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FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
4165358501
Adult Trials: 18+ Years
- 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.
- 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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- Toronto, Ontario
| 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:
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 |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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 | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Bernard Le Foll, Centre for Addiction and Mental Health | ||||||||
| Study Sponsor ICMJE | Centre for Addiction and Mental Health | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| 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 | |||||||||