ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy male and female subjects between the ages of 12 and 19, inclusive.
- Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
- Subjects must have at least one prior failed attempt to quit smoking.
- Subjects with history, current diagnosis, or treatment of major depression disorder,
anxiety disorders, panic disorder, hostility or aggression disorder,
perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality
disorder, eating disorder or severe emotional problems (in the past year).
- Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months
due to suicidal ideation or suicidal behavior; subjects considered to have serious
suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation
or behavior identified at the screening or baseline visit.
- Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3
months prior to screening.
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Descriptive Information | |||||
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Brief Title ICMJE | Smoking Cessation Study In Healthy Adolescent Smokers | ||||
Official Title ICMJE | A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers | ||||
Brief Summary | The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
Condition ICMJE | Smoking Cessation | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Gray KM, Rubinstein ML, Prochaska JJ, DuBrava SJ, Holstein AR, Samuels L, McRae TD. High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial. Lancet Child Adolesc Health. 2020 Nov;4(11):837-845. doi: 10.1016/S2352-4642(20)30243-1. Epub 2020 Sep 25. | ||||
* 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 | Completed | ||||
Actual Enrollment ICMJE | 312 | ||||
Original Estimated Enrollment ICMJE | 300 | ||||
Actual Study Completion Date ICMJE | January 2018 | ||||
Actual Primary Completion Date | January 2018 (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 | 12 Years to 19 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, Georgia, Korea, Republic of, Russian Federation, Taiwan, United States | ||||
Removed Location Countries | Israel | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01312909 | ||||
Other Study ID Numbers ICMJE | A3051073 CHANTIX ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | July 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |