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Completed

NCT Number: NCT03841292

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

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.

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Key information

Conditions

Tobacco Dependence Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Health Behavior Impulsive Behavior Mental Disorders Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Smoking Smoking Cessation Substance Use Disorders Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1P7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

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 names: Champix

active tDCS

Device

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 tDCS

Device

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Using Non-invasive Brain Stimulation (tDCS) to Improve the Effectiveness of Varenicline for Treating Tobacco Dependence: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2019
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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