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Smoking Cessation Study In Healthy Adolescent Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312909
First Posted: March 11, 2011
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Condition Intervention Phase
Smoking Cessation Drug: Varenicline 1mg BID Drug: Varenicline 0.5mg BID Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The 4-week continuous quit rate (CQR) [ Time Frame: Weeks 9-12 ]

Secondary Outcome Measures:
  • 7-day point-prevalence of smoking abstinence at Weeks 12 [ Time Frame: Week 12 ]
  • 7-day point prevalence of smoking abstinence at Week 24 [ Time Frame: Week 24 ]
  • 7-day point prevalence of smoking abstinence at Week 52 [ Time Frame: Week 52 ]
  • Reduction in number of cigarettes smoked at Weeks 12 [ Time Frame: Weeks 12 ]
  • Reduction in number of cigarettes smoked at Week 24 [ Time Frame: Week 24 ]
  • Reduction in number of cigarettes smoked at Week 52 [ Time Frame: Week 52 ]
  • Continuous abstinence rate from Week 9 through Week 24 [ Time Frame: Weeks 9-24 ]
  • Continuous abstinence rate from Week 9 through Week 52 [ Time Frame: Weeks 9-52 ]

Enrollment: 312
Actual Study Start Date: April 26, 2011
Estimated Study Completion Date: January 24, 2018
Estimated Primary Completion Date: January 24, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
Placebo Comparator: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Drug: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312909


  Show 83 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01312909     History of Changes
Other Study ID Numbers: A3051073
CHANTIX ( Other Identifier: Alias Study Number )
First Submitted: March 9, 2011
First Posted: March 11, 2011
Last Update Posted: October 23, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
smoking cessation in adolescents

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs