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

This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01456936
First received: October 14, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Smoking Cessation
 Drug: Placebo
Drug: varenicline tartrate
Drug: bupropion hydrochloride
Drug: Nicotine Replacement Therapy Patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Double Blind, Active And Placebo Controlled Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1MG BID And Bupropion Hydrochloride 150MG BID For Smoking Cessation In Subjects With And Without A History of Psychiatric Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • At least 1 severe AE of anxiety depression, feeling abnormal, or hostility and/or moderate or severe AE of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation/behavior/completed [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • 4 week Carbon Monoxide (CO) confirmed continuous abstinence for Weeks 9 through 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carbon Monoxide (CO) confirmed continuous abstinence from Week 9 through Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • The presence or absence of each component comprising the primary neuropsychiatric adverse event endpoint. [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Individual item responses and overall scores for Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Individual item responses and overall scores for Columbia Suicide Severity Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Individual item responses and overall scores for Global Clinical Impression of Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: November 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
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.
 Drug: Placebo
Triple dummy placebo for each treatment arm
Active Comparator: varenicline Drug: varenicline tartrate
Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks
Other Name: Chantix; Champix
Active Comparator: bupropion Drug: bupropion hydrochloride
Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).
Active Comparator: Nicotine Replacement Therapy Patch Drug: Nicotine Replacement Therapy Patch
Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
Other Name: NRT

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456936

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 119 Study Locations
Sponsors and Collaborators
Pfizer
GlaxoSmithKline
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01456936     History of Changes
Other Study ID Numbers: A3051123
Study First Received: October 14, 2011
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation
psychiatric disease

Additional relevant MeSH terms:
Smoking
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013