Smoking Cessation Study In Healthy Adolescent Smokers

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Drug: Varenicline 1mg BID; Drug: Varenicline 0.5mg BID; Drug: Placebo	Phase 4

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	313 participants
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
Actual Study Start Date :	April 26, 2011
Actual Primary Completion Date :	January 18, 2018
Actual Study Completion Date :	January 18, 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The 4-week continuous quit rate (CQR) [ Time Frame: Weeks 9-12 ]

Secondary Outcome Measures :

1. 7-day point-prevalence of smoking abstinence at Weeks 12 [ Time Frame: Week 12 ]
2. 7-day point prevalence of smoking abstinence at Week 24 [ Time Frame: Week 24 ]
3. 7-day point prevalence of smoking abstinence at Week 52 [ Time Frame: Week 52 ]
4. Reduction in number of cigarettes smoked at Weeks 12 [ Time Frame: Weeks 12 ]
5. Reduction in number of cigarettes smoked at Week 24 [ Time Frame: Week 24 ]
6. Reduction in number of cigarettes smoked at Week 52 [ Time Frame: Week 52 ]
7. Continuous abstinence rate from Week 9 through Week 24 [ Time Frame: Weeks 9-24 ]
8. Continuous abstinence rate from Week 9 through Week 52 [ Time Frame: Weeks 9-52 ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 80 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01312909 History of Changes
Other Study ID Numbers:	A3051073; CHANTIX ( Other Identifier: Alias Study Number )
First Posted:	March 11, 2011
Last Update Posted:	March 12, 2018
Last Verified:	March 2018

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