Smoking Cessation Study In Healthy Adolescent Smokers
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01312909
First received: March 9, 2011
Last updated: February 9, 2015
Last verified: February 2015
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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: | January 2018 |
| Estimated Primary Completion Date: | January 2018 (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
Show 73 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312909
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 73 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: | February 9, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
smoking cessation in adolescents |
Additional relevant MeSH terms:
|
Varenicline Cholinergic Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Nicotinic Agonists Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015