Deep rTMS and Varenicline for Smoking Cessation

NCT04083144

Last updated date
Study Location
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Contact
4165358501

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tobacco Use Disorder, Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Tobacco Use Disorder, Smoking CessationDeep rTMS and Varenicline for Smoking Cessation
NCT04083144
  1. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Deep rTMS and Varenicline for Smoking Cessation
Official Title  ICMJE Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Use Disorder
  • Smoking Cessation
Intervention  ICMJE
  • Device: Deep Repetitive Transcranial Magnetic Stimulation (Active)
    Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
  • 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
Study Arms  ICMJE
  • Active Comparator: Deep rTMS active + Varenicline
    Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
    Interventions:
    • Device: Deep Repetitive Transcranial Magnetic Stimulation (Active)
    • Drug: Varenicline
  • Sham Comparator: Deep rTMS sham + Varenicline
    Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
    Interventions:
    • Device: Deep Repetitive Transcranial Magnetic Stimulation (Sham)
    • Drug: Varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bernard Le Foll, MD,PhD,MCFP4165358501 ext 33111[email protected]
Contact: Christine Ibrahim, HBSc4165358501 ext 34542[email protected]
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04083144
Other Study ID Numbers  ICMJE 051/2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Bernard Le Foll, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE
  • Pfizer
  • Brainsway
Investigators  ICMJE
Principal Investigator:Bernard Le Foll, MD,PhD,MCFPCentre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP