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Deep rTMS and Varenicline for Smoking Cessation

CompletedNA

Sponsor: Centre for Addiction and Mental Health

Conditions: Tobacco Use Disorder, Smoking Cessation

Interventions: Deep Repetitive Transcranial Magnetic Stimulation (Active), Deep Repetitive Transcranial Magnetic Stimulation (Sham), Varenicline

Countries: Canada

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 hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (1)

Toronto, Ontario, Canada