Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).

Key facts

Study ID

NCT01456936

Run by

Pfizer

People needed

8144

Starts

2011-11-01

Expected to finish

2015-01-01

Last updated by the study team

2016-06-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
• Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at screening.
• For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

You may not qualify if…

• Subjects with a past or current diagnosis of one of the following disorders:
• a. Psychotic Disorders:
• Schizophreniform
• Delusional Disorder
• Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)

Where it is running

• NoesisPharma Research — Phoenix, Arizona, United States
• Pharmacology Research Institute — Encino, California, United States
• Synergy Clinical Research of Escondido — Escondido, California, United States
• Sun Valley Research Center — Imperial, California, United States
• Omega Clinical Trials — La Habra, California, United States
• Pacific Treatment and Research Center UC San Diego Health System — La Jolla, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• David Geffen School of Medicine at University of California, Los Angeles — Los Angeles, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• North County Clinical Research — Oceanside, California, United States
• Neuropsychiatric Research Center of Orange County — Orange, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program — Aurora, Colorado, United States
• Western Affiliated Research Institute — Denver, Colorado, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
• Broward Research Group — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions,Inc. — Jacksonville, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Ocala Psychiatric Associates — Ocala, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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