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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Smoking Cessation

Treatments

Drug: bupropion hydrochloride

Drug: varenicline tartrate

Drug: Placebo

Drug: Nicotine Replacement Therapy Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT01456936

EAGLES (Other Identifier)

2010-022914-15 (EudraCT Number)

A3051123

Details and patient eligibility

About

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).

Enrollment

8,144 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

8,144 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Subjects randomized to placebo will receive placebo treatments for all three study drugs. Blinded placebo will be provided for varenicline, bupropion hydrochloride and transdermal nicotine patch (NRT). In addition, subjects will receive blinded placebo treatments for the study drugs they are not randomized to receive.

Treatment:

Drug: Placebo

varenicline

Active Comparator group

Treatment:

Drug: varenicline tartrate

bupropion

Active Comparator group

Treatment:

Drug: bupropion hydrochloride

Nicotine Replacement Therapy Patch

Active Comparator group