Status:
COMPLETED
Deep rTMS and Varenicline for Smoking Cessation
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Pfizer
Brainsway
Conditions:
Tobacco Use Disorder
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is h...
Detailed Description
This study will be a randomized, double-blind, sham-controlled clinical trial. Nicotine dependent participants will be recruited and randomized tor receive either active or sham rTMS intervention for ...
Eligibility Criteria
Inclusion
- Age 18-65;
- Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
- Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm;
- Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
- Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7.
Exclusion
- Reported smoking abstinence in the 3 months preceding screening visit;
- Current use of other smoking cessation aids;
- Allergy and/or contraindication to varenicline or rTMS;
- Pregnancy, trying to become pregnant or breastfeeding;
- Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension;
- Current or historical evidence of suicidal behavior;
- Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.);
- Current, personal history or family history of seizures;
- Cognitive impairment as defined as a Mini Mental State Examination (MMSE) score \<24;
- Concomitant use of medication that lowers seizure threshold
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04083144
Start Date
August 22 2019
End Date
December 30 2022
Last Update
November 4 2024
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1