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

Not Applicable

Completed

• Conditions: Tobacco Dependence; Smoking Cessation; Tobacco Smoking; Tobacco Use Disorder; Substance Use Disorders; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs
• Interventions: Drug: Varenicline; Device: Active tDCS; Device: Sham tDCS

• Registration Number: NCT03841292
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS+Varenicline	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. Daily stimulation between Monday to Friday for the first two weeks and then booster sessions every other week for the next 10 weeks.
Sham tDCS+Varenicline	Sham tDCS	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.
Active tDCS+Varenicline	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.
Sham tDCS+Varenicline	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.

Primary Outcome Measures

Name	Time	Method
Change in smoking status over time	At weeks 12 and 26 following start of treatment	30 Day Continuous abstinence confirmed by expired CO \</= 4 ppm

Secondary Outcome Measures

Name	Time	Method
Change in functional brain activation during cognitive tasks	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
Change in preference of attention towards visual cues	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

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada