Smoking Cessation Study In Healthy Adolescent Smokers

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NCT01312909

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Study Location
IICR, Inc. (DBA: International Institute of Clinical Research)
Ozark, Alabama, 36360, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-19 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

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


- 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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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
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
  • Drug: Varenicline 1mg BID
    Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
  • Drug: Varenicline 0.5mg BID
    Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
  • Drug: Placebo
    Oral placebo for twelve weeks,follow-up through Week 52
Study Arms  ICMJE
  • Experimental: Varenicline 1mg BID
    Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
    Intervention: Drug: Varenicline 1mg BID
  • Experimental: Varenicline 0.5mg BID
    Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
    Intervention: Drug: Varenicline 0.5mg BID
  • Placebo Comparator: Placebo
    Oral placebo for twelve weeks,follow-up through Week 52
    Intervention: Drug: Placebo
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
 (submitted: May 29, 2018)		312
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2011)		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:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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