Smoking Cessation Study In Healthy Adolescent Smokers

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01312909
First received: March 9, 2011
Last updated: April 16, 2014
Last verified: April 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
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: April 16, 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 April 17, 2014