, Canada) (30 seconds of 2mA and 19.5 minutes of 0 mA) with the anode placed over the left dorsolateral prefrontal cortex (dlPFC) and the cathode placed over the right dlPFC for 20 minutes per session.
Change in smoking status over time
30 Day Continuous abstinence confirmed by expired CO \</= 4 ppm
Time frame: At weeks 12 and 26 following start of treatment
Change in functional brain activation during cognitive tasks
change in fMRI BOLD response in the brain in response to smoking cues or when anticipating a monetary reward
Time frame: At baseline and 12 weeks following start of treatment
Change in preference of attention towards visual cues
Attentional bias to smoking cues, negative/positive cues and high-risk cues measured using an automated eye-tracking apparatus
Time frame: At weeks 4,8, 12 and 26 weeks following start of treatment.
Change in brain neurocircuitry over time
Differences in water diffusion in the brain when participants are at rest in a MRI scanner.
Time frame: At baseline and 12 weeks following start of treatment
Change in dynamic functional connectivity of the brain at rest over time
Related to differences in resting state functional brain networks when participants are not doing an explicit task in a fMRI scanner.
Time frame: At baseline and 12 weeks following start of treatment
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health