Deep rTMS and Varenicline for Smoking Cessation

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborators: Brainsway; Pfizer
• Treatments: Varenicline

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