Smoking Cessation Clinical Trial
Official title:
Using Non-invasive Brain Stimulation (tDCS) to Improve the Effectiveness of Varenicline for Treating Tobacco Dependence: a Randomized Controlled Trial
Verified date | March 2022 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in brain neurocircuitry over time | Differences in water diffusion in the brain when participants are at rest in a MRI scanner. | At baseline and 12 weeks following start of treatment | |
Other | Change in dynamic functional connectivity of the brain at rest over time | Related to differences in resting state functional brain networks when participants are not doing an explicit task in a fMRI scanner. | At baseline and 12 weeks following start of treatment | |
Primary | 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 | 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 | At baseline and 12 weeks following start of treatment | |
Secondary | 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 | At weeks 4,8, 12 and 26 weeks following start of treatment. |
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