Deep rTMS and Varenicline for Smoking Cessation
1 other identifier
interventional
50
1 country
1
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 hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2019
CompletedFirst Submitted
Initial submission to the registry
September 6, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedResults Posted
Study results publicly available
November 4, 2024
CompletedNovember 4, 2024
August 1, 2024
3.1 years
September 6, 2019
February 16, 2024
August 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (9)
Fagerstrom Test For Nicotine Dependence (FTND) Score
26 weeks
Expired CO Measurements
26 weeks
Cigarettes Per Day (TLFB)
26 weeks
Minnesota Nicotine Withdrawal Scale (MNWS) Score
26 weeks
Tiffany Questionnaire for Smoking Urges (T-QSU) Score
26 weeks
- +4 more secondary outcomes
Study Arms (2)
Deep rTMS active + Varenicline
ACTIVE COMPARATORParticipants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep rTMS sham + Varenicline
SHAM COMPARATORParticipants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Interventions
Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
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.
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre for Addiction and Mental Healthlead
- Pfizercollaborator
- Brainswaycollaborator
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Related Publications (1)
Ibrahim C, Malik S, Barr MS, Blumberger DM, Daskalakis ZJ, Le Foll B. Insula deep rTMS and varenicline for smoking cessation: A randomized control trial study protocol. Front Pharmacol. 2022 Sep 8;13:969500. doi: 10.3389/fphar.2022.969500. eCollection 2022.
PMID: 36160428DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Bernard Le Foll
- Organization
- Centre for Addiction and Mental Health
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Le Foll, MD,PhD,MCFP
Centre for Addiction and Mental Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head,Translational Addiction Research Laboratory
Study Record Dates
First Submitted
September 6, 2019
First Posted
September 10, 2019
Study Start
August 22, 2019
Primary Completion
September 13, 2022
Study Completion
December 30, 2022
Last Updated
November 4, 2024
Results First Posted
November 4, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share