Deep rTMS and Varenicline for Smoking Cessation

Centre for Addiction and Mental Health50 enrolled

Overview

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.

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 4 weeks (5 sessions/week). All participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions. The aims of the study are: 1. To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment. 2. To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving, cigarette smoking and dependence severity. 3. To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up. Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26. This will be confirmed using plasma cotinine levels. All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence (FTND), Timeline Follow-Back (TLFB), Minnesota Nicotine Withdrawal Scale (MNWS), and Tiffany Questionnaire of Smoking Urges (T-QSU).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Tobacco Use Disorder Smoking Cessation

Interventions

Deep Repetitive Transcranial Magnetic Stimulation (Active)DEVICE

Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula

Deep Repetitive Transcranial Magnetic Stimulation (Sham)DEVICE

Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations.

VareniclineDRUG

12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Point Prevalence Abstinence at the End of 12 Weeks

Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.

Time frame: 12 weeks

Secondary Outcomes

Fagerstrom Test For Nicotine Dependence (FTND) Score

This will be used to assess physical dependence severity in participants. It is a 6 item scale and total scores can range from 0-10. A higher score indicates more severe nicotine dependence.

Time frame: 26 weeks

Expired CO Measurements

This will be used as a biological confirmation of recent smoking.

Time frame: 26 weeks

Cigarettes Per Day (TLFB)

Self-reported measure of cigarette consumption.

Time frame: 26 weeks

Minnesota Nicotine Withdrawal Scale (MNWS) Score

This will be used to assess withdrawal symptoms. It is an 8 item scale and total scores range from 0 to 24. A higher score indicates more severe nicotine withdrawal.

Time frame: 26 weeks

Tiffany Questionnaire for Smoking Urges (T-QSU) Score

This will be used to assess symptoms of craving/urges for tobacco. It is a 32 item scale and total scores range from 0 to 224. A higher score indicates more severe smoking craving/urges.

Time frame: 26 weeks

Point Prevalence Abstinence at the End of 4 Weeks

Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.

Data from ClinicalTrials.gov

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