Smoking Cessation Study In Healthy Adolescent Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01312909
First received: March 9, 2011
Last updated: June 30, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-day point-prevalence of smoking abstinence at Weeks 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 7-day point prevalence of smoking abstinence at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 7-day point prevalence of smoking abstinence at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Reduction in number of cigarettes smoked at Weeks 12 [ Time Frame: Weeks 12 ] [ Designated as safety issue: No ]
  • Reduction in number of cigarettes smoked at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Reduction in number of cigarettes smoked at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Continuous abstinence rate from Week 9 through Week 24 [ Time Frame: Weeks 9-24 ] [ Designated as safety issue: No ]
  • Continuous abstinence rate from Week 9 through Week 52 [ Time Frame: Weeks 9-52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline 1mg BID 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 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 Drug: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312909

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 68 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01312909     History of Changes
Other Study ID Numbers: A3051073
Study First Received: March 9, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation in adolescents

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

ClinicalTrials.gov processed this record on July 23, 2014