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Deep rTMS and Varenicline for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083144
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborators:
Pfizer
Brainsway
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Smoking Cessation Device: Deep Repetitive Transcranial Magnetic Stimulation (Active) Device: Deep Repetitive Transcranial Magnetic Stimulation (Sham) Drug: Varenicline Not Applicable

Detailed Description:

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 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Deep rTMS active + Varenicline
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Device: Deep Repetitive Transcranial Magnetic Stimulation (Active)
Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula

Drug: 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).
Other Name: Champix

Sham Comparator: Deep rTMS sham + Varenicline
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
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.

Drug: 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).
Other Name: Champix




Primary Outcome Measures :
  1. Point prevalence abstinence at the end of 12 weeks [ Time Frame: 12 weeks ]
    Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.


Secondary Outcome Measures :
  1. Fagerstrom Test For Nicotine Dependence (FTND) score [ Time Frame: 26 weeks ]
    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.

  2. Expired CO Measurements [ Time Frame: 26 weeks ]
    This will be used as a biological confirmation of recent smoking.

  3. Cigarettes per day (TLFB) [ Time Frame: 26 weeks ]
    Self-reported measure of cigarette consumption.

  4. Minnesota Nicotine Withdrawal Scale (MNWS) score [ Time Frame: 26 weeks ]
    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.

  5. Tiffany Questionnaire for Smoking Urges (T-QSU) score [ Time Frame: 26 weeks ]
    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.

  6. Point prevalence abstinence at the end of 4 weeks [ Time Frame: 4 weeks ]
    Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.

  7. Continuous abstinence at 6 months [ Time Frame: 26 weeks ]
    Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083144


Contacts
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Contact: Bernard Le Foll, MD,PhD,MCFP 4165358501 ext 33111 bernard.lefoll@camh.ca
Contact: Christine Ibrahim, HBSc 4165358501 ext 34542 christine.ibrahim@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: Bernard Le Foll, MD,PhD,MCFP    416-535-8501 ext 33111    bernard.lefoll@camh.ca   
Principal Investigator: Bernard Le Foll, MD,PhD,MCFP         
Sub-Investigator: Daniel Blumberger, MD         
Sub-Investigator: Jeff Daskalakis, MD,PhD         
Sub-Investigator: Saima Malik, PhD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Pfizer
Brainsway
Investigators
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Principal Investigator: Bernard Le Foll, MD,PhD,MCFP Centre for Addiction and Mental Health
Additional Information:
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Responsible Party: Bernard Le Foll, Head,Translational Addiction Research Laboratory, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04083144    
Other Study ID Numbers: 051/2017
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bernard Le Foll, Centre for Addiction and Mental Health:
smoking cessation
varenicline
deep rTMS
insula
addiction
tobacco use disorder
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs