NCT03841292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

January 8, 2019

Last Update Submit

March 14, 2022

Conditions

Tobacco DependenceSmoking CessationTobacco SmokingTobacco Use DisorderSubstance Use DisordersMolecular Mechanisms of Pharmacological ActionPhysiological Effects of Drugs

Keywords

Smoking Cessation MedicationSmoking TreatmentTobacco TreatmentQuitting SmokingVareniclineTranscranial Direct Current StimulationNeuroimagingfMRIAttentional BiasEye-trackingDependenceAddictionCigarettesBiochemical ConfirmationCue reactivityReward AnticipationDiffusion Tensor ImagingResting State Functional ConnectivityBOLD fMRIQuantitative T1

Outcome Measures

Primary Outcomes (1)

  • Change in smoking status over time

    30 Day Continuous abstinence confirmed by expired CO \</= 4 ppm

    At weeks 12 and 26 following start of treatment

Secondary Outcomes (2)

  • Change in functional brain activation during cognitive tasks

    At baseline and 12 weeks following start of treatment

  • Change in preference of attention towards visual cues

    At weeks 4,8, 12 and 26 weeks following start of treatment.

Other Outcomes (2)

  • Change in brain neurocircuitry over time

    At baseline and 12 weeks following start of treatment

  • Change in dynamic functional connectivity of the brain at rest over time

    At baseline and 12 weeks following start of treatment

Study Arms (2)

Active tDCS+Varenicline

ACTIVE COMPARATOR

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: VareniclineDevice: Active tDCS

Sham tDCS+Varenicline

SHAM COMPARATOR

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: VareniclineDevice: Sham tDCS

Interventions

VareniclineDRUG

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 tDCS+VareniclineSham tDCS+Varenicline
Active tDCSDEVICE

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

Active tDCS+Varenicline
Sham tDCSDEVICE

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.

Sham tDCS+Varenicline

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1P7, Canada

Location

Related Publications (1)

  • Zawertailo L, Zhang H, Rahmani N, Rajji TK, Selby P. Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. PLoS One. 2022 Dec 8;17(12):e0277408. doi: 10.1371/journal.pone.0277408. eCollection 2022.

    PMID: 36480510DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking CessationTobacco SmokingSubstance-Related DisordersBehavior, Addictive

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHealth BehaviorBehaviorSmokingTobacco UseCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Laurie A Zawertailo, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Sham Controlled Randomized Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

January 8, 2019

First Posted

February 15, 2019

Study Start

October 1, 2018

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

CA(1)