Smoking CessationPhase 4NCT01312909
Smoking Cessation Study In Healthy Adolescent Smokers
A Phase 4 study testing Varenicline 1mg BID and Varenicline 0.5mg BID in people with Smoking Cessation, run by Pfizer at 80 sites in 6 countries.
Trial summary
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline 1mg BID and Varenicline 0.5mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 80 sitesin 6 countries
- Study dates
- Apr 2011to Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
80 sites in 6 countries.
80 sites in 6 countries
United States56 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Medical University of South Carolina
Charleston, South Carolina, 29425
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Avail Clinical Research, LLC
DeLand, Florida, 32720
Western Affiliated Research Institute
Denver, Colorado, 80209
Insite Clinical Research, LLC
DeSoto, Texas, 75115
Midwest Behavioral Health
Evansville, Indiana, 47715
Dedicated Clinical Research
Goodyear, Arizona, 85395
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Hope Clinical Research
Kissimmee, Florida, 34741
Omega Clinical Trials, LLC
La Habra, California, 90631
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72211
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Barney Greenspan, Ph.D
Meridian, Idaho, 83646
Solaris Clinical Research
Meridian, Idaho, 83646
Pharmax Research Clinic, Inc.
Miami, Florida, 33126
L & L Research Choices
Miami, Florida, 33144
Dean Foundation for Health Research and Education
Middleton, Wisconsin, 53562
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Synergy Clinical Research Center
National City, California, 91950
Connecticut Mental Health Center
New Haven, Connecticut, 06511
Yale University, SATU
New Haven, Connecticut, 06511
Yale University
New Haven, Connecticut, 06520
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114
Pedia Research, LLC
Newburgh, Indiana, 47630
Bravo Health Care Center
North Bay Village, Florida, 33141
Psychiatric Care & Research Center
O'Fallon, Missouri, 63368
Pacific Research Partners, LLC
Oakland, California, 94607
North County Clinical Research
Oceanside, California, 92054
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Medical Research Group of Central Florida
Orange City, Florida, 32763
Pedia Research, LLC
Owensboro, Kentucky, 42301
Research Integrity, LLC
Owensboro, Kentucky, 42303
IICR, Inc. (DBA: International Institute of Clinical Research)
Ozark, Alabama, 36360
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, 27612
Wake Research Associates
Raleigh, North Carolina, 27612
Zain Research, LLC
Richland, Washington, 99352
Clinical Research Partners, LLC
Richmond, Virginia, 23235
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Thomas Murray DeMoor, MD
San Antonio, Texas, 78230
Mid-America Clinical Research, LLC
St Louis, Missouri, 63109
Comprehensive Clinical Development Inc.
St. Petersburg, Florida, 33716
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472
Heartland Research Associates, LLC
Wichita, Kansas, 67207
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Russia10 sites
GBUZ City childrens out-patient clinic # 10 of Moscow
Moscow, 119331
GOBUZ Murmansk Regional Narcology Dispensary
Murmansk, 183036
LLC City Neurological Center "Sibneuromed"
Novosibirsk, 630091
LLC " Alliance Biomedical - Russian Group"
Saint Petersburg, 190068
LLC Medical Technologies
Saint Petersburg, 191025
FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
Saint Petersburg, 192019
LLC Medical Technologies
Saint Petersburg, 192148
First St. Petersburg State Medical University
Saint Petersburg, 197022
GBUZ Samara Regional Childrens Health camp Yunost
Samara, 443031
Leningrad Regional Dispensary of Narcology
Village Novoe Devyatkino, Leningradskaya Oblast', 188661
Taiwan6 sites
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Far Eastern Memorial Hospital
New Taipei City, 220
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 704
Taipei Veterans General Hospital
Taipei, 11217
South Korea4 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Keimyung University Dongsan Hospital
Daegu, 41931
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, 442 723
Canada3 sites
Kids Clinic
Ajax, Ontario, L1Z 0M1
Private Practice of Robert J. Camargo
Newmarket, Ontario, L3Y 5G8
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8
About this study
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
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline 1mg BID, Varenicline 0.5mg BID, Placebo
- Keywords
- smoking cessation in adolescents
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline 1mg BIDDrug
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
Varenicline 0.5mg BIDDrug
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
PlaceboDrug
Oral placebo for twelve weeks,follow-up through Week 52
| Study group | Role | What they receive |
|---|---|---|
| Varenicline 1mg BID | Experimental | 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 Receives: Drug: Varenicline 1mg BID |
| Varenicline 0.5mg BID | Experimental | 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 Receives: Drug: Varenicline 0.5mg BID |
| Placebo | Placebo comparator | Oral placebo for twelve weeks,follow-up through Week 52 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
Measured: Week 9 through Week 12
Secondary outcomes (4)
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.
Measured: Weeks 12, 24 and 52
Daily Number of Cigarettes Smoked at Baseline
The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Measured: Baseline
Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Measured: Baseline, Weeks 12, 24, and 52
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.
Measured: Week 9 through Week 24; Week 9 through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312909
- Sponsor's protocol ID
- A3051073
- Other IDs
- CHANTIX
- Status last verified
- Jul 2018
- First submitted
- 9 Mar 2011
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17.
PubMed 34062053Gray KM, Rubinstein ML, Prochaska JJ, DuBrava SJ, Holstein AR, Samuels L, McRae TD. High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial. Lancet Child Adolesc Health. 2020 Nov;4(11):837-845. doi: 10.1016/S2352-4642(20)30243-1. Epub 2020 Sep 25.
PubMed 32979939
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01312909
- Acronym / sponsor ID
- A3051073
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation in adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2011 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 28 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Varenicline 1mg BID | Experimental | Drug: Varenicline 1mg BIDOral 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 |
| Varenicline 0.5mg BID | Experimental | Drug: Varenicline 0.5mg BIDOral 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 | Placebo comparator | Drug: PlaceboOral placebo for twelve weeks,follow-up through Week 52 |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varenicline 1mg BIDOral 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 |
| Varenicline 0.5mg BIDOral 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 |
| PlaceboOral placebo for twelve weeks,follow-up through Week 52 | Drug | Placebo |
Primary outcome
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Time frame: Week 9 through Week 12
The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
4 secondary outcomes
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Time frame: Weeks 12, 24 and 52
Daily Number of Cigarettes Smoked at Baseline
Time frame: Baseline
Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
Time frame: Week 9 through Week 24; Week 9 through Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34062053Fediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17.
- Derived from this study: PubMed 32979939Gray KM, Rubinstein ML, Prochaska JJ, DuBrava SJ, Holstein AR, Samuels L, McRae TD. High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial. Lancet Child Adolesc Health. 2020 Nov;4(11):837-845. doi: 10.1016/S2352-4642(20)30243-1. Epub 2020 Sep 25.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
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Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
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Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
80 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline 1mg BID and Varenicline 0.5mg BID in people with Smoking Cessation, run by Pfizer at 80 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Russia, Taiwan, South Korea, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12 (time frame: Week 9 through Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312909, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.