Smoking Cessation Study In Healthy Adolescent Smokers

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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

Key facts

Study ID

NCT01312909

Run by

Pfizer

People needed

312

Starts

2011-04-01

Expected to finish

2018-01-01

Last updated by the study team

2018-08-09

Who can join

Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Dedicated Clinical Research — Goodyear, Arizona, United States
• Arkansas Psychiatric Clinic Clinical Research Trials, P.A. — Little Rock, Arkansas, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Omega Clinical Trials, LLC — La Habra, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• North County Clinical Research — Oceanside, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• MCB Clinical Research Centers — Colorado Springs, Colorado, United States
• Western Affiliated Research Institute — Denver, Colorado, United States
• Connecticut Mental Health Center — New Haven, Connecticut, United States
• Yale University, SATU — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Hope Clinical Research — Kissimmee, Florida, United States
• Florida Clinical Research Center, LLC — Maitland, Florida, United States
• Pharmax Research Clinic, Inc. — Miami, Florida, United States
• L & L Research Choices — Miami, Florida, United States
• Bravo Health Care Center — North Bay Village, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Comprehensive Clinical Development Inc. — St. Petersburg, Florida, United States
• Barney Greenspan, Ph.D — Meridian, Idaho, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Midwest Behavioral Health — Evansville, Indiana, United States
• IICR, Inc. (DBA: International Institute of Clinical Research) — Ozark, Alabama, United States

Full record on ClinicalTrials.gov

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