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Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence

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ClinicalTrials.gov Identifier: NCT03841292
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Laurie Zawertailo, Centre for Addiction and Mental Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Smoking Cessation Tobacco Smoking Tobacco Use Disorder Substance Use Disorders Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Drug: Varenicline Device: Active tDCS Device: Sham tDCS Not Applicable

Detailed 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-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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Sham Controlled Randomized Trial
Masking: Double (Participant, Investigator)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: Using Non-invasive Brain Stimulation (tDCS) to Improve the Effectiveness of Varenicline for Treating Tobacco Dependence: a Randomized Controlled Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active tDCS+Varenicline
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
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).
Other Name: Champix

Device: Active tDCS
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

Sham Comparator: Sham tDCS+Varenicline
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
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).
Other Name: Champix

Device: Sham tDCS
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.




Primary Outcome Measures :
  1. Change in smoking status over time [ Time Frame: At weeks 12 and 26 following start of treatment ]
    30 Day Continuous abstinence confirmed by expired CO </= 4 ppm


Secondary Outcome Measures :
  1. Change in functional brain activation during cognitive tasks [ Time Frame: At baseline and 12 weeks following start of treatment ]
    change in fMRI BOLD response in the brain in response to smoking cues or when anticipating a monetary reward

  2. Change in preference of attention towards visual cues [ Time Frame: At weeks 4,8, 12 and 26 weeks following start of treatment. ]
    Attentional bias to smoking cues, negative/positive cues and high-risk cues measured using an automated eye-tracking apparatus


Other Outcome Measures:
  1. Change in brain neurocircuitry over time [ Time Frame: At baseline and 12 weeks following start of treatment ]
    Differences in water diffusion in the brain when participants are at rest in a MRI scanner.

  2. Change in dynamic functional connectivity of the brain at rest over time [ Time Frame: At baseline and 12 weeks following start of treatment ]
    Related to differences in resting state functional brain networks when participants are not doing an explicit task in a fMRI scanner.



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female
  • Aged 19-65
  • Treatment seeking smoker
  • Daily smoker of CPD>8
  • Able to attend daily appointments for tDCS for the first 2 weeks and booster sessions for the next 10 weeks.
  • Wiling to undergo 3 fMRI sessions

Exclusion Criteria:

  • Current/recent DSM-IV Axis I diagnosis
  • Current use of psychoactive drugs or medications
  • History of seizures/epilepsy
  • Current use of NRT, e-cigarettes or other medications for smoking cessation
  • Metal embedded in skull or implanted electrical devices
  • No head injury (concussion or loss of consciousness for more than an hour)
  • Contraindications to fMRI
  • Contraindications to varenicline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841292


Contacts
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Contact: Laurie A Zawertailo, PhD 4165358501 ext 77422 laurie.zawertailo@camh.ca
Contact: Helena Zhang, MSc 4165358501 ext 77297 helena.zhang@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T1P7
Contact: Laurie Zawertailo, PhD    4165358501 ext 77422    laurie.zawertailo@camh.ca   
Contact: Helena Zhang, MSc    4165358501 ext 77297    helena.zhang@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Laurie A Zawertailo, PhD Centre for Addiction and Mental Health

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Responsible Party: Laurie Zawertailo, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03841292     History of Changes
Other Study ID Numbers: REB #044/2016
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Laurie Zawertailo, Centre for Addiction and Mental Health:
Varenicline
Smoking Cessation Medication
Smoking Treatment
Tobacco Treatment
Quitting Smoking
Transcranial Direct Current Stimulation
Neuroimaging
fMRI
Attentional Bias
Eye-tracking
Dependence
Addiction
Cigarettes
Biochemical Confirmation
Cue reactivity
Reward Anticipation
Diffusion Tensor Imaging
Resting State Functional Connectivity
BOLD fMRI
Quantitative T1

Additional relevant MeSH terms:
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Varenicline
Disease
Substance-Related Disorders
Tobacco Use Disorder
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs