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Smoking Cessation Study In Healthy Adolescent Smokers

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
IICR, Inc. (DBA: International Institute of Clinical Research)
Ozark, Alabama, 36360 United States
Contact
1-800-718-1021
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.

NCT01312909
Pfizer
Completed
Smoking Cessation Study In Healthy Adolescent Smokers

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Smoking Cessation Study In Healthy Adolescent Smokers
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
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking Cessation
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
312
January 24, 2018
January 24, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 19 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Georgia,   Korea, Republic of,   Russian Federation,   Taiwan,   United States
Israel
 
NCT01312909
A3051073
CHANTIX ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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