Deep rTMS and Varenicline for Smoking Cessation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Tobacco Use Disorder Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Deep rTMS active + Varenicline

Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.

Group Type ACTIVE_COMPARATOR

Deep Repetitive Transcranial Magnetic Stimulation (Active)

Intervention Type DEVICE

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

Varenicline

Intervention Type DRUG

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).

Deep rTMS sham + Varenicline

Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.

Group Type SHAM_COMPARATOR

Deep Repetitive Transcranial Magnetic Stimulation (Sham)

Intervention Type 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.

Varenicline

Intervention Type DRUG

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).

Interventions

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Deep Repetitive Transcranial Magnetic Stimulation (Active)

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

Intervention Type DEVICE

Deep Repetitive Transcranial Magnetic Stimulation (Sham)

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.

Intervention Type DEVICE

Varenicline

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).

Intervention Type DRUG

Other Intervention Names

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Champix

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No