R-015: Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES)
| Field | Value |
|---|---|
| Research ID | R-015 |
| Authors | Anthenelli RM, Benowitz NL, West R, et al. |
| Year | 2016 |
| Journal / publisher | The Lancet |
| DOI | 10.1016/S0140-6736(16)30272-0 |
| PMID | Not reported |
| ISBN | Not reported |
| Research type | Randomized Controlled Trial (double-blind, triple-dummy, 16 countries) |
| Evidence strength | Strong |
| Population | 8,144 adult smokers: 4,116 with and 4,028 without psychiatric disorders |
| Intervention | Varenicline 1 mg twice daily; bupropion 150 mg twice daily; nicotine patch 21 mg/day |
| Comparator | Placebo |
| Last verified | 2026-10-04 |
Main question
Do cessation medications increase the risk of moderate-to-severe neuropsychiatric adverse events?
Main findings
No significant increase in moderate-to-severe neuropsychiatric adverse events with varenicline or bupropion versus placebo or patch; varenicline was more effective than placebo, bupropion and patch for continuous abstinence.
Limitations
Excluded some unstable psychiatric conditions; sponsored trial designed with FDA/EMA.
Why this record matters
The key modern safety trial that underpinned removal of the varenicline black-box warning.
Related topics
Varenicline; Bupropion; Quit Smoking Medications