Smoking Cessation Study In Healthy Adolescent Smokers - Full Text View

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:

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

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:	May 2014
Estimated Primary Completion Date:	August 2013 (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

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

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:	May 28, 2013
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 June 18, 2013