Clinical trial NCT03841292: Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence
Official title: Using Non-invasive Brain Stimulation (tDCS) to Improve the Effectiveness of Varenicline for Treating Tobacco Dependence: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Smoking Cessation
Tobacco Smoking
Tobacco Use Disorder
Substance Use Disorders
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
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
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sham Controlled Randomized Trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in smoking status over time
timeFrame: At weeks 12 and 26 following start of treatment
Secondary outcomes:
measure: Change in functional brain activation during cognitive tasks
timeFrame: At baseline and 12 weeks following start of treatment
measure: Change in preference of attention towards visual cues
timeFrame: At weeks 4,8, 12 and 26 weeks following start of treatment.
Other outcomes:
measure: Change in brain neurocircuitry over time
timeFrame: At baseline and 12 weeks following start of treatment
measure: Change in dynamic functional connectivity of the brain at rest over time
timeFrame: At baseline and 12 weeks following start of treatment
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Laurie A Zawertailo, PhD
role: PRINCIPAL_INVESTIGATOR
References: