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Tobacco DependenceNCT03841292

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

A study testing Varenicline and Active tDCS in people with Tobacco Dependence and Smoking Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 years
What is being tested?
Varenicline and Active tDCS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteCanada
Study dates
1 Oct 2018to 31 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T1P7

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Varenicline, Active tDCS, Sham tDCS
Keywords
Smoking Cessation Medication, Smoking Treatment, Tobacco Treatment, Quitting Smoking, Varenicline, 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
Medical subject headings
Tobacco Use Disorder, Smoking Cessation, Tobacco Smoking, Substance-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VareniclineDrug

    Also called Champix

    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).

  • 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

  • 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.

Study groups in NCT03841292
Study groupRoleWhat they receive
Active tDCS+VareniclineActive comparatorActive 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.
Receives: Drug: Varenicline; Device: Active tDCS
Sham tDCS+VareniclineSham comparatorSham 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.
Receives: Drug: Varenicline; Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in smoking status over time

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

    Measured: At weeks 12 and 26 following start of treatment

Secondary outcomes (2)

  1. 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

    Measured: At baseline and 12 weeks following start of treatment

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start1 Oct 2018
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sham Controlled Randomized Trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841292
Sponsor's protocol ID
REB #044/2016
Status last verified
Mar 2022
First submitted
8 Jan 2019
Last updated
15 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36480510

Questions about this trial

What is this clinical trial studying?

A study testing Varenicline and Active tDCS in people with Tobacco Dependence and Smoking Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in smoking status over time (time frame: At weeks 12 and 26 following start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03841292, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.

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