Smoking Cessation Study In Healthy Adolescent Smokers

NCT01312909 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: A3051073CHANTIX
• Study Type: interventional
• Target: 312
• Locations: 6 countries
• Sites: 80

Brief Summary

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

Conditions

Smoking Cessation

Keywords

smoking cessation in adolescents

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Weeks 12, 24 and 52

• Daily Number of Cigarettes Smoked at Baseline

  Baseline

• Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52

  Baseline, Weeks 12, 24, and 52

• Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52

  Week 9 through Week 24; Week 9 through Week 52

Other Outcomes (9)

• Number of Participants With Treatment-Emergent Adverse Events (AEs)

  First dose up to last dose (up-to Week 12) plus 30 days

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  First dose up to last dose (up-to Week 12) plus 30 days

• Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)

  First dose up to last dose (up-to Week 12) plus 30 days

Study Arms (3)

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

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

Drug: Varenicline 0.5mg BID

Placebo

PLACEBO COMPARATOR

Oral placebo for twelve weeks,follow-up through Week 52

Drug: Placebo

Interventions

Varenicline 1mg BID DRUG

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 1mg BID

Varenicline 0.5mg BID DRUG

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

Varenicline 0.5mg BID

Placebo DRUG

Oral placebo for twelve weeks,follow-up through Week 52

Placebo

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (80)

IICR, Inc. (DBA: International Institute of Clinical Research)

Ozark, Alabama, 36360, United States

Location

Dedicated Clinical Research

Goodyear, Arizona, 85395, United States

Location

Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

Little Rock, Arkansas, 72211, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Omega Clinical Trials, LLC

La Habra, California, 90631, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94607, United States

Location

North County Clinical Research

Oceanside, California, 92054, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Western Affiliated Research Institute

Denver, Colorado, 80209, United States

Location

Connecticut Mental Health Center

New Haven, Connecticut, 06511, United States

Location

Yale University, SATU

New Haven, Connecticut, 06511, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Hope Clinical Research

Kissimmee, Florida, 34741, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Pharmax Research Clinic, Inc.

Miami, Florida, 33126, United States

Location

L & L Research Choices

Miami, Florida, 33144, United States

Location

Bravo Health Care Center

North Bay Village, Florida, 33141, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Comprehensive Clinical Development Inc.

St. Petersburg, Florida, 33716, United States

Location

Barney Greenspan, Ph.D

Meridian, Idaho, 83646, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Midwest Behavioral Health

Evansville, Indiana, 47715, United States

Location

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, 46260, United States

Location

Pedia Research, LLC

Newburgh, Indiana, 47630, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Pedia Research, LLC

Owensboro, Kentucky, 42301, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

Louisiana Research Associates, Inc

New Orleans, Louisiana, 70114, United States

Location

Adams Clinical Trials, LLC

Watertown, Massachusetts, 02472, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, 64114, United States

Location

Psychiatric Care & Research Center

O'Fallon, Missouri, 63368, United States

Location

Mid-America Clinical Research, LLC

St Louis, Missouri, 63109, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

Wake Internal Medicine Consultants, Inc

Raleigh, North Carolina, 27612, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

Neurology & Neuroscience Center of Ohio

Toledo, Ohio, 43623, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, 75231, United States

Location

Insite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Thomas Murray DeMoor, MD

San Antonio, Texas, 78230, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23235, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Zain Research, LLC

Richland, Washington, 99352, United States

Location

Dean Foundation for Health Research and Education

Middleton, Wisconsin, 53562, United States

Location

Kids Clinic

Ajax, Ontario, L1Z 0M1, Canada

Location

Private Practice of Robert J. Camargo

Newmarket, Ontario, L3Y 5G8, Canada

Location

SKDS Research Inc.

Newmarket, Ontario, L3Y 5G8, Canada

Location

LTD" Rustavi Psychological Health Center"

Rustavi, 3700, Georgia

Location

Leningrad Regional Dispensary of Narcology

Village Novoe Devyatkino, Leningradskaya Oblast', 188661, Russia

Location

GBUZ City childrens out-patient clinic # 10 of Moscow

Moscow, 119331, Russia

Location

GOBUZ Murmansk Regional Narcology Dispensary

Murmansk, 183036, Russia

Location

LLC City Neurological Center "Sibneuromed"

Novosibirsk, 630091, Russia

Location

LLC " Alliance Biomedical - Russian Group"

Saint Petersburg, 190068, Russia

Location

LLC Medical Technologies

Saint Petersburg, 191025, Russia

Location

FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH

Saint Petersburg, 192019, Russia

Location

LLC Medical Technologies

Saint Petersburg, 192148, Russia

Location

First St. Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

GBUZ Samara Regional Childrens Health camp Yunost

Samara, 443031, Russia

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

The Catholic University of Korea St. Vincent Hospital

Suwon, Gyeonggi-do, 442 723, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 34062053 DERIVED

• 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.

  PMID: 32979939 DERIVED

Related Links

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

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline; BID protein, human

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 11, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 9, 2018
• Results First Posted: June 28, 2018

Record last verified: 2018-07

Locations

US (56); CA (3); GE (1); TW (6); KR (4); RU (10)