Clinical trial NCT01312909: Smoking Cessation Study In Healthy Adolescent Smokers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking cessation in adolescents
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 312
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
timeFrame: Week 9 through Week 12
Secondary outcomes:
measure: Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
timeFrame: Weeks 12, 24 and 52
measure: Daily Number of Cigarettes Smoked at Baseline
timeFrame: Baseline
measure: Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
timeFrame: Week 9 through Week 24; Week 9 through Week 52
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: First dose up to last dose (up-to Week 12) plus 30 days
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: First dose up to last dose (up-to Week 12) plus 30 days
measure: Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)
timeFrame: First dose up to last dose (up-to Week 12) plus 30 days
measure: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Week 12
measure: Change From Baseline in Blood Pressure (BP) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Pulse Rate at Week 12
timeFrame: Baseline, Week 12
Locations:
city: Ozark
country: United States
facility: IICR, Inc. (DBA: International Institute of Clinical Research)
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: La Habra
country: United States
facility: Omega Clinical Trials, LLC
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University, SATU
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: Hope Clinical Research
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: L & L Research Choices
state: Florida
city: North Bay Village
country: United States
facility: Bravo Health Care Center
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Clinical Development Inc.
state: Florida
city: Meridian
country: United States
facility: Barney Greenspan, Ph.D
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Evansville
country: United States
facility: Midwest Behavioral Health
state: Indiana
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Newburgh
country: United States
facility: Pedia Research, LLC
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc
state: Louisiana
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: O'Fallon
country: United States
facility: Psychiatric Care & Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Mid-America Clinical Research, LLC
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, L.P.
state: Texas
city: DeSoto
country: United States
facility: Insite Clinical Research, LLC
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Thomas Murray DeMoor, MD
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Richland
country: United States
facility: Zain Research, LLC
state: Washington
city: Middleton
country: United States
facility: Dean Foundation for Health Research and Education
state: Wisconsin
city: Ajax
country: Canada
facility: Kids Clinic
state: Ontario
city: New Market
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Newmarket
country: Canada
facility: Private Practice of Robert J. Camargo
state: Ontario
city: Rustavi
country: Georgia
facility: LTD" Rustavi Psychological Health Center"
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Village Novoe Devyatkino
country: Russian Federation
facility: Leningrad Regional Dispensary of Narcology
state: Leningrad Region
city: Moscow
country: Russian Federation
facility: GBUZ City childrens out-patient clinic # 10 of Moscow
city: Murmansk
country: Russian Federation
facility: GOBUZ Murmansk Regional Narcology Dispensary
city: Novosibirsk
country: Russian Federation
facility: LLC City Neurological Center "Sibneuromed"
city: Saint-Petersburg
country: Russian Federation
facility: LLC " Alliance Biomedical - Russian Group"
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Technologies
city: Saint-Petersburg
country: Russian Federation
facility: FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Technologies
city: Saint-Petersburg
country: Russian Federation
facility: First St. Petersburg State Medical University
city: Samara
country: Russian Federation
facility: GBUZ Samara Regional Childrens Health camp Yunost
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung city
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Gray 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.