NCT01456936: EAGLES

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

Completed Phase 4 Results posted Last updated 9 May 2016

What this trial tests

Phase 4 trial testing Placebo in Smoking Cessation in 8,144 participants. Completed in 1 January 2015.

Timeline

1 November 2011

Primary endpoint
1 January 2015

1 January 2015

Quick facts

Lead sponsor	Pfizer
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	8,144
Start date	1 November 2011
Primary completion	1 January 2015
Estimated completion	1 January 2015
Sites	156 locations across United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Denmark

Drugs / interventions tested

• Placebo
• varenicline tartrate — full drug profile →
• bupropion hydrochloride — full drug profile →
• Nicotine Replacement Therapy Patch

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 75, any sex, with Smoking Cessation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
  Time frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
  The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior,
• Estimated NPS AE Rate (%), by Cohort
  Time frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
  The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior,

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial.
   Anthenelli RM, Benowitz NL, West R, St Aubin L, et al · · 2016 · cited 629× · PMID 27116918 · DOI 10.1016/s0140-6736(16)30272-0
2. Nicotine receptor partial agonists for smoking cessation.
   Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, et al · · 2016 · cited 228× · PMID 27158893 · DOI 10.1002/14651858.cd006103.pub7
3. Smoking cessation for improving mental health.
   Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, et al · · 2021 · cited 160× · PMID 33687070 · DOI 10.1002/14651858.cd013522.pub2
4. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial.
   Benowitz NL, Pipe A, West R, Hays JT, et al · · 2018 · cited 85× · PMID 29630702 · DOI 10.1001/jamainternmed.2018.0397
5. Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES.
   West R, Evins AE, Benowitz NL, Russ C, et al · · 2018 · cited 56× · PMID 29508470 · DOI 10.1111/add.14208
6. Neuropsychiatric Safety and Efficacy of Varenicline, Bupropion, and Nicotine Patch in Smokers With Psychotic, Anxiety, and Mood Disorders in the EAGLES Trial.
   Evins AE, Benowitz NL, West R, Russ C, et al · · 2019 · cited 55× · PMID 30811371 · DOI 10.1097/jcp.0000000000001015
7. Assessment of Racial Differences in Pharmacotherapy Efficacy for Smoking Cessation: Secondary Analysis of the EAGLES Randomized Clinical Trial.
   Nollen NL, Ahluwalia JS, Sanderson Cox L, Okuyemi K, et al · · 2021 · cited 31× · PMID 33464316 · DOI 10.1001/jamanetworkopen.2020.32053
8. Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES.
   Evins AE, West R, Benowitz NL, Russ C, et al · · 2021 · cited 21× · PMID 33138708 · DOI 10.1176/appi.ps.202000032